8th International Argos Symposium p12 - ArgoSpine
8th International Argos Symposium p12 - ArgoSpine
8th International Argos Symposium p12 - ArgoSpine
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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 />
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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 />
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Scientific & Technical Advisor :<br />
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Associate Editors :<br />
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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 />
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<strong>Argos</strong> SpineNews is published twice a year by<br />
Surgiview SAS. Printed by ICL Lens France. It is sent<br />
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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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(1999) Biphasic synthetic bone substitute use in<br />
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(1998) Utilisation d’une céramique<br />
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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 />
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57. Steib JP, Bogorin J (2001) Greffes<br />
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recul. Rachis 13 (3) 203-207<br />
58. Delecrin J, Takahashi S, Gouin F, Passuti N<br />
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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 />
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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 />
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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