BIOLOX - CeramTec

BIOLOX ®
BIOLOX ® – Ceramics for Hip Arthroplasty
Contains CD ROM
with 3-D Animation
It’s in Your Hands:
The Low Wear Choice
Against Osteolysis
Scientific Information on Wear Couples

Particle Problem
Material Answers
Large Diameters
Wear Couples
Particle-induced Osteolysis: The Most Important Cause
for Aseptic Loosening and Related Complications
Inevitable Revision
Greater Activity, More Wear
2
Total hip replacement (THR) is one of the
most successful surgical procedures in general.
Yet, a few problems remain unsolved,
and aseptic loosening is probably the most
important of them. One of the main
reasons for aseptic loosening in total hip
replacement is the foreign body reaction
caused by the wear particles which are
created by the articulating femoral ball
head and cup inlay. 29 (Fig. 1). The end result
of this process is osteolysis, making
revision surgery necessary in roughly 75%
of these cases. 26
The younger and more active patients of
today place very high demands on the
performance of their THR. Daily work,
sports, an intensive social and family life
often add up to a high level of activity.
What improves the quality of life on the
one hand also leads to a rising quantity of
wear particles from the artificial joint on
the other, eventually increasing the risk of
particle-induced osteolysis.
Known factors influencing the
production of wear particles are:
• patient activity
• the wear couple material properties
• the diameter of the wear couple
• the roughness of the surface
• the presence of third body wear.
Fig. 1:
Severe osteolysis
caused by the wear
particles of a metalpolyethylene
bearing,
15 years post-op
Wollmerstedt et al. clinical study:
Wollmerstedt et al. 32 measured real life
activity levels of THR patients. The result
was roughly 2 million load cycles per year
at an average age of 70, twice as high
as the assumption of 1 million cycles
equalling 1 year used in simulator studies.
The authors conclude that the quality of
the wear couples is even more important
than previously thought.

BIOLOX ® Makes the Difference
Goals to Achieve
The problems created by wear debris in THR
bearing systems containing polyethyl ene or
metal make reducing wear an imperative.
The objective must be to avoid the need
for revision while still allowing the patient
to live a normal or even high activity lifestyle.
Therefore, articulating materials
should have:
• the lowest production of wear particles
• the best biological behaviour from
generated wear particles
• the lowest osteolytic potential
• the lowest coefficient of friction.
Fig. 2:
Neocapsule of an
autopsy specimen of
a patient with ceramicceramic
couple after
8 years in vivo
show ing no ceramic
particles, smooth
syno vial surface and
moderate fibrosis. 6
3
All of these goals combined can be met
by utilizing ceramic bearing surfaces.
BIOLOX ® components can greatly help
in the prevention of revision surgery.
Source: Bos I, Institute of Pathology, University of Lübeck (Germany)
Fig. 3 Fig. 4
Fig. 3:
Male, 30 years,
preoperative X-ray of
left hip joint with
coxarthrosis; right hip
joint with ceramic-onceramic
THR 8 years
after implantation
Source: Garino J, University of Pennsylvania (USA)
Fig. 4:
Postoperative X-ray,
left hip joint also with
ceramic-on-ceramic
THR

Particle Problem
Material Answers
Large Diameters
Wear Couples
The Ideal Technology for Preventing Osteolysis:
The BIOLOX ® Ceramic Family of Products
Reducing Wear
The Advantages of BIOLOX ® Products
4
There is a direct relationship between the
amount of wear and the risk of osteolysis.
The use of ceramic femoral ball heads that
articulate against ceramic, polyethylene or
crosslinked polyethylene inserts provides
the best solution for a selective approach
to the problems of osteolysis.
• They produce the lowest particle
and osteolytic potential of all commonly
used bearing materials.
• They have the potential to create the
lowest risk of particle-induced osteolysis
and loosening.
• They have an extremely low level of
biological activity due to their chemical
composition, size and shape of ceramic
particles.
• They are also specially suited for patients
with hypersensitivity to metals.
Linear Wear Rates in Vivo
mm per year
0.2
0.15
Tab. 1:
Linear wear rates produced
by different wear couples
in total hip joints. Different
XPE varieties show widely
differing results in the Me/
XPE studies.
0.1
0.05
0
Me/PE Ce/PE Me/XPE Ce/XPE Me/Me Ce/Ce
Sources:
Greenwald AS, Garino JP. Alternative bearing surfaces: the good, the bad, and the ugly. J Bone Joint Surg 83-A, Suppl 2 Pt 2: 68-72, 2001
Hendrich C, Wollmerstedt N, Ince A, Mahlmeister F, Göbel S, Nöth U. Highly Crosslinked Ultra Molecular Weight Polyethylene- (UHMWPE-) Acetabular
Liners in combination with 28mm BIOLOX ® heads, in: F. Benazzo, F. Falez, M. Dietrich (eds): Bioceramics and Alternative Bearings in Joint
Arthroplasty. 11th BIOLOX ® Symposium Proceedings. Steinkopff Verlag Darmstadt: p.182, 2006
Martell JM, Verner JJ, Invaco SJ. Clinical performance of a highly cross-linked polyethylene at two years in total hip arthroplasty: A randomized prospective
trial. J Arthroplasty 18 (7 suppl. 1):55-59, 2003
Zichner LP, Willert HG: Comparison of Alumina Polyethylene and Metal Polyethylene in Clinical Trials. Clin Orthop Rel Res 282:86-94, 1992
Zichner LP, Lindenfeld T. In-vivo-Verschleiß der Gleitpaarungen Keramik-Polyetyhlen gegen Metall-Polyethylen. (In vivo wear of ceramics-polyethylene
in comparison with metal-polyethylene.) Orthopäde 26:129-134, 1997
Bragdon CR, Barrett S, Martell J, Greene ME, Malchau H, Harris WH. Steady-State Penetration Rates of Electron Beam–Irradiated, Highly Cross-
Linked Polyethylene at an Average 45-Month Follow-Up. J Arthroplasty 21/7: 935-943, 2006;
Manning, DW, Chiang PP, Martell J, Galante JO, Harris WH. In Vivo Comparative Wear Study of Traditional and Highly Cross-linked Polyethylene in
Total Hip Arthroplasty. J Arthroplasty 20/7: 880-886, 2005

Compatible Materials:
BIOLOX ® forte and BIOLOX ® delta
Proven technology
Additional options
BIOLOX ® has been in use since 1974.
More than 4,500,000 components have
been implanted since then all over the
world. The clinical results have been excellent.
The material has proven its superior
properties and is considered the standard
by which all other ceramics used in orthopedics
are evaluated.
Still, CeramTec is continuously working
on making the good even better. New
challenges placed by young, active
and heavy patients have to be met.
Ad ditional head sizes, smaller acetabular
components, increased stability and longevity
are the obvious goals of research and
development.
The new alumina matrix composite,
BIOLOX ® delta, meets these increased
demands. It is a high performance ceramic
developed by CeramTec as a logical
complement to our well-proven BIOLOX ®
forte. It allows us to offer new sizes and
applications not achievable with BIOLOX ®
forte. BIOLOX ® delta provides all the
advantages of BIOLOX ® forte: excellent
biocompatibility, highly enhanced mechanical
properties, superb chemical and
hydrothermal stability. At the same time
it has tribological characteristics even
superior to BIOLOX ® forte.
5
From a tribological
point of view femoral
ball heads and cup inserts
made of
BIOLOX ® forte and
BIOLOX ® delta can be
combined with one
another. BIOLOX ® forte
and BIOLOX ® delta
femoral ball heads can
also be combined with
cup inserts made of
polyethylene and highly
crosslinked polyethylene
(XPE).

Particle Problem
Material Answers
Large Diameters
Wear Couples
BIOLOX ® Ceramic Wear Couples in Larger Sizes:
Even More Longevity and Safety
More ROM, More Stability
6
Instability and dislocation of THR represent
serious complications. After aseptic loosening,
they are the most common reasons
for revision surgery. 26 The incidence of
dislocation following primary THR ranges
from roughly 1% and 5% and for revision
22, 28
surgery it can be as high as 10%.
40mm Ø
ROM 152°
Many everyday activities
require strong
flexion or abduction
of the hip joint.
In a conventional
artificial hip these
move ments may
cause impingement
and dislocation.
Large diameter wear
couples increase
the range of motion
(ROM) significantly.
28mm Ø
ROM 123°

Lower Risk of Impingement
and Subluxation
Increased diameter wear couples enhance
the stability, post-operative mobility and
Clinical studies confirm that there is a
statistically significant decrease in impinge-
7
range of motion of THR. All of these gains ment, subluxation and dislocations with
be obtained. 2,8,9,15,23,24 28mm wear couple (assuming
are very helpful in providing the patient
with a more reliable joint replacement.
32mm and 36mm ceramic wear couples
(0.88%) when compared to 28mm femoral
ball heads (4.63%) in THR. 33
One of the key advantages of the use of
increased diameter ceramic femoral ball
heads is that the distance required for a
femoral ball head to subluxate increases by
However, studies have shown that utilizing
a large femoral ball head diameter could
also increase the risk of bone impingement Comparison of the ROM
between a 28mm and
up to 4mm when comparing the 28 to the and cause dislocation. Therefore a good a 40mm ceramic wear
36mm wear couple, making it less likely to compromise of head size to managed couple shows a gain of
29° in ROM when selecting
the 40mm wear
dislocate. 20
pros thetic and bone impingement must
the same head-
to-neck ratio). The angles
refer to the technical
Fig. 5: A larger head allows a wider range of motion
range of motion.
28mm Ø 32mm Ø
36mm Ø 40mm Ø
123° 130°
136° 152°
Fig. 6: More resistance to dislocation
28mm Ø 36mm Ø 40mm Ø
32mm Ø

Particle Problem
Material Answers
Large Diameters
Wear Couples
Large Diameters: Advantages and Disadvantages
of Different Materials
8
The advantages of ceramic materials in
wear couples become even more evident
with large diameters. Hip joint simulator
studies show that even though the surfaces
exposed to friction are much bigger,
the wear rates remain very low and are
significantly lower than with other materials.
With the use of ceramics the surgeon
doesn’t have to compromise between
wear rate and head size and can choose
the best option for the patient.
Hip Joint Simulator – Highly Crosslinked Polyethylene
Long-term wear rate after 10 million cycles
Negative Effect of Increased
Metal Head Size
Hip Joint Simulator – Highly Crosslinked Polyethylene
Long-term wear rate after 10 million cycles
Tab. 2 Positive Effect of Alumina Ceramic
Femoral Ball Head Compared to
Tab. 3
Metal Femoral Ball Head
Volume wear rate (mm 3 per million cycles)
Volume wear rate (mm 3 per million cycles)
12
10
8
12
10
8
6
4
2
0
Fisher J, University of Leeds, 2006
6
4
2
0
Fisher J, University of Leeds, 2006
28mm
Metal femoral
ball head on XPE
36mm
Metal femoral
ball head on XPE
36mm
Metal femoral
ball head on XPE
36mm
Alumina ceramic
femoral ball head on XPE
Source: Fisher J, University of Leeds (UK), 2006

Ceramic-on-ceramic bearings with large
diameters combine all of the advantages
of today’s tribological technology. Their
biological and biomechanical properties
help to spare natural anatomy and physiology
to the greatest possible extent. Drastically
reduced wear, a large range of
motion as well as additional resistance to
dislocation make these bearings the ideal
choice for safety and longevity in total hip
replacement.
9
In contrast to polyethylene and crosslinked
polyethylene wear couples, the wear rate
of ceramic-on-ceramic couples does not
rise with increased head size. 1
Fig. 7:
Retrieval of a PE liner
with a large diameter
articulation, after 19
years in vivo
Source :
Zweymüller K,
Vienna (Austria)
Function
Tab. 4
Head size (mm)
40
36
36
36
40
36
Optimize function
Increased stability, range of motion
Maximize survivorship
32
32
28
28
28
28
28
22
Metal on
polyethylene
22
Metal
on XPE
Alumina
on XPE
Alumina on
alumina ceramic
Charnley principle
High wear
Survivorship
Low wear
Sources: Fisher J, University of Leeds (UK), 2006; Pandorf T, CeramTec AG (Germany), 2006

Particle Problem
Material Answers
Large Diameters
Wear Couples
The Charnley Principle Upgraded
Step 1: BIOLOX ® Ceramic on Polyethylene (PE)
10
BIOLOX ® ceramic components have been
clinically proven by the test of time as
being effective in reducing wear and the
incidence of osteolysis.
• The use of BIOLOX ® ceramic femoral ball
heads in conjunction with UHMWPE
acetabular
• The use of BIOLOX ® ceramic femoral ball
heads in conjunction with UHMWPE
acetabular modular components has
demonstrated statistically significant
reduction of wear debris (2 to 5 times
less than a metal-on-polyethylene cou-
21, 34, 35
ple).
• Long-term retrieval studies (see also Fig. 8)
of components that have been implanted
for 15–20 years demonstrate that
BIOLOX ® femoral ball heads are com-
pletely stable and do not undergo any
changes in diameter, sphericity and
surface rough ness when articulating
30, 31, 36
against poly ethylene.
et al. Clinical Study:
In a clinical study 34 , the same surgical technique
was used to implant the same prosthesis
with a BIOLOX ® femoral ball head
or a metal femoral ball head. At a 10 year
follow-up, the revision rate in the ceramicon-polyethylene
THR group was reduced
to one fifth of the level of the metal-onpolyethylene
THR group.
Urban et al. Clinical Study:
Perhaps the strongest clinical proof available
today on the use of BIOLOX ® ceramic
femoral ball heads was published by Urban
et al. 27 In their long-term follow-up study
on ceramic-on-polyethylene THR using
32mm BIOLOX ® femoral ball heads and
cemented all-polyethylene cups, the mean
linear polyethylene wear rates were
0.034mm/yr. The survival rate without
revision was 95% at 10 years, 89% at
15 years and 79% at 20 years.
• BIOLOX ® ceramic components have reduced
the rate of loosening by a factor
of more than 2 when compared to metal-
Zichner
34, 35
on-polyethylene.
Fig. 8:
Retrieved BIOLOX ®
femoral ball head on
polyethylene after 15
years in vivo

Step 2: BIOLOX ® Ceramic on Crosslinked Polyethylene (XPE)
The new highly crosslinked Ultra High
Molecular Weight Polyethylene (XPE) appears
in the short term to be a significant
advance in reducing polyethylene wear
in combination with ceramic femoral ball
heads of up to 40mm.
Hendrich, Martell et al. Clinical Study:
Hendrich, Martell et al. 18 showed a significantly
reduced linear wear rate of 28mm
BIOLOX ® forte heads in combination with
highly crosslinked polyethylene after
5 years of follow-up (see Tab. 1, p. 4). The
patients were less than 60 years with a
moderate activity level. In contrast patients
with conventional polyethylene were significantly
older with a lower activity level.
This study suggests that the use of 28mm
BIOLOX ® forte femoral ball heads and
highly crosslinked polyethylene will be useful
in further reducing wear even when
comparing these diverse groups of patients.
11
Fig. 9:
Total hip replacement
combining a 28mm
BIOLOX ® forte femoral
ball head articulating
against highly crosslinked
polyethylene.
Source:
Hendrich C, Wollmerstedt N, Ince A, Mahlmeister F, Göbel S, Nöth U. Highly Crosslinked Ultra High Molecular Weight Polyethylene- (UHMWPE-)
Acetabular Liners in combination with 28mm BIOLOX ® heads, in: F. Benazzo, F. Falez, M. Dietrich (eds): Bioceramics and Alternative Bearings in Joint
Arthroplasty. 11th BIOLOX ® Symposium Proceedings. Steinkopff Verlag Darmstadt:p.182, 2006

Particle Problem
Material Answers
Large Diameters
Wear Couples
The Ultimate Solution for the
Younger and More Active Patient
Step 3: BIOLOX ® Ceramic-on-Ceramic Articulations
12
The BIOLOX ® ceramic-on-ceramic articulation
has been consistently shown to
provide the lowest wear rates both in vitro
and in vivo when compared with other
bearing surfaces (see Tab. 1, p. 4). BIOLOX ®
ceramic-on-ceramic articulations generate
wear particles with the lowest level of reactivity
due to their size, shape and chemical
composition. 5,11,12,16,19,25
The much lower osteolytic potential of the
ceramic debris 11,12,13 predicts the advantage
that can be achieved by the clinical use of
BIOLOX ® ceramic-on-ceramic articulations.
The excellent performance is based
on the following facts:
• possesses unsurpassed wear reduction
capability
• offers superb biocompatibility and excellent
stability in the human body 6,7,14,17
• it is biocompatible in either bulk or in
particulate
• the hardness of the material is surpassed
only by diamond, providing superb
scratch resistance and the highest resistance
of all bearing materials to thirdbody
wear.
• has an extensive and successful longterm
clinical history.
With ceramic wear
couples the use of
materials especially
susceptible to wear can
be avoided. The ceramics’
material properties
offer the low friction,
low wear option for the
longevity of total hip
replacement.

Laboratory studies 12 conducted at the
University of Leeds predicted that the
functional biological activity (FBA) and
osteo lytic potential of the ceramic-
on-ceramic bearing combination will
be lower than the metal-on-crosslinked
combination as a result of the lower wear
rate (see Tab. 5). Clinical evidence of this
fact is demonstrated in the presence of
limited anecdotal reports of osteolysis
in THR systems utilizing the BIOLOX ®
ceramic components.
Bizot et al. Clinical Study:
Hybrid alumina-on-alumina THR were performed
on patients with a mean age of
60.4 years. 32mm alumina femoral ball
heads were used. The 12-year survival rate
was 95.8% when aseptic loosening was
considered as the end-point. 4
Hip Joint Simulator
Alumina Ceramic on Ceramic
compared to Metal on Crosslinked PE
Wear rate (mm 3 per million cycles)
6
Summary
In vitro wear studies and in vivo retrieval
studies confirm the fact that the use of
ceramic bearings in THR provide the
potential for the lowest risk of particleinduced
osteolysis and increase the
longevity of THR.
D’Antonio et al. Clinical Study:
In an FDA-controlled, prospective, double
blinded, multi-center study 10 identical THR
systems using either a ceramic-on-ceramic
or a metal-on-polyethylene articulation were
compared. The survival rate for ceramic-onceramic
was 99.2% as opposed to 95.2%
for metal-on-polyethylene at a minimum
follow-up of 7 years. Osteolysis was present
in three cases of the metal-on-polyethylene
group while no osteolysis was reported for
the ceramic-on-ceramic group.
13
5
4
3
2
1
0
Alumina
ceramic –
50 times
lower wear
Alumina ceramic
28mm
CoCr 28mm
Nevelos et al. Mat. in Med 2001, Galvin et al. Soc Biomat 2004
Source: Fisher J, University of Leeds, 2006
Tab. 5:
Even in comparison to
metal-on-XPE the wear
rate of ceramic-onceramic
is lower by a
factor of fifty.
Alumina ceramic
10 Mrad XPE
Source: Fisher J, University of Leeds (UK), 2006

BIOLOX ® Ceramic Components for Hip Arthroplasty
(Standard Products)
Femoral Ball Heads
14
Head size Ø Neck length Material
22.2mm s, m, l BIOLOX ® delta
28mm s, m, l BIOLOX ® delta, BIOLOX ® forte
32mm s, m, l BIOLOX ® delta, BIOLOX ® forte
32mm xl BIOLOX ® delta
36mm s, m, l, xl BIOLOX ® delta, BIOLOX ® forte
40mm s, m, l, xl BIOLOX ® delta
Inserts
Inside Ø femoral ball head Outside Ø metalback *
Material
22.2mm not available not available
28mm 42–70mm BIOLOX ® delta, BIOLOX ® forte
32mm 46–70mm BIOLOX ® delta, BIOLOX ® forte
36mm 50–70mm BIOLOX ® delta, BIOLOX ® forte
40mm 54–70mm BIOLOX ® delta
* The outside diameters of acetabular liners correspond with the size of
the matching cup shells specific to implant system and manufacturer.
Disclaimer
This document is intended exclusively for experts in the
field, i.e. physicians in particular, and is expressly not for
the information of laypersons.
The information on the products and / or procedures
contained in this document is of a general nature and
does not represent medical advice or recommendations.
Since this information does not constitute any diagnostic
or therapeutic statement with regard to any individual
medical case, individual examination and advising of the
respective patient are absolutely necessary and are not
replaced by this document in whole or in part.
The information contained in this document was gathered
and compiled by medical experts and qualified
CeramTec employees to the best of their knowledge.
The greatest care was taken to ensure the accuracy
and ease of understanding of the information used
and presented. CeramTec does not assume any liability,
however for the up-to-dateness, accuracy, completeness
or quality of the information and excludes any liability
for tangible or intangible losses that may be caused by
the use of this information.
In the event that this document could be construed as
an offer at any time, such offer shall not be binding
in any event and shall require subsequent confirmation
in writing.

More Information
Contents of the CD ROM
References
The literature cited in this
brochure is listed on the attached
CD ROM
PowerPoint
Presentations
• Arthroplasty
(Clinical Pictures)
• Bone Sparing HR
(Clinical and Product
Pictures, Animations)
• Products, Material,
Tribology (Pictures
and Animations)
• The Production
of Ceramics
(Pictures)
Product and
Material Pictures
• Ceramics
– Material Properties
– Heads and Inserts
– Ceramic-on-Ceramic
– Ceramic-on-PE
– Revision Femoral
Ball Head
• Material Combinations
• Metal
• Wear Rates
Clinical Pictures
• Arthroplasty
• Bone Sparing
Hip Replacement
The Production
of Ceramics
• Pictures
Technical Monograph
“Current Perspective
on the Use of Ceramics
in Total Hip Arthroplasty”
15
Please, find further detailed
information on the enclosed
CD ROM.
The pictures, animations and
presentation files, whether in
total or as single slides, may be
used freely for scientific and
education purposes. The 3-D
animations are included in files
ending with the postfix “AVI”.
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If so, please contact us. We’ll be glad
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BIOLOX ®
Ceramics in
Orthopaedics
CeramTec GmbH
Medical Products Division
CeramTec-Platz 1–9
D-73207 Plochingen
Tel. +49 7153 611 828
Fax +49 7153 611 950
E-Mail: medical_products@ceramtec.de
www.biolox.com
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