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N°9 - April 2004<br />

SpineNews<br />

News from the world of Spinal surgery and Biomechanics<br />

www.argos-europe.com<br />

6The <strong>8th</strong> <strong>International</strong><br />

<strong>Argos</strong> <strong>Symposium</strong><br />

Adjacent level degeneration after fusion<br />

20A classification<br />

of biomaterials<br />

Yves Debacker<br />

Consultant in Biomaterials<br />

substitutes in 2004<br />

Claude Schwarz<br />

23Bone<br />

Founding president<br />

of Pro Biomateria Group (GECO)<br />

as a bone supply<br />

Pr Evelyne Lopez<br />

32Nacre<br />

Muséum d’histoire naturelle<br />

Paris FRANCE<br />

N. Francaviglia<br />

37Biospacer<br />

Sant’Elia Hospital<br />

Caltanissetta ITALY<br />

with Charles D.<br />

Ray, MD, MS, FACS, FRSH<br />

39Interview<br />

Snowmass Village, Colorado USA<br />

Focus on :<br />

Biomaterials<br />

T H E<br />

O F F I C I A L A R G O S P U B L I C A T I O N


N°9 - April 2004<br />

SpineNews<br />

News from the world of Spinal surgery and biomechanics<br />

Summary<br />

Communication<br />

<strong>8th</strong> <strong>International</strong> <strong>Argos</strong> <strong>Symposium</strong> 6<br />

Best poster presentation award 12<br />

Interview with Charles D. Ray 39<br />

Evaluation<br />

Nacre as a bone supply 32<br />

Biospacer : an innovative intervertebral alumina spacer 37<br />

Training<br />

A classification of Biomaterials 20<br />

Bone substitutes in 2004 23<br />

Clinical case discussion 46<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 3


<strong>Argos</strong> SpineNews<br />

Commercial advertising offer 2004<br />

Advertiser information :<br />

Diffusion : Direct mailing<br />

Frequency : 2 times a year<br />

Print run : 10.000 samples<br />

Addressed to : orthopedic surgeons,<br />

neurosurgeons, biomedical staff, spine<br />

specialists<br />

10.000 biannual issues of <strong>Argos</strong><br />

SpineNews are distributed for free<br />

by direct mailing to surgeons and<br />

spine professionals all over the<br />

world. We regularly include in our<br />

journal commercial advertisings for<br />

clinical devices and accessories<br />

manufacturers. Would you be<br />

interested in putting an ad or more<br />

in the <strong>Argos</strong> SpineNews journal, we<br />

would be glad to provide you with a<br />

complete information on our offer.<br />

Print mode : Offset CTP (digital)<br />

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fonts included (bitmap and postscript in<br />

Apple Macintosh font format).<br />

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Size : A4 (210x297mm) for a single<br />

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Delay : digital files required 4 weeks<br />

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Estimate :<br />

Double page ad (double A4, 4 colors) 4500$<br />

Single page ad (A4, 4 colors) 3000$<br />

Double page illustrated article (describing a product) 4500$<br />

Single page illustrated article (describing a product) 3000$<br />

Half page ad (vertical or horizontal) 1500$<br />

Extra journal sample (10 issues are delivered by default to your address)7$<br />

Discounts on the overall estimate per issue :<br />

2 ads/issue : 5%<br />

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Discounts per number of issues :<br />

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4 (or more) issues : 15%<br />

For more information, please contact :<br />

Alexandre Templier<br />

a.templier@argos-europe.com<br />

Anca Mitulescu<br />

anca@argos-europe.com<br />

Fax +33 (0)1 42 33 06 62<br />

The discounts per number of ads and per number of issues may be<br />

cumulated. E.g. : Discount for 4 (or more) ads in 4 consecutive or non<br />

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Our industrial partners are also provided with a complete feedback on the<br />

readers interest in their products and/or services. This particular service is<br />

offered for free to all our partners.<br />

4 <strong>Argos</strong> SpineNews - N°9 April 2004


SpineNews<br />

Editorial headquarters<br />

Surgiview<br />

64, rue Tiquetonne 75002 Paris France<br />

Phone : +33 (0)1 42 33 06 88<br />

Fax : +33 (0)1 42 33 06 62<br />

Editorial staff<br />

Editorial Director :<br />

Alexandre Templier, PhD<br />

Editor in chief :<br />

Anca Mitulescu, PhD<br />

Production/Art Director :<br />

Karim Boukarabila<br />

Editorial advisory board :<br />

The ARGOS committees<br />

Writers/Translators<br />

William Blake Rodgers, MD<br />

Catherine Libessart<br />

Karen E. Warden, PhDc<br />

Marjorie Salé<br />

Amir Vokshoor, MD<br />

Scientific & Technical Advisor :<br />

Yves Debacker<br />

Associate Editors :<br />

Pierre Antonietti, MD<br />

William Blake Rodgers, MD<br />

Karen E. Warden, PhDc<br />

Amir Vokshoor, MD<br />

Christopher Ullrich, MD<br />

<strong>Argos</strong> association :<br />

President : Pr Christian Mazel, MD<br />

General secretary : Pr Pierre Kehr, MD<br />

Treasurer : Alain Graftiaux, MD<br />

Communication Committee :<br />

Anca Mitulescu, PhD, President<br />

Moreno D’Amico, PhD<br />

Raphaël Dumas, PhD<br />

Pr Tamas Illes, MD, PhD<br />

Denis Kaech, MD<br />

Pr Pierre Kehr, MD<br />

Panagiotis Korovessis, MD, PhD<br />

Junichi Kunogi, MD<br />

William Blake Rodgers, MD<br />

Karen E. Warden, PhDc<br />

Training Committee :<br />

Pr Jean-Paul Steib, MD, President<br />

Laurent Balabaud, MD<br />

Pr Denis Cordonnier, MD<br />

Pierre-Jacques Finiels, MD<br />

Samo Fokter, MD<br />

Pr Tamas Illes, MD, PhD<br />

Pr Mihai Jianu, MD<br />

Venugopal Menon, MD<br />

Olivier Ricart, MD<br />

Pr Jean-Marc Vital, MD<br />

Evaluation Committee :<br />

Pr Wafa Skalli, PhD, President<br />

Sabri El Banna, MD<br />

Charles-Marc Laager, MD<br />

Mongi Miladi, MD<br />

Joël Sorbier, MD<br />

Constantin Schizas, MD<br />

Pr Jean-Paul Steib, MD<br />

David A. Wiles, MD<br />

Advertising sales, please contact :<br />

Alexandre Templier<br />

a.templier@argos-europe.com<br />

Anca Mitulescu<br />

anca@argos-europe.com<br />

Fax +33 (0)1 42 33 06 62<br />

<strong>Argos</strong> SpineNews is published twice a year by<br />

Surgiview SAS. Printed by ICL Lens France. It is sent<br />

for free to physicians, surgeons, researchers and<br />

industrial companies on an international scale. Single<br />

copy price is 7 €.<br />

Copyright© 2001 by Surgiview, all rights<br />

reserved. Reproduction in any forms is<br />

forbidden without express permission of<br />

copyright owner.<br />

Editorial<br />

Alexandre TEMPLIER, PhD ><br />

ARGOS General Manager<br />

Editorial Director<br />

The ever-expanding use of biomaterials is<br />

revolutionizing spinal surgery. Indeed, these<br />

adjuncts have now become essential parts<br />

of daily practice.<br />

Currently, biomaterials are used to replace defective or damaged bone, augment or<br />

enhance spinal fusion, and limit or prevent perineural fibrosis. Clearly, however, the<br />

ever-expanding biomaterial options available to the spinal surgeon highlight how far<br />

these products have developed, and how much potential development remains.<br />

The term “Biomaterials” can be used broadly to encompass all<br />

materials that can be safely implanted into the human body.<br />

Traditionally, the definition has been somewhat more narrow,<br />

excluding metallic compounds, even those that are biologically<br />

active. Furthermore, biomaterials can be sub-classified into<br />

resorbable and non-resorbable varieties. The non-resorbable<br />

biomaterials – ceramics, bioglass, polymers, and poly-carbons – will<br />

not be discussed in this issue. Our primary focus will be on<br />

resorbable materials, whether active or inert.<br />

Because this topic has captured the imagination of all spinal<br />

surgeons, we will dedicate this issue to investigating certain<br />

fundamental questions. What are these compounds ? How do they<br />

work in the body ? Where can they best be applied to spinal surgery ?<br />

Specifically, we have asked some of the world’s leading experts to<br />

share with us their ideas and opinions on biomaterial options for bone<br />

substitution, fusion augmentation, and vertebroplasty reconstruction.<br />

We hope that you will enjoy your reading. ●<br />

< Christian MAZEL, MD<br />

ARGOS President<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 5


<strong>8th</strong> <strong>Argos</strong> <strong>Symposium</strong><br />

Communication<br />

The <strong>8th</strong> <strong>International</strong> <strong>Argos</strong> <strong>Symposium</strong> was held<br />

on January 29 and 30, 2004, at Maison des Arts &<br />

Métiers Paris FRANCE.<br />

More than 300 participants from all over the world gathered<br />

to discuss on the adjacent levels degeneration after lumbar<br />

fusion.<br />

“Degeneration of adjacent levels after fusion” was the topic<br />

chosen for the 8TH <strong>Argos</strong> <strong>International</strong> <strong>Symposium</strong>, held in Paris,<br />

on January 29 & 30, 2004. The invited speakers contributed to<br />

an interesting debate on this very controversial topic. Pr Jean-<br />

Louis Husson, MD from the University of Rennes, France, Jean-<br />

Marc Fuentes, MD from Montpellier, France, described the<br />

natural history of spinal degenerative diseases. Pr Jean-Claude<br />

Dosch, MD from the University of Strasbourg, France, reviewed<br />

the medical imaging of degenerative spine. The second part of<br />

the <strong>Symposium</strong> was dedicated to the causes of disc<br />

degeneration at the levels above and below fused segments.<br />

The next day Pr Wafa Skalli, PhD from the Laboratoire de<br />

Biomécanique de l’École Nationale Supérieure des Arts et<br />

Métiers, presented an overview of the biomechanical behaviour<br />

of the levels adjacent to the fused segment. Then, Pierre<br />

Roussouly, MD from the Centre des Massues in Lyon, France,<br />

and Gilles Dubois, MD from Toulouse, France, discussed the<br />

different methods currently in use to prevent or treat<br />

degeneration, i.e. detailed sagittal balance analysis and new<br />

surgical techniques allowing a better protection of adjacent<br />

levels. The well-known phenomenon of adjacent level<br />

degeneration after spinal fusion is well-described but poorly<br />

understood. It is common, but not routine ; it is progressive, but<br />

maybe slow or rapid in developing. It is a cause for consternation<br />

and debate, but its causes are myriad and controversial.<br />

The last session was devoted to open oral communications. In a<br />

change from previous years, there were special sections of the<br />

oral communications devoted to papers from <strong>Argos</strong>-North<br />

America and <strong>Argos</strong>-Belgium. A special presentation was made of<br />

the research that won the 2004 <strong>Argos</strong> Thesis Award. The best<br />

poster communication was selected by electronic vote of the<br />

meetings’ participants and, as is traditional every year, there was<br />

constant, rapid interaction – both verbal and electronic –<br />

between the audience and the speakers.<br />

8 TH <strong>International</strong><br />

<strong>Argos</strong> <strong>Symposium</strong><br />

“Adjacent levels degeneration after lumbar<br />

fusion. How to prevent it ? What to do ?”<br />

Session 1<br />

The first two discussants for the first session were Pr Jean-<br />

Louis Husson, MD, Rennes, France and Jean-Marc Fuentes,<br />

MD, Montpellier, France. Pr Husson opened the session with<br />

a presentation on the natural history of degeneration in the unoperated<br />

spine. During his talk, he insisted on the fact that<br />

“instability” is often an improper term used for what should be<br />

called “destabilization”. In his opinion, destablization has two<br />

phases, i.e. elastic and plastic, that occur when spinal flexion<br />

constraints are lost. Therefore, muscle degeneration plays a<br />

major role in disc degeneration. Pr Husson then described the<br />

4 stages of the lumbar disc degeneration<br />

(DIVA–Dysfonctionnement Intervertebral Acquis/Acquired<br />

Intervertebral Dysfunction) : Elastic deformation, Occasional<br />

Dysfunction, Dynamic Stenosis, Degenerative Pseudo-<br />

Spondylolisthesis or rotatory dislocation. Throughout this<br />

continuum, there is progressive histological devolution into<br />

irreversible degeneration of the disc.<br />

Following Pr Husson’s lecture, Dr Jean-Marc Fuentes<br />

presented a contrasting point of view on degeneration of unoperated<br />

spine. In his opinion, there are innate factors and<br />

acquired factors that lead to disc degeneration sooner or later.<br />

Dehydration of the discal matrix after the age of 40 is a<br />

common process that will yield a decrease in discal height and<br />

disc bulging. In 20 to 30% of the population, annulus fissures<br />

occur after the age of 30, which will lead to increased pressure<br />

in the disc and later to ostheophyte formation and, eventually,<br />

to disc calcification. Posterior arch atrophy is a reaction to this<br />

process. In conclusion, he indicated that an olisthesis higher<br />

than 3 mm combined with a 15° angulation will probably result<br />

into lumbar destabilization. He stressed, furthermore, that the<br />

posterior joints play a major role in the degeneration process.<br />

6 <strong>Argos</strong> SpineNews - N°9 April 2004


Communication<br />

<strong>8th</strong> <strong>Argos</strong> <strong>Symposium</strong><br />

The roundtable discussion of the first session involved Jean-<br />

Louis Husson, Jean-Marc Fuentes, Pierre Roussouly and<br />

Gilles Dubois who collectively debated the differences<br />

between the two approaches to spinal destabilization. Jean-<br />

Louis Husson argued that destabilization occurs when<br />

anatomical “brakes” are overloaded while Jean-Marc Fuentes<br />

countered that the spinal degeneration is an age-related<br />

patient specific process. In other words, while Jean-Louis<br />

Husson would consider degeneration mostly a chemical<br />

process, Jean-Marc Fuentes emphasizes the mechanical<br />

component of destabilization. Pierre Roussouly, MD, Lyon,<br />

France, added that the sagittal balance and posture as well as<br />

muscles will greatly impact the development of degenerative<br />

phenomena.<br />

An interesting question was discussed in detail : Why do some<br />

patients complain of pain while others, with the same clinical<br />

signs of degeneration, do not ? In each case, P Roussouly<br />

analyses all possible factors and stresses that one must<br />

differentiate between dynamic pain resulting from facetal<br />

dysfunction and postural pain arising from muscular<br />

alteration. In reply, Jean-Louis Husson said that he always<br />

tries to identify the definitive pain generator. He added that<br />

the retraction of ischiocavernous muscles should be prevented<br />

in order to unload the lumbo-sacral transition segment. Jean-<br />

Marc Fuentes believes that pain does not always come from<br />

radicular compression but from sometimes venous stasis. He<br />

also indicated that, in his opinion, obesity will maintain spinal<br />

pathology but plays no major role in the development of the<br />

degenerative disease.<br />

The second part of the first session was dedicated to imaging<br />

of the degenerative spine, presented by Pr Jean-Claude<br />

Dosch, MD, Illkirch, France. In contrast to spine surgeons,<br />

the radiologist’s description of degeneration does not take into<br />

account the chronology of the destabilization process. In this<br />

context, the role of the radiologist is to use the appropriate<br />

medical imaging methods in order to detect all of<br />

degeneration’s signs. Thus, MRI is mostly utilized to detect<br />

discal degeneration while static Xrays will show a loss of disc<br />

height. As for destabilization, dynamic Xrays, i.e.<br />

flexion/extension lateral radiographs, are the most appropriate<br />

studies, even though MacNab traction osteophytes, which are<br />

destabilization indicators, may be detected on static Xrays as<br />

well. As for the facet joint dysfunction and stenosis, both CT<br />

scan and Xrays will allow for detection.<br />

In conclusion, Pr Dosch indicated that degenerative lesions<br />

are quite frequent, even in asymptomatic volunteers with as<br />

many as of them showing degenerative signs. Later on,<br />

pathologic degeneration may occur depending on the<br />

individual situation at a given moment. Pr Christian Mazel,<br />

MD, Paris, France and Jean-Marc Fuentes, MD closed the first<br />

session with two lectures on adjacent level degeneration after<br />

fusion. Pr Mazel reminded the audience that up to 50-70% of<br />

operated patients will develop adjacent level degeneration 5 to<br />

10 years after surgery. Furthermore there is no consistant<br />

pattern of adjacent level degeneration, nor is its pattern and<br />

development dependant on the initial diagnosis – HNP,<br />

stenosis, spondylolisthesis, or discopathy. Pr Mazel stressed<br />

the importance of a thorough pre-operative evaluation of<br />

destabilization and instability. Second, but no less important,<br />

he believes that the patient’s position on the operating table<br />

plays a major role in the sagittal correction. Instrumentation<br />

features are also very important, in situ contouring may help<br />

to restore the sagittal balance, but remains highly operatordependent.<br />

In conclusion, adjacent level degeneration after<br />

fusion is multifactorial. Therefore careful pre-operative<br />

evaluation and surgical planning are mandatory.<br />

Jean-Marc Fuentes then explained that degeneration after<br />

fusion is still a controversial issue, emphasizing that some<br />

believe that all degeneration after fusion is directly due to the<br />

fusion while others would argue that post-fusion degeneration<br />

follows the same pattern as the natural degenerative process.<br />

With this much controversy about the causes of this<br />

degenerative process, one would not expect consensus about<br />

the methods available to prevent it. Several instrumentation<br />

modifications have been proposed - semi-rigid<br />

instrumentation (Twinflex) as developed by Mazel,<br />

ligamentoplasty as proposed by Graff, dynamic neutralization<br />

as recommended by Dubois or, today’s hottest topic, discal<br />

arthroplasty. Jean-Marc Fuentes concluded by reminding the<br />

audience that the aging process is inevitable for us all.<br />

A heated discussion followed these two lectures. Gilles Dubois<br />

remarked that Modic I stage, when asoociated with pain, used<br />

to be and still is a good indication for fusion but it is now<br />

proven that this stage may be reversible after orthopaedic<br />

treatment and dynamic stabilization. In reply, Pr Dosch<br />

argued that Modic I was often associated with subtle subclinical<br />

instability. Pr Jean-Paul Steib, Strasbourg, France,<br />

emphasized the role of discography to detect painful discs,<br />

while P Roussouly reminded again the importance of sagittal<br />

balance and of the construct length to prevent adjacent level<br />

degeneration. In addition, Franck Ganem, MD, Caen, France<br />

said that he often sees patients that will not develop pain in<br />

spite of a degenerated adjacent level because their postural<br />

balance has been maintained or reconstructed. Pr Wafa Skalli,<br />

Paris, France added that muscles play a vital, and often<br />

overlooked, role in the re-balancing process. Good muscular<br />

tone would probably explain the absence of pain in certain<br />

patients with evident adjacent level degeneration after fusion.<br />

Session 2<br />

The second session began with a description of the<br />

biomechanical behavior of the adjacent levels after fusion<br />

presented by Pr Wafa Skalli, Paris, France. Pr Skalli showed<br />

the importance of Finite Element Modeling for the simulation<br />

of the biomechanical behavior of vertebral and discal<br />

structures, either individually and collectively, within the<br />

spine. This new and evolving techniques allow for the<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 7


<strong>8th</strong> <strong>Argos</strong> European <strong>Symposium</strong>school Communication of surgery<br />

Buzzer vote results<br />

Thursday 29 st January 2004-pm<br />

You are :<br />

simulation of alterations in disc constraints in pathological<br />

situations as well as after fusion. The latest studies in the field<br />

show that a slight alteration in the gravity line (10 mm ventral<br />

from its physiological location) will result in a 10-fold increase<br />

in the loads seen by the disc. Nevertheless, the body may<br />

compensate for these alterations with good muscular tone. In<br />

Pr Skalli’s words, posture plays a paramount role in the<br />

degeneration process – in either the un-operated or postfusion<br />

spine. She stressed that 50% of lumbar motion is<br />

concentrated between L4 and S1. Fusion of these segments<br />

necessitates stress transfer to adjacent discs and the hip joints.<br />

Excellent muscular tone and balance are required to<br />

compensate for such a significant alteration in spinal motion.<br />

New computerized tools for dynamic analysis, such as<br />

SpineView ® (SurgiView, Paris, France) are now available to<br />

quantify postural parameters and the Mean Centers of<br />

Rotation (MCR) for lumbar and cervical spinal units. Mobility<br />

is defined both by the amplitude of the flexion extension<br />

movement and by the way the movement is obtained through<br />

the MCRs. The location of these centers of rotation will<br />

indicate whether or not the vertebral units have a<br />

physiological movement, whatever the amplitude of the<br />

movement. MCR analysis must be included when<br />

investigating the degenerative spine, before and after surgery,<br />

Orthopaedic surgeon<br />

Neurosurgeon<br />

Researcher<br />

Radiologist<br />

Other profession<br />

52%<br />

Both<br />

You are from :<br />

Africa<br />

Asia<br />

Australia<br />

Europe<br />

North America<br />

South Africa<br />

49%<br />

33%<br />

3%<br />

3%<br />

13%<br />

28%<br />

English speaker<br />

21%<br />

French speaker<br />

3%<br />

10%<br />

0%<br />

18%<br />

1%<br />

In your professional activity,<br />

how many spine surgeries<br />

do you perform per year ?<br />

According to you, adjacent<br />

level degeneration<br />

after fusion can<br />

be avoided thanks to :<br />

69%<br />

less than 30 years old<br />

between 30 & 40 years old<br />

between 40 & 50 years old<br />

between 50 & 60 years old<br />

60 years old & more<br />

Male<br />

Female<br />

13%<br />

4%<br />

19%<br />

34%<br />

32%<br />

11%<br />

87%<br />

How many times did you<br />

attend the <strong>Argos</strong> <strong>Symposium</strong> ?<br />

Once<br />

Twice<br />

Three times<br />

Four times or more<br />

0 to 50<br />

50 to 100<br />

100 to 150<br />

150 & more<br />

A preoperative analysis of the sagittal balance<br />

A complementary soft restabilization<br />

A dynamic fusion<br />

A combination of all these<br />

35%<br />

20%<br />

10%<br />

35%<br />

22%<br />

29%<br />

17%<br />

32%<br />

40%<br />

8%<br />

13%<br />

40%<br />

Are you convinced about<br />

the interest of posterior<br />

soft stabilization systems ?<br />

Yes completly<br />

I would rather say yes<br />

I would rather say no<br />

Not at all<br />

24%<br />

32%<br />

24%<br />

19%<br />

> Visit of the posters<br />

Have you ever used a system<br />

intended to avoid adjacent level<br />

degeneration overlying a fusion ?<br />

Yes<br />

No<br />

49%<br />

51%<br />

8 <strong>Argos</strong> SpineNews - N°9 April 2004


Communication<br />

<strong>8th</strong> <strong>Argos</strong> <strong>Symposium</strong><br />

as they can prove to be excellent predictors of degeneration.<br />

Muscle modeling by means of Finite Element Models is also<br />

available. Since muscular compensation is one of the main<br />

factors that affect restabilization and mobility transfer,<br />

individual analysis of the muscular capacity may provide a<br />

prognosis on the success or failure of fusion.<br />

Gilles Dubois then presented the biomechanical issues related<br />

to the soft stabilization techniques. Research studies have<br />

shown that mobility increases at the upper adjacent level and<br />

will decrease at the lower adjacent level after fusion. To achieve<br />

the same global displacement, upper levels are required to<br />

move more. Dr Dubois believes that the controversies<br />

surrounding the biomechanics of the adjacent level after fusion<br />

are, yet unresolved but, in his opinion, adjacent levels may be<br />

preserved by a dynamic neutralization device.<br />

Next, Pierre Roussouly, Lyon, France, discussed the “ideal”<br />

physiological balance hypotheses, emphasizing the<br />

importance of the pelvic incidence in defining the best posture<br />

for a given individual. In his opinion, the pelvic incidence will<br />

determine the compensatory capacities of each individual, i.e.<br />

a lower incidence will result in a lower capacity of<br />

compensation. He also presented a computerized tool<br />

designed by his research team for the calculation of the<br />

posture and balance parameters from plain Xrays. The<br />

research studies he conducted led him to classifiy the sagittal<br />

profiles into 4 groups, depending on the pelvic and spinal<br />

parameters. Each class has different prognostic factors for<br />

early or late degeneration. He also stated that spinal<br />

curvatures are not always defined by same vertebrae, e.g.<br />

theoretical L1-L5 lordosis does not necessarily correspond to<br />

the real lordosis, which is defined by the vertebrae located at<br />

the area of curvature change. Depending on the sacral slope,<br />

the lordosis apex will change.<br />

The discussion that followed the second session was mostly<br />

concerned with compensation ability. P. Roussouly explained<br />

that a balanced posture requires that C7 be always placed<br />

directly above the center of gravity. However, as added by Pr<br />

Skalli one cannot “force” postural balance, which depends on<br />

different morphotypes. Nevertheless, prognostic factors do exist<br />

and should be taken into consideration in order to help the<br />

patient develop individual compensation strategies. In response<br />

to Dr Roussouly, Jean-Marc Fuentes reminded the audience<br />

that, whatever the spinal pathology, the labyrinth system will<br />

always bring head in an adequate position. So, he asked, why<br />

use C7 instead of the center of external acoustic meatus<br />

(CEAM) ? Pierre Roussouly replied that pelvic parameters<br />

should be the starting point in posture and balance analysis.<br />

Pr Christian Mazel raised the issue of pain in the seated<br />

position. Is there any biomechanical reason for this ? Pr W<br />

Skalli responded that when seated, the individual is in a<br />

hypolordotic situation, and that the thereby tensed ligaments<br />

result in an alteration in proprioception and, thus, the muscles<br />

will not be appropriately activated.<br />

Guest speakers round table discussion :<br />

> From left to right : G. Dubois, MD, Pr JL. Husson, JM Fuentes, MD, P. Roussouly, MD, Pr W. Skalli, PhD<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 9


<strong>8th</strong> <strong>Argos</strong> European <strong>Symposium</strong>school Communication of surgery<br />

Future potential topics in <strong>Argos</strong> symposiums :<br />

- arthritic lumbar scoliosis, correction<br />

and decompression or<br />

decompression & fixation ?<br />

Interesting<br />

Unintersting 8%<br />

92%<br />

- degenerative spondylolisthesis :<br />

decompression and fixation<br />

or decompression alone ?<br />

- Cervical disc prostheses,<br />

indications, complications,<br />

results<br />

Buzzer vote results<br />

Friday 30 st January 2004-pm<br />

Interesting<br />

Unintersting<br />

Interesting<br />

Unintersting<br />

16%<br />

15%<br />

84%<br />

85%<br />

In rebuttal, P Roussouly argued that the seating position is not<br />

necessarily more risky than standing, particularly standing and<br />

bending and lifting as laborers do. At the same time, there is<br />

no general rule for fusion indications. In cases of painful<br />

instability fusion may be the best alternative, but one must not<br />

forget that some patients are more likely to recover with<br />

physiotherapy than others. Therefore fusion should be<br />

indicated mostly for patients with very stiff spines, when<br />

reeducation is impossible.<br />

According to you, adjacent<br />

level degeneration<br />

after fusion can<br />

be avoided thanks to :<br />

Detailed appreciation of the session :<br />

Knowledge content<br />

Profitability in my practice<br />

Poor<br />

Fair<br />

Good<br />

Excellent<br />

2%<br />

6%<br />

Personnal interest<br />

Poor<br />

Fair<br />

Good<br />

Excellent<br />

Welcome conditions<br />

Excellent<br />

Good<br />

1%<br />

8%<br />

A preoperative analysis of the sagittal balance<br />

A complementary soft restabilization<br />

A dynamic fusion<br />

A combination of all these<br />

30%<br />

29%<br />

63%<br />

62%<br />

45%<br />

47%<br />

Poor<br />

Fair<br />

Good<br />

Excellent<br />

0%<br />

0%<br />

Quality of animation<br />

Poor<br />

Fair<br />

Good<br />

Excellent<br />

Scientific sessions<br />

Excellent<br />

Good<br />

8%<br />

33%<br />

5%<br />

20%<br />

2%<br />

10%<br />

Average 7%<br />

Average 11%<br />

44%<br />

45%<br />

67%<br />

67%<br />

30%<br />

59%<br />

The last part of the session was dedicated to the presentation<br />

of soft stabilizations of the adjacent level of fusion. These<br />

techniques, presented by Gilles Dubois, are meant to prevent<br />

degeneration by dynamic neutralization of abnormal<br />

movements. In laboratory testing, the Dynesis system was<br />

able to normalize the movement of the levels adjacent to the<br />

fused segment. Examples were provided that showed Modic I<br />

degeneration reversing over time in segments stabilized by<br />

the Dynesis system. These phenomena could be explained by<br />

rehydration of the disc. Christian Mazel asked if there was an<br />

increased risk of developing kyphosis with Dynesys. Gilles<br />

Dubois answered that there does not appear to be a significant<br />

risk since Dynesys strives to restore physiological lordosis. Pr<br />

Jean Louis Husson then asked whether osteolysis around the<br />

screws had been observed, presumably due to excessive<br />

stiffening. Dr Dubois replied that the fixation is customized to<br />

the individual patient and, therefore, no excessive rigidity was<br />

noticed.<br />

A pertinent question was raised by the audience : Is there an<br />

“ideal” posture that all fusions should aspire to recreate or<br />

should individual morphotypes be taken into account? P<br />

Roussouly explained that a “bad” spine will always be a “bad”<br />

spine, meaning that morphotypes must always play an<br />

important role in decision making. Nevertheless, he advocated<br />

restoration of lordosis when possible. ●<br />

10 <strong>Argos</strong> SpineNews - N°9 April 2004


Free oral presentation session :<br />

This year’s symposium ended with a series<br />

of very interesting and original free oral<br />

presentations.<br />

Frank Fumich, MD, and<br />

Melvin Law, MD, from<br />

<strong>Argos</strong> North America<br />

presented 3 papers on<br />

evaluation studies of new<br />

techniques, i.e<br />

> Frank Fumich, MD<br />

microplate laminoplasty<br />

for cervical stenosis, cage and pedicle<br />

screw stabilization with morselized<br />

autograft for the lumbar spine and<br />

biportal transforaminal endoscopy for<br />

treatment of pyogenic lumbar discitis.<br />

Later on, Jean Legaye,<br />

MD, from <strong>Argos</strong><br />

Belgium first explained<br />

the importance of gravity<br />

measurements for the<br />

assessment of sagittal<br />

> Jean Legaye, MD<br />

balance during his first<br />

talk. Passing to a totally different field, Dr<br />

Legaye then exposed the performances<br />

and limits of navigation in spine surgery.<br />

Agnes Raould, MD, from<br />

Beaujon Hospital,<br />

France (team of<br />

Professor Pierre Guigui,<br />

MD) gave a talk on the<br />

importance of the<br />

> Agnès Raould MD<br />

evolution of mean<br />

centers of rotation (MCR) of levels<br />

adjacent to a postero-lateral lumbar<br />

fusion. Indeed the evolution of the MCRs<br />

location plays a major role in the<br />

mechanical behavior of lumbar spine and<br />

may therefore predict adjacent<br />

degeneration, concluded Ms Raould.4<br />

David Mitton, PhD, from<br />

the Biomechanics<br />

Laboratory of ENSAM,<br />

presented an original<br />

study on the dynamic<br />

response<br />

of<br />

> David Mitton, PhD<br />

intervertabral discs,<br />

based on an experimental approach. The<br />

study allowed the evaluation of the<br />

intervertebral disc’s viscoelastic<br />

properties and the results of the study<br />

showed high correlations between these<br />

properties and the degeneration grade. A<br />

direct consequence of this study may be<br />

the design of more appropriate nonfusion<br />

systems for lumbar motion<br />

restoration.<br />

After this Biomechanics session, Kiyochi<br />

Kumano, MD, from Japon, discussed the<br />

changes in lumbar sagittal alignment after<br />

TLIF, based on a radiological evaluation.<br />

His study on 36 patients operated<br />

between December 2000 to June 2003<br />

with TLIF for degenerative lumbar<br />

diseases, showed that lombosacral lumbar<br />

lordoses in single level fusions were stable<br />

several months postoperatively. He<br />

thereby concluded that the single level<br />

fusion with TLIF is more advantageous<br />

than the multi level one.<br />

> Antonio Castellvi, MD<br />

The evaluation of the<br />

impact of semirigidity on<br />

the prevention of<br />

adjacent level<br />

degenerative disc<br />

disease is the purpose of<br />

a prospective study<br />

presented by Antonio E. Castellvi, MD,<br />

from Florida, USA. Dr Castellvi intends<br />

to enroll up to 100 patients in 2 years,<br />

with either L5-S1 DDD, dynamic<br />

stenosis, or iatrogenic instability and<br />

failed previous fusion, in order to have a<br />

clear estimation of the clinical outcome<br />

after fusion with semirigid<br />

instrumentation.<br />

Michel Bidermann, MD, Switzerland,<br />

presented his results involving 20<br />

patients who have underwent<br />

monosegmental fusion above the L5-S1<br />

level, in order to determine whether or<br />

not the floating L4-L5 fusion leads to<br />

better mobility recovery than<br />

lumbosacral fusions. His study showed<br />

that a good outcome of L4-L5 fusions is<br />

correlated with preoperative clinical and<br />

radiological signs of instability.<br />

Therefore, Dr Bidermann concluded that<br />

the best indication for L4-L5 fusions is<br />

instability in young patients.<br />

During the non-fusion techniques<br />

session, several speakers addressed the<br />

new stabilization system called Dynesys.<br />

Othmar Schwarzenbach, MD, form<br />

Switzerland, presented his first clinical<br />

results involving 42 patients operated<br />

with the Dynesys stabilization system in<br />

addition to PLIF or PLF. Olivier Ricart,<br />

MD, France, presented the results of a<br />

prospective study in patients suffering<br />

from spinal stenosis with degenerative<br />

spondylolisthesis, while Darrell<br />

Goertzen, Switzerland discussed the<br />

effects of flexible devices in motion at the<br />

adjacent segment after lumbar fusion.<br />

Another non-fusion restabilization<br />

instrumentation is the Wallis device.<br />

Panagiotis Korovessis,<br />

MD, used this device in<br />

24 patients in order to<br />

prevent adjacent levels<br />

> Panagiotis Korovessis, MD<br />

degeneration after<br />

lumbar fusion. His study<br />

showed that the use of<br />

such a device in addition to fusion<br />

maintained the lumbar lordosis and<br />

reduced disc mobility. No alteration of<br />

posterior vertebral displacement in<br />

extension was observed. However,<br />

olisthesis in flexion increased. G. Matgé,<br />

MD, Luxemburg, then presented a<br />

review of interspinous fixation systems,<br />

dynamic neutralization ones as well as<br />

the semirigid fixation devices, in order to<br />

better define the appropriate indications<br />

for each of these systems. He concluded<br />

that the non-fusion systems, when used<br />

instead of rigid systems, may not only<br />

have a curative indication but also onein<br />

the prevention of junction syndrome. In<br />

his opinion, except for severe lytic<br />

spondylolisthesis, rigid fixation should<br />

not be indicated anymore for<br />

degenerative lumbar instability.<br />

Finally, J.R. Jinkins, MD,<br />

USA, presented the first<br />

clinical results of the<br />

clinical trials on the<br />

upright, weight bearing,<br />

dynamic-kynetic MRI<br />

> Randy Jinkins, MD<br />

device for spine analysis.<br />

The potential relative beneficial aspects<br />

in spinal imaging of the stand-up MRI<br />

over that of recumbent MRI include the<br />

revelation of occult disease dependent on<br />

axial loading, the unmasking of kinetic<br />

dependent disease, and the ability to scan<br />

the patient in the position of clinically<br />

relevant signs and symptoms. ●<br />

A. MITULESCU, P. KEHR, C. MAZEL<br />

<strong>Argos</strong> SpineNews - N° 9 April 2004 11


Bone substitutes in 2004<br />

Communication<br />

1 2<br />

Best poster<br />

presentation award :<br />

Inter-individual variations<br />

of the cervical spine biomechanics<br />

and postural parameters.<br />

Methods :<br />

Eighteen asymptomatic subjects (9 men and 9<br />

women), mean age : 31 years (23-51), mean<br />

weight : 68 Kg (52-93) were included in the<br />

study. A stereoradiography exam (fig. 1, 2) (front<br />

and lateral Xrays) in a standing position, using a<br />

specific low irradiation Xray system was used to<br />

obtain a 3D reconstruction of the subject C0-C7<br />

cervical spine (fig. 3) [1] .<br />

– R. Saintonge, A. Assi, V. Pomero<br />

B. Frechede, S. Laporte, W. Skalli<br />

Laboratoire de biomécanique<br />

de l’ENSAM Paris FRANCE<br />

Context :<br />

The cervical spine posture and global loads<br />

induced by head weight are important in the<br />

cervical spine pathology analysis, but they are not<br />

yet well documented. Our aim is to analyze the<br />

inter-individual variations of the cervical spine<br />

biomechanical and postural parameters using the<br />

EOS low irradiation Xray system<br />

and 3D reconstruction.<br />

3<br />

The external envelopes of the neck and head<br />

were also reconstructed (fig. 4). Frontal and<br />

sagittal curvatures between the intervertebral<br />

level of C3-C7 were then calculated, as well as<br />

the posterio-anterior and lateral location of the<br />

center of external acoustic meatus (CEAM,<br />

estimating the gravity center of the head [2] ) with<br />

12 <strong>Argos</strong> SpineNews - N° 9 April 2004


Communication Bone substitutes in 2004<br />

regard to the intervertebral center of C7-T1. A<br />

mass distribution model of the head and of neck<br />

slices allowed to estimate global loads at each<br />

intervertebral level (fig. 5). The head mass was<br />

evaluated using a regression equation based on<br />

the subject weight and head perimeter (fig. 6) [3] .<br />

The mass of each neck intervertebral slice were<br />

obtained using density, volume and center of<br />

gravity of vertebrae and soft tissues (fig. 7) [4] .<br />

4<br />

5<br />

Results :<br />

The observed cervical spine curvatures were<br />

straight (5 subjects) or lordotic (11 subjects)<br />

(fig. 8). For the lordotic curve, the mean sagittal<br />

curve was 20° (6.5-43°) and the mean frontal<br />

curve was 11° (4.6-21°). The mean CEAM<br />

location was 33 mm (4-77 mm)<br />

anterior to C7-T1 center. CEAM<br />

was often laterally deviated, left or<br />

right, 5 to 13mm, either left (2<br />

subjects) or right (6 subjects). The<br />

main global loads were<br />

compression forces and flexion<br />

moments (see table). A slight<br />

lateral bending moment also was<br />

observed, reaching 0.4 Nm.<br />

Discussion and Conclusion :<br />

Head location varied in a wide range<br />

inducing inter-individual variations<br />

in flexion moments. The global loads<br />

obtained were compatible with<br />

published load tolerances [5] . This<br />

study underlines relationship<br />

between global intervertebral loads<br />

and spine configuration. Future<br />

muscle regulation model should<br />

allow to better understand normal or<br />

pathologic cervical spine behavior.<br />

References :<br />

[1] V. Pomero, D. Mitton et al, Clin<br />

Biomech, 2004, in press.<br />

[2] JM. Vital and J. Senegas, SRA,<br />

vol. 8, pp. 169-73, 1986.<br />

[3] C. Clausser, J. Mc Conville,<br />

and J. Young, AMRL-TR-69-<br />

70, 1969.<br />

[4] J. Mc Conville, C. Clausser,<br />

and J. Cuzzi, AFAMRL-TR-80-<br />

119, 1980.<br />

[5] R. W. Nightingale, BA.<br />

Winkelstein et al, J Biomech,<br />

vol. 35, pp. 725-32, 2002.<br />

Acknowledgements :<br />

1. 3D reconstruction methods<br />

were developed in collaboration<br />

with LIO Montréal.<br />

Loads due to gravity : mean (extreme) values<br />

Global intervertebral loads for the cervical spine in standing position (mean and extreme values)<br />

C0-C1 C1-C2 C2-C3 C3-C4 C4-C5 C5-C6 C6-C7 C7-T1<br />

Compression forces (N) 41 (37-49) 44 (41-52) 46 (42-53) 48 (43-56) 49 (44-58) 51 (45-60) 54 (47-64) 57 (50-69)<br />

Flexion moments (Nm) 0,6 (0-2) 0,6 (0-2,1) 0,7 (0-2,2) 0,7 (0-2,3) 0,8 (0-2,5) 0,9 (0-2,7) 1 (0-3) 1,3 (0,2-3,3)<br />

2. EOS system was developed in<br />

collaboration between LBM-<br />

ENSAM, SVP Hospital, LIO,<br />

Pr Charpak and Biospace<br />

company.<br />

6 7<br />

8a<br />

8b<br />

Fig 1 : Stereoradiography in the EOS ® system<br />

Fig 2 : Frontal and lateral X rays in standing position<br />

Fig 3 : 3D reconstruction of C0-C7 [1]<br />

Fig 4 : 3D reconstruction of head and neck envelope<br />

Fig 5 : Calculation of loads due to gravity forces<br />

Fig 6 : Calculation of the head mass<br />

Fig 7 : Calculation of the mass and COG of<br />

intervertebral slices<br />

Fig 8 : Types of curvature<br />

8a : Straight for 5 subjects<br />

8b : Lordotic for 11 subjects<br />

Mean sagittal curve : 20° (6.5-43)<br />

Mean frontal curve : 11° (4.6-21)<br />

<strong>Argos</strong> SpineNews - N° 9 April 2004 13


Third Annual<br />

ARGOS NORTH AMERICA<br />

CONFERENCE<br />

West Coast Attitude, East Coast Latitude <br />

Lumbar Degenerative Diseases :<br />

When and How to Fuse ?<br />

Indications, Graft Alternatives and Instrumentation.<br />

6-7 AUGUST 2004<br />

Sessions to include :<br />

- Scoliosis<br />

- Lumbar Fusion<br />

- Biologic graft alternatives<br />

Educational objectives :<br />

Following this course, participants should :<br />

- Understand the relevant benefits and limitations of biologic alternatives<br />

to autologous grafting<br />

- Compare and contrast the various surgical approaches to the treatment<br />

of lumbar degenerative conditions and relative merits and limitations<br />

- Have a working understanding of several different instrumentation<br />

alternatives for fusion of the degenerative lumbar spine.<br />

- Begin to understand the relative role of fusion vs. discal arthroplasty in<br />

the treatment of the degenerative lumbar spine.<br />

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation<br />

Council for Continuing Medical Education (ACCME) through the joint sponsorship of the WVU School of Medicine and<br />

ARGOS North America. The WVU School of Medicine is accredited by the Accreditation Council for Continuing Medical<br />

Education to provide continuing medical education for physicians. The WVU Office of CME designates this educational<br />

activity for a maximum of 11.5 category 1 credits toward the AMA Physician’s Recognition Award. Each physician should claim only<br />

those credits that he/she actually spent in the activity.<br />

Educational Grant provided<br />

by REO SpineLine, LLC


GUEST SPEAKERS<br />

TO INCLUDE:<br />

Julie Bearcroft, PhD<br />

Edward Benzel, MD<br />

John E. Hall, MD<br />

John F. Kay, PhD<br />

Henry J. Mankin, MD<br />

Jack Parr, PhD<br />

Jean-Paul Steib, MD<br />

Michael Y. Wang, MD<br />

C ALL FOR ABSTRACTS<br />

Electronic submission deadline :<br />

June 1, 2004 11:59 pm cst<br />

Submit to : argosNA@argosna.org<br />

Submission rules :<br />

• Abstracts must be submitted by June 1, 2004. All abstracts<br />

received after that date will not be considered.<br />

• Abstract must be submitted electronically.<br />

• Abstract must be submitted in English<br />

• Abstract must contain the following :<br />

- No more than 200 words<br />

- Title<br />

- List all authors associated with the abstract<br />

- Presenting author<br />

- Presenting Author contact information - phone, fax,<br />

eMail address, mailing address.<br />

- Institutional affiliations<br />

• Abstracts are reviewed by ARGOS-NA board members and<br />

will be read in “blind” fashion.<br />

• ARGOS-NA will send notification of acceptance via eMail<br />

to the presenting author on or after June 15, 2004.<br />

Policies :<br />

- ARGOS-NA reserves the<br />

right to withdraw an abstract<br />

at any time.<br />

- Presenters of the accepted<br />

abstracts must register for<br />

the meeting and pay their<br />

own expenses.<br />

- All presenters must adhere<br />

to the AMA code of Medical<br />

Ethics, Opinion 8.061 “Gifts<br />

to Physicians form Industry”<br />

- All presenters are required<br />

to provide Conflict of<br />

Interest Disclosure information<br />

and FDA disclosure.<br />

- Authors will be listed in<br />

Final Program. ARGOS-NA<br />

will not assume responsibility<br />

of information provided<br />

inaccurately. Once an abstract<br />

is accepted, additional<br />

authors cannot be added<br />

- Prior to submission of your<br />

abstract please ensure that<br />

you are available to present<br />

at the meeting. If it is<br />

impossible for you to present<br />

your abstract at the<br />

assigned time, you must<br />

choose a substitute presenter<br />

or request to be withdrawn.<br />

Once Final program<br />

is printed we will be unable<br />

to make changes.<br />

- To withdraw an abstract,<br />

the presenter must notify<br />

ARGOS-NA via eMail.


– Pr Kiyoshi Kumano<br />

FOUNDER & PRESIDENT OF<br />

THE JPSSSTSS<br />

– Shigeru Hirabayashi<br />

CHAIRMAN OF THE 11TH<br />

MEETING OF THE JPSSSTSS<br />

11 th Annual meeting of the<br />

JPSSSTSS *<br />

18-19 SEPTEMBER 2004<br />

*Japan Society for the Study of Surgical Techniques for Spine and Spinal Nerves<br />

Omiya Sonic City Hall<br />

Omiya Saitama<br />

www.sonic-city.or.jp<br />

Sonic-City BLDG 5F, 1-7-5<br />

Sakuragi-cho, Omiya-ku,<br />

Saitama-shi, Saitama<br />

330-8669 JAPAN<br />

The 11th Annual Meeting of the Japan<br />

Society for the Study of Surgical<br />

Techniques for the Spine and Spinal<br />

Nerves (JPSTSS) will be held at Omiya<br />

Sonic City Hall, Omiya, Saitama, on the<br />

1<strong>8th</strong> and 19th September, 2004. As<br />

President of the meeting, I would like to<br />

give a few words of greeting.<br />

Last year, the memorable 10th annual meeting<br />

was held under Dr. Hiroshi Takahashi as<br />

President. Starting this year, the society enters<br />

into its second decade. There are three<br />

fundamental ideas of the JPSTSS society. First, to<br />

actively welcome foreign doctors and exchange<br />

each idea. Second, to encourage cooperation<br />

among doctors of different departments involved<br />

in treating the spine and spinal cord to discuss<br />

many unresolved problems. Third, to encourage<br />

individual participation in the meeting, that is,<br />

without restriction due to policies at the place of<br />

employment. These ideas have been maintained<br />

since foundation of the society in 1994. The<br />

numbers of participants who agree with the ideas<br />

have been increased year by year. The journal of<br />

the society has been published since 1999.<br />

Currently, the JPSTSS society has grown to<br />

become one of the representatives of Japanese<br />

medical society for study of spine and spinal cord.<br />

Recently, the concept of EBM (Evidence-Based<br />

Medicine) has become widely established even in<br />

Japan and the evidence presented seem to become<br />

absolute guidelines in medicine. The main<br />

purpose of this concept is to objectively<br />

reconsider medical outcomes that have previously<br />

been subjectively determined by doctors<br />

themselves. Certainly, this concept has one proper<br />

direction. However, the evidence is the integrated<br />

result obtained statistically by comparing cases.<br />

Therefore, there is possibility that problems<br />

existing in each individual has disappeared or is<br />

masked. The evidence may be changed or affected<br />

by the selection of objects and methods adopted.<br />

We must recognize that the evidence is evidence<br />

obtained under restricted conditions, and<br />

therefore, is not an absolute guideline. Everyday<br />

we surgeons face patients who have these<br />

problems and must cure and care each patient in<br />

a manner suitable for the individual conditions.<br />

The purpose of the JPSTSS society is to manage<br />

these individual complexities by making efforts to<br />

devise surgical techniques. This is one alternative<br />

direction that differs from that of EBM.<br />

I have selected two main themes for the 11th<br />

meeting. One is the surgical management for<br />

disorders at the junction of the spinal column, a)<br />

the craniocervical junction, b) the cervicothoracic<br />

junction. The other is new or recently devised<br />

surgical techniques for lumbar spinal canal<br />

stenosis. The junction of the spinal column is<br />

very peculiar from both anatomical and<br />

biomechanical perspectives. The disorders at the<br />

levels are sometimes difficult to manage,<br />

especially at the craniocervical and cervicothoracic<br />

junctions, and the treatment must be more<br />

intensively discussed. Although lumbar spinal<br />

canal stenosis (LSCS) is a common disease, the<br />

pathomechanism has not yet been fully<br />

elucidated. Despite the fact that LSCS is a<br />

complex syndrome, the treatment has previously<br />

been discussed as if it is one disease. Treatment of<br />

this syndrome must be developed in accordance<br />

with each pathomechanism.<br />

Omiya is the center of Saitama Shin-Toshin (new<br />

metropolitan) and convenient to access from<br />

anywhere in Japan including Narita Airport.<br />

Omiya Sonic City Hall, the venue for the 11th<br />

meeting, is very near Omiya Station and adjacent<br />

to Omiya Palace Hotel. I hope that many doctors<br />

will take part in the meeting and discuss many<br />

issues actively. I expect the meeting will be a<br />

suitable opening for our second decade.<br />

– Shigeru Hirabayashi<br />

Department of Orthopaedic Surgery<br />

Saitama Medical Center, Saitama Medical<br />

School


<strong>Argos</strong>’ members list<br />

Algeria<br />

Dr BENCHENOUF Mohamed Kamel<br />

Argentina<br />

Pr AYERZA Ivan R<br />

Dr BERNASCONI Juan Pablo<br />

Dr COLL Pedro Ariel<br />

Dr D’INNOCENZO Alysudro Cesar<br />

Dr FERNANDEZ BOAN Osvaldo<br />

Dr GELOSI Frederic J<br />

Dr GRECCO Marcelo HG<br />

Dr LANARI ZUBIAUR Felipe<br />

Dr LEGARRETA Aroldo Carlos<br />

Dr MARIANO Noël<br />

Dr MONAYER Jose Luis<br />

Dr MOUNIER Carlos Maria<br />

Dr NEMIROVSKY Carlos E<br />

Dr PATALANO Luis A<br />

Dr PLATER Pablo<br />

Dr RAMANZIN Victor Gust<br />

Dr RAMIREZ Gustavo<br />

Dr RODRIGUEZ Roberto Carlos<br />

Dr ROSITTO Gabriel<br />

Dr ROSITTO Victor<br />

Dr RÜDT Tomas<br />

Dr SELSER Jorge Guillermo<br />

Dr SEMBER Eduardo<br />

Dr SIRNA Pablo Mario<br />

Dr SOLA Carlos A<br />

Dr SOSA Eduardo Angel<br />

Dr ZISUELA Roberto Gustavo<br />

Belgium<br />

Dr COSTA Henri*<br />

Dr DELEFORTRIE Guido<br />

Dr DESMETTE Damien*<br />

Dr EL BANNA Sabri*<br />

Dr FORTHOMME Jean-Paul*<br />

Dr MATHEI Frédéric*<br />

Dr LEGAYE Jean<br />

Dr RYSSELINCK Yves<br />

Brazil<br />

Dr HÜBNER André Rafaël*<br />

Canada<br />

Pr DE GUISE Jacques*<br />

China<br />

Dr LEONG John*<br />

Egypt<br />

Dr EL-HADIDI Talaat<br />

Dr SALAH Hossam<br />

France<br />

Dr ANTONIETTI Pierre*<br />

Dr ABIKHALIL Joseph<br />

Dr ARTIERES Xavier<br />

Dr BALABAUD Laurent*<br />

Dr BERNARD Pierre<br />

Dr BOGORIN Ioan<br />

Dr BOUVET Robert<br />

Dr BRAUN Emmanuel<br />

Dr CORDONNIER Denis*<br />

Dr CHOPIN Daniel (Honorary member)<br />

Dr CIAUDO Oreste<br />

Pr DEBURGE Alain (Honorary member)<br />

Dr DEHOUX Emile<br />

Dr DESROUSSEAUX Jean-François*<br />

Dr DOSCH Jean-Claude*<br />

Pr DUBOUSSET Jean*<br />

Dr/Ing DUMAS Raphaël*<br />

Dr DUPUIS Raphaël<br />

Dr EDOUARD Brice<br />

Dr FINIELS Pierre-Jacques*<br />

Dr GAGNA Gilles<br />

Dr GANEM Franck*<br />

Dr GOSSET Franck*<br />

Dr GRAFTIAUX Alain*<br />

Pr GUIGUI Pierre<br />

Dr GUILLAUMAT Michel (Honorary member)<br />

Dr HEISSLER Pierre*<br />

Dr HOVORKA Etienne<br />

Dr JABY Yves<br />

Dr JUDET Henri*<br />

Pr KEHR Pierre*<br />

Pr LAVASTE François*<br />

Dr LEMAIRE Jean-Philippe<br />

Dr LEONARD Philippe<br />

Pr LOUIS René (Honorary member)<br />

Dr MARMORAT Jean-Luc*<br />

Pr MAZEL Christian*<br />

Dr/Ing MITULESCU Anca Andreia*<br />

Dr MORENO Pierre<br />

Pr NAZARIAN Serge<br />

Pr ONIMUS Michel (Honorary member)<br />

Pr POINTILLART Vincent (Honorary member)<br />

Dr RAKOVER Jean-Patrick<br />

Dr RAMARE Stéphane<br />

Dr RICART Olivier*<br />

Pr SAILLANT Gérard (Honorary member)<br />

Dr SAMAHA Dominique<br />

Pr SENEGAS Jacques (Honorary member)<br />

Pr SKALLI Wafa*<br />

Dr SORBIER Joël*<br />

Dr STEIB Jean-Paul*<br />

Dr TALEGHANI David Hamid<br />

Dr/ing TEMPLIER Alexandre*<br />

Dr TERRACHER Richard*<br />

Dr VITAL Jean-Marc*<br />

Germany<br />

Dr DANNENBERG Jens<br />

Pr HARMS Jüergen<br />

Dr KRAPPEL Ferdinand<br />

Pr WEIDNER Andreas<br />

Greece<br />

Dr KALIVAS Lambros<br />

Dr KORRES Demetre (honorary member)*<br />

Dr KOROVESIS Panagiotis<br />

Dr PATSIAOURAS Thomas<br />

Pr SAPKAS George<br />

Dr TSAFANTAKIS Manolis<br />

Dr ZACHARIOU Konstantinos Zacharias<br />

Hungary<br />

Dr CSERNATONY Zoltan<br />

Pr ILLES Tamas*<br />

India<br />

Dr MENON K Venugopal*<br />

Israël<br />

Dr BRUSKIN Alexander<br />

Dr CASPI Israel<br />

Dr LEVINKOPF Moshe<br />

Dr NERUBAY Jacob*<br />

Pr SHOHAM Moshe*<br />

Italy<br />

Dr ACAMPORA Sergio<br />

Dr ASCANI Elio PhD<br />

Dr BADO Flavio<br />

Dr BASSANI Roberto<br />

Dr BONACINA Paolo<br />

Dr BONFIGLIO Giuseppe<br />

Dr BUSCH Rolf<br />

Dr/Ing D’AMICO Moreno*<br />

Pr DENARO Vincenzo<br />

Dr FRANCAVIGLIA Natale<br />

Dr GAMBADORO Cesare Maria<br />

Dr LAAGER Charles-Marc*<br />

Dr RODIO Dario<br />

Pr ROSA Michele Attilio<br />

Dr RUSSO Tullio Claudio<br />

Pr SALPIETRO Francesco<br />

Dr TAMORRI Marco<br />

Dr UGGERI Massimo<br />

Pr VENTURA Fausto<br />

Japan<br />

Dr DEZAWA Akira<br />

Dr KUMANO Kiyoshi*<br />

Dr KUNOGI Jun-Ichi*<br />

Dr TSUNODA Nobuaki<br />

Korea<br />

Pr CHO Jae-Lim<br />

Pr KIM Young-Soo (Honorary member)<br />

Pr KIM Yung-tae<br />

Dr LEE Sang Ho<br />

Pr OH Seong-Hoon<br />

Luxembourg<br />

Dr WIJNE Adrien*<br />

Marocco<br />

Dr BENZAKOUR Thami<br />

The Netherlands<br />

Dr LUITJES Willem F<br />

New Zealand<br />

Dr DUTOIT Francois<br />

Nigeria<br />

Dr ADEBULE Gbolahan<br />

Poland<br />

Dr ZARZYCKI Daniel<br />

Portugal<br />

Dr CANNAS Joao<br />

Dr DE ALMEIDA Luis<br />

Romania<br />

Pr JIANU Mihai*<br />

Senegal<br />

Dr SEYE Seydina Issa Laye SENEGAL<br />

Slovenia<br />

Dr CORBACHO GIRONES Jose Maria<br />

Dr FOKTER Samo K*<br />

South Africa<br />

Dr WASSERMAN Johan<br />

Spain<br />

Dr ALVAREZ RUIZ Fernando<br />

Dr BOTELLA Carlos<br />

Dr BRAGADO NAVARRO Diego<br />

Dr CABRERA MEDINA Sergio<br />

Dr CAMPUZANO Alfonso<br />

Dr CASAMITJANA FERRANDIZ JM*<br />

Dr CHAROSKY Sebastian<br />

Dr CIMARA DIAZ J Ignacio<br />

Dr CORBACHO GIRONES Jose Maria<br />

Dr DE BLAS ORLANDO Alvaro<br />

Dr DE MIGUEL VIELBA Jose Antonio<br />

Dr DIAZ-MAURINO Juan<br />

Dr ECHEVERRI BARREIRO Angel Jorge*<br />

Dr FERNANDEZ BOAN Osvaldo<br />

Dr FERNANDEZ GONZALEZ Manuel<br />

Dr FERNANDEZ MANCILLA Fernando<br />

Dr FONT VILA Frederic<br />

Dr GARCIA RODRIGUEZ Luis Antonio<br />

Dr GIMENEZ Antonio<br />

Dr GONZALEZ Francisco<br />

Dr GONZALEZ RODRIGUEZ Ernesto<br />

Dr GONZALEZ SAMANIEGO Angel<br />

Dr HERNANDEZ GARCIA Cesar<br />

Dr HERNANDO ARRIBAS Carlos<br />

Dr HEVIA Eduardo<br />

Dr HUERTA Juan<br />

Dr ISLA GUERRERO Alberto<br />

Dr MARTIN BENLLOCH Antonio*<br />

Dr LAGUIA Manuel<br />

Dr LLOMBART AIS Rafael<br />

Dr LOPEZ-OLIVA MUNOZ Felipe<br />

Dr LOZANO-REQUENA Juan Antonio<br />

Dr LUNA Carlos<br />

Dr MARUENDA Jose Ignacio<br />

Dr MATA Pedro Ramon<br />

Dr MATA Jr Pedro Ramon<br />

Dr PEREZ JIMENEZ Cesar<br />

Dr RODA FRADE Enrique<br />

Dr SANCHEZ VERA Manuel<br />

Dr SANFELIU GINER Miguel<br />

Dr SANTOS BENITEZ Hugo<br />

Dr SOPESEN MARIN José Luis<br />

Dr VELLOSO LANUZA Agustin<br />

Dr VICENTE THOMAS Javier<br />

Dr VILAR PEREZ Julio Alfonso<br />

Switzerland<br />

Dr BEDAT Philippe*<br />

Dr BIEDERMANN Michel<br />

Dr DUTOIT Michel*<br />

Pr JEANNERET Bernhard<br />

Dr KAECH Denis*<br />

Dr LUTZ Thomas Walter<br />

Dr SCHIZAS Constantin*<br />

Dr SELZ Thierry*<br />

Syria<br />

Dr ALOMAR Taha<br />

Tunisia<br />

Dr KAMOUN Mohamed Habib<br />

Dr KHOUADJA Fathi<br />

Dr LADEB M Fethi<br />

Dr M’BAREK Mondher<br />

Dr MILADI Mongi*<br />

Dr TRABELSI Mohsen<br />

Turkey<br />

Pr HAMZAOGLU Azmi<br />

United Kingdom<br />

Pr O’BRIEN John P*<br />

USA<br />

Dr ALBERT Michael<br />

Dr BECKNER Mark<br />

Dr BITAN Fabien*<br />

Dr BONASSO Christian L<br />

Dr COX Curtis<br />

Pr FARCY Jean-Pierre*<br />

Dr HOFFMAN William<br />

Pr IBRAHIM Kamal<br />

Dr JALLO George<br />

Dr JONES Eric T*<br />

Dr KNAPP D Raymond<br />

Dr LANGE David<br />

Dr LAW JR Melvin<br />

Dr LEONE Vincent J<br />

Dr LOWE Robert W<br />

Pr MARGULIES Joseph<br />

Dr MUNSON Gregory<br />

Dr PARK Kee<br />

Dr PHILLIPS Jonathan<br />

Dr PINO Wilbert<br />

Dr REZAIAN SM<br />

Dr RODGERS William*<br />

Dr SCHNEIER Michael<br />

Dr SCHWAB Frank<br />

Dr SHARF Howard<br />

Dr SWANK Michael L<br />

Dr TAYLOR Brett<br />

Dr ULLRICH Christopher*<br />

Dr VELISKAKIS Kostas P<br />

Dr/Ing WARDEN Karen E*<br />

Dr WILES David*<br />

Pr WOLF Alon<br />

Dr ZERICK William R*<br />

* Full members being entitled to sponsor<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 17


2004 new members<br />

Roberto Bassani, MD<br />

Orthopaedic and Spine Surgeon<br />

IRCCS Policlinico Universitario<br />

“San Matteo” - Pavia ITALY<br />

robertobassani@hotmail.com<br />

Thami Benzakour, MD<br />

Orthopaedic and Trauma Surgeon/Spine<br />

Director of Zerktouni Orthopaedic Clinic<br />

Angle Bd 9 Avril & Bd Abdou<br />

20100 Casablanca MOROCCO<br />

t.benzak@menara.ma<br />

Pierre Bernard, MD<br />

Clinique Saint-Martin<br />

Allée des Tulipes<br />

33608 Pessac FRANCE<br />

pb@cad-fr.com<br />

Former student of Pr Sénégas (University<br />

Hospitals of Bordeaux, France) and of Pr<br />

Dubousset (Saint-Vincent de Paul<br />

Hospital, Paris, France), Dr Bernard did<br />

most of his training and clinical practice<br />

at the Hôpitaux de Bordeaux from 1985<br />

to 2000. Since 1999 he has a private<br />

practice is spine surgery with Centre<br />

Aquitain du Dos, Clinique Saint Martin.<br />

Mark Beckner, MD<br />

8701 Maitland Summitt Blvd<br />

32810 Orlando (FL) USA<br />

Michel Biedermann, MD<br />

Orthopedic and trauma surgeon<br />

Main activity : Trauma, Children, Spine<br />

Hôpitaux de la Ville de Neuchâtel<br />

2000 Neuchâtel SWITZERLAND<br />

pir-bie@bluewin.ch<br />

Giuseppe Bonfiglio, MD<br />

Head of CTO<br />

Hospital Spine Surgery Dept<br />

Via Bignami<br />

20126 Milano ITALY<br />

giuseppebonfi@tiscalinet.it<br />

Carlos Botella, MD, PhD<br />

Head Division Neurosurgery<br />

Hospital General Universitario de Alicante<br />

Pintor Baeza, s/n - 03010 Alicante SPAIN<br />

cbotella@neurocirugia.com<br />

Dr Botella graduated in Medicine and<br />

Surgery at the Medical School of<br />

Valencia (Spain) in 1978. He did his<br />

Neurosurgery residency in Hospital La<br />

Fe (Valencia, Spain) from 1982 to1987<br />

and earned his PhD “cum laude” at the<br />

Medical School of Valencia (Spain) in<br />

1993. Since 1995 he is the head of the<br />

Neurosurgery Division at the General<br />

Hospital of Alicante (Spain).<br />

Sebastian Charosky, MD<br />

Orthopeadic Surgeon<br />

Institut Calot, Secretariat Rachis<br />

54 rue du Dr Calot<br />

62608 Berck FRANCE<br />

scharosky@hotmail.com<br />

Dr Charosky graduated with honours<br />

from the university of Buenos Aires.<br />

Former Resident of the Dupuytren<br />

Institut in Buenos Aires, Argentina. He is<br />

a member of the Groupe d’Étude de la<br />

Scoliose and of the Argentina<br />

Orthopeadic Association He is now<br />

working as a fellow in the Calot Institut,<br />

in the Spine Surgery Department<br />

directed by Dr Daniel Chopin.<br />

Oreste Ciaudo, MD<br />

Ortopaedic surgeon<br />

40 boulevard Victor Hugo<br />

06000 Nice FRANCE<br />

dr.ciaudo@wanadoo.fr<br />

Dr Ciaudo did his training at Pitié<br />

Salpétrière with Pr R Roy-Camille and<br />

has working in private practice in<br />

orthopaedic surgery of the spine since<br />

1983. He earned a Doctorate in Anatomy<br />

and in Law and is currently working as an<br />

expert for the Court.<br />

Curtis Cox, MD<br />

Neurosurgery-Spine Specialists Inc.<br />

1705 Christy Drive Suite 201<br />

65101 Jefferson City (MO) USA<br />

William Hoffman, MD<br />

1155 Dunn Road<br />

63136 St Louis (MO) USA<br />

Dennis Raymond<br />

Knapp Jr, MD<br />

Nemours Children’s Clinic<br />

Division of Pediatric<br />

Orthopaedic Surgery<br />

83 West Columbia Street<br />

Orlando, FL 32806 USA<br />

rknapp@nemours.org<br />

Dr Knapp graduated the Medical School<br />

at the West Virginia University in 1981.<br />

He did his residency in Orthopaedics at<br />

the West Virginia University from 1981<br />

to 1986 and he was a fellow in Pediatric<br />

Orthopaedics at theOrlando Regional<br />

Health-Care System from 1986 to 1987.<br />

Melvin D. Law, MD<br />

Spine, Reconstructive Spine<br />

Surgery & General Orthopaedics<br />

Centennial Medical Center<br />

Physicians Plaza<br />

2400 Patterson Street Suite 300<br />

37203 Nashville (TN) USA<br />

tnspine@aol.com<br />

Dr Melvin D. Law did his medical school<br />

training at the Medical College of<br />

Virginia, Richmond and did his<br />

internship in general surgery, then his<br />

residency in Orthopedic surgery and<br />

became a chief resident at the University<br />

of Tennessee College of Medicine,<br />

Chattanooga Unit. Erlanger Medical<br />

Center. He was a Hogan Spine Fellow at<br />

the Beth Israel Hospital (Harvard<br />

Medical School) and did a Fellowship in<br />

Trauma and Spine at the Harborview<br />

Medical Center (University of<br />

Washington). He is a member of the<br />

NASS, the AAOS, Nashville Academy of<br />

18 <strong>Argos</strong> SpineNews - N°9 April 2004


Medicine, Tennessee Orthopaedic and J.<br />

Robert Gladden Orthopaedic Societies.<br />

He is also a journal reviewer for Spine<br />

(Chairman of the Spine Review<br />

Committee since 2001) and board<br />

member of ARGOS North America,<br />

Centennial Medical Center Board of<br />

Trustees, Nursing Resource Solutions<br />

and Premier Orthopaedics and Sports<br />

Medicine PLC.<br />

Gregory O. Munson, MD<br />

Spine Surgeon<br />

Jewett Orthopaedic Clinic, PA<br />

2876 South Osceola Avenue<br />

320806 Orlando (FL) USA<br />

Dr Munson graduated the Medical<br />

School at the University of Missouri in<br />

1975. He was a spine fellow at the<br />

Southern Illinois University in 1981. He<br />

works with Jewett Orthopaedic Clinic,<br />

P.A. since 1982.<br />

Wilbert Pino, MD<br />

10131 W. Forest Hill Blvd<br />

33414 Welington (FL) USA<br />

Jean-Patrick Rakover, MD<br />

Centre de Chirurgie Vertebrale<br />

Clinique du Pré<br />

13 av René Laennec<br />

72018 Le Mans FRANCE<br />

j-p.rakover@wanadoo.fr<br />

From 1984 to 1991, Dr Rakover did his<br />

internship in several hospitals in France,<br />

among which Pitié Salpétrière Hospital,<br />

Paris, with Pr R Roy-Camille and Saint<br />

Vincent Hospital, Paris, with Pr J<br />

Dubousset. He graduated the Medical<br />

School at the Université Paris VI in 1991,<br />

then he was a Chief Resident in<br />

Ortopaedic Surgery with Pr R Roy-<br />

Camille at the Pitié Salpétrière Hospital<br />

in Paris. Dr Rakover is the author of over<br />

25 scientific papers, presented and/or<br />

published in national and international<br />

meetings and journals.<br />

surgical internship at the New England<br />

Deaconess Hospital, Boston,<br />

Massachusetts from 1992 to 1993 and his<br />

Orthopaedic Residency and was a Chief<br />

Resident at the Massachusetts General<br />

Hospital, Boston, Massachusetts, within<br />

the Harvard Combined Program,<br />

from1993 to 1998. From 1998 to 1999 he<br />

was a fellow in spine surgery in the<br />

Department of Orthopaedic Surgery of<br />

Thomas Jefferson University,<br />

Philadelphia, Pennsylvania.<br />

Howard Sharf, MD<br />

4000 Park St. N<br />

33709 St Petersburg (FL) USA<br />

Manolis Tsafantakis, MD<br />

41 Agia Paraskevi<br />

15343 Athens GREECE<br />

Thomas Patsiaouras, MD<br />

Orthopaedic Surgeon<br />

Asklepeion Hospital<br />

Vas. Paulou 1, Voula - Athens GREECE<br />

thomaspa@hol.gr<br />

Jonathan H. Phillips, MD<br />

Practices: Nemours Children’s Clinic<br />

Orthopaedic Division<br />

83 W. Columbia Street<br />

Orlando, Florida 32806 USA<br />

jphillips@nemours.org<br />

Dr. Phillips attended St. George’s<br />

Hospital Medical School at the<br />

University of London in London,<br />

England. He did his residency in<br />

Indianapolis, Indiana USA and a<br />

fellowship in Pediatric Orthopaedics with<br />

the Gillette Children’s Hospital in St.<br />

Paul, Minnesota USA and the Shriner’s<br />

Hospital for Crippled Children in<br />

Minneapolis, Minnesota USA. Dr.<br />

Phillips has been practicing in Pediatric<br />

Orthopaedics for 11 years.<br />

Francois Du Toit, MD<br />

MB ChB, M Med (Orth) (Pret)<br />

Consultant Orthopaedic Surgeon<br />

Rotorua Hospital, 83 Mountain Road<br />

Rotorua Rotorua NEWZEALAND<br />

devon15a@xtra.co.nz<br />

Dr Du Toit is a member of the South<br />

African Spine Society, South African<br />

Orthopaedic Association, AO Alumni,<br />

NEW ZEALAND Pedicle Club.<br />

Brett A. Taylor, MD<br />

Assistant Professor of Orthopaedic<br />

Surgery Adult Spine Specialist<br />

Washington University<br />

School of Medicine, Department of Orthopaedic<br />

Surgery One Barnes<br />

Jewish Hospital Plaza, Suite 11300<br />

63110 St. Louis, Missouri USA<br />

Dr Taylor graduated the Harvard<br />

University Medical School, Boston,<br />

Massachusetts in 1992. He did his<br />

Konstantinos<br />

Zachariou, MD<br />

Director of Scoliosis & Spine Unit<br />

Saint Paul’s Kat Hospital<br />

Nikis 2, Kifisia<br />

Athens 145 61 GREECE<br />

kzax@hol.gr<br />

Dr Zachariou has been involved into the<br />

Nationwide School Screenings and<br />

Research on Scoliosis and other spinal<br />

deformities since 1976. Among other<br />

achievements, i.e. design, manufacturing<br />

and clinical application of orthopaedic<br />

braces, he is the first user of<br />

transpedicular screws for spinal fixation<br />

in Greece in 1988. Dr Zachariou is a<br />

member of AAOS, ESS, EFORT, NYAS,<br />

AASS, ARGOS, HAOST, CHOS and the<br />

author of more than 200 announcements<br />

and publications in major National and<br />

<strong>International</strong> Meetings and Scientific<br />

Journals.<br />

<strong>Argos</strong> SpineNews - N° 9 April 2004 19


A classification of biomaterials<br />

Training<br />

A Classification<br />

of Biomaterials<br />

– Yves Debacker<br />

Consultant in Biomaterials<br />

About…<br />

… Yves Debackaer<br />

Consultant in Biomaterials<br />

(Clinical & Regulatory Affairs)<br />

Yves Debacker<br />

earned his PhD in<br />

Pharmaceutical<br />

Sciences and in<br />

Biochemistry and he<br />

also graduated the<br />

IAE of Lille, France<br />

in Business Management. He<br />

worked as an <strong>International</strong> Project<br />

Manager, General Manager and<br />

consultant for well known Drugs<br />

and Biomedical devices<br />

manufacturers. He was an<br />

international project manager for<br />

Bristol Myers Squibb holding and<br />

its subsidiary Zimmer, where he<br />

was in charge of clinical and<br />

regulatory affairs for bone<br />

substitutes. He also developed the<br />

collagen based range of<br />

biomaterials for Sofamor Danek<br />

where he was the general<br />

manager of the drugs and<br />

biomaterials subsidiary.<br />

…<br />

The term “Biomaterials” can be used broadly to encompass all<br />

materials that can be safely implanted into the human body. In<br />

common parlance, however, “biomaterials” are defined more<br />

narrowly and exclude metallic biomaterials, such as titanium or<br />

stainless steel, even though they are intensively used for<br />

implants. Historically, the first developments in biomaterial<br />

science consisted of finding a good biomaterial and testing its<br />

bio-compatibility, then trying to find as many applications as<br />

possible for that material. Nowadays biomaterials are custom<br />

designed to address a specific, precisely formulated need. This<br />

see change was caused by two factors. Firstly, technological<br />

progress has allowed customization of material production.<br />

Once materials could be reliably manufactured, the attitude<br />

toward their use evolved with phenomenal rapidity. The need for<br />

biomaterials is as old as time, but the explosive growth in the<br />

last three decades is derived from these changes in production<br />

and attitude. Wood and ivory were found in Egyptian mummies<br />

but, until recently, one could not refine the chemical properties<br />

of material. Once the first modern biomaterials were developed,<br />

health care professionals began to more clearly define their<br />

needs. The ability to design the products coupled with a more<br />

demanding clientele has produced the wide range of options<br />

currently available.<br />

THE PURPOSE of this article is to offer a general<br />

classification system for biomaterials. By codifying a<br />

classification system, we can better understand the best uses<br />

of specific products. For the purposes of our discussion, the<br />

main classification of biomaterials will derive from their<br />

resorption properties ; all these materials will thus be divided<br />

into resorbable or non-resorbable.<br />

Non-resorbable Biomaterials<br />

Alumina ceramics, bio-glass produced from silica salts,<br />

polymers (PEEK-polyetheretherketone, carbon fibres, PEpolyethylene,<br />

PMMA-polymetacrylate) are the most<br />

commonly used non-resorbable biomaterials. In spinal<br />

20 <strong>Argos</strong> SpineNews - N°9 April 2004


Training<br />

A classification of biomaterials<br />

surgery, the materials have been fashioned into<br />

interbody cages and spacers. Others have been<br />

used for bone replacement, such as the use of<br />

alumina ceramics for vertebral body<br />

replacement after corpectomy.<br />

Resorbable Biomaterials<br />

The resorbable biomaterials may be<br />

further divided into two classes : active<br />

and passive biomaterials.<br />

The resorption phenomenon at its most basic<br />

level is a chemical interaction between the<br />

biomaterial itself and the cells of the host.<br />

Passive biomaterials are materials that allow<br />

tissue development and tissue ingrowth inside<br />

the material network. The newly created tissue<br />

will then be integrated into and resorbed by<br />

the tissues around. This category includes most<br />

of the currently available biomaterials :<br />

• Bio-polymers : either natural (collagen,<br />

hyaluronic acid, chitosan, etc) or synthetic<br />

(PLLA, PGA or a mixture of both)<br />

• Resorbable ceramics (HAP-hydroxyapatite,<br />

TCP-tricalcium phosphates, BCP-biphasic<br />

ceramics) and phosphocalcium cements.<br />

These materials can be bio-chemically<br />

engineered to address different needs. For<br />

example, PLLA can be fashioned into resorbable<br />

interbody cages, while some other polymers<br />

(like hyaluronate) have anti-adhesion<br />

characteristics and may be used to reduce perineural<br />

adhesions. Hydroxyapatite and tricalcium<br />

phosphate have long been used for bone<br />

replacement. Phosphocalcium cements, as new<br />

and growing products, have been produced to<br />

act as an injectable viscous putty to fill bone<br />

voids.<br />

Active biomaterials directly act at the tissue or<br />

cellular level. These products release a chemical<br />

meditator that causes differentiation of<br />

precursor cell lines. Any material that has a true<br />

bio-chemical impact on tissues or cells is<br />

considered an active biomaterials.<br />

Active biomaterials may also be used as a carrier<br />

for therapeutic agents into the body. The<br />

biomaterial will, in this case, serve as an inert<br />

matrix into which the active agent - hormones,<br />

antibiotics, oncologic material - is infused and<br />

from which the material will be released into the<br />

body.<br />

Combinations of various biomaterials<br />

also hold great promise. Take for<br />

example, polylactic acid (PLLA)<br />

which is easily resorbable but is not<br />

osteo-conductive and, when<br />

resorbed, may induce fibrosis instead<br />

of bone formation. By adding a<br />

ceramic which is osteo-inductive but<br />

less resorbable, a material can be<br />

produced that yields a bone-forming<br />

resorbable composite.<br />

The border between active and<br />

passive biomaterials has become<br />

quite indistinct. Few of the newer<br />

products are either purely passive or<br />

active. As an example, researchers<br />

have recently shown that ceramics,<br />

which should be totally inert<br />

(passive), can induce slight bone<br />

formation (active) when implanted<br />

into muscle. This blurring of<br />

boundaries has led to a<br />

subclassification of biomaterials based<br />

on the activity of the individual<br />

chemical components of the product<br />

rather than of the material as a whole.<br />

Currently, spinal surgeons use<br />

biomaterials as fillers for bony<br />

defects, extenders or augmenters of<br />

graft materials, and as stabilizing or<br />

reconstituting frameworks for<br />

vertebroplasty. Devices and implants<br />

such as interbody cages have also<br />

been produced from biomaterials.<br />

Active biomaterials are currently<br />

being used as growth factors or antiadhesive<br />

agents for specific surgical<br />

indications.<br />

Newer trends in bio-material<br />

research are focussing on the<br />

development of autologus bone cell<br />

lines that form bone itself after reimplantation<br />

in the body and may<br />

help to repair or replace severely<br />

damaged body parts. The frontier of<br />

this research remains ever-changing<br />

and the potential limitless. ●<br />

… He also worked for Merck<br />

Biomet and for Boerhinger<br />

Mannheim as a biomaterials<br />

engineer and he was Clinical and<br />

Regulatory Affairs vice president<br />

for Europe for Regeneration<br />

Technology, a tissue bank based in<br />

California, USA, manufacturer of<br />

grafts for orthopaedic surgery.<br />

Among his clients, we may cite<br />

WRIGHT CREMASCOLI, DEPUY,<br />

LINK, HOWMEDICA ; SOFAMOR<br />

DANEK, FMS, KASIOS,<br />

ARTHREX ; EUROSURGICAL,<br />

ISOTIS, REGENERATION<br />

TECHNOLOGY, BIOBANK,<br />

TUTOGEN, BIOMET ; SPINE<br />

SOLUTIONS, ABS, LINKSPINE,<br />

STRYKER BIOTECH, ORTHOVITA.<br />

Today he is also an associate<br />

professor in Biomaterials at the<br />

Lariboisière - St Louis School of<br />

Medicine, Université Paris 7. Yves<br />

Debacker is member of numerous<br />

scientific societies, acting in the<br />

field of biomaterials : GESTO<br />

(groupe de recherche sur les<br />

substituts tissulaires osseux -<br />

research group on bone tissue<br />

substitutes), GRIO (groupe de<br />

recherche et d’informations sur<br />

l’ostéoporose - research and<br />

information group on osteoporosis),<br />

GRIBOI (groupe de recherche sur<br />

les biomateriaux injectables -<br />

research group on injectable<br />

biomaterials), AETB (association<br />

européennes des banques de<br />

tissus - European association of<br />

tissue bank), AATB : American<br />

association of tissue bank. ●<br />

Contact information :<br />

13 Gravier du robinet<br />

59117 Werdicq Sud FRANCE<br />

TEL+33 (0)3 20 39 28 60<br />

Fax+33 (0)3 20 39 03 79<br />

yves.debacker@orange.fr<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 21


Agenda<br />

Training<br />

ISCAS-<strong>8th</strong> Annual Conference of the<br />

<strong>International</strong> Society for Computer Aided<br />

Surgery<br />

June 23-26, 2004 - Chicago, IL USA<br />

www.cars-int.de<br />

State of the Art in Chronic Low Back Pain<br />

April 4-6, 2004 - Bodrum TURKEY<br />

www.vitalmedbodrum.com<br />

BritSpine 2004 III<br />

Combined Meeting of British Scoliosis Society,<br />

British Cervical Spine Society, Society for Back<br />

Pain Research, British Association of Spinal<br />

Surgeons<br />

April 28-30, 2004 - Nottingham ENGLAND<br />

www.qmc.nhs.uk/britspine<br />

2004 POSNA Annual Meeting<br />

April 28-May 1st, 2004 - St Louis, Missouri USA<br />

www.posna.org<br />

Advanced Techniques in Spinal<br />

Decompression & Fixation<br />

April 16-18, 2004 - St Louis, MO USA<br />

http://pawslab.slu.edu<br />

NASS Spring Break : Innovations in Spine Care<br />

April 22-24, 2004 - Boca Raton, FL USA<br />

www.spine.org<br />

55th Annual Meeting of the German Society<br />

of Neurosurgery (DGNC)<br />

1st Joint Meeting with the Hungarian<br />

Neurosurgical Society<br />

25-28 April 2004 - Cologne GERMANY<br />

www.dgnc.de<br />

Bone Summit : The Clinical Science of<br />

Making New Bone<br />

May 13-15, 2004 - Cleveland, OH USA<br />

www.clevelandclinicmeded.com<br />

IOF World Congress on Osteoporosis<br />

May 14-18, 20004, Rio de Janeiro BRAZIL<br />

www.osteofound.org<br />

Agenda<br />

Meetings of interest for spine surgeons<br />

and Biomechanics specialists<br />

ASIA, American Spinal Injury Association<br />

30th Annual Scientific Meeting<br />

May 14-16, 2004 - Denver, CO USA<br />

www.asia-spinalinjury.org<br />

6th European Trauma Congress<br />

May 16-19, 2004 - Prague Congress Centre<br />

CZECH REPUBLIC<br />

www.guarant.cz - www.trauma2004.com<br />

4th Annual AAOS/OTA Trauma Course :<br />

Current Management Concepts, Techniques<br />

and Practical Solutions<br />

May 20-23, 2004 - Phoenix, AZ USA<br />

www.aaos.org<br />

1st National Congress of the Romanian<br />

Society of Pediatric Orthopaedics and Trauma<br />

May 26-29, 2004 - Calimanesti, Caciulata<br />

ROMANIA<br />

www.sorop.ro<br />

Spineweek 2004 :<br />

Combined Meeting of Leading Spine Societies :<br />

<strong>International</strong> Society for the Study of the Lumbar<br />

Spine (ISSLS) - Spine Society of Europe (SSE)<br />

Cervical Spine Research Society European Section<br />

(E-CSRS) - Sociedad Iberolatinoamericana de<br />

Columna Vertebral (SILACO) - Sociedade<br />

Brasileira de Patologia da Coluna Vertebral<br />

(SBPCV) - Asia-Pacific Orthopaedic Association<br />

Spinal Section (APOA)<br />

May 30-June 5, 2004 - Porto PORTUGAL<br />

www.medicongress.com/spineweek<br />

<strong>International</strong> Research Society for Spinal<br />

Deformities Meeting<br />

June 10-12, 2004 - Vancouver, British Columbia<br />

CANADA<br />

www.interprofessional.ubc.ca/irssd<br />

The 10th Advanced Techniques in Cervical<br />

Spine Decompression & Stabilization<br />

July 30-Aug 01, 2004 - St Louis, MO USA<br />

http://pawslab.slu.edu<br />

New Techniques in Orthopaedics<br />

Aug 04-06, 2004 - Brisbane AUSTRALIA<br />

kevin@wickhams.com.au<br />

coralyn@wickhams.com.au<br />

<strong>Argos</strong> North America 2004<br />

August 6-7, 2004 - Nemacolin Woodlands Resort<br />

& Spa, Farmington, PA USA<br />

argosNA@argosna.org<br />

www.argos-europe.com<br />

Interdisciplinary Neck Course<br />

Sept 10, 2004 - Helsinki FINLAND<br />

www.oerg.at<br />

3rd World Congress World Institute of Pain<br />

Sept 21-25, 2004 - Barcelona SPAIN<br />

http://wipain.org<br />

3rd SICOT/SIROT Annual <strong>International</strong><br />

Conference<br />

26-29 September 2004 - Havana CUBA<br />

www.sicot.org<br />

TraumaCare 2004<br />

Oct 15-17, 2004 - Sydney, NSW AUSTRALIA<br />

www.traumacare2004.com<br />

19th Annual Meeting of the North American<br />

Spine Society<br />

Oct 26-30, 2004 - Chicago, IL USA<br />

www.spine.org<br />

5th World Congress on Low Back and Pelvic Pain<br />

Nov 10-13, 2004 - Melbourne AUSTRALIA<br />

www.worldcongresslbp.com<br />

Spine Surgery : Advanced Applications and<br />

Techniques<br />

Nov 19-21, 2004 - Rosemont, IL USA<br />

www.aaos.org<br />

SOFCOT (Société Française de Chirurgie<br />

Orthopedique et Traumatologique)<br />

Nov 09-12, 2004 - Paris FRANCE<br />

www.sofcot.com.fr<br />

22 <strong>Argos</strong> SpineNews - N°9 April 2004


Training<br />

Clinical case discussion<br />

Bone substitutes<br />

in 2004<br />

– Claude SCHWARTZ<br />

Founding president of Pro Biomateria group (GECO)<br />

Bone substitutes are frequently used in orthopedic and trauma<br />

surgery as an alternative or an additional adjunct to bone grafts.<br />

The use of biomaterials as yet another substitute has enjoyed a<br />

rapid development in the last few years.<br />

THIS GROWTH can be explained by two major problems<br />

with both autograft and allograft usage : the first one is the<br />

associated morbidity, as well as the volume deficiency of iliac<br />

autograft, a deficiency that is well recognized by spinal<br />

surgeons as they badly need it ; the other reason is the fear of<br />

a potential infectious contamination as well as the reported<br />

failures of allografts in some long term studies, which may be<br />

immunologically mediated. Some indications for the use of<br />

biomaterials are no longer in question, others are undergoing<br />

investigations and still much needs to be learned in this<br />

exciting field. Certainly, autologous bone graft is still the gold<br />

standard and it is obvious that we should not hesitate to use it<br />

when we have the possibility. From the time of its inception,<br />

in posterior spinal surgery, the articular processes and various<br />

resected bone fragments have been kept to be used as local<br />

autografts.Every user knows the associated complications and<br />

the morbidity of iliac autografts but it has been but seldom<br />

quantified ; publications on the subject are rare on this very<br />

well recognized subject. A recent meta-analysis [1] on 30 years<br />

(1966 to 1997) of publications in orthopedic surgery has had<br />

the merit to review the subject and the results were quite<br />

astonishing : there is no less than 49% associated morbidity !<br />

These authors have thus listed these as residual problems<br />

which are far from being exceptions : 29% developed chronic<br />

pain at the iliac graft harvest level. There were cosmetic<br />

deformity or concern in 40% of the cases. Other problems<br />

consist of : 10% resultant hematomas, 1.2 to 1.7% infection<br />

rate, 5% hernias, fractures of the anterior iliac spine, and<br />

rarely injuries of nerves or arteries. Moreover, the quantity of<br />

the harvested cancellous graft is often far from desirable. All<br />

this has obviously encouraged many investigators to search for<br />

an alternative solution to the use of autografts. Allograft, which<br />

has recently come under even more scrutiny for possible<br />

infectious complication [2] , seems generally to have been<br />

adequately tried and tested for the past twenty years following<br />

the publications of our American and Canadian colleagues,<br />

Harris [3] , then Mankin [4] and Gross [5] . Like some of them who<br />

began at that time to use it in this indication (most often in<br />

cryo-preserved form) we observed that some ten years later<br />

some patients had iterative pseudarthrosis. During those<br />

revision surgeries, we found little traces of allografts<br />

remaining, both for cases with massive grafts and split grafts.<br />

This resorption phenomenon, which is sometimes almost<br />

complete has been shown to us during a meeting organized in<br />

Quimper : Lazennec and La Pitié-Salpêtrière team had shown<br />

disturbing CT scans of allografts which had became literally<br />

hollow over time. Unfortunately this fundamental work does<br />

not seem to have been published. Considering that this<br />

phenomenon is quite frequent and severe, it is likely to be<br />

immunologically mediated. Some authors like B Loty [6] , AA<br />

Czitrom [7] , MC Horowitz [8] and most of all GE Friedlaender [9]<br />

had mentioned this possible immunologic rejection. At that<br />

time, it was common to think that frozen bone did not lead to<br />

an immunologic reaction, and that respecting blood type<br />

compatibility would be largely sufficient. When we preformed<br />

biopsies of allografts in revision surgeries for pseudarthroses,<br />

we had the histological confirmation of our worries : there<br />

were still signs of bone necrosis in the remaining allograft,<br />

both in block or split, with a few spindly trabeculae of new<br />

bone (fig. 1). Incorporation or true fusion remained superficial<br />

and never exceeded 2 to 3 mm in depth, what we readily call<br />

surface osteo-conduction, instead of true incorporation. In the<br />

literature, there are but a few publications stating long term<br />

success of allografts, (i.e. after over ten to twelve years) Such<br />

1<br />

Histology of morselized allograft after 5 years (C SCHWARTZ, Colmar)<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 23


w w w . a r g o s - e u r o p e . c o m<br />

PRELIMINARY PROGRAM :<br />

Session 1 :<br />

- Total vertebrectomty : when ?<br />

- Multimetastatic patients : what strategy ?<br />

Session 2 :<br />

- How to treat a recurrent tumor ?<br />

- When not to operate a metastatic patient ?<br />

Lectures :<br />

- New trends in treatment of tumors<br />

by radiotherapy<br />

- Complications during and after total<br />

“en bloc” corpectomy<br />

GUEST SPEAKERS TO INCLUDE :<br />

Stefano Boriani, MD<br />

ITALY<br />

Alan M Levine, MD<br />

USA<br />

John G Heller, MD<br />

USA<br />

Vincent Pointillart, MD FRANCE<br />

Antonio Martin Benlloch, MD SPAIN<br />

Katsuro Tomita, MD<br />

JAPAN<br />

ORGANIZING COMMITTEE :<br />

Pierre ANTONIETTI, MD<br />

Laurent BALABAUD, MD<br />

Philippe BEDAT, MD<br />

Jean-Paul FORTHOMME, MD<br />

Frank GANEM, MD<br />

Alain GRAFTIAUX, MD<br />

Mihai JIANU, MD<br />

Pierre KEHR, MD<br />

Christian MAZEL, MD<br />

Pr Wafa SKALLI, PhD<br />

Jean-Paul STEIB, MD<br />

Anca MITULESCU, PhD<br />

Alexandre TEMPLIER, PhD<br />

Richard TERRACHER, MD<br />

TH<br />

INTERNATIONAL AR<br />

“Pitfalls in spin<br />

THURSDAY 27 TH AND FRI<br />

MAISON DES ARTS ET MÉTIERS


GOS SYMPOSIUM<br />

al metastasis”<br />

AY 28 TH JANUARY 2005<br />

9 BIS AVENUE D’IÉNA PARIS XVI<br />

2005 STUDENT THESIS AWARD<br />

Rewarding the best thesis in spinal surgery or Biomechanics.<br />

The <strong>Argos</strong> Thesis Award recognizes outstanding medical<br />

and/or Biomechanics research targeting a contemporary clinical<br />

problem in the management of spinal pathologies. This<br />

award is open to all scientists having completed a PhD or PhD<br />

candidates at the end of their PhD program as well as to<br />

medical students for a Master of Sciencies Thesis or for a<br />

Medical School Thesis.<br />

Nominees must not have completed/defended their research<br />

work prior to November 2002. A cover letter specifying the<br />

candidate’s interest in being considered for the <strong>Argos</strong> Thesis<br />

Award, 2 copies of the final manuscript of the thesis (in the<br />

original language*) and 3 copies of a long abstract (in English),<br />

i.e. up to 5 pages, clearly presenting the nominee’s work and<br />

having the nominee as first or sole author should be submitted<br />

to the <strong>Argos</strong> Secretary Office no later than October 1st 2004<br />

(see also Instructions for long abstract presentation).<br />

The award decision will be based on the quality and originality<br />

of the research work, its potential impact on the management<br />

of spinal diseases, its clear and rigourous presentation.<br />

The awardee is expected to attend the 9th <strong>International</strong> <strong>Argos</strong><br />

<strong>Symposium</strong> in Paris, next January and to deliver a presentation<br />

of the work recognized by the award (7’ oral presentation + 3’<br />

discussion).<br />

The award includes a 1000€ prize, winner’s travel and accomodation<br />

expenses on the occasion of the 9th <strong>International</strong> <strong>Argos</strong><br />

<strong>Symposium</strong>, publication of the long abstract in the European<br />

Journal of Orthopaedic Surgery and Traumatology (EJOST).<br />

Instructions for long abstract preparation :<br />

To prepare your long abstract please refer to the Instructions to<br />

Authors in the European Journal of Orthopaedic Surgery and<br />

Traumatology (EJOST). For more information, please visit<br />

Springer website www.springerlink.com<br />

*Depending on <strong>Argos</strong> Board members capacities of reading<br />

the original language, i.e. at least one Board member curently<br />

reads and speaks your language. For more information, please<br />

contact Marjorie Salé :<br />

marjorie@argos-europe.com<br />

CALL FOR ABSTRACT<br />

Electronic submission deadline September 1, 2004<br />

Submit to abstract@argos-europe.com or directly on the website :<br />

www.argos-europe.com/abstract.html<br />

Submission rules :<br />

• Abstracts must be submitted by September 1st, 2004. All<br />

abstracts received after that date will not be considered<br />

• Abstracts must be submitted electronically<br />

• Abstracts must be submitted in English<br />

• Abstract recommended format :<br />

- Title<br />

- List all authors associated with the abstract<br />

- Main headlines : 1) Introduction and purpose<br />

2) Material and Methods - 3) Results - 4) Discussion and<br />

conclusion - 5) References - 6) Acknowledgements<br />

- Presenting Author contact information (phone, fax, eMail<br />

address, mailing address)<br />

- Institutional affiliations<br />

- Abstracts should not exceed 500 words<br />

• Abstracts are reviewed by the members of the <strong>Argos</strong><br />

Scientific Committee and will be read in “blind” fashion.<br />

• <strong>Argos</strong> will send notification of acceptance via eMail to the<br />

presenting author on or after November 22, 2004.


Bone substitutes in 2004<br />

Training<br />

confirmation would be necessary and more and more<br />

questions are arousing on this subject. Heterologous grafts<br />

have been used ever since the 19th century, but very early<br />

after Ollier [10] showed the existence of immunological<br />

problems. Xenografts had a renewal of popularity in the 50’s<br />

when Maatz [11] and his collaborators Graf et Lentz in Germany<br />

developed a bovine bone of which they had removed a<br />

maximum proteins by a process of dissolution : it was the hour<br />

of glory of Kiehl’s bone, which was short-lived in front of<br />

clinical failures, more late but constant, because of the<br />

remaining organic fraction. Progress to improve the purity of<br />

xenografts enabled to improve the tolerance ; however there<br />

had never been a true integration [12] , even in interbody<br />

arthrodesis [13, 14] and our experience [15, 16] with a prepared bovine<br />

bone (Surgibone ® ), on about thirty cases in various<br />

implantation sites confirms it in every case (fig. 2, 3). To that<br />

substitutes because of their regular porous structure and<br />

interconnected internal architecture, not unlike the human<br />

bone. There is the Porites variety which was most successful,<br />

marketed under the name Biocoral ® after various treatments of<br />

purification and chemical transformations. This ceramic is<br />

composed of about 98% of calcium carbonate, and thus is<br />

different from the human bone, which contains much less. In<br />

our experience there must be a total absence of contact with<br />

an organic fluid, such as synovial fluid, which seems to be able<br />

to slow down and even stop the re-colonization by the<br />

recipient’s cells. This is what can more probably explain the<br />

failures, with sequestration and aseptic serous discharges,<br />

which have been described and published both in<br />

traumatology and in opening osteotomies in the superior<br />

tibia [18, 21] . On the contrary, in spine surgery good results were<br />

reported [22] (fig. 4). The good results obtained with all those<br />

above-mentioned substitutes are far from being constant ; they<br />

4<br />

Coral (Biocoral © postoperatively, after 1 year, 2 years and 6.5 years, in a cervical interbody graft (P KEHR,<br />

Strasbourg)<br />

2<br />

Bovine Xenograft (Surgibone © behind the anterior tibia tuberose after 7 years and in a femur length<br />

adjustment after 5 years (C SCHWARTZ, Colmar)<br />

3<br />

Histology of bovine xenograft after 5 years in a femoral cortical zone<br />

(C SCHWARTZ, Colmar)<br />

was further added the problem of bovine spongiform<br />

encephalitis with a potential risk of contamination still<br />

possible by the said non conventional contamination agents<br />

which has obviously eliminated the interest for those<br />

xenografts. The bovine bone turned into ceramics at high<br />

temperature is one of the natural ceramics that has been<br />

hardly used [17] . On the subject of ceramics from natural origin<br />

as another biomaterial substitute, the coral must be revisited.<br />

Formed from the skeleton of marine animals of which<br />

numerous species exist, some of them have been used as bone<br />

vary a lot both according to implantation sites and to the type<br />

of bone substance loss, in addition, of course, to the type of<br />

substitute itself. Two paths have been the most explored by<br />

this research, that of calcium phosphate ceramics, mainly<br />

synthetic, and that of phosphocalcic cements, still called ionic<br />

or hydraulic. Their integration in the skeleton is different ; as<br />

well as their indications. Phosphocalcic cements are very old<br />

since Dresman [23] at the end of the last century reported about<br />

ten cases of various bone filling with calcium sulfate, also<br />

called plaster of Paris. For some fifteen years they were<br />

subjected to very interesting works by various high level<br />

teams [24, 26] . Those cements have been introduced on the market<br />

only recently, with clinical experiences which are still very<br />

limited. They result from an acid-base or hydrolysis reaction<br />

depending on cases with formation of different crystals fit into<br />

each other. For those phosphocalcic cements, considering the<br />

experimental works and the first clinical results, whether there<br />

is or not an absence of general or topical toxicity, despite a<br />

certain acidity during the reaction ; there is no harmful<br />

exothermic reaction either ; this is a stoichiometric reaction<br />

which is therefore very sensitive to the presence of water or of<br />

various ions, which can disturb it and therefore make the<br />

properties of cement vary once the cement has set ; the<br />

directions for use must therefore be strictly followed and most<br />

of all we must avoid an implantation site that would be too<br />

liquid and that would slow down or even inhibit the setting,<br />

which means that the implantation site must be accordingly<br />

prepared. Those cements look likely to resorb gradually and<br />

be progressively replaced by bone, as they disappear, without<br />

26 <strong>Argos</strong> SpineNews - N°9 April 2004


Training Bone substitutes in 2004<br />

slowing down the usual bone callus formation. The resorption<br />

velocity depends on the cement solubility, which depends<br />

itself on the setting characteristics. Besides there is the<br />

possibility which is still theoretical to add antibiotics (or even<br />

other active principles) ; their sustained release could<br />

constitute a considerable contribution in some treatments, as<br />

that of osteomyelitis. Those cements require an<br />

extemporaneous preparation, which means that it takes time,<br />

variable in length according to the operating room<br />

temperature ; they also must preferably be injectable, so that<br />

they can be inserted by minimal approach in the site and must<br />

well conform to substance loss which are sometimes deep and<br />

rifted ; then they must harden within a reasonable time for<br />

intraoperative use and have sufficient mechanical resistance.<br />

Finally there is the cost issue which is more and more<br />

important in surgery. This poses a real challenge. Some of<br />

these cements have appeared or are currently appearing on<br />

the market with very precise indications.Thanks to their<br />

mechanical properties, those bone substitutes can be used to<br />

complete the osteosynthesis ; they can be likely to replace a<br />

loss of post-traumatic substance in site of cancellous bone<br />

tissue, to help stabilizing a standard osteosynthesis only ; they<br />

are not adhesive substance. The fracture by compression in<br />

extension of the aging wrist, the pushing down of cancellous<br />

tissue in some fractures of tibial plates and of calcaneum<br />

(fig. 5, 6) are probably good indications ; for the moment, they<br />

rely on the results of the first series that could have been<br />

published on the fracture of the wrist [27, 28] . Another indication<br />

5<br />

Fig 5 : Ionic cement (Norian SRS © postoperatively and after 3 years in the distal radius (C SCHWARTZ,<br />

Colmar)<br />

Fig 6 : Ionic cement (Eurobone © 6 weeks postoperatively in the calcaneum (C SCHWARTZ, Colmar)<br />

can be the filling by injection of small benign tumors (like<br />

chondromas of phalanxes) after curettage by a minimal<br />

invasive approach ; in such cases, the patient could resume an<br />

activity almost immediately without particular need for further<br />

protection or immobilization. Considering experimental<br />

studies, there is also the possibility to use an injectable cement<br />

in some cases of vertebroplasty ; if all problems of rheology are<br />

solved, such technique will obviously be more satisfying than<br />

the use of acrylic cement. Therefore we can imagine that they<br />

be used as complementary treatment in some traumatic<br />

fractures with loss of cancellous substance of the vertebral<br />

body, which will perhaps enable to lighten the different<br />

osteosynthesis constructs in proportion, thanks to the filling of<br />

6<br />

the void by a solid bio-active substitute. More recently have<br />

appeared suspensions in aqueous phase of different pure or<br />

composite phosphocalcic ceramics ; they are also injectable<br />

but have no mechanical property ; our first uses in filling of an<br />

aqueous hydroxyapatite suspension (Ostim 35) show an<br />

excellent tolerance of the product and a quick and good quality<br />

consolidation of opening osteotomies where we have used it.<br />

(fig. 7, 8). This use is still too recent and isolated to already<br />

draw conclusions. As far as synthesis phosphocalcic ceramics<br />

7<br />

Hydrohylapatite aqueous suspension (Ostim 35 © after one year in the proximal tibia, after osteotomy (frontal<br />

and sagittal Xrays). (C SCHWARTZ, Colmar)<br />

are concerned, they are most often the result of a very high<br />

temperature heating (over 1000°C or 1100°C), called fritting,<br />

of a slurry, suspension of basis powders with a pore forming<br />

material, whose sublimation leads to macro-pores forming<br />

(from 100 to 500 microns of diameter) indispensable to bioactivity<br />

; micro-porosity, which considerably increases the<br />

surface of exchange with biologic fluids, corresponds to the<br />

interstices between grains assembled by matter bridges<br />

between themselves, interstices remaining after fritting. So<br />

those ceramics are bio-active that means they directly react<br />

with biological fluids and neighbouring cells, and this occurs<br />

all the more so since they have an important surface of<br />

exchange. The first works [29, 30] are already quite old, resulting<br />

mostly from research in the field of odontology and maxillofacial<br />

surgery. The first clinical series in humans seem to have<br />

been Australian and Japanese authors [31] , quite rapidly<br />

followed by Daculsi, Passuti and their collaborators in<br />

France [32, 34] . Various publications, particularly from De Bruijn,<br />

[35, 37]<br />

Mainard and Frayssinet and their collaborators have<br />

focused on the relationship between physico-chemical<br />

characteristics and osteo-integration. For their part, Le Huec<br />

and Clément [38] published very interesting experimental<br />

results proving the use to the spot of radio-labeled calcium,<br />

component of the ceramic, for bone reconstruction in the<br />

rabbit, but the existence of bio-activity itself has been known<br />

for a long time [39, 40] . Osteo-integration of ceramics in human<br />

bone, without fibrous interface between recipient bone and<br />

substitute, or between substitute and restored bone, has been<br />

[41, 42]<br />

proven more recently on the basis of convincing<br />

histological results. The conclusion is that it probably occurs<br />

on the following mode (fig. 9, 10) : there is first a migration<br />

phase of monocytic cells or multinucleate cells at the material<br />

surface without any vascular or connective consequence. Then<br />

8<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 27


Bone substitutes in 2004<br />

Training<br />

9 10<br />

Fig 9 : First stages of the integration of bi-phased ceramics (Eurocer ® ) (HA)<br />

Fig 10 : Total integration of bi-phased ceramics (Eurocer © ). A relatively spongious bony tissue filled the<br />

ceramic (HA). The latter was fragmented by bone remodeling. Bone trabeculae penetrated within the<br />

ceramic structure.<br />

we observe a fibroblasts and vascular elements infiltration,<br />

forming a connective loosened tissue, in the pores. We then<br />

observed a osteoblasts differentiation at the ceramic surface<br />

and the synthesis of an extra cellular bone matrix on this<br />

surface constituting an immature bone tissue. Finally there is<br />

a remodeling of this immature bone tissue, and then a very<br />

progressive remodeling of the ceramic, both replaced with a<br />

mature bone tissue. This phenomenon could be visualized up<br />

to some 5 to 6 mm depth in the bi-phasic porous<br />

ceramic.There is today two main types of ceramics : the beta<br />

tricalcium phosphate and the bi-phasic ceramics ; the latter<br />

have a variable percentage of hydroxiapatite and of tricalcium<br />

phosphate and are increasing on the market. However beta<br />

tricalcium phosphate alone is still used [43, 46] . Saragaglia shows<br />

quite interesting x-rays on the long term about such use in<br />

tibia opening osteotomies, with a perfect integration, but with<br />

much less resorption than what was first expected and that<br />

could have been described<br />

by others (fig. 11). As in<br />

every use of synthesis bone<br />

substitutes, whatever the<br />

anatomical site, the respect<br />

of standard practice in<br />

orthopaedic surgery is still<br />

necessary : thus a good<br />

preparation is needed<br />

together with a meticulous<br />

cleaning of the recipient site<br />

11<br />

Tricalcium Phosphate (Biosorb © after 5 years in the<br />

proximal tibia, after osteotomy (D SARAGAGLIA,<br />

Grenoble)<br />

to be in contact with a living<br />

bone. Therefore all of the<br />

granuloma must be removed<br />

in a prosthesis<br />

pseudarthrosis ; ceramics<br />

have no osteo-inducer effect in man, contrary to what has been<br />

proved in the dog [47] . After that, scraping of this recipient bone<br />

must be performed, especially if it is stiff and sclerotic ; this<br />

can be performed either with the bur or with a rongeur,<br />

depending on the local status and the operating site ; some<br />

minimal-perforations can be performed with a very thin drill,<br />

all this to favour the “escaping” of bone cells which are meant<br />

to gradually colonized those ceramics, and up to a certain<br />

depth. They are used only as reconstruction material. The<br />

addition of various autologous bone fragments which have<br />

been found on the spot (bone fragments resulting from<br />

reaming, fragmentation of laminas and other articular<br />

processes, osteophytes or possible ossifications) constitutes a<br />

certain biological benefit. A group of surgeons of the GECO<br />

(Groupe d’études pour la chirurgie osseuse - Group of Study<br />

for Bone Surgery), the Pro Biomateria group, has drawn up a<br />

book of requirements (pore size, global porosity, chemical<br />

composition with respective rates of hydroxyapetite and<br />

tricalcium phosphate) for 2 new bi-phasic ceramics according<br />

to their daily use. The first one (Eurocer 400 ® ), in form of<br />

granules with a diameter of a few millimetres, has nothing<br />

really original and is like other ceramics of this type ; it has<br />

been used and is still used in every case of significant loss of<br />

bone substance in which a mechanical support was not<br />

needed ; the second one (Eurocer 200 ® ), presented under<br />

various forms (discs, cubes, sticks…) has a mechanical<br />

resistance in compression<br />

similar to that of the<br />

cancellous bone. This was<br />

quite innovative at the time.<br />

It has been progressively<br />

and cautiously used in cases<br />

with significant absence/loss<br />

of substance, with a size<br />

sufficient enough to receive<br />

a graft, and in which a<br />

mechanical contribution was<br />

also needed [48, 49] (fig. 12).<br />

12<br />

Oonishi [50] had opened the<br />

Reconstruction of a stage 4 cotyle in a 78 year old<br />

woman with bi-phased ceramic granules and blocs<br />

(Eurocer © , after 6.5 years (C SCHWARTZ, Colmar)<br />

way with a published report<br />

two years before on the use<br />

of pure hydroxyapatite in<br />

thin granules to press sealed acetabulums on it. In review of<br />

our radiological results, use of granules seems beneficial, as<br />

contributing to reconstruction material on the spot, along the<br />

osteotomies performed in the approach of femurs (and along<br />

intra-operative fractures which sometimes occur) in difficult<br />

revision surgeries of the femurs (fig. 13). Our results were<br />

13<br />

Reconstruction with bi-phased ceramic granules and blocs (Eurocer © of 2 femurs in an 83 year old woman, after 2<br />

years in the right femur and 3 years in the left femur (C SCHWARTZ, Colmar)<br />

confirmed by F Gouin [51] for the cotyle and by L Sedel [52] for the<br />

femur. From 1996, through the impetus given by P Lecestre,<br />

we have used ceramics in cases of significant loss of bone<br />

substance in traumatology [53] (fig. 14). Successful results have<br />

been obtained with regularity. The absence of complications<br />

characteristic of those substitutes explains that the indications<br />

rapidly expanded to some pseudarthroses, as well as to<br />

osteotomies and to benign tumors [53] . Other teams of<br />

28 <strong>Argos</strong> SpineNews - N°9 April 2004


Training Bone substitutes in 2004<br />

References<br />

14<br />

Reconstruction of a burst inferior femur with bi-phased ceramic granules (Eurocer © after 1 month on the left<br />

side and after 18 months on the right side (P LECESTRE, La Rochelle)<br />

investigators had a similar approach concerning synthesis<br />

[43, 46, 54, 55]<br />

calcium phosphate ceramics (fig. 15, 16). Finally,<br />

honour when honour is due, our Pro Biomateria team took of<br />

15<br />

Fig 15 : Bone filling after benign tumor resection with bi-phased ceramic granules<br />

(Triosite © after 5 years (F GOUIN, Nantes)<br />

Fig 16 : Bi-phased ceramic granules (Eurocer © in a proximal tibia osteotomy, after 2.5 years<br />

(P LE COUTEUR, St Herblain)<br />

course an instant interest in the applications of synthesis<br />

substitutes in spinal surgery : JP Rakover, E Laloux and G<br />

Gagna published their first results on a large series of posterior<br />

fusions [56] , JP Steib on interbody fusions [57] (fig. 17). Besides,<br />

spinal surgery was the first to be concerned [21, 33] in France by<br />

the use of ceramics in orthopaedic surgery. However this<br />

spinal surgery also poses the most problems of evaluation<br />

since imaging is still often difficult to interpret and therefore<br />

clinical results are the only true available criteria, in addition<br />

to a few histological results [42] after material removals ;<br />

However as years go by, according to Delecrin and a team<br />

from Nantes [58] , who have worked a lot on this subject, it seems<br />

that ceramics combined with bone found on the spot could<br />

safely and accurately allow to avoid a complementary<br />

autologous graft harvest (both in postero-lateral fusions and in<br />

interbody fusions). The evolution of<br />

technologies has allowed the finalization of<br />

various synthesis bone phosphocalcium<br />

substitutes, accurately, safely and<br />

progressively replacing anything that could<br />

have been used so far. In addition,<br />

iatrogenic complications of those<br />

substitutes do not exist due to the way they<br />

are manufactured and to their composition.<br />

Clinical results on the medium term (almost<br />

up to 10 years) seem encouraging ; for this<br />

reason it seems quite natural that they are<br />

gaining wider acceptance and are used<br />

more frequently. ●<br />

17<br />

Interbody fusion with bi-phased ceramic granules (Eurocer ® ) (JP STEIB, Strasbourg)<br />

16<br />

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13. Motuo Fotso MJ, Brunon J, Duthel R (1993)<br />

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44. Lantuejoul JP, Cambuzat A, Clément D, Merloz<br />

P, Faure C, Plaweski S (1996) Utilisation du<br />

phosphate tricalcique comme substitut osseux :<br />

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45. Bonnevialle P, Abid A, Mansat P, Verhaeghe L,<br />

Clement D, Mansat M (2002) Ostéotomie tibiale de<br />

valgisation par addition médiale d’un coin de<br />

phosphate tricalcique. Rev Chir Orthop 88, 486-492<br />

46. Galois L, Mainard D, Delagoutte JP (2002) Beta<br />

tricalcium phosphate ceramic as a bone<br />

substitute in orthopaedic surgery. Int Orthop 26<br />

(2) 109-115<br />

47. Yang Z, Yuan H, Tong W, Zou P, Chen W, Zhang<br />

X (1996) Osteogenesis in extraskeletally<br />

implanted porous calcium phosphate ceramics :<br />

variability among different kinds of animals.<br />

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48. C Schwartz, P Lecestre (1997) Premiers résultats<br />

de l’utilisation de nouvelles céramiques<br />

biphasées de synthèse comme substitut osseux<br />

en chirurgie orthopédique et traumatologique.<br />

Rapport de la réunion annuelle du GRECO<br />

(société française de recherche en chirurgie<br />

orthopédique) Grenoble, 24 octobre 1997<br />

49. Schwartz C, Salloum B, Zehkini C, Frayssinet P<br />

(1999) Utilisation de céramiques biphasées<br />

dans la chirurgie de reprise des prothèses<br />

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Biomatériaux V, Romillat Ed, Paris. 269-276<br />

50. Oonishi H, Iwaki Y, Kin N, Kushitani S, Murata N,<br />

Wakitani S, Imoto (1997) Hydroxyapatite in<br />

revision of total hip replacements with massive<br />

acetabular defects : 4- to 10-year clinical results<br />

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51. C Perrier, V Gaudiot, D Waast, N Passuti, J<br />

Delecrin, F Gouin (2001) Analyse critique d’une<br />

série de reconstruction acétabulaire par<br />

biomatériaux et cupule sans ciment : à propos<br />

de 48 cas. Rev Chir Orthop 88, suppl 6, 2S88<br />

52. Nich C, Bizot P, Nizard R, Sedel L (2003)<br />

Femoral reconstruction with macroporous<br />

biphasic calcium phosphate ceramic in revision<br />

hip replacement. Key Engineering Mat, 240-<br />

242 : 853-856<br />

53. Schwartz C, Liss P, Lecestre P, Frayssinet P<br />

(1999) Biphasic synthetic bone substitute use in<br />

orthopaedic and trauma surgery : clinical,<br />

radiological and histological results. J Mater Sci :<br />

Mater Med 10 ; 821-825<br />

54. Gouin F, Passuti N, Delecrin J, Bainvel JV (1993)<br />

Utilisation d’une céramique poreuse biphasique<br />

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Chir Orthop 79, 554<br />

55. Meyrueis JP, Cazenave A, Le Saint B, Gadea J<br />

(1998) Utilisation d’une céramique<br />

macroporeuse biphasée en traumatologie. Rev<br />

Chir Orthop 84, Suppl II<br />

56. Rakover JP, Laloux E, Gagna G. (2001) Intérêts<br />

des céramiques biphasées de synthèse dans les<br />

arthrodèses postérieures du rachis lombaire :<br />

technique et résultats à propos de 264 cas.<br />

Rachis 13(3) 215-22<br />

57. Steib JP, Bogorin J (2001) Greffes<br />

intersomatiques rachidiennes par céramiques<br />

phospho-calciques. Evolution à plus d’un an de<br />

recul. Rachis 13 (3) 203-207<br />

58. Delecrin J, Takahashi S, Gouin F, Passuti N<br />

(2000) A synthetic porous ceramic as a bone<br />

graft substitute in the surgical management of<br />

scoliosis : a prospective, randomized study.<br />

Spine 25 : 563-569<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 29


Web review<br />

Internet<br />

Web review<br />

Orthopedic surgery appears on the internet in a variety of<br />

contexts ranging from academic institutional websites and<br />

websites for commercial ventures to personal webpages for<br />

individual surgeons. Educational material and product information is<br />

now avalaible around the clock.<br />

opportunities, industrial developments,<br />

market analyzes, jobs and every other<br />

initiative related to biomaterials science<br />

and associated fields, such as Tissue<br />

Engineering.<br />

Biomaterials<br />

www.biomaterials.org<br />

Since the 1950s, the research field of<br />

biomaterials has evolved from a side<br />

interest of pioneering engineers, dentists,<br />

and surgeons into a multi-disciplinary<br />

effort where professionals from dozens of<br />

different disciplines and educational<br />

backgrounds contribute significantly to<br />

the success of surgical, dental, and<br />

medical devices. Biomaterialists include<br />

physical scientists, engineers, dentists,<br />

biological scientists, surgeons, and<br />

veterinary practitioners in industry,<br />

government, clinical specialties, and<br />

academic settings.<br />

Biomaterials scientists study the<br />

properties of biological cells, their<br />

components, and complexes such as<br />

tissues and organs in their interactions<br />

with synthetic substances and implanted<br />

prosthetic devices. Biomaterials engineers<br />

develop and characterize the materials<br />

used to measure, restore and improve<br />

physiologic function, and enhance survival<br />

and quality of life. The Society For<br />

Biomaterials is a professional society<br />

which promotes advances in all phases of<br />

materials research and development by<br />

encouragement of cooperative educational<br />

programs, clinical applications, and<br />

professional standards in the biomaterials<br />

field. <strong>International</strong>ly recognized leaders in<br />

the biomaterials field participate in the<br />

Society and sponsored events.<br />

Biomat<br />

www.biomat.net<br />

The “Biomaterials Resources on the<br />

Internet WebPage” was created in May<br />

1998 and has considerably changed since<br />

then. In February 2000 it has become the<br />

Biomaterials Network, changing from the<br />

original collection of WWW links to an<br />

interactive source of information, where<br />

users can actively participate and<br />

communicate with each other. Biomat.net<br />

is aimed at linking the biomaterials<br />

community worldwide. Membership to<br />

Biomat.net is free, and members can<br />

browse all of Biomat.net without charge.<br />

This site is a collection of some selected<br />

internet links related to Biomaterials and<br />

also some relevant links to biomedical<br />

engineering, biology, medicine and<br />

health sciences in general. Biomat.net<br />

facilities also include a job exchange<br />

section, the Directory of Researchers,<br />

where research expertise can be<br />

searched, and a monthly newsletter. The<br />

major goals of Biomat.net consist in :<br />

• Providing an organized and meaningful<br />

biomaterials communication resource for<br />

scientists, researchers, members from the<br />

business community, government,<br />

academia, and the general public.<br />

• Acting as a resource center to disclose<br />

resources, organizations, research<br />

activity, educational initiatives, scientific<br />

events, journals, books, articles, funding<br />

ESB<br />

www.esb-news.org<br />

The European Society for Biomaterials<br />

(ESB) is non-profit making and its<br />

objectives are :<br />

• To encourage, foster, promote and<br />

developresearch, progress and<br />

information concerningthe science of<br />

biomaterials, as well as to promote,<br />

initiate, sustain and bring to a satisfactory<br />

conclusion research with others and<br />

programs of development and<br />

information in this particular field.<br />

• To collaborate with other associations<br />

and bodies whose efforts are directed at<br />

the same objectives and whose interest<br />

are allied with or are similar to those of<br />

the Society itself.<br />

• To promote the propagation of scientific<br />

information through publications and<br />

meetings.<br />

• To co-operate with other scientific<br />

organizations, governmental and private<br />

30 <strong>Argos</strong> SpineNews - N°9 April 2004


Internet<br />

Web review<br />

bodies, both national and international, in<br />

order to establish specifications and<br />

standards for biomaterials in general<br />

• To encourage progress in the field of<br />

biomaterials in all its aspects, including<br />

research, teaching and clinical<br />

applications, as well as to foster any other<br />

activity pertinent thereto.<br />

Biomaterials.org.uk<br />

www.biomaterials.org.uk<br />

Biomaterials.org.uk is designed to<br />

promote the growth and competitiveness<br />

of the UK biomaterials industry by<br />

engaging all parts of the supply chain in<br />

the successful development and<br />

exploitation of new and improved<br />

biomaterials-based medical devices<br />

which meet the needs of patients,<br />

clinicians and others in the healthcare<br />

services. Specifically we have been<br />

charged with the following tasks :<br />

- improve industry benefit from research<br />

base<br />

- optimise the biomaterials supply chain<br />

- promote best practice in<br />

product/process development<br />

- enhance UK design and manufacturing<br />

capabilities in active biomaterials<br />

- increase UK access to global markets<br />

devices, tissue replacement and<br />

engineering, cell therapies, biomedical<br />

engineering, microtechnology and<br />

nanotechnology in medicine and other<br />

topics in healthcare and body repair that<br />

are even nearer the boundaries of the<br />

known and possible. Until May 2000, the<br />

site was supported by funding from the<br />

European Commission through the<br />

Brite-EuRam programme. Now it is a<br />

production of BioBridge Publications.<br />

Center for Intelligent Biomaterials<br />

www.uml.edu/res/misc/intelbio.html<br />

The Center for Intelligent Biomaterials<br />

carries out basic and applied research on<br />

the evolved intelligent properties of<br />

specific biological macromolecules. This<br />

research involves studies to understand<br />

and utilize the informational and<br />

intelligent properties (such as selfassembly<br />

and self-diagnosis) of specific<br />

biological macromolecules, including<br />

proteins and DNA. High tech and<br />

biotech companies can gain access to the<br />

informational properties of biological<br />

macromolecules, novel biomaterials,<br />

conceptualizations of novel systems<br />

involving biological macromolecules and<br />

their applications to the companies‚<br />

specific problems and, whenever<br />

possible, equipment support to<br />

encourage and promote industry.<br />

objective of this website is to create<br />

interest, a sense of community, and<br />

enhanced understanding in mineralized<br />

tissue research amongst all the<br />

participants, especially the involved<br />

graduate and undergraduate students.<br />

This website is one of three<br />

communications devises used to foster<br />

the progress of research on the<br />

mechanosensory system in bone. The<br />

general phrase “mineralized tissue<br />

research” rather than the specific phrase<br />

“research on the mechanosensory system<br />

in bone” is used in the naming the<br />

website and describing these activities<br />

because it is believed that focus on the<br />

topic described by the specific phrase<br />

will actually involve almost all of the<br />

topics covered by the general phrase.<br />

The primary objective of this proposed<br />

communication activity is to create<br />

interest, a sense of community, and<br />

enhanced understanding in mineralized<br />

tissue research amongst all the<br />

participants, especially the involved<br />

graduate and undergraduate students.<br />

This will be achieved by assimilating<br />

information and making this information<br />

accessible and useful to national and<br />

international participants and researchers<br />

and the public at large. ●<br />

Your site here<br />

Your website may be interesting for our<br />

readers. Please send the address to :<br />

anca@argos-europe.com<br />

Biomateria<br />

www.biomateria.com<br />

In September 2000 the new Biomateria<br />

site was launched, open to anyone with<br />

an interest in biomaterials, medical<br />

Bonenet<br />

www.bonenet.net<br />

This website is designed to foster the<br />

progress of research on the<br />

mechanosensory system in bone. The<br />

Now available<br />

on the web<br />

One of our articles seems interesting<br />

enough for you to keep it in your<br />

archives or send it to a colleague ?<br />

You can now download it<br />

in Acrobat PDF from our<br />

website :<br />

www.argos-europe.com<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 31


Nacre as a European bone supplyschool<br />

Evaluation of surgery<br />

Nacre as a bone supply :<br />

basic data lead up<br />

to a promising alternative<br />

* Museum National d’Histoire<br />

Naturelle. Département des Milieux<br />

et Peuplements Aquatiques. USM<br />

401. UMR CNRS 5178. 7, rue<br />

Cuvier 75231 Paris cedex 05.<br />

** Département de Chirurgie<br />

Orthopédique, Clinique Jouvenet,<br />

Square Jouvenet 75016 Paris.<br />

*** CHRU de Fort de France. Sce<br />

de Chirurgie Orthopédique et<br />

traumatologique. BP 632 97261<br />

Fort de France Martinique Cedex.<br />

– Evelyne Lopez*, Pierre Antonietti**,<br />

Olivier Delattre***, Christian Milet*,<br />

Sophie Berland*<br />

About 10 years ago, mother-of-pearl or “nacre”<br />

was discovered to be bone biocompatible and<br />

basic studies (1, 2) have demonstrated the<br />

physiological conditions for their compatibility.<br />

Nacre and bone are both biogenic calcified<br />

compounds and both result from a<br />

biomineralization process in which mineral is<br />

deposited onto an organic matrix scaffold.<br />

IT IS WELL KNOWN that the bone matrix<br />

entraps molecules triggering bone<br />

regeneration. Nacre undergoes self-repair when<br />

damaged and this process also involves a cellular<br />

stimulation. Ongoing research reports the<br />

retrieval of like-proteins in the mineralizing<br />

matrix from distant taxa, not only for molecules<br />

involved in calcium binding, but also for those<br />

related to growth factors or cytokines.<br />

Consequently, these results support of the<br />

conservation of molecular signals for<br />

biomineralization control within the organic<br />

framework of biomineralized structures. Our<br />

working hypothesis is that the nacre matrix is a<br />

source for molecular signals that possess the<br />

ability to trigger bone cell commitment. Raw<br />

nacre bioactivity in bone systems was<br />

established by means of in vivo experiments. We<br />

used the mother-of-pearl inner layer of the shell<br />

of Pinctada maxima, a bivalve mollusk. The<br />

Pinctada nacre is composed of calcium<br />

carbonate crystallized in aragonite form on an<br />

organic matrix scaffold.<br />

The osteogenic activity of the nacre was<br />

investigated in the vertebral trabecular bone of<br />

sheep [3] . Cavities, 3mm in diameter, were<br />

prepared in the upper lumbar vertebrae via a<br />

posterior lateral extracanal percutaneous route<br />

(fig. 1a). Raw nacre, in powder form, was<br />

evaluated as an injectable bone void filler while<br />

the control cavities were left empty. The control<br />

specimens confirmed that the cavities were<br />

above critical size ; at 12 weeks, spontaneous<br />

bone healing was at a standstill and only a ring of<br />

new bone formation lining the edge of the cavity.<br />

A quiescent marrow lattice filled 62% of the<br />

32 <strong>Argos</strong> SpineNews - N°9 April 2004


Evaluation<br />

Nacre as a bone supply<br />

control cavities. The vertebral cavities filled with the nacre in<br />

powder form underwent a trabecular bone regeneration<br />

process and bone ingrowth occurred at the expense of the<br />

nacre (fig. 1b). Radiographic analysis showed that new bone<br />

formation was fully mineralized bone and subjected to<br />

remodeling, i.e., equivalent to normal, healthy bone (fig. 1c).<br />

The osteogenic effects of nacre were also evaluated in a rabbit<br />

model [4] . An intertransverse arthrodesis, between the fifth and<br />

sixth lumbar vertebrae, was performed with either autologous<br />

iliac crest bone or nacre powder mixed with autologous blood.<br />

The results indicate that Pinctada nacre can, like autologous<br />

bone, stimulate the formation of a bone bridge between the<br />

transverse processes of rabbit lumbar vertebrae. The spines<br />

implanted with nacre revealed bone between the vertebrae<br />

starting 5 weeks post-implantation. The nacre implanted at<br />

sites lacking stem cells or precursor cells led to endochondral<br />

bone formation (fig. 2). This suggests the release of active<br />

factors from the nacre as it dissolves leading to the recruitment<br />

and differentiation of fibroblasts from the connective tissue<br />

between the transverse processes to give rise to bone cells.<br />

In this experimental series, where nacre was used in powder<br />

form, bone ingrowth occurred at the expense of the nacre<br />

material. On the other hand, in a series of in vivo experiments,<br />

raw nacre pieces were designed for large bone defects and<br />

used as replacement bone devices in the femur of the sheep [5] .<br />

In this form, the nacre pieces showed a persistence in the<br />

bone without alteration of the implant’s general shape over a<br />

period of 12 months. However, there was surface microerosion<br />

at the edge of the nacre implant and new bone formation<br />

occured after implantation. Histological analysis showed that<br />

osteogenesis began within an intervening activated cell layer.<br />

Xray diffraction electron microscopy performed at the<br />

interface of the nacre and the recipient tissue characterized<br />

the initial step of osteogenesis to be a calcium and phosphorus<br />

rich layer, the elements of the bone mineral phase [6] . The<br />

complete sequence of osteogenesis resulted in direct contact<br />

between newly formed bone and the nacre, thereby anchoring<br />

the nacre implant (fig. 3).<br />

References<br />

1. E. Lopez, C. Milet, M. Lamghari, L. Pereira-Mouriès, S. Borzeix & S. Berland.<br />

The dualism of nacre. Key Engineering Materials, 2004, 254-256 : 733-736.<br />

2. P. Wesbroek, F. Marin. A marriage of bone and nacre. Nature 1998 ; 392:<br />

861-862.<br />

3. M. Lamghari, S. Berland, A. Laurent, H. Huet, E. Lopez. Bone reactions to<br />

nacre injected percutaneously in the vertebrae of sheep. Biomaterials, 2001,<br />

22 (6) : 555-562.<br />

4 M. Lamghari, P. Antonietti, S. Berland, A. Laurent, E. Lopez. Arthrodesis of<br />

lumbar spine transverse processes using nacre in rabbit. Journal of Bone and<br />

Mineral Research, 2001, 16 (12) : 2232-2237.<br />

5. O. Delattre, S. Berland, E. Lopez, Y. Catonné. La nacre : substitution du<br />

cartilage et de l’os Revue de Chirurgie Orthopédique, 1999, 85 (5) : 530.<br />

6. G. Atlan, O. Delattre, S. Berland, A. Le Faou, G. Nabias, D. Cot, E. Lopez.<br />

Interface between bone and Nacre implants in sheep. Biomaterials, 1999, 20 :<br />

1017-1022.<br />

7. L. Pereira, C. Milet, MJ. Almeida, M. Rousseau, F. Robichon, E. Lopez.<br />

Biological effect of the water-soluble matrix extract from the nacre of the<br />

bivalve mollusk Pinctada maxima on vertebrate cell proliferation and<br />

differentiation. Bone, 2001, 28 (5) : S249<br />

8. MJ. Almeida, L. Pereira, C. Milet, J. Haigle, M. Barbosa, E. Lopez. Comparative<br />

effects of nacre water-soluble matrix and dexamethasone on the alkaline<br />

phosphatase activity of MRC-5 fibroblasts. Journal of Biomedical Materials<br />

Research, 2001, 57 : 306-312.<br />

9. M. Rousseau, L. Pereira-Mouriès, M. J. Almeida, C. Milet, E. Lopez. The<br />

water-soluble matrix fraction extracted from the nacre of Pinctada maxima<br />

produces earlier mineralization of MC3T3-E1 mouse pre-osteoblasts.<br />

Comparative Biochemistry and Physiology A, 2003, 135 (2) : 271-278.<br />

Figure 1a : General image (scanning) of a sheep<br />

lumbar vertebrae showing the route of the bone void.<br />

Figure 1b : Microradiograph of an undecalcified<br />

section of a nacre injected vertebral cavity at 12<br />

weeks. New bone formation occurred within the bone<br />

void filled with the nacre powder (N). The bone foci<br />

formed at the expense of the nacre filling material.<br />

Recipient bone at the edge of the bone void (B).<br />

(magnification x25)<br />

Figure 1c : A higher magnification shows that new<br />

bone formation is subjected to remodeling. Numerous<br />

concentric bone-forming units are observed which,<br />

with remodeling, give rise to elongated trabeculae.<br />

Newly formed bone is being fully mineralized ; the<br />

Xray density is related to the degree of maturity of the<br />

mineralizing bone. (magnification x25)<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 33


Nacre as a bone supply<br />

Evaluation<br />

We demonstrated that the nacre organic matrix is the source<br />

for the signal molecules responsible for bone cell stimulation.<br />

Recent cellular biology studies have shown that the<br />

dissolution products of the organic matrix of nacre control the<br />

stimulation of osteoprogenitor cells [7, 8, 9] . The water-soluble<br />

components of the organic matrix were extracted from nacre<br />

following a patented process ; no demineralization step was<br />

performed. In in vitro experiments, bone cells and bone stem<br />

cells were supplied with the extracted nacre water-soluble<br />

matrix. Bone cells cover a variety of phenotypes - we used the<br />

different mammalian cell types involved in bone regeneration.<br />

The cells were chosen to provide a set of osteogenic lineage<br />

from precursors to differentiated and mature bone cells. Bone<br />

marrow stromal cells, fibroblasts (MRC5 cell line), and<br />

preosteoblasts (MC3T3-E1 cell line) were supplied with the<br />

nacre water-soluble matrix extract. The commitment of these<br />

cells to bone formation was assessed by means of alkaline<br />

phosphatase activity and osteocalcin measurements. The<br />

effects of the nacre organic matrix extract were compared to<br />

those of well-known bone inducers, dexamethazone and BMP-<br />

2. The nacre organic extract induces the recruitment of bone<br />

marrow stromal cells and the maturation of osteoblastic cells<br />

up to the bone matrix mineralization phase. This effect was<br />

assessed by the increase in osteocalcin production, a specific<br />

marker of bone matrix mineralization in the cultures.<br />

Bone marrow cells, supplemented with the nacre organic<br />

extract, started to mineralize after 14 days of culture.<br />

Meanwhile, the osteocalcin level increased consistently,<br />

corroborating the maturation of the bone marrow cells into<br />

bone forming cells.<br />

The MRC5 fibroblastic response to the nacre organic extract<br />

treatment was an early increase in alkaline phosphatase<br />

activity when compared with the differentiating factors effects<br />

in the control groups. Alkaline phosphatase activity and<br />

osteocalcin measurements showed that preosteoblastic cells<br />

were induced to maturation, up to mineralization in MC3T3-<br />

E1 cultures.<br />

The organic matrix isolated from Pinctada nacre contains the<br />

signals responsible for bone cell commitment, e.g., the<br />

biological activity of the whole nacre that we observed in the<br />

in vivo studies. Indeed, this matrix acts, in particular, on bone<br />

cell recruitment and differentiation until the final step of<br />

mineralization.<br />

The nacre can provide a biomaterial basis for bone<br />

regeneration. For a biomaterial to be successful, bioactivity<br />

must be achieved. The objective in bone reconstruction is<br />

biomechanical quality of the newly formed bone and/or the<br />

bone provided by an implant. Implant fixation implies the<br />

need to obtain a strong bond while preserving physiological<br />

conditions and normal stress patterns. Failure of the interface<br />

integrity between host bone and a bone graft implant results<br />

in loosening and continues to be the leading cause of bone<br />

implant fracture. Our studies gave evidence that bone and<br />

nacre can form a hybrid interactive system, transient or<br />

sustained, because the durability of implanted nacre is shaperelated.<br />

Nowadays, biomaterials are not only dedicated to<br />

replace organs, they are required to have bioactive properties<br />

so that the self repairing capability of the tissue is stimulated.<br />

Nacre belongs to this generation of biomaterials.<br />

The mother-of-pearl from the Pinctada shell has proven to be<br />

a biomaterial that stimulates bone regeneration. Basic studies<br />

have shown that nacre is bone biocompatible and is a natural<br />

delivery system for signals inducing the bone cells and their<br />

precursors to take part in a healthy bone formation process. ●<br />

Figure 2a : Light microscopy of an histologic<br />

undecalcified section 11 weeks after arthrodesis using<br />

a nacre graft. Endochondral bone formation process<br />

occurred after nacre implantation. N = nacre, C=<br />

cartilage, B = bone. Toluidine blue staining.<br />

(magnification x16)<br />

Figure 2b : Contact microradiograph of a section at<br />

the arthrodesis site. Nacre particles (N) remain at the<br />

edge of newly formed mineralized bone in which bone<br />

trabeculae are organized around bone marrow spaces.<br />

(magnification x2).<br />

Figure 3 : Microradiograph of an undecalcified<br />

section of trabecular bone provided by a raw piece of<br />

nacre implant (N). One year after the implantation, the<br />

nacre implant is sustained. Bone ingrowth and<br />

remodeling occurred within the recipient tissue and<br />

trabeculae bridge the nacre implant.<br />

34 <strong>Argos</strong> SpineNews - N° 8 April 2004


Communication<br />

Litterature update<br />

Source PubMed - Keywords : biomaterials & spinal<br />

Litterature<br />

update<br />

Rodgers KE, Robertson JT, Espinoza T, Oppelt W, Cortese S, diZerega GS,<br />

BergRA. Reduction of epidural fibrosis in lumbar surgery with Oxiplex<br />

adhesion barriersof carboxymethylcellulose and polyethylene oxide. Spine J.<br />

2003 Jul-Aug ; 3(4) : 277-83 ; discussion 284.<br />

Mehbod A, Aunoble S, Le Huec JC. Vertebroplasty for osteoporotic spine<br />

fracture : prevention and treatment. Eur Spine J. 2003 Oct ; 12 Suppl 2 :<br />

S155-62. Epub 2003 Sep 19. Review.4<br />

Pavlov PW. Anterior decompression for cervical spondylotic myelopathy. Eur<br />

Spine J. 2003 Oct ; 12 Suppl 2 : S188-94. Epub 2003 Sep 10. Review.<br />

Narotam PK, Pauley SM, McGinn GJ. Titanium mesh cages for cervical spine<br />

stabilization after corpectomy : aclinical and radiological study. J Neurosurg.<br />

2003 Sep ; 99(2 Suppl) : 172-80.<br />

Mitchell MJ, Baz MA, Fulton MN, Lisor CF, Braith RW. Resistance training<br />

prevents vertebral osteoporosis in lung transplantrecipients. Transplantation.<br />

2003 Aug 15 ; 76(3) : 557-62.<br />

Fini M, Giavaresi G, Greggi T, Martini L, Aldini NN, Parisini P, Giardino R.<br />

Biological assessment of the bone-screw interface after insertion of<br />

uncoatedand hydroxyapatite-coated pedicular screws in the osteopenic<br />

sheep. J Biomed Mater Res. 2003 Jul 1 ; 66A(1) : 176-83.<br />

Boone DW. Complications of iliac crest graft and bone grafting alternatives in<br />

foot andankle surgery. Foot Ankle Clin. 2003 Mar ; 8(1) : 1-14. Review.<br />

Takahashi H, Ejiri T, Nakao M, Nakamura N, Kaga K, Herve T. Microelectrode<br />

array on folding polyimide ribbon for epidural mapping offunctional evoked<br />

potentials. IEEE Trans Biomed Eng. 2003 Apr ; 50(4) : 510-6.<br />

Lange U, Knop C, Bastian L, Blauth M. Prospective multicenter study with a<br />

new implant for thoracolumbar vertebralbody replacement. Arch Orthop<br />

Trauma Surg. 2003 Jun ; 123(5) : 203-8. Epub 2003 Apr 24.<br />

Blattert TR, Delling G, Weckbach A. Evaluation of an injectable calcium<br />

phosphate cement as an autograft substitutefor transpedicular lumbar<br />

interbody fusion : a controlled, prospective study inthe sheep model. Eur<br />

Spine J. 2003 Apr ; 12(2) : 216-23. Epub 2002 Oct 29.<br />

Nuzzo S, Meneghini C, Braillon P, Bouvier R, Mobilio S, Peyrin F.<br />

Microarchitectural and physical changes during fetal growth in human<br />

vertebralbone. J Bone Miner Res. 2003 Apr ; 18(4) : 760-8.<br />

Martin-Benlloch JA, Maruenda-Paulino JI, Barra-Pla A, Laguia-Garzaran M.<br />

Expansive laminoplasty as a method for managing cervical multilevel<br />

spondyloticmyelopathy. Spine. 2003 Apr 1 ; 28(7) : 680-4.<br />

Takahata M, Kotani Y, Abumi K, Shikinami Y, Kadosawa T, Kaneda K, Minami<br />

A. Bone ingrowth fixation of artificial intervertebral disc consisting<br />

ofbioceramic-coated three-dimensional fabric. Spine. 2003 Apr 1 ; 28(7) :<br />

637-44 ; discussion 644.<br />

Cahill DW, Martin GJ Jr, Hajjar MV, Sonstein W, Graham LB, Engelman RW.<br />

Suitability of bioresorbable cages for anterior cervical fusion. J Neurosurg.<br />

2003 Mar ; 98(2 Suppl) : 195-201.<br />

Iguchi T, Kanemura A, Kurihara A, Kasahara K, Yoshiya S, Doita M, NishidaK.<br />

Cervical laminoplasty : evaluation of bone bonding of a high<br />

porosityhydroxyapatite spacer. J Neurosurg. 2003 Mar ; 98(2 Suppl) : 137-42.<br />

Aouba A, Lidove O, Gepner P, Brousse C, Somogyi A, Piette AM, Scherrer<br />

A,Graveleau P, De Bandt M, Patri B, Bletry O. [Crowned dens syndrome :<br />

three new cases] Rev Med Interne. 2003 Jan ; 24(1) : 49-54. French.<br />

Meneghini C, Dalconi MC, Nuzzo S, Mobilio S, Wenk RH. Rietveld refinement<br />

on x-ray diffraction patterns of bioapatite in human fetalbones. Biophys J.<br />

2003 Mar ; 84(3) : 2021-9.<br />

McAfee PC, Cunningham BW, Orbegoso CM, Sefter JC, Dmitriev AE, Fedder<br />

IL. Analysis of porous ingrowth in intervertebral disc prostheses : a<br />

nonhumanprimate model. Spine. 2003 Feb 15 ; 28(4) : 332-40.<br />

Turner AW, Gillies RM, Svehla MJ, Saito M, Walsh WR. Hydroxyapatite<br />

composite resin cement augmentation of pedicle screw fixation. Clin Orthop.<br />

2003 Jan ; (406) : 253-61.<br />

Salamon ML, Althausen PL, Gupta MC, Laubach J. The effects of BMP-7 in a<br />

rat posterolateral intertransverse process fusionmodel. J Spinal Disord Tech.<br />

2003 Feb ; 16(1) : 90-5.<br />

Ozgur BM, Florman JE, Lew SM, Taylor WP, Gross C. Laminectomy<br />

contributes to cervical spine deformity demonstrated by<br />

holographicinterferometry. J Spinal Disord Tech. 2003 Feb ; 16(1) : 51-4.<br />

Kasai Y, Takegami K, Uchida A. Mixture ratios of local bone to artificial bone<br />

in lumbar posterolateralfusion. J Spinal Disord Tech. 2003 Feb ; 16(1) : 31-7.<br />

Kubo S, Goel VK, Yang SJ, Tajima N. Biomechanical evaluation of cervical<br />

double-door laminoplasty usinghydroxyapatite spacer. Spine. 2003 Feb 1 ;<br />

28(3) : 227-34.<br />

Seino H, Yamagata M, Takahashi K, Murata Y, Suzuki H, Moriya H.<br />

Biomechanical study of human cadaveric lumbar spine reinforced by<br />

newlydeveloped hydroxyapatite bone cement. J Orthop Sci. 2003 ; 8(1) : 50-4<br />

Stulik J, Krbec M, Vyskocil T. [Use of bioceramics in the treatment of<br />

fractures of the thoraco-lumbar spine] Acta Chir Orthop Traumatol Cech.<br />

2002 ; 69(5) : 288-94. Czech.<br />

Tay BB, Berven S. Indications, techniques, and complications of lumbar<br />

interbody fusion. Semin Neurol. 2002 Jun ; 22(2) : 221-30. Review.<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 35


Evaluation Biospacer ®<br />

With this in mind and in co-operation with Fin-<br />

Ceramica Faenza, we designed, produced and<br />

clinically tested a range of intervertebral spacers<br />

for the cervical spine. These spacers,<br />

made of Al2O3 Alumina with a<br />

bioactive coating (CE #0546), are<br />

designed to perform better in the<br />

most common clinical situations<br />

where interbody fusion is needed in<br />

the cervical spine.<br />

The shape of the implant has been<br />

designed to optimize immediate<br />

mechanical stability through alumina<br />

posts ; crevices and holes within the<br />

device facilitate bone in-growth and<br />

fusion. The advantages of the new<br />

device may be summarized thusly :<br />

BIOSPACER ®<br />

an innovative intervertebral Alumina spacer with a<br />

bioactive coating for the cervical spine surgery<br />

– N Francaviglia MD<br />

CM Laager PhD<br />

A Nataloni PhD<br />

Introduction<br />

The intervertebral spacers we designed to perform<br />

cervical fusions are made of Al2O3 Alumina with a<br />

bioactive coating and, compared to those currently<br />

in use, represent a step forward both in terms of<br />

design and materials. The particular shape of this<br />

new spacer has been designed using the finite<br />

element analysis (FEM*) in order to take into<br />

account the loads which the spacers will bear, and<br />

to plan to optimize the implants’ response to<br />

compression and flexion stress.<br />

* See Ceramica Acta, N°5/97, p. 5-13, 1997<br />

outstanding biocompatibility,<br />

anatomic and functional design, and<br />

proven bioactivity In this brief report,<br />

we present our results, at maximum<br />

follow-up of seven years, using this<br />

new device.<br />

Methods<br />

The Biospacer ® was designed based<br />

on a finite element analysis of the<br />

cervical spine from C1 to C7. After a<br />

thorough investigation of various<br />

available biomaterials we chose an<br />

Al2O3 ceramic (composed of crystals<br />

of Al2O3 with a polycrystalline<br />

structure) with a bioactive glass<br />

coating in a complete range of sizes.<br />

We chose the Al2O3 ceramic because<br />

the mechanical properties of the material are ten<br />

fold stronger than bone (after examination under<br />

the ISO 6474 Standard). The Biospacer ® has a<br />

About…<br />

… Natale Francaviglia<br />

Natale Francaviglia was born in<br />

Catania, Italy, in 1953. He<br />

graduated the medical and surgery<br />

school cum laude and published<br />

his thesis on<br />

“Coiling and kinking<br />

of the internal<br />

carotidis” in 1977.<br />

From 1980 to 1981<br />

he specialized in<br />

Neurosurgery.<br />

(Specialization thèsis on<br />

“Myelopathy due to cervical<br />

spondylartrosis”). He practiced as<br />

a neurosurgeon in several<br />

Neurosurgery departments in the<br />

world : Amsterdam, Upsala,<br />

London (with Professor Crockard),<br />

Hanover (with Professor Samii),<br />

Washington (with Professor<br />

Sekhar). From 1991 to 1996 he<br />

was a professor of Neurosurgery<br />

at the University of Genova. Since<br />

2000, he is the Head of the<br />

Neurosurgery department of<br />

Sant’Elia Hospital in Caltanissetta,<br />

Italy.<br />

Dr Francaviglia performed more<br />

than 1600 surgeries in Genova and<br />

about 800 in Caltanissetta, and<br />

published almost 100 scientific<br />

papers and book chapters. ●<br />

<strong>Argos</strong> SpineNews - N° 9 April 2004 37


Biospacer ®<br />

Evaluation<br />

micro-porous surface (manufactured using a<br />

proprietary technology) with pores of 0.05-0.06<br />

microns with a grain dimension of 2-5 microns.<br />

This microscopic architectural configuration<br />

optimizes coating with the bioactive glass and<br />

facilitates bony in-growth (fig. 1). The bioactive<br />

glass is derived from silica and sodium and<br />

calcium phosphates. Its ceramic properties have<br />

been modified in the microcrystalline phase to<br />

enhance bioreactivity during chemical bone<br />

resorption and reconstitution. At a chemical<br />

level, the goal is to activate immediate ionic<br />

exchange between the coating and the adjacent<br />

bone to produce an autologous hydroxyapatite<br />

and thus form an active bone-implant interface.<br />

Surgical procedure<br />

The surgical technique utilized is the standard<br />

anterior microscopic decompression facilitated by<br />

the use of the Caspar distractors. After preparation<br />

of the fusion bed, stainless steel trials are used to<br />

determine implant size. The Biospacer is then<br />

implanted and compressed. Fluoroscopy is used to<br />

confirm position. In multi-level procedures, an<br />

anterior cervical plate is applied. Postoperatively,<br />

patients wear a Philadelphia cervical collar for 8<br />

weeks (fig. 2).<br />

The follow-up period ranged from 3 months to 7<br />

years (with an average follow-up of 42.3 months<br />

and a standard deviation of ± 27.8 months).<br />

Cervical anterior-posterior and flexionextension<br />

lateral radiographs were obtained at<br />

two, six and twelve months after surgery (fig. 3a<br />

& 3b). Computerized tomography was obtained<br />

at six and twelve months.<br />

Fig 3a - Check CAT patient treated at one level<br />

Fig 3b - Check CAT patient treated at two level<br />

Results<br />

One hundred and two patients were treated<br />

with the Biospacer, six were lost to follow-up. In<br />

the remaining 96 patients, successful fusion was<br />

achieved in all cases. Implant stability was<br />

observed in all cases with no evidence of<br />

subsidence of any of the implants. Follow-up<br />

radiographs confirmed maintenance of the<br />

lordosis achieved at surgery and the CT scans at<br />

six and twelve months demonstrated bony ingrowth<br />

into the pores and bonding of the bone to<br />

the implant surface.<br />

Complications<br />

None.<br />

Patients groups<br />

Between 1996 and 2003 the senior author has<br />

treated 102 patients with a total of 144<br />

Biospacers ® implants. 64 of the procedures were<br />

at one level, 33 at two levels, 4 at three levels<br />

and 1 at four levels. Patients were operated for<br />

degenerative or traumatic cervical pathologies.<br />

70 were men and 32 were women. Patients’ ages<br />

ranged from 35 to 73 years with a mean age of 52<br />

years :<br />

Pathology<br />

Disc extrusion<br />

Trauma<br />

Spondylosis<br />

Pseudarthrosis<br />

Patients treated<br />

50<br />

16<br />

35<br />

1<br />

Conclusion<br />

This brief article reports our experience with the<br />

Biospacer ® for anterior cervical fusion at followup<br />

out to seven years. The three dimensional<br />

architecture of the implant facilitates immediate<br />

stability. The high compressive strength of the<br />

microporous alumina ceramic is a prerequisite<br />

to implant survival over the thousands of motion<br />

cycles that the cervical spine undergoes on a<br />

daily basis. Finally, the active bioglass coating<br />

enhances osteointegration of the spacer. Based<br />

on the long-term postoperative results, we<br />

believe our technique of interbody fusion is safe<br />

and effective. The use of the implant has<br />

eliminated the need for autogenous graft (and its<br />

incumbent morbity) and provided reliable<br />

fusion with preservation of cervical lordosis. The<br />

Biospacer ® not only acts as a spacer for<br />

reconstructing the defect left by decompression<br />

but also serves as a scaffold on which the fusion<br />

mass can be laid down. ●<br />

38 <strong>Argos</strong> SpineNews - N°9 April 2004


Communication<br />

Interview with C. Ray<br />

Interview with<br />

Charles Ray<br />

“<br />

When I was 9 years old, I knew that I wanted to be a doctor<br />

and my father, who was an engineer, also wanted me to be an<br />

engineer. I was also very mechanical ; at age 11 or 12, I could<br />

take a clock apart, then put it back together and it would work.<br />

Mechanical aptitude is something outside of education and<br />

intelligence. It is a set of skills that not everyone has. Today, I<br />

know of surgeons who are great thinkers but who are not<br />

mechanically so capable. They cannot help it because they do<br />

not have the same cerebellum. Anyway, I ultimately became<br />

involved in the field of spine work through my training in both<br />

neurosurgery and engineering. Approaching engineering, I<br />

started in physics, then became involved in engineering<br />

activities, then I did some graduated work in engineering<br />

during the time that I was a resident in neurosurgery. When I<br />

went to the Mayo clinic, for a graduate program in<br />

neurophysiology, a program was started between the Mayo<br />

clinic and the University of Minnesota in bio-engineering. I was<br />

one of the four students. Later, I taught a course in engineering<br />

as applied to medicine for the Clinic Staff. Organizing this<br />

course, which I later also gave after I went on the staff at Johns<br />

Hopkins Medical School as well as in Switzerland, forced me to<br />

put all such thoughts in proper perspective. As a result, I<br />

ultimately published a very large book on the principles of<br />

medical engineering.<br />

When I was 9 years old, I knew<br />

that I wanted to be a doctor…<br />

”<br />

interested in bio-engineering and others. Several were very<br />

creative people, like Vladimir Zworykin, who invented the<br />

television tube and camera. His brother was the founder of<br />

RCA (Radio Corporation of America). A Canadian friend, John<br />

Davis initiated the <strong>International</strong> Institute of Bio-Engineering<br />

based in Paris. We established a journal, with an international<br />

membership. This group formed a basis for further societies,<br />

but as industry became involved everything changed. More<br />

importantly, once the US-FDA (Food and Drug Administration)<br />

became involved in 1978, things really changed. While a fellow<br />

in the Mayo clinic I was given a key to the machine shop, since<br />

I was already a skilled machinist. Working there in the evenings<br />

1 2<br />

* Diversification of medical devices - from laparoscopy to electric stimulation<br />

My involvement in bio-engineering began in 1958, quite early,<br />

so I had the chance to meet several others who pioneered this<br />

field. There were NASA people, astronauts, professors<br />

Fig 1 : Drawing of a stereotactic brain instrument, affixed to the skull of a patient. The orientation components<br />

are visualized on Xray films and adjusted to reach the desired target. A hollow guide pin is drilled and driven<br />

into the skull and a narrow electrode probe inserted through it afterwards. Electroencephalographic<br />

recordings are made from the multicontact probe to localize foci of epileptic discharges prior to brain<br />

resection to stop the seizures. This device system was the only surgical device ever manufactured and sold in<br />

IBM. A component of the system is in the Design Collection of the Museum of Modern Art in New York City.<br />

Fig 2 : Drawing of the instrument of figure 1 attached by nailing to the skull, showing the orientation adjusted<br />

to reach the deep brain target (point 40). The probe length was then chosen.<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 39


Interview with C. Ray<br />

Communication<br />

I developed and prototyped a brain stereotactic machine and<br />

deep brain diagnostic electrodes which later became the only<br />

medical devices ever manufactured and sold by IBM. A<br />

component of this system is in the design collection of the<br />

Museum of Modern Art in New York. A small number of the<br />

systems were sold, but with FDA controls coming along, it was<br />

too complex and expensive to prepare all the documentation,<br />

that is, too expensive for a small marketed device, so it was<br />

abandoned.<br />

At John Hopkins, in Baltimore, I began to work on my book of<br />

1300 pages, entitled “Medical Engineering”, published in 1974<br />

but is now available again in offprint. This reference and<br />

teaching book details the entire field of medical engineering ; it<br />

required seven and a half years to finish, mostly while I lived<br />

and worked in Switzerland.<br />

Hoffman-La Roche, the pharmaceutical giant, became interested<br />

in diversifying into medical devices. A scout came to one of our<br />

meetings of the <strong>International</strong> Society of Bio-Engineering and<br />

asked me if I would come to Basel start this diversification in<br />

medical devices. I had never worked in industry. When I was at<br />

the Mayo Clinic I met Earl Bakken the founder of Medtronic.<br />

Thus, when I went into industry in Switzerland, Earl came to me<br />

and invited me to come and work with him at Medtronic. At that<br />

moment, I felt that I had a moral commitment to continue in<br />

Basel as long as it would be successful. I found that working in<br />

Switzerland was somewhat difficult. Many Swiss are interesting<br />

and personable people but from a business point of view they are<br />

difficult. So, after five years, having had considerable<br />

interference with upper management I felt the need to move on.<br />

At Roche I unsuccessfully proposed a variety of potential<br />

projects. One proposal in 1968, long before anyone else thought<br />

about it was instrumentation for laparoscopic surgery. But they<br />

expressed no interest in working on “gadgets”. Another long term<br />

project was the development of in vivo chemistry, using special<br />

solid state electrodes and fiber optic reflection/absorption<br />

spectroscopy to do wet chemistry inside the body. Some of these<br />

concepts are now slowly coming from other laboratories. The<br />

problem I had was many of the projects were away before their<br />

time and therefore speculative. We did, however, develop solid<br />

state oxygen electrodes and for measuring lactic acid levels in the<br />

arterial circulation of the body, which turned out to be a very<br />

good way to predict impending shock. After it was clear that the<br />

majority of these long-term projects were of no interest there and<br />

Earl Bakken had come again to ask me to come to Medtronic to<br />

start a diversification for them, I agreed. The diversification I<br />

started at Medtronic, now the world’s largest medical device<br />

company, made use of adapted cardiac pacemaker<br />

instrumentation to stimulate nerve tissue for pain and motion<br />

control. So the TENS units as well as peripheral nerves<br />

stimulators, vagus nerve stimulators, spinal cord stimulators,<br />

deep brain and cerebellum stimulators were used for pain and<br />

also for the control of abnormal movement and ultimately for<br />

epilepsy.<br />

“<br />

…the major cause of chronic<br />

disabling pain in North America<br />

was bad surgery of the spine…<br />

”<br />

These devices all started in my department there. Later I told<br />

Mr. Bakken that the development of the implantable pulse<br />

generators based on heart pacemaker technology had reached<br />

the point where there was nothing major left to be done.<br />

However, most important then was to find the targets in the<br />

body in which the electrodes should be placed, and to adapt the<br />

electrodes and pulse forms to best perform the stimulation.<br />

Thus the pressing need was for clinical applications. He agreed<br />

and I started a neurological rehabilitation institute in<br />

Minneapolis. It soon became obvious that the major cause of<br />

chronic disabling pain in North America was bad surgery of the<br />

spine and the use of oil contrast media for spinal myelography.<br />

These had the problems of nerve root injury and the potential<br />

for producing adhesions in the intradural space and its<br />

contained nerve tissue. These problems led to terrible pain<br />

conditions having little chance for cure. So we developed<br />

electrodes and targets for stimulation of the various nerve<br />

tissues which effectively blocked the pain sensations, giving<br />

relief in most cases. This Institute for Low Back and Neck Care<br />

in Minneapolis was begun together with a young neurosurgeon<br />

Charles Burton who had formerly been a resident of mine when<br />

I was on the faculty of John Hopkins. This institute was started<br />

in 1982, and is still prominent after 21 years. It is one of the<br />

original multidisciplinary spine institutes of the world. We had<br />

three neurosurgeons, three orthopaedic surgeons, three nonsurgeons<br />

and several certified physician’s assistants in our<br />

practice. That’s when I learned more about fusions, also<br />

learning to be dissatisfied with fusion technology in use at that<br />

time, 1986-1990. This was interbody fusion with bone alone,<br />

which did not work very well. Because of my engineering<br />

background, I worked on different methods such as<br />

approaching fusion through the facets joints then into the disc<br />

space. The method proved to be both hazardous and too<br />

difficult for surgeons to learn, however.<br />

When I attended the NASS (North American Spine Society, my<br />

being one of its founders) meeting 1987 in Canada, Doctor George<br />

Bagby gave a lecture showing the use of a perforated tubular<br />

device that he called “baskets” to create fusions in the necks of<br />

horses, I suddenly realized that if this basket were threaded, like<br />

3 4<br />

Fig 3 : Photography of Ray-Threaded Fusion Cages (TFC), developed and patented by the author. Over<br />

200,000 of these fusion devices have been successfully implanted in the USA and many countries of the<br />

world, without the need for additional instrumentation, pedicle screws, etc.<br />

Fig 4 : Drawing by the author showing the placement of Ray-TFC devices into the intervertebral disc space to<br />

promote a fusion.<br />

40 <strong>Argos</strong> SpineNews - N°9 April 2004


Communication<br />

Interview with C. Ray<br />

bone had been described by a Spanish surgeon friend, Ortero-Vich<br />

of Cordoba, Spain, then I would have a fusion cage. Thus, I<br />

developed the Ray threaded fusion cage, the instrumentation for it<br />

and the surgical technique. It has since been used in about 300 000<br />

people around the world. However, after working with the cage for<br />

five or six years, I again decided that there had to be something<br />

additional for chronic, disabling disc pain.<br />

“<br />

The fusions, although they serve<br />

well in selected cases, are not the<br />

best solution for many spine<br />

problems<br />

”<br />

For the last 16 or more years I had been doing intensive studies<br />

on the biology and pathology of the human intervertebral disc,<br />

beginnning at a time when few others were seriously studying<br />

the disc and its nucleus, except for investigators, like Jill Urban<br />

of London, and Gosh who had published a book on the biology<br />

of the disc, and a few others. From an engineering point of<br />

view, I assumed that the nature of the annulus depended upon<br />

the nature of the nucleus that in turn depended upon the nature<br />

of the endplate. And understanding this combination was the<br />

real approach that led to the development of a replacement for<br />

the disc nucleus.<br />

Fig 5 : Drawing of the new Prosthetic Disc Nucleus (Ray-PDN) placed into the emptied disc nucleus cavity to<br />

replicate the normal function of the nucleus, restore mobility and height of the disc space and relieve back<br />

pain. These devices (now inserted in about 3000 patients in 37 countries) ; are implanted in a dehydrated<br />

condition ; they then draw in water and swell, filling the emptied nucleus cavity, lifting and tightening the<br />

surrounding fibers of the outer disk annulus, restabilizing the spine segment. They are used to prevent postdiscectomy<br />

collapse with latent degeneration and to remove the necessity for a rigid fusion at selected spinal<br />

levels. A cervical spine version is also being developed. This easily implanted device may well replace the<br />

need for most spinal fusions and total artificial discs in the future.<br />

When the vertebral endplate is damaged or degenerated with<br />

age, the normal transmission of nutrients through it to the<br />

nucleus is largely finished. This loss of transport of nutrients<br />

into and anerobic waste products removal out of the nucleus is<br />

why the nucleus degenerates. The normall swelling of the<br />

nucleus hydrogel tightens and stabilizes the annulus. When the<br />

nucleus degenerates, much like letting the air out of an<br />

automobile tire, the tire (like the annulus) deflates, buckles,<br />

delaminates and fails. This prosthetic disc nucleus (PDN) had<br />

to be made of an inert hydrogel with considerable swelling<br />

power that did not depend upon endplate transport. This<br />

realization led to the development of the PDN, requiring about<br />

sixteen years. A key component was finding a proper polymer<br />

About…<br />

… Charles Dean Ray, MD<br />

Charles dean Ray, MD, MS, FACS, FRSH was born in<br />

Americus, Georgia, USA, Aug 1, 1927. He earned his A.B. in<br />

Pre-med Sciences, in Physics, at Emory University, Atlanta, GA,<br />

in 1950, and his M.S. with Honours in Experimental Physics at<br />

the University of Miami, in 1952. He was in charge of graduate<br />

courses in Bioengineering at the Christian Brothers Col.,<br />

Memphis, & the Univ. of Minnesota, Mayo Clinic. Later on, he<br />

also graduated with honors the Medical College of Georgia,<br />

1956.<br />

From 1956 to1957, he was a surgical Intern, then from 1957 to<br />

1962 neurosurgical resident at the Semmes-Murphey Clinic,<br />

Baptist Memorial Hospital, Memphis. In 1960 he became a<br />

Research Associate, Director of Neurosurgical Research Lab,<br />

University of Tennessee, Memphis, and from 1962 to 1964 he<br />

was also a Fellow in Neurophysiology and Course study &<br />

Lecturer in Bioengineering at the Mayo Clinic and Foundation.<br />

From 1964 to 1968 he was an Assistant Professor of<br />

Neurosurgery, Lecturer in Bioengineering, Director of the<br />

Neurometrics Laboratory, John’s Hopkins University and<br />

Hospital, Later on he moved to Switzerland and then Chief of<br />

Department of Medical Engineering, Corporation Vice-Dierector<br />

F. Hoffman-LaRoche & Co and also a visiting professor and<br />

Lecturer in Bioengineering, Bürgerspital, Univ. of Basel,<br />

Switzerland. He collaborated with Medtronic, Minneapolis, and<br />

acted as a Corporate Vice-President for almost 7 years (1972 -<br />

1979), and later on as a Senior Consultant (1979-1992), Neuro<br />

Division, being very much involved in the medical research. By<br />

the same period he was a Clinical Associate Professor in<br />

Neurosurgery at the University of Minnesota (1972-1982),<br />

Industry Rep. Advisory Panel on Neurology Devices, U.S.Food<br />

and Drug Admin, Washington, DC, (1975-1979), Editor-in-Chief,<br />

Medical Engineering, (1968-1974). and Medical Progress<br />

Through Technology (1970-1980), member of the Editorial<br />

Board, Medical Instrumentation, and other similar journals.<br />

From 1975 to 1982 he was the Chief of the USA Delegation for<br />

Neurosurgical Devices, ISO (<strong>International</strong> Organization for<br />

Standards).<br />

From 1980 to 1996 he was a President and Chairman of the<br />

Board for CeDaR Surgical Inc. and Senior Director, Spinal<br />

Neurosurgeon Institute for Low Back & Neck Care, Minneapolis,<br />

member of the Board of Directors (1977-1997), Herman Miller,<br />

Inc. (Fortune 500 Company), Zeeland, Michigan. Just after, in<br />

1996, he became the Director of Research & Development for<br />

the Spinal Research & Education Foundation, Norfolk VA until<br />

1999. He is also Past President and First chairman of Board for<br />

the North American Spine Society. Today Dr Ray acts as a<br />

neurosurgeon in the Medical Staff at Sentara Hospitals, (Norfolk<br />

General, Leigh Memorial), Norfolk, VA, he is the President of the<br />

American College of Spine Surgery, member of the Board of<br />

…<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 41


Interview with C. Ray<br />

Communication<br />

… Directors, American Board of Spine Surgery, Director<br />

Emeritus, Spinal Neurosurgeon, Institute for Low Back & Neck<br />

Care, Minneapolis MN, Senior Member of the American<br />

Medical Association, American Association of Neurological<br />

Surgeons & Congress of Neurological Surgeons, Senior Life<br />

Member, Institute of Electrical and Electronic Engineers, Board<br />

member for Spine-Health.Com, Chairman Emeritus & Medical<br />

Director, RayMedica Inc., Minneapolis, President InveRay,<br />

Ltd.Yorktown, VA, Member of the Board of Directors, A.A.M.I.<br />

Foundation, Chairman of the Committee on Materials and<br />

Devices, World Federation of Neurosurgical Societies, Editorial<br />

Reviewer for SPINE<br />

Member of the Joint Section of Spine & Peripheral Nerves,<br />

AANS/CNS, member of the Editorial Board and Publications<br />

Committee for the North American Spine Society<br />

President of the <strong>International</strong> Spinal Arthroplasty Society,<br />

member of the Amerercian College of Physician Executives,<br />

National Associate Member of The Oriental Institute, University<br />

of Chicago, and Archaeological Institute Of America.<br />

He is also a visiting professor in over 25 countries around the<br />

world. He was also the nominee of several prestigious honors :<br />

Distinguished Alumnus, Medical College of GA, 1994. Leon<br />

Wiltse Award (research and leadership in spinal surgery) NASS<br />

1997. Alpha Omega Alpha (Honor Medical Society)<br />

Sigma Xi (Science)<br />

WHO’S WHO in : The World, America, Midwest, Frontiers of<br />

Science, Science & Engineering, and Biomedical Engineering,<br />

American Men and Women of Science<br />

Cosmos Club (Washington, D.C.)<br />

Wisdom Society Honoree<br />

Recipient “Golden Spine Award” 1985. Pres. Discretionary<br />

Award, Medical College of GA,’53<br />

Bausch & Lomb Scientific award, Tech. High School 1945. For<br />

the design of the PDN (Prosthetic Disc Nucleus), he received<br />

the Gold Prize for the Most Important Medical Device Design of<br />

2000. Charles D. Ray published over 350 papers, including 2<br />

books on medical engineering, 1 on spinal surgery, 6<br />

monographs, 52 US & over 100 foreign patents, 2 device<br />

standards, many special reports, audio-visuals & original papers,<br />

abstracts or chapters.<br />

His works cover various fields, such as : neurosurgery, spinal<br />

surgery, clinical neurophysiology, medical business, health care<br />

administration, clinical engineering, psychometrics, research &<br />

development, medical/surgical materials & devices, medical<br />

ethics and regulatory control of med. devices. ●<br />

which would behave like the nucleus ; then we had to find a<br />

way to contain the polymer, the surgical technique to implant it<br />

and so on. Interestingly enough, there were no polymers<br />

available which would (1) hydrate rapidly under pressure, (2)<br />

allow for daily fluctuation in height in order to pump the<br />

nucleus juices through the endplate and (3) have the expansile<br />

ability to lift the disc space, when the normal force on the disc<br />

can be as much as 1.8 times the total body weight. This is a very<br />

large pressure distributed over a small surface area. So finally<br />

we modified a biocompatible polymer so that it could perform<br />

these tasks.<br />

“<br />

The molecular construction of the<br />

nucleus tissue cannot be imitated.<br />

”<br />

The means to achieve these functions is to permit the hydrogel<br />

to absorb water from surrounding tissues, while bearing the<br />

pressure. We found that if the polymer is manufactured so that<br />

it is in planar layers, therefore anisotropic, then under pressure<br />

while it is absorbing water, the layers slide apart and the<br />

height, therefore the volume of the prosthetic nucleus<br />

decreases. I have a patent on this expansile behavior. This<br />

change in height from day over night, performed by the normal<br />

nucleus tissue behaves opposite to our prosthetic nucleus,<br />

because when the normal nucleus absorbs water it increases in<br />

height, which could not be imitated by polymers, and still<br />

under pressure, fluctuate or pump. The molecular construction<br />

of the nucleus tissue cannot be imitated. It is too complex, a<br />

strange material, able to exchange free water under changes in<br />

presure, functioning in a strange way unlike any other<br />

hygrtoscopic material in nature. Even the animal nucleus<br />

material is different, being more fluid, more oil like, not having<br />

the same lifting power, which is not needed in quadrupeds. On<br />

finally developing the polymer pellet to be implanted, having<br />

the lifting power we needed, it was too rigid and if we<br />

increased the water content to soften the pellet before it was<br />

inserted it was too big. So we had to learn how to control the<br />

polymer size versus hydration so that even though we increased<br />

the hydration, promoting a faster hydration after implantation,<br />

the height was reduced ; no easy task. The trick here was to<br />

subject the layered partly hydrated polymer pellet to higher<br />

pressure during manufacturing before being implanted in the<br />

patient. Achieving these goals was almost like black magic,<br />

because there was no science that led us to it - only trial and<br />

error.<br />

“<br />

Material science generally is almost<br />

like black magic<br />

”<br />

One almost cannot predict how metal alloys will behave so one<br />

must make trials. Material science generally is almost like black<br />

magic. Polymers and co-polymers are largely the same. Indeed,<br />

44 <strong>Argos</strong> SpineNews - N°9 April 2004


Communication<br />

Interview with C. Ray<br />

so is the pharmacokinetics of pharmaceuticals. We were<br />

fortunate to have stumbled into the right combination not<br />

because we were so very smart but because we were very<br />

persistent. And now the PDN device is working remarkably<br />

well, better than I had ever expected. We have now implanted<br />

more than 2000 cases in 36 different countries of the world.<br />

This is why I travel a lot, to perform demonstrative surgery in<br />

these countries. We have a great research, development and<br />

professional marketing team that has made these effects come<br />

true. Every good project has to have a good team.<br />

I do not know of anybody more fortunate than I am, with these<br />

opportunities at this stage of science and by staying focused on<br />

the spine. Indeed, I feel that God has blessed me immensely.<br />

“<br />

…it takes experience to know what<br />

not to do…<br />

”<br />

I knew Prof. Roy Camille, a real genius in spinal stabilization.<br />

I do not perform scoliosis surgery, and do not appreciate or<br />

have need for long segment fusion, which present completely<br />

different biomechanical problems. The lumbar spine and much<br />

of the thoracic and cervical spine use short segment fusions.<br />

Arthur Steffe and Leon Wiltse are close colleagues and I used<br />

several of their devices and methods, interfacing as well with<br />

practically every surgeon of note in the spine field. It’s been a<br />

wonderful opportunity that will not come again because these<br />

pioneers are mostly gone. Today’s spine pioneers are involved<br />

in other things, particularly in spine arthroplasty. These giants<br />

include Karin Büttner Janz, Thierry Marnay, Hansen Yuan, Hal<br />

Mathews and others, plus several internationally famous<br />

surgeons who perform these methods with good clinical<br />

success. They are all members of the latest group of young<br />

lions, although none of us is very young anymore ; clearly, it<br />

takes time and experience to know what not to do. Classical<br />

training primarily teaches us what we should do, but it is only<br />

at the operating table and in a clinical environment that we<br />

learn what we should not do and what we cannot do ; these are<br />

equally important things that guide us.<br />

destruction of structural mechanics. So, to preserve anatomy<br />

and biology of a joint and not destroy it mechanically, leads to<br />

the concept of arthroplasty ; to repair the function of the disc,<br />

although not necessarily the structure. In a word, it is to<br />

stabilize without pain and without fusion. One of the clever<br />

things in medicine is knowing, in devices as in pharmaceuticals,<br />

what can be done functionally that does not necessarily appear<br />

the same structurally. This is like automobiles, which do not<br />

resemble covered wagons but they accomplish the same things.<br />

I think that the next target is to go after the source of the<br />

problem, to affect the endplate. It is the endplate that regulates<br />

or controls the biological and physiological behavior of the<br />

nucleus, which then affects the behavior and the structure of<br />

the annulus. So, when the endplate becomes sick or damaged,<br />

at the present time the result is irreversible. This is why I do not<br />

trust the idea of tissue transplants, genetic manipulation,<br />

cloning and the like to replace a sick nucleus, as long as the<br />

endplate is sick. One cannot improve the technique of warfare<br />

unless the supply lines are working. Therefore the project for<br />

the future is to heal the endplate. However, we do not fully<br />

know why normal endplates become damaged. At the present<br />

time there is no way to reverse most of the many degenerative<br />

processes. We do know that cigarette smoking damages<br />

endplates, some of the vasoactive drugs may damage them, but<br />

we otherwise have limited knowledge of what affects them,<br />

other than trauma or collapse. So the competition to develop<br />

proper arthroplasty devices arises not from existing devices,<br />

per se, but from knowledge in the field of biology, its<br />

physiology. My friend, Doctor Bob Mulholland, from<br />

Nottingham, England, an editor of the Journal of Bone and<br />

Joint Surgery, feels very strongly the same. Typical in science,<br />

when we run to the end of our knowledge we must circle back<br />

to study the fundamentals. ●<br />

“<br />

… the competition to develop<br />

proper arthroplasty devices arises<br />

not from existing devices, per se,<br />

but from knowledge in the field of<br />

biology, it’s physiology …<br />

”<br />

None of us is endowed with the power to predict the future. We<br />

can only predict trends ; the trend is now towards the<br />

preservation of anatomy and restoration of physiology without<br />

6<br />

Fig 6 : Drawing of a surgical kneeling frame for spine<br />

surgery, attached to the end of a standard operating table.<br />

Fig 7 : Drawing showing a patient in the kneeling position on<br />

the operating platform of Figure 3. On the back is a sterile<br />

'ring' that holds a variety of essential devices, such as<br />

retractors and illuminators used during surgery. Several<br />

additional patents detail these ancillary devices.<br />

7<br />

<strong>Argos</strong> SpineNews - N° 9 April 2004 45


Clinical case discussion<br />

Training<br />

In early 2001, she underwent a T6-S1 posterior fusion. The<br />

construct consisted of pedicle screws at T6-9, L1-3 on the left.<br />

There were screws at T6-9 on the right. For unclear reasons, a<br />

short rod was employed on the left at L1-3 with pedicle<br />

screws. No instrumentation was performed of L4, L5, or S1.<br />

Iliac bolts were placed bilaterally.<br />

Within six months the iliac bolts disconnected from the rods.<br />

The patient developed progressive loss of ambulatory ability,<br />

right leg radiculopathy, and severe, unrelenting back pain. She<br />

was unable to stand, sit, or lie comfortably. Two years after<br />

surgery, she sought an opinion from another surgeon.<br />

On examination, both ankle jerk reflexes were absent, straight<br />

leg raising on the right produced pain at 30°, and, on standing<br />

she pitched forward unto her walker. The distal ends of the<br />

rods were palpable through the skin, and stuck out like sticks<br />

when she stood up.<br />

Clinical<br />

case<br />

discussion<br />

Case presentation :<br />

The patient is an 82 yo female who initially underwent a<br />

decompressive laminectomy from L3-5 in 1997 (at age 76).<br />

About one year later, she developed severe back and leg pain<br />

and radiographs showed an unstable spondylolisthesis of L3-4.<br />

She was treated with an instrumented L3-5 postero-lateral<br />

fusion. Her pain initially improved but then she developed a<br />

recurrence of low back and bilateral radicular pain in 2000. By<br />

report, CT-myelography showed stenosis above her fusion.<br />

At the time of my evaluation, radiographs revealed<br />

displacement of the iliac bolts from the rods and an unstable<br />

listhesis of L3-4.<br />

She was treated surgically with anterior discectomies and<br />

interbody fusions at L2-3, L3-4, L4-5. Vertebral body screws<br />

were placed anteriorly at L2, 3, 4. On the same operative day,<br />

the posterior hardware was removed and a reconstruction was<br />

performed with pedicle screws bilaterally at T6, 7, 8, 9, L1, 2,<br />

3, 4, 5, and S1. Divergent sacral alar fixation was also<br />

employed.<br />

Currently, she is 8 months after surgery and walking with a<br />

cane. She has rare right leg discomfort and occasional back<br />

pain relieved by anti-inflammatory medicines.<br />

– W.B. Rodgers, MD<br />

Spine Midwest<br />

Jefferson City, MO, USA<br />

82 years old female :<br />

2 years TLS fusion<br />

Hardware failure at 6 months post-op.<br />

Revised anterior and posterior.<br />

46 <strong>Argos</strong> SpineNews - N°9 April 2004


Training<br />

Clinical case discussion<br />

Case comment 1 :<br />

“<br />

From the history it transpired that this lady at the age of 80<br />

underwent posterior stabilization from T6 to the pelvis for<br />

spinal stenosis cranial to a previously decompressed and<br />

stabilized spine (L3 to L5).<br />

The initial construct appears unusually long and with rather<br />

poor caudal fixation. In addition there appears to be an amount<br />

of sagital imbalance. This explains the failure of this long<br />

construct. It was interesting to note that the rod disconnected<br />

rather than the iliac bolts cut out. The revision has nicely<br />

addressed the sagital imbalance and distal fixation<br />

insufficiency.<br />

Nevertheless I still find this construct rather long. One could<br />

have perhaps considered during the previous (i.e. 2001)<br />

surgery limiting the stabilization to the decompressed level(s)<br />

taking into account the age of the patient. Alternatively one<br />

could stop at T10 or T11.<br />

Such long constructs in the elderly can be a problem.<br />

Pseudarthrosis is not uncommon and implant loosening is a<br />

major concern. In fact Zurbriggen et al* reported their long<br />

term experience in 40 patients with degenerative scoliosis<br />

(slightly different setting) treated surgically and noted that in<br />

half of them they had to remove the metalwork on average 4<br />

years later due to painful loosening. One would hope that the<br />

addition of anterior fixation limits this problem. I have to<br />

admit that I would personally hesitate to offer front and back<br />

same day surgery to a 82 year old lady. If the penultimate<br />

fixation was limited to L2 one might have got away with it for<br />

a couple of years…<br />

* Zurbriggen C. Markwalder TM. Wyss S. Long-term results in patients treated<br />

”<br />

with posterior instrumentation and fusion for degenerative scoliosis of the lumbar<br />

spine. Acta Neurochirurgica. 141(1):21-6, 1999.<br />

– Dr Constantin Schizas MD MSc Orth FRCS<br />

Médecin Associé<br />

Hôpital Orthopédique de la Suisse Romande, Lausanne SWITZERLAND<br />

(former Consultant Spinal Surgeon Whittington Hospital, London UK)<br />

Case comment 2 :<br />

“<br />

The case presented hereafter is strange. Why strange ?<br />

Because we do not know the diagnosis and the indication. We<br />

suppose it is an anterior imbalance, i.e. camptocormia, due to<br />

muscular deficiency.<br />

Why strange ? Because the spinal instrumentation with a great<br />

lever arm is bound to be dismantled and a single point of<br />

rod/screw fixation into the sacro-iliac joint has to maintain the<br />

whole spine and the head. This assembly together with the<br />

obvious absence of anterior bone graft explain why it was<br />

bound to be dismantled. The high lumbar instrumentation,<br />

through which the long rod is not inserted, supposes that the<br />

deformation was important in the thoraco-lumbar area. As a<br />

French former student of Mister Roy-Camille, on one hand I<br />

am surprised by the audacity of the surgeon who inserts<br />

screws in the high thoracic spine, on the other hand I don’t<br />

understand his prudery concerning the lack of implants in the<br />

low lumbar spine.<br />

On a 82 year old patient, the bone is never of exceptional<br />

quality, therefore the spine has to be multi-instrumented to<br />

obtain a solid fixation. The mobility is important as shown on<br />

the selective Xrays. Morover there is certainly an extensive<br />

pseudarthrosis. The deformation may therefore be considered<br />

as being flexible. A posterior surgery would probably solve the<br />

reduction problem but an anterior surgery will have to solve<br />

the stability issue.<br />

First, a posterior approach with removal of the<br />

instrumentation should be performed, cleaning of the spine,<br />

opening of all articulations and posterior osteotomies if<br />

needed. Then the spine should be re-instrumented keeping<br />

the same screw holes (larger diameter) and of course<br />

multiplying the fixation points in almost each instrumented<br />

vertebra in staggered rows. The sacral fixation will have to<br />

include a pedicular, alar and iliac fixation. A posterior graft and<br />

the rods will then be inserted.<br />

Once both rods have been inserted and the implants closed<br />

but not tightened, the bending of both rods must be<br />

performed at the same time, around each lumbar screw, one<br />

after the other, which will allow for a good restoration of the<br />

patient’s lumbar lordosis, by means of repeated maneuvers all<br />

along the spine. Then the anterior approach should be<br />

assessed.<br />

It seems obvious that the posterior surgery on a 82 year old<br />

patient is already a great challenge, but it will remain fruitless<br />

if an anterior intervertebral support is not put forward. This<br />

anterior surgery could be performed on the same day or a few<br />

weeks after. The approach will be at best video-assisted with<br />

small incisions but will have to include the whole lumbar part<br />

from T12 to S1 or even a little higher than T12. The graft could<br />

be composed of bone substitutes and cages could be used but<br />

they might sink into this soft bone. Once the graft is solid and<br />

if the sagittal balance<br />

”<br />

has been restored, the patient will be<br />

Ok. Good luck ! ●<br />

– Professor Jean-Paul Steib<br />

Hospital Physician - Spinal surgery, Hip and foot surgery<br />

Hôpitaux Universitaires de Strasbourg<br />

Hôpital Civil, Strasbourg FRANCE<br />

<strong>Argos</strong> SpineNews - N°9 April 2004 47

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