BIOLOX

BIOLOX Ceramics for Hip Arthroplasty

Contains CD ROM
with 3-D Animation

Its 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

Total hip replacement (THR) is one of the

The younger and more active patients of

most successful surgical procedures in gen-

today place very high demands on the

eral. Yet, a few problems remain unsolved,

performance of their THR. Daily work,

and aseptic loosening is probably the most

sports, an intensive social and family life

important of them. One of the main

often add up to a high level of activity.

reasons for aseptic loosening in total hip

What improves the quality of life on the

replacement is the foreign body reaction

one hand also leads to a rising quantity of

caused by the wear particles which are

wear particles from the artificial joint on

created by the articulating femoral ball

the other, eventually increasing the risk of

head and cup inlay. (Fig. 1). The end re-

particle-induced osteolysis.

29

sult of this process is osteolysis, making

revision surgery necessary in roughly 75%

Known factors influencing the

of these cases.

production of wear particles are:

26

patient activity
the wear couple material properties
the diameter of the wear couple
the roughness of the surface
the presence of third body wear.
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.
Fig. 1:
Severe osteolysis
caused by the wear
particles of a metalpolyethylene bearing,
15 years post-op

BIOLOX Makes the Difference

Goals to Achieve
The problems created by wear debris in THR

bearing systems containing polyethylene 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

Fig. 2:

should have:

Neocapsule of an
autopsy specimen of
a patient with ceramicceramic couple after
8 years in vivo
showing no ceramic
particles, smooth
synovial surface and
moderate fibrosis.6

the lowest production of wear particles

the best biological behaviour from
generated wear particles
the lowest osteolytic potential
the lowest coefficient of friction.
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 Lbeck (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
Fig. 4:
Postoperative X-ray,
left hip joint also with
ceramic-on-ceramic
THR

Source: Garino J, University of Pennsylvania (USA)

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

There is a direct relationship between the

They produce the lowest particle

amount of wear and the risk of osteolysis.

and osteolytic potential of all commonly

The use of ceramic femoral ball heads that

used bearing materials.

articulate against ceramic, polyethylene or

crosslinked polyethylene inserts provides
the best solution for a selective approach
to the problems of osteolysis.

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

0.1

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.

0.05

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, Gbel S, Nth 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-Verschlei der Gleitpaarungen Keramik-Polyetyhlen gegen Metall-Polyethylen. (In vivo wear of ceramics-polyethylene in comparison with metal-polyethylene.) Orthopde 26:129-134, 1997
Bragdon CR, Barrett S, Martell J, Greene ME, Malchau H, Harris WH. Steady-State Penetration Rates of Electron BeamIrradiated, Highly CrossLinked 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.

The new alumina matrix composite,

More than 4,500,000 components have

BIOLOXdelta, meets these increased

been implanted since then all over the

demands. It is a high performance ceramic

world. The clinical results have been excel-

developed by CeramTec as a logical

lent. The material has proven its superior

complement to our well-proven BIOLOX

properties and is considered the standard

forte. It allows us to offer new sizes and

by which all other ceramics used in ortho-

applications not achievable with BIOLOX

pedics are evaluated.

forte. BIOLOXdelta provides all the

advantages of BIOLOXforte: excellent

Still, CeramTec is continuously working

biocompatibility, highly enhanced mechani-

on making the good even better. New

cal properties, superb chemical and

challenges placed by young, active

hydrothermal stability. At the same time

and heavy patients have to be met.

it has tribological characteristics even

Additional head sizes, smaller acetabular

superior to BIOLOXforte.

components, increased stability and longe

vity are the obvious goals of research and
development.

From a tribological
point of view femoral
ball heads and cup inserts made of
BIOLOXforte and
BIOLOXdelta can be
combined with one
another. BIOLOXforte
and BIOLOXdelta
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

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
surgery it can be as high as 10%.22, 28

Many everyday acti

vities require strong
flexion or abduction
of the hip joint.
In a conventional
artificial hip these
movements may
cause impingement
and dislocation.
Large diameter wear
couples increase
the range of motion
(ROM) significantly.

40mm
ROM 152

28mm
ROM 123

Lower Risk of Impingement

and Subluxation

Increased diameter wear couples enhance

Clinical studies confirm that there is a

the stability, post-operative mobility and

statistically significant decrease in impinge-

range of motion of THR. All of these gains

ment, subluxation and dislocations with

are very helpful in providing the patient

32mm and 36mm ceramic wear couples

with a more reliable joint replacement.

(0.88%) when compared to 28mm femo-

ral ball heads (4.63%) in THR.33

One of the key advantages of the use of
increased diameter ceramic femoral ball

However, studies have shown that utilizing

heads is that the distance required for a

a large femoral ball head diameter could

femoral ball head to subluxate increases by also increase the risk of bone impingement
up to 4mm when comparing the 28 to the

and cause dislocation. Therefore a good

36mm wear couple, making it less likely to

compromise of head size to managed

dislocate.

prosthetic and bone impingement must

20

be obtained.2,8,9,15,23,24

Fig. 5: A larger head allows a wider range of motion

Comparison of the ROM

between a 28mm and
a 40mm ceramic wear
couple shows a gain of
29 in ROM when selecting the 40mm wear
couple compared to the
28mm wear couple (assuming the same headto-neck ratio). The angles
refer to the technical
range of motion.

28mm

32mm

36mm

40mm

123

130

136

152

Fig. 6: More resistance to dislocation

28mm

32mm

36mm

40mm

Particle Problem
Material Answers
Large Diameters
Wear Couples

Large Diameters: Advantages and Disadvantages

of Different Materials

The advantages of ceramic materials in

wear couples become even more evident
with large diameters. Hip joint simulator
studies show that even though the sur
faces 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
doesnt 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

Hip Joint Simulator Highly Crosslinked Polyethylene

Long-term wear rate after 10 million cycles

Negative Effect of Increased

Metal Head Size

Positive Effect of Alumina Ceramic

Femoral Ball Head Compared to
Metal Femoral Ball Head

Tab. 2

Volume wear rate (mm3 per million cycles)

12

12

10

10

4
2
0
28mm
Metal femoral
ball head on XPE

36mm
Metal femoral
ball head on XPE

Source: Fisher J, University of Leeds (UK), 2006

Tab. 3

Fisher J, University of Leeds, 2006

Volume wear rate (mm3 per million cycles)

Fisher J, University of Leeds, 2006

4
2
0
36mm
Metal femoral
ball head on XPE

36mm
Alumina ceramic
femoral ball head on XPE

Ceramic-on-ceramic bearings with large

diameters combine all of the advantages
of todays 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.
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 :
Zweymller K,
Vienna (Austria)

Tab. 4

Function
Head size (mm)

40

40

36

32

28

22

36

36

36

Optimize function
Increased stability, range of motion

Maximize survivorship

32
28
Metal on
polyethylene

22

28

28

Metal
on XPE

Alumina
on XPE

28
Alumina on
alumina ceramic

Charnley principle
High wear

Survivorship

Sources: Fisher J, University of Leeds (UK), 2006; Pandorf T, CeramTec AG (Germany), 2006

Low wear

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

Zichner et al. Clinical Study:

clinically proven by the test of time as

In a clinical study34, the same surgical tech-

being effective in reducing wear and the

nique was used to implant the same pros-

incidence of osteolysis.

thesis with a BIOLOX femoral ball head

or a metal femoral ball head. At a 10 year

The use of BIOLOX ceramic femoral ball

follow-up, the revision rate in the ceramic-

heads in conjunction with UHMWPE

on-polyethylene THR group was reduced

acetabular

to one fifth of the level of the metal-onpolyethylene THR group.

The use of BIOLOX ceramic femoral ball

heads in conjunction with UHMWPE

Urban et al. Clinical Study:

acetabular modular components has

Perhaps the strongest clinical proof avail-

demonstrated statistically significant

able today on the use of BIOLOX ceramic

reduction of wear debris (2 to 5 times

femoral ball heads was published by Urban

less than a metal-on-polyethylene cou

et al.27 In their long-term follow-up study

ple).

on ceramic-on-polyethylene THR using

21, 34, 35

32mm BIOLOX femoral ball heads and

Long-term retrieval studies (see also Fig. 8) cemented all-polyethylene cups, the mean
of components that have been implan-

linear polyethylene wear rates were

ted for 1520 years demonstrate that

0.034mm/yr. The survival rate without

BIOLOX femoral ball heads are com-

revision was 95% at 10 years, 89% at

pletely stable and do not undergo any

15 years and 79% at 20 years.

changes in diameter, sphericity and

surface roughness when articulating
against polyethylene.30, 31, 36
BIOLOX ceramic components have re
duced the rate of loosening by a factor
of more than 2 when compared to metalon-polyethylene.34, 35
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

Hendrich, Martell et al. Clinical Study:

Molecular Weight Polyethylene (XPE) ap-

Hendrich, Martell et al.18 showed a signifi-

pears in the short term to be a significant

cantly reduced linear wear rate of 28mm

advance in reducing polyethylene wear

BIOLOXforte heads in combination with

in combination with ceramic femoral ball

highly crosslinked polyethylene after

heads of up to 40mm.

5 years of follow-up (see Tab. 1, p. 4). The

11

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
BIOLOXforte femoral ball heads and
highly crosslinked polyethylene will be useful in further reducing wear even when
comparing these diverse groups of patients.
Fig. 9:
Total hip replacement
combining a 28mm
BIOLOXforte femoral
ball head articulating
against highly crosslinked polyethylene.

Source:
Hendrich C, Wollmerstedt N, Ince A, Mahlmeister F, Gbel S, Nth 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 articula-

The excellent performance is based

tion has been consistently shown to

on the following facts:

provide the lowest wear rates both in vitro

and in vivo when compared with other
bearing surfaces (see Tab. 1, p. 4). BIOLOX

possesses unsurpassed wear reduction

capability

ceramic-on-ceramic articulations generate

offers superb biocompatibility and excel-

wear particles with the lowest level of re-

lent stability in the human body 6,7,14,17

activity due to their size, shape and chemical composition.

5,11,12,16,19,25

it is biocompatible in either bulk or in

particulate

The much lower osteolytic potential of the the hardness of the material is surpassed
ceramic debris11,12,13 predicts the advantage

only by diamond, providing superb

that can be achieved by the clinical use of

scratch resistance and the highest resis

BIOLOX ceramic-on-ceramic articulations.

tance of all bearing materials to third-

body 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.

Summary
Laboratory studies12 conducted at the

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.

University of Leeds predicted that the

functional biological activity (FBA) and
osteolytic potential of the ceramicon-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

DAntonio et al. Clinical Study:

ceramic components.

In an FDA-controlled, prospective, double

Bizot et al. Clinical Study:

blinded, multi-center study10 identical THR

Hybrid alumina-on-alumina THR were per-

systems using either a ceramic-on-ceramic

formed on patients with a mean age of

or a metal-on-polyethylene articulation were

60.4 years. 32mm alumina femoral ball

compared. The survival rate for ceramic-on-

heads were used. The 12-year survival rate

ceramic was 99.2% as opposed to 95.2%

was 95.8% when aseptic loosening was

for metal-on-polyethylene at a minimum

considered as the end-point.

follow-up of 7 years. Osteolysis was present

in three cases of the metal-on-polyethylene

group while no osteolysis was reported for
Hip Joint Simulator

the ceramic-on-ceramic group.

Alumina Ceramic on Ceramic

compared to Metal on Crosslinked PE
Wear rate (mm3 per million cycles)

CoCr 28mm

5
4
3

Alumina
ceramic
50 times
lower wear

2
1
0

Alumina ceramic
28mm
Alumina ceramic

10 Mrad XPE

Source: Fisher J, University of Leeds (UK), 2006

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.

13

BIOLOX Ceramic Components for Hip Arthroplasty

(Standard Products)

Femoral Ball Heads

14

Head size

Neck length

Material

22.2mm

s, m, l

BIOLOXdelta

28mm

s, m, l

BIOLOXdelta, BIOLOXforte

32mm

s, m, l

BIOLOXdelta, BIOLOXforte

32mm

xl

BIOLOXdelta

36mm

s, m, l, xl

BIOLOXdelta, BIOLOXforte

40mm

s, m, l, xl

BIOLOXdelta

Inserts
Inside femoral ball head Outside metalback * Material
22.2mm

not available

not available

28mm

4270mm

BIOLOXdelta, BIOLOXforte

32mm

4670mm

BIOLOXdelta, BIOLOXforte

36mm

5070mm

BIOLOXdelta, BIOLOXforte

40mm

5470mm

BIOLOXdelta

* 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

Product and

Clinical Pictures

The literature cited in this

Material Pictures

Arthroplasty

brochure is listed on the at-

Ceramics

Bone Sparing

tached CD ROM

Material Properties

Hip Replacement

Heads and Inserts

PowerPoint

Ceramic-on-Ceramic

The Production

Presentations

Ceramic-on-PE

of Ceramics

Arthroplasty

Revision Femoral

Pictures

(Clinical Pictures)

Ball Head
Material Combinations

Technical Monograph

(Clinical and Product

Metal

Current Perspective

Pictures, Animations)

Wear Rates

on the Use of Ceramics

Bone Sparing HR

Products, Material,

in Total Hip Arthroplasty

Tribology (Pictures
and Animations)
The Production
of Ceramics
(Pictures)

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.

Is the CD ROM missing from this brochure?

If so, please contact us. Well be glad
to send you one.

15

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Medical Products Division
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Tel. +49 7153 611 828
Fax +49 7153 611 950
E-Mail: medical_products@ceramtec.de
www.biolox.com

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