In the long-term performance of the temporomandibular joint (TMJ) =
implant, wear must be considered.
Thus retrieved and laboratory test implants were examined both optically =
and in a scanning electron
microscope (SEM). In laboratory testing, the volumetric wear of =
metal-on-metal was about an order of=20
magnitude less than that ofacrylic-on-metal TMJ implants. This =
metal-on-metal wear was also about half of
that reported in the literature for a laboratory test of =
polyethylene-on-metal TMJ implants. The retrieved
TMJ implants shelved some abrasive wear occurred during =
multi-directional articulation with smaller wear
zones for the metal-on-metal compared to the acrylic-on-metal =
configuration. Further efforts to characterize=20
and minimize wear were recommended as prudent in the continuing =
development of TMJ arthroplasty.
The metal-on-metal temporomandibular=20
joint (TMJ) implant is not a
new concept to the oral maxillofacial
surgeon. In the early 1970s, Kiehn et
al.1 reported on the clinical use of a
Christensen Fossa-Eminence component mated with a Cargill-Hahn
condyle component both of which were
made of a cast cobalt-chromium-molybdenum (Co-Cr-Mo) metal alloy =
(Vitallium®). They reported a short-term follow-up of 27 cases, =
which were rated as
successful through reduction of pain
and increase in the range of motion of
jaw opening.2 Later, Kummoona reported a short-term clinical =
trial of a similar
Co-Cr-Mo metal-on-metal TMJ
implant3 and an animal study using the
same TMJ implant system. In the animal study, the microradiographic =
examination=20
of histiologic ground sections
demonstrated, in the author's terms,
"biological acceptance of the metal
implants by the natural tissue." However, neither Kiehn et al. or =
Kummoona
studied the long-term performance of
metal-on-metal TMJ implants.
Kummoona also reported3 the formation of a fibrous tissue =
layer approximately 2 mm thick, that was interposed
between the two metal surfaces and
seemed to function as a meniscus. The
development of this "pseudo-meniscus"
was noted by other research groups, 4,5
but the extent of the load bearing by
this structure was not ascertained. Consequently, it was not clear =
whether this
fibrous tissue would protect the implant
surfaces from wear.
The acrylic-on-metal TMJ implant
also has a long history of application in
oral maxillofacial surgery.5,6 In addition,
acrylic (PMMA or polymethylmethacrylate)=20
was used for the articular surface of a femoral head implant for hip
hemiarthroplasty by Judet and Judet7,8
in the early 1950s. Mechanical failure of
the Judet hip prosthesis forced discontinuance of the device after a =
decade of
use.9,10 However, some recent publications11-13 =
reported that the long-term
performance of a few remaining Judet
implants seemed to be well tolerated by
the surrounding tissues despite evidence
of wear. For acrylic-on-metal TMJ
implants, the relevant issues in long
term performance are the wear and tissue response to wear particles.
Other polymeric materials have been
used for TMJ implants with very poor
results. Oral maxillofacial surgeons are
familiar with the pain, foreign body
reaction and bone loss caused by particles generated from =
Proplast-Teflon and
Silastic materials that were used in TMJ
implants.14-20
In orthopaedics, the cause of smaller-scale but somewhat similar =
problems
has been identified as wear particle
induced osteolysis.21-27 Because of the
small particle sizes, this osteolysis is not
easy to identify and early orthopedic
papers incorrectly attributed the granulomas sac and/or radiolucent line =
that
developed around implants as the onset
of late infection or inadequate stress
transfer through the implant-bone
interface.28,29 Wear particle-induced
osteolysis is now considered the leading
problem in orthopaedic surgery.30 It is
likely that the bone loss and/or development of granulomas sacs of =
tissue
observed in the Proplast-Teflon
implants are caused by this same particle-induced osteolysis.
Because of the problem of wear particle-induced osteolysis in =
orthopaedic
joint replacement, wear phenomena
have been studied with some rigor with
joint simulator devices.31-34 However,
very little wear test data has been published on TMJ implant systems. =
The
testing of the Proplast-Teflon TMJ
Interpositional implant by Fontenot and
Kent35 ended suddenly at 21,786 cycles
when the implant itself fell apart and
they concluded it would have a "very
short in situ service life." A premarket
notification report36 (51Ok) to the Federal Drug =
Administration (FDA) by
Anspach, Inc. describes wear testing of
a polyethylene-on-metal TMJ implant
system(original Techmedica, Inc. Custom TMJ System). An average wear
rate 0.389 mm3/million cycles was
reported for the polyethylene of the
fossa component. Unfortunately, the
"Anspach report" described wear testing=20
with a uniaxial motion based on the
protocols in the F732 test ofthe American Society for Testing and =
Materials
(ASTM). This test (Standard Practice
for Reciprocating Pin-on-Flat Evaluation of Friction and Wear Properties =
of
Polymeric Materials for Use in Total
Joint Prostheses) was subsequently
withdrawn by ASTM in 1997 because it
was recognized that unrealistically low
wear rates occurred when uniaxial
rather than biaxial motion was
employed. Support for this sensitivity
to motion was provided by Bragdon et
al31 who showed that the wear of polyethylene hip sockets in =
a simulator
apparatus changed from a undetectable
level with uniaxial motion to about 27
mm3/million cycles with biaxial
motion. Thus the wear of a polyethylene-on-metal TMJ implant in =
vivo might
be much higher than the wear measured
in the simulator apparatus of the
Anspach report.36
The purpose of the present study is
to examine the wear of both metal-on-metal and acrylic-on-metal =
Christensen
TMJ Implants. This study is part of an
overall development program described
previously37 and includes the comparison of retrieval =
implants (up to 11=20
years) with laboratory wear test
implants. The assessment includes the
measurement of changes in the macrogeometry=20
with a three dimensional profiling=20
system and the examination of the
microgeometry with a SEM. The focus
of the present study is to begin to characterize wear behavior of these =
two
implant systems and thus eventually
evaluate the risk of clinical complications associated with wear =
particle
release into the surrounding tissues.
The scope of the work is not yet com
prehensive but complements other
wide-range development work.38-51 The
aim of the overall development program is to provide a well-engineered
TMJ implant system with minimal risk
of either short- or long-term complications.
Laboratory wear tests were conducted for 2 million cycles on =
commercial
TMJ implants (5 metal-on-metal and 5
acrylic-on-metal) by an independent
laboratory (Rose Musculoskeletal
Research Laboratory, Denver, CO).51 A
custom apparatus was designed and
built to provide conditions in the laboratory that were close to those =
in vivo
(Figure 1). Only two previous studies
involved wear testing of TMJ implants
(Table 1).=20
In the laboratory wear test,
the implant specimens were fixed in a
position similar to that encountered in
vivo by screws in an epoxy material
which was an analogue for bone. However,=20
the fossa component oscillated
(rather than the condyle component as
in vivo) through an arc of 30=B0 at a frequency of 2 Hz. Both the range =
of
motion and the frequency were some
what higher than the previous laboratory wear testing of TMJ implants =
(Table
1). Also, previous wear tests (Table 1)
had used a constant load of 20 Ibs (9.1
kg) based on predictions of various
investigators.36 However, in the laboratory wear test, the =
forces found by
Brehnan et al.52 and Bovd et al.,53 who
performed direct measurements by
interposing a piezoelectric foil transducer on the condyle of TMJ in =
primates, were adjusted to human levels
following the work by Smith.54 This
approach resulted in the application of a
cyclic "saw tooth" load pattern varying
from 10 lb to 35 lb (4.5 kg to 15.9 kg).
In a separate study,38 a load of 35 Ib.
(15.9 kg) gave an average contact stress
of 7,01 Ipsi (48.34MPa) with a standard
deviation of 812 psi (5.6MPa) for 5
Christensen metal-on-metal implants.
The same load gave an average contact
stress of 5,562 psi (38.35 MPa) with a
standard deviation of 580 psi (4.0 MPa)
for five Christensen acrylic-on-metal
implants. It was interesting to note that
the average contact stress for the metal-
on-metal hip implants at the beginning
of the wear test was about the same as
that found at the beginning of the simulator tests of metal-on-metal as =
reported in the orthopaedic literature.55 This
average contact stress was much less
than the yield strength of the cast Co-
Cr-Mo metal alloy. On the other hand,
the average contact stress for the
acrylic-on-metal implants was about
one-half of the tensile strength (of
about 10,000 psi or 69 MPa), 39 which
means that some local plastic deformation might have accelerated the =
wear at
the beginning of the testing.
The lubricant that was employed in
the laboratory wear test was a mixture
of 90% by volume filtered sterilized
bovine calf serum (HyClone Laboratories, Logan, UT), ethylene diamine
tetraacetic acid (EDTA) in distilled
water (9%) making a 20 mM solution
and streptomycin (1%).51 The bovine
serum was selected because it had been
used as an analogue for synovial fluid
wear testing in orthopedics.55,56 The
EDTA was intended to suppress excessive calcium and phosphorus rich
deposits. 57 The streptomycin was used
as an antibacterial agent.55 The acrylic
condyle components were soaked in the
bovine scrum mixture for 5 days prior
to testing to ensure an equilibrium fluid
absorption level.
The volumetric wear was evaluated
by converting mass loss measurement
(weight), taken every 0.25 million
cycles using an analytical balance, to
volume estimates assuming a density of
8.28 mg/mm3 for the Co-Cr-Mo alloy.
In addition, volumetric wear was determined using surface profile =
measurements58,59 taken before testing and after
2 million cycles. This profiling system
(MTS Systems Corp., Minneapolis,
MN) had been developed in conjunction with the University of Minnesota
Dental Research for Biomaterials and
Biomechanics Laboratory for dental
research (Figure 2).59
The wear zones on a typical metal-
on-metal implant showed oriented surface scratches in the direction of =
motion
that were visible to the naked eye (Fig
ure 3). The wear zone of an acrylic
condylar head was larger (Figure 2) and
oriented surface scratches were not
clear to the naked eye. The metal fossa
had no detectable wear when tested
against the acrylic condylar head. The
volumetric wear of the fossa components in the metal-on-metal implants
was calculated from mass loss measurements conducted every 0.25 million
cycles and showed essentially a linear
variation over the 2 million cycle duration. After 2 million cycles the =
mass
loss measurement procedure gave about
the same volumetric wear as the profiling system procedure (Figure 4). =
However,=20
both the metal and acrylic heads
seemed to gain mass during the wear
testing and thus some unknown error
must have been present in the measure
ment procedure. Consequently, the
mass loss procedure was not reported
further in the present study.
The profiling system procedure was
used to provide volumetric wear data
corresponding to 2 million cycles. For
the metal-on-metal implants (Figure
5a), there was usually more wear on the
fossa compared with the condyle component. Furthermore, there was =
considerable scatter in the results, which all
had the same nominal conditions. For
the acrylic condyle components (Figure
5b), there was a similar scatter and
about an order of magnitude more
wear. Such scatter in wear test data was
not considered unusual.32,55,56,60 However, one of the =
metal-on-metal and one
of the acrylic-on-metal implants showed
no detectable signs of wear (Figures 5a
and 5b).
This suggested that load was not
applied properly to these two implants
in the wear test. If these two implants
that did not wear were eliminated as
erroneous data, the average wear rate
was 0.197 mm3/million cycles for the
metal-on-metal implants and 1.64
mm3/million cycles for the acrylic-on-
metal implants.
Interestingly, the wear of the metal-on-metal=20
TMJ implants was about the
same level as that reported in the
orthopedic literature for some metal-on-metal=20
hip implants.32 In general, the
metal-on-metal TMJ implants experi
enced lower wear than the acrylic-on-metal=20
implants, but the large scatter in
the wear results for each material pairing=20
introduced some overall imprecision into this observation. The average
wear of the metal-on-metal was about
half ot the average wear of 0.389
mm3/million cycles reported for the
polyethylene fossa components in the
Anspach report.36 However, the previously mentioned =
application of uniaxial
motion in the wear tests of the Anspach
report might have suppressed the wear
compared with that likely to occur in
vivo and thus the wear of metal-on-metal=20
implants might be much less than
half the polyethylene-on-metal wear for
the TMJ implants in vivo.
The wear of the acrylic-on-metal
TMJ implants was measurable on the
condylar head alone and was about 8
times higher than the total wear of the
metal-on-metal TMJ implants. While
the body seems to tolerate the acrylic
wear debris,11-13 the lower wearing
metal-on-metal TMJ implant may be
advantageous in the long term.
In the retrieval group, 4 metal-on-metal=20
implants, 3 acrylic-on-metal
implants, 2 metal condyle components
and I metal tossa-eminence component
were examined both optically and in a
SEM (JSM-840, JEOL, Tokyo, Japan).
In addition, 3 acrylic-on-metal implants
and I acrviic condyle component were
examined opticallv. The period of use
in the body ranked from 3 to 5 years for
the metal-on-metal implants and from 1
to 11 years for the acrylic-on-metal
implants.
The group of laboratory wear test
implants included 5 metal-on-metal and
5 acrylic-on-metal configurations.51 All
implants were examined optically but
only two of each type were examined in
the SEM. To examine the acrylic condylar heads, it was necessary to =
sputter
coat them with gold.
For the metal-on-metal retrievals,
distinct wear zones were present on
both the condyle head and fossa components. The wear zones were oval in
shape with an average size of 3 x 2 mm.
On the condylar heads, separate wear
zones were on the anterior and posterior=20
sides of the dome with the long axis
aligned in the superior-inferior (S-1)
direction.
Separate wear zones were also found
on the anterior and posterior walls ot
the sulcus (or valley) of the fossa with
the long axis in the medial-lateral (M-L)
direction. The wear zones were shiny
and smooth and had a distinct edge
(Figure 6a).
At higher magnifications, fine randomly oriented scratches and small =
pits
(I to 10 \im across) were observed in
the wear zone (Figure 6b), while away
from the wear zone carbides ( 1 to 10
[µm in size) were present as well as pits
and scratches (Figure 6c).
The shape and position of the wear
zones on the retrieved metal-on-metal
implants suggested that much of the
sliding motion was in the M-L direction. However, the sliding motion was
not uniaxial. If that were the case, the
scratches on the wear zone would be
straight and aligned in the direction of
motion. Therefore, it was concluded
that a reciprocating sliding action
occurred in both the M-L direction and
the vertical plane to produce a multi
directional motion. The presence of
scratches in the wear zone indicated
that the surfaces were subjected to
abrasive wear, the abrasive agent being
the hard carbides in the surface of the
metal. The similar size of pits and carbides suggested the pits were =
sites
where carbides had been detached from
the surface. Thus, free carbides would
also abrade the metal surfaces through a
process known as "third-body" abrasive
wear.
On the retrieved acrylic condylar
heads, the wear zones tended to be saddle-shaped,=20
extending from the anterior
side, over the apex, and down the posterior side of the dome. The wear =
was
visible to the naked eye (Figure 7).
Considering all the acrylic condylar
heads, the average size of the wear zone
was 10 x 7 mm, with the long axes
extending down both sides in the S-1
direction. At higher magnifications, the
surfaces were covered with randomly
oriented scratches and some pits (Figures=20
8a and 8b). No wear zones were
observed on the mating fossa, except
for the 11 year implant, and none were
expected because the acrylic polymer
was much softer than the Co-Cr-Mo
alloy of the fossa. In the case of the 11=20
year fossa, the observed wear zones
resulted not from the contact with the
acrylic polymer, but rather with the
central metal post around which the
acrylic had been molded. Wear of the
acrylic head had exposed the metal post
which had then rubbed against the
metal fossa.
The presence of randomly oriented
scratches in the wear zone of the
retrieved acrylic heads (Figure 8a)
showed that abrasive wear had
occurred, the abrasive agent being the
carbides in the mating fossa (Figure 8b).
Once again, random orientation of the
scratches implied a multidirectional
sliding action. The shape of the wear
zone, although different from those on
the metal-on-metal implants, was
formed essentially by the same wear
mechanism. Initially, contact on the
acrylic head was on the anterior and
posterior aspects of the dome. Because
the polymer was softer and therefore
wore faster than the Co-Cr-Mo alloy,
the dome was worn away rapidly on its
anterior and posterior sides and thus
penetrated more deeply into the sulcus
of the fossa, resulting in contact
between the dome and the bottom of
the sulcus, and hence wear of the apex
of the dome.
The metal-on-metal implants from
the laboratory wear tests51 had wear
zones that were very different from the
retrieved metal-on-metal implants. The
wear zones tended to be saddle-shaped
and straddled the apex of the condylar
head and the sulcus of the fossa with the
long axis in the A-P direction (Figure
3). The average size of these wear zones
was 5 x 2 mm. At higher magnifications, parallel scratches were clearly
visible, oriented in the A-P direction
(Figure 9). In contrast, the retrieved
implants had two separate smaller wear
zones (each averaging 3 x 2 mm in size)
on both the condylar head and the fossa
with fine scratches of random orientation and a highly polished =
appearance
(Figures 6a and 6b).
On the acrylic-on-metal implants
from the laboratory wear tests,51 similar
wear zones, although slightly larger
when compared with the metal-on-
metal implants, were found with an
average size of 7 x 2 mm. The wear
zone was smooth but large pits and
some surface cracks were visible at low
magnification (Figure lOa). At higher
magnification, there were parallel
scratches predominantly in the A-P
direction together with pits (Figure
10b).=20
These scratches did not seem to
be as deep or as numerous as those on
the metal-on-metal implants. In contrast, the retrieved acrylic condylar
heads had larger wear zones (10 x 7
mm) with randomly oriented scratches
(Figure 8a) and smaller pits (Figure 8b).
No wear zones were found on the mating=20
fossa of the implants from the laboratory wear tests,51 =
although a few
parallel scratches were observed in the
anticipated contact zone.
In both the metal-on-metal and
acrylic-on-metal implants from the laboratory=20
wear tests,51 the shape of the
wear zones reflected the simple sliding
action of the testing, in which the fossa
rotated through a 30º arc about the M-L
axis. Contact occurred over the dome
and sulcus apexes because the largest
fossa were chosen for the wear tests
such that each sulcus was wider than
the dome of the contacting condylar
head. Abrasion was again the dominant
wear mechanism, the scratches being
parallel because of the uniaxial reciprocating motion. The absence of =
wear
zones on the mating fossa for the acrylic
heads was to be expected. However,
some abrasion of the fossa did occur as
demonstrated by the presence of parallel scratches in the contact zone. =
Presumably, these scratches were made by
the abrasive action of carbides detached
from the metal fossa surfaces, the carbides either moving freely within =
the
joint space or embedding in the softer
acrylic head.
The comparison between the
retrieved and the laboratory wear test
implants revealed some differences in
the wear test kinematics. Although both
the metal-on-metal and the acrylic-on-metal=20
implants were subject to abrasive
wear in vivo and in the wear tests, the
wear test kinematics did not fully represent the multi-directional =
sliding actions
occurring in vivo. Examination of the
retrievals showed that movement of the
condylar head within the fossa was
restricted in the A-P direction by the
walls of the sulcus. The head moved
from side-to-side in the M-L direction
with an additional vertical movement.
As a result, the in vivo kinematic inter
action involved cross-shear and this
motion was not reproduced in the laboratory wear tests,51 =
where the head was
stationary and the mating fossa rotated
about a M-L axis. While this kinematic
difference was significant, Tipper et
al 61 recently showed in pin-on-plate
wear testing of high carbon Co-Cr-Mo
(a wrought rather than a cast alloy as
used in Christensen TMJ implants but
with similar carbon content) that metal-on-metal=20
wear was not influenced much
by changing the motion from uniaxial
to biaxial. Thus the wear in the laboratory tests of the metal-on-metal
implants might be similar to wear in
vivo.
On the other hand, wear tests should
strive to represent in vivo conditions as
closely as possible to improve the likelihood=20
of producing wear similar to that
found in vivo and, therefore, some
uncertainty was introduced by the different kinematics of the laboratory =
wear
tests,51 particularly for the acrylic-metal
implants.
Furthermore, the use of the large
fossa in the laboratory wear tests51 gave
a single contact area on both mating
components rather than two smaller
ones observed in the retrievals of the
present study. These larger fossa could
have been used in clinical practice and
were chosen to reduce geometric con
formity, in an attempt to give a worst
case scenario. In retrospect, however, a
closer representation ot the in vivo conditions of the retrievals =
would have
occurred by selecting smaller fossa
components.
The average wear of Co-Cr-Mo
metal-on-metal TMJ implants in laboratory tests for 2 million cycles was =
0.197
mm3/million cycles. When compared
with wear in laboratory testing of other
TMJ implants with different material
combinations, the metal-on-metal had
the lowest wear.
The average wear of acrylic-on-metal=20
TMJ implants in laboratory tests
for 2 million cycles in a simulator apparatus was 1.64 =
mm3/million cycles,
occurring almost exclusively on the
acrylic condylar head.
Examination of the wear tested
acrylic and metal components optically
and in the SEM showed single wear
zones with parallel surface scratches
oriented in the uniaxial direction of
motion imposed by the wear test apparatus. These scratches seemed deeper
and more numerous on the metal-on-metal=20
implant surfaces. In both types of
implants, the mechanism of wear
appeared to be abrasion with additional
"third body" abrasion by carbides
detached from the metal surfaces.
Examination of retrieved metal-on-
metal TMJ implants optically and in the
SEM showed evidence of abrasive wear,
in particular, "third body" abrasion by
detached surface carbides. Each component=20
had two wear zones with randomly
oriented scratches.
Examination of retrieved acrylic-on-metal=20
TMJ implants optically and in the
SEM showed almost zero wear of the
metal fossa and a single large saddle
shaped wear zone on the acrylic condylar head with randomly oriented
scratches. Evidence was found for abrasive wear with additional "third =
body"
abrasion by carbides detached from the
metal fossa surface.
The randomly oriented surface
scratches of the retrieved implants indicated that multidirectional =
motion
occurs in the articulation of TMJ
implants in vivo.
The laboratory wear test apparatus
did not represent all of the features of
the TMJ implants in vivo with regards to
the kinematic detail and contact
mechanics, but the results could still
provide useful information on TMJ
implant performance. For example, the
abrasive wear occurring in both material combinations and the amount of =
wear
in the metal-on-metal TMJ implants
was comparable to that reported for
laboratory testing metal-on-metal hip
implants in the orthopaedic literature.32
Furthermore, the lowest wear in laboratory testing occurred tor the =
metal-
on-metal implants compared with
acrylic-on-metal or polyethylene-on-metal36=20
implants. This same ranking of
wear performance is expected to occur
in vivo.
Use of metal-on-metal as an articulating=20
surface for load bearing joints has
been criticized in the literature.5,35 It
was stated that a metal-on-metal combination=20
of materials would produce
"galling" and lead to catastrophic failures. While galling may occur in =
some
softer metal materials such as the stain
less steel or titanium alloys, harder
cobalt-based alloys arc known to be
very wear resistant materials in their
industrial applications. It is true that the
wear test in this study produced a
rough, dull surface with parallel
scratches over the wear zone due to
uniaxial reciprocating motion, but the
surface profile measurements indicated
that low material loss occurred - leading one to believe that minimal =
wear
debris was produced. The retrieval
implants exhibited a "smooth and shiny"
wear zone surface to the naked eye,
much different in appearance from the
laboratory wear test surfaces. The
multi-directional motions of the mating
Co-Cr-Mo components in vivo along
with an abrasive slurry of small carbides
must be the mechanism to produce
these "lapped and highly polished" wear
zone surfaces.
The wear was not sufficient to suggest any risk of device failures in =
either
the laboratory tested or retrieved
implants. Thus, the statements predicting catastrophic failure of =
metal-on-
metal implants made of Co-Cr-Mo arc
not justified.
Retrieved and laboratory tested
acrylic-on-metal implants have shown
higher wear than metal-on-metal
implants in both the laboratory wear
tests as well as implant retrievals.
Although a correspondingly larger volume of acrylic wear in particulate =
form
is generated in vivo, no report of deleterious foreign body =
reaction in sur
rounding tissue has been found in the
oral maxillofacial literature. Some long
term retrievals (20 to 40 years) of
orthopaedic Judet hip implants showed
high acrylic wear yet no significant
adverse tissue reaction.11-13
Wear particle-induced osteolysis is a
new issue that must be considered in
the development of implants for load
bearing joints. Osteolysis development
is dependent on (1) volume of particles
accumulated, (2) particle size and
shape, and (3) threshold levels of particles that surrounding tissues of =
an individual patient can tolerate.37 The
influence of these factors on osteolysis
involving cell phagocytosis of particles
through the release of tissue destructive
biological substances, is the focus of
current implant research.62-65 New
designs are being explored to reduce
the volume of particles.
This research includes improving the
material composition and manufacturing methods of the Co-Cr-Mo alloys to
reduce wear. Research centers have
looked at various heat treatments,66-68
the alloy composition in the generation
of microstructure carbides,69,70 and the
"sliding contact" microstructure deformation processes with twinning and
stacking fault energies,71-73 as an explanation for the =
superior wear resistance
of Co-Cr-Mo. New methods of
decreasing wear such as coating Co-Cr-
Mo with diamond-like-carbon (DLC)
coatings,74,75 have demonstrated
improved wear resistance with effective
corrosion resistance and biocompatability. Adhesion of the coating to =
the substrate is critical and is the subject of
on-going research. Both laboratory testing and retrieval analysis of the =
metal-
on-metal and acrylic-on-metal
Christensen TMJ System (s) show that
the use of these implant devices for
combating temporomandibular joint
disease is a viable option for the oral
maxillofacial surgeon.
In TMJ laboratory wear testing, the
protocol for mass loss rncasurements
must be improved to yield realistic and
repeatable mass loss values. In the labo
ratory wear testing, multi-directional
motion should be imposed in the surface articulations.
Further examination of retrieved
TMJ implants is required, particularly
those in situ (or more than 10 years.
The retrieval process should include
study of tissue samples collected from
surrounding tissues so that both the
wear particles and the response to wear
particles can be studied. New
approaches in design and materials
should be explored to further reduce
wear.
This paper was supported by TMJ
Implants, Inc. (Golden, CO), manufacturer ot the TMJ implant devices. =
All
testing as reported was conducted by
independent laboratory research facilities as referenced in the =
publication.
The authors would like to thank Eric J.
Northcut of Rose Musuloskelctal
Research Lahoratorv, Denver, CO, for
his assistance in supplying information
and performing the wear testing ofthe
TMJ devices. Appreciation is also
expressed to Dr. Maria R. Pintado from
the Minnesota Dental Research Center
for Biornatcrials and Biomechanics,
University of Minnesota, Minneapolis,
MN, for preparing the surface profile
measurements on the wear test
implants. And finally, we would like to
thank Dr. Subrata Saha, Professor,
Department of Bioengineering, College
of Engineering and Science, Clernson
University, Clemson, SC. for his
detailed testing and study of TMJ
implants in contact mechanics through
the Robert W. Christensen Biomechanics Laboratory. STI
BIOENGINEER CONSULTANT
ENGINEERING CONSULTING SERVICES, INC.
PRIOR LAKE, MNJOHN B. MEDLEY, PH.D., P.ENG.
ASSOCIATE PROFESSOR
DEPT. OF MECHANICAL ENGINEERING
UNIVERSITY OF WATERLOO
WATERLOO, ONTARIO, CANADAJUDITH M. DOWLING, D.PHIL., C.ENG.
RESEARCH SCIENTIST
DEPT. OF MECHANICAL ENGINEERING
UNIVERSITY OF WATERLOO
WATERLOO, ONTARIO, CANADA
PRESIDENT OF TMJ IMPEANTS, INC.
GOLDEN, COLORADO
ADJUNCT PROFESSOR OF BIOENGINEERING
COLLEGE OF ENGINEERING AND SCIENCE,
CLEMSON UNIVERSITY
CLEMSON, SCLABORATORY WEAR TESTING OF TMJ =
IMPLANTS
System =
Tested Loads Motion Duration=
Frequency Lubricant
Proplast teflon interpositional implant35 20 lb =
(9.1 kg) constant 20 degree arc rotation 21,786 =
cycles 0.5 Hz Circulating distilled water at room =
temp
Custom Co-Cr/Ti condyle to polyethylene fosa36 =
20 lb (9.1 kg) constant 25 degree arc =
rotation 5,000,000 cycles 0.9 Hz Bovine serum at =
room temp. pre-soak poly 14 days
Christensen Co-Cr & acrylic condyle to Co-Cr =
fossa-eminence51 (summerized and disclosed in the present =
study) 10-35lb (4.5- 15.9 kg) cyclic 30 degree arc =
rotation 2,000,000 cycles 2.0 Hz Circulating =
distilled filtered bovine serum at 37± 2ºC pre-soak acrylic =
5 days
MICROSCOPY- RETRIEVED AND WEAR TESTED =
IMPLANTS
CONCLUSIONS
CLOSING REMARKS
RECOMMENDATIONS FOR FUTURE WORK
ACKNOWLEDGEMENTS
REFERENCES