Mueller 2017 - Wear In Vitro

Prévia do material em texto

ORIGINAL ARTICLE
Influence of humeral head material on wear
performance in anatomic shoulder joint
arthroplasty
Ulrike Mueller, MSc1, Steffen Braun, MEng1, Stefan Schroeder, MSc,
Mark Schroeder, MSc, Robert Sonntag, MSc, Sebastian Jaeger, PhD,
Jan Philippe Kretzer, PhD*
Laboratory of Biomechanics and Implant Research, Clinic for Orthopedics and Trauma Surgery, Heidelberg University
Hospital, Heidelberg, Germany
Background: The number of total shoulder arthroplasties has increased in the past years, with encour-
aging results. However, the survival of anatomic total shoulder arthroplasty (aTSA) is lower compared
with that of knee and hip replacements. Wear-associated problems like loosening are well-known causes
of long-term failure of aTSA. The main purpose of this study was to investigate the wear behavior of ceramic-
polyethylene bearings compared with the standard metal-polyethylene bearings. Because there is a lack
of valid experimental wear testing methods, the secondary aim was to develop a validated wear simulation.
Methods: The wear assessment was performed using a force-controlled joint simulator for 3 × 106 cycles,
and polyethylene wear was assessed gravimetrically and by particle analysis. Kinetic and kinematic data
were adopted from in vivo loading measurements and from several clinical studies on shoulder joint ki-
nematics. The reaction of the rotator cuff was simulated on the basis of a virtual soft tissue model. As
activity, an abduction-adduction motion of 0°-90° lifting a load of 2 kg superimposed by an anteversion-
retroversion has been chosen.
Results: The studied aTSA resulted in a polyethylene wear rate of 62.75 ± 1.60 mg/106 cycles in com-
bination with metallic heads. The ceramic heads significantly reduced the wear rate by 26.7% to
45.99 ± 1.31 mg/106. There were no relevant differences in terms of the particle characteristics.
Conclusion: This is the first study that experimentally studied the wear behavior of aTSA based on patient-
related and biomechanical data under load-controlled conditions. Regarding polyethylene wear, the analyzed
aTSA could benefit from ceramic humeral heads.
Level of evidence: Basic Science Study; Biomechanics
© 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved.
Keywords: Total shoulder arthroplasty; polyethylene wear; glenoid; ceramic; humeral head; wear testing
*Reprint requests: Jan Philippe Kretzer, PhD, Laboratory of Biomechanics and Implant Research, Clinic for Orthopedics and Trauma Surgery, Heidelberg
University Hospital, Schlierbacher Landstraße 200a, D-69118 Heidelberg, Germany.
E-mail address: philippe.kretzer@med.uni-heidelberg.de (J.P. Kretzer).
1Both authors contributed equally to the work and share first authorship.
Basic Science studies do not require specific Institutional Review Board approval.
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http://dx.doi.org/10.1016/j.jse.2017.05.008
J Shoulder Elbow Surg (2017) ■■, ■■–■■
mailto:philippe.kretzer@med.uni-heidelberg.de
http://www.elsevier.com/locate/YMSE
The number of total shoulder joint replacements has in-
creased during the past years, with encouraging clinical
results.51 Patients may benefit from reduced pain, better joint
function, and increased range of motion.28 However, as with
all joint replacements, revision surgery may be required over
time for various reasons.2 Based on registry data, the revi-
sion rates of shoulder arthroplasties are higher compared with
total hip or total knee replacements (Fig. 1, A).16,17 The reasons
for revision surgery in shoulder arthroplasties are multifac-
torial, but they are dominated by dislocation/instability, rotator
cuff insufficiency, and loosening/lysis (Fig. 1, B).16 Whereas
the progression over time for dislocations or instabilities and
rotator cuff insufficiencies seems to become somehow stable,
there is a continuing rise in loosening/lysis (Fig. 1, B). A further
database analysis of 1806 total shoulder revision surgeries re-
vealed that implant-associated mechanical complications like
aseptic loosening, surface wear, and implant failure (break-
age) were the most prevalent reasons for revision in the
analyzed cohort within a period of 17 years.2 Thus, it seems
likely that loosening/lysis is going to be the most relevant com-
plication in shoulder joint replacements in the long term.2
Osteolysis is often provoked by a biologic response to wear
debris.1,14,43 Wear particles are released by the articulating sur-
faces. These particles may cause a cytokine-driven
inflammatory response that depends on the material, size, dose,
and morphology of the wear particles.18,22 This is also of par-
ticular importance in the progression of aseptic loosening for
shoulder prostheses.2,53,56 In this context, several studies on
retrieved glenoid components have shown wear-related al-
terations of the implants.7,21,24,38,40 For glenoid components,
different failure modes are observed compared with hip and
knee implants.9 This is caused by increased eccentric loads,
particularly in the case of malalignment, which leads to higher
stresses at the polyethylene.9,42 Thus, polyethylene wear might
be high in shoulder joint replacements and has to be consid-
ered a relevant cause of complications. A recent clinical study
of 165 patients with cementless implants revealed a surviv-
al rate of 46% at 12 years, and 80% of the implants undergoing
revision surgery had evidence of wear.6 Consequently, it can
be concluded that wear might be a serious issue in shoulder
prostheses in the long term.
Total shoulder arthroplasties can be either anatomic
or reverse. In reverse shoulder joint replacements, the
articulation consists of a ball-in-socket configuration that
is limited to rotational movements but stabilizes the joint.
On the contrary, if the shoulder joint is still well stabilized
by the rotator cuff, anatomic total shoulder arthroplasty
(aTSA) can be chosen. The aTSAs are based on a radial
mismatch configuration (ball-on-flat), which also allows
translational motions of the humeral head on the glenoid
component. In shoulder total arthroplasties, the articulation
mostly occurs between a metallic part that is typically
made of a cobalt-chromium-molybdenum alloy and a coun-
terpart that is made from ultrahigh-molecular-weight
polyethylene.
To overcome the problem of polyethylene wear, alterna-
tive materials may be considered. For example, in total hip
replacements, ceramic materials have been introduced to reduce
polyethylene wear, and several experimental and clinical
studies confirmed that ceramic heads produce lower wear rates
compared with metal heads.10,55,58 The favorable wear per-
formance and wide use of ceramics can be attributed to its
inertness, low coefficient of friction, wettability, scratch re-
sistance, and hardness.33,54
Therefore, the first aim of this study was to evaluate whether
ceramic humeral heads reduce polyethylene wear in com-
parison to metallic humeral heads in aTSA. In contrast to total
hip23 and total knee32 arthroplasty, there is lack of appropri-
ate wear measurement methods for aTSA in terms of
biomechanically valid test parameters and boundary condi-
tions. Therefore, the second purpose of this study was to
develop a wear testing method and to define the essential ex-
perimental parameters, like loading conditions and joint
kinematics, for aTSA.
Materials and methods
Biomechanical rationale
Articulation in the anatomic shoulder joint occurs between the
humeral head and the glenoid cavity. Compared with the round
Figure 1 (A) Comparison of revision rates between anatomic shoulder and hip joint replacements. (B) Reasons for revision surgery in
anatomic shoulder joint replacements. (Data from the Australian joint registries.16,17)
ARTICLE IN PRESS
2 U. Mueller et al.
sphericity of the humeral head, the glenoid cavity is relatively
shallow, and the humeralhead is stabilized in the glenoid cavity
by the surrounding ligaments and muscles.34 This anatomic forma-
tion allows a huge variety of local contact kinematics, including
translations and rotations.39 The contact kinematics is governed by
active forces that originate from the muscles as well as by dynamic
and gravitational forces.15 These forces must be restrained by the
passive structure of the joint. Because of their passive elastic
nature, the soft tissues and in particular the rotator cuff provide
the restraining forces needed to balance the active forces during
physiologic motion.52
Anatomic shoulder prostheses offer a wide range of different con-
formities that are achieved by a radial mismatch between the humeral
head and the glenoid component to mimic the anatomic function
of the joint. To simulate shoulder joint articulation in an experi-
mental setting, the local contact kinematics should be reproduced
as close as possible to the anatomic situation. This includes the rep-
lication of motions and loadings as well as the simulation of the
surrounding soft tissues. For low conforming implants, like knee
joint replacements, force-controlled simulation has been estab-
lished to account for the effect of the varying implant designs and
the surrounding soft tissues. The purpose behind force control is that
the local translations and rotations will be a function of the shape
of the bearing surfaces, the frictional forces, and the overall design
of the implant.20,31 In this regard, it has to be expected that a low
conforming implant will show higher local contact kinematics between
the humeral head and the glenoid component compared with a high
conforming implant. This has also been described for shoulder joint
replacements, in which an increased radial mismatch between the
components (lower conformity) leads to higher glenohumeral (GH)
translations.41 Consequently, a force-controlled experimental wear
test allows the implant conformity to influence the local contact ki-
nematics and also to consider the reaction of the surrounding soft
tissue.31
Testing setup
To perform the wear simulation, a servohydraulic joint simulator
(KS2-6-1000; AMTI, Watertown, MA, USA) was chosen. This sim-
ulator has 3 wear stations and 1 axial-loaded soak control station.
The wear stations are equipped with 4 controlled degrees of freedom
that have been adapted to the shoulder joint (Fig. 2) and include the
axial load, GH rotation (in the direction of adduction-abduction),
superior-inferior (SI) translation, and anteversion-retroversion (arm
forward flexion–extension). The anterior-posterior translation is free
to move without any limitations, subject to constructional features
of the implant. Anatomically, the glenoid is slightly rotated in the
sagittal plane.44 This orientation has been considered in the test setup
by rotating the glenoid component relative to the SI direction of the
simulator. Therefore, the glenoid component has been rotated by 20°
so that the inferior part of the glenoid component is oriented in the
posterior direction. The position of head center relative to the glenoid
was determined as the position that gives no force reaction in the
SI direction (static equilibrium) when the components are loaded
by a positive axial force. This has been defined as neutral position.
Determination of forces and kinematics on the
shoulder joint
To develop an experimental shoulder wear test, active forces and
kinematics that drive the joint simulator have to be specified. There-
fore, a representative motion should be selected. In contrast to the
knee or the hip joint, a common daily activity is not directly de-
finable as the shoulder joint has a large range of complex motions.
A well-defined and often-described motion is the abduction-
adduction of the arm, which is also a submotion of most shoulder
activities.15,39 In detail, an abduction-adduction of 0°-90° while slowly
lifting a load of 2 kg has been selected because in vivo load data
Figure 2 In the test setup, the orientation of the glenoid component and of the humeral head and the anatomic axis are shown. GH, glenohumeral.
ARTICLE IN PRESS
Ceramic humeral head as alternative material? 3
are available for this type of activity.4,5 Three patients from the
OrthoLoad database have been considered (S8R, S3L, and S2R).4
First, the abduction-adduction arm motion has been analyzed from
the published videos in the database at 0°, 15°, 30°, 45°, 60°, 75°,
and 90° during abduction-adduction motion, and the correspond-
ing time, forces, and torques were recorded. The time and body weight
data of each patient were averaged and recalculated according to a
single motion cycle regarding the resulting forces and torques. As
the forces in the OrthoLoad database are oriented to the humerus,
whereas in the testing setup they are related to the glenoid compo-
nent, a coordinate transformation has been performed. The determined
data points were connected with splines to get harmonic progres-
sion curves.
As the GH rotation (that acts on the implant) is a submotion of
the abduction-adduction motion, the GH rotation has been ex-
tracted on the basis of the scapular rhythm.12 To create multidirectional
motions and to account for combined motions in the shoulder joint,
an anteversion-retroversion of ±10° has been superimposed.27
The resulting progression curves of the axial load, SI force, GH
rotation, and anteversion-retroversion are specified in Figure 3 for
1 motion cycle.
Soft tissue restraint system
SI translations of the humeral head relative to the glenoid are ob-
served in shoulder joints during the abduction motion, and this
translation depends on the soft tissue restraint of the rotator cuff,
the glenoid conformity, and the ligaments.15,39 The SI translation is
typically limited to a few millimeters, and it achieves displace-
ments of 1.8 mm and 2.1 mm during arm elevation.15,39 In these
studies, healthy shoulders have been analyzed, and it can be assumed
that aTSA-treated shoulders may have larger translations.36 Hence,
it is necessary to include a soft tissue restraint model in the force-
controlled simulation to limit the SI translation and to avoid luxation
of the joint. To consider the reaction of the soft tissue, a virtual soft
tissue model has been developed.31 To define the counteracting soft
tissue stiffness, the SI force (Fig. 3) has been applied to a metal-
polyethylene bearing in the test setup. Subsequently, the stiffness
has been iteratively varied, and the resulting SI translation has been
determined. The process revealed that a linear soft tissue stiffness
of 80 N/mm creates SI translation of approximately 3-3.5 mm, which
has been considered to appropriately replicate the clinical situation.
Analyzed components
For wear simulation, the Turon Shoulder System (DJO Surgical, Vista,
CA, USA) was chosen. The keeled glenoid components, size 54,
were made of ultrahigh-molecular-weight polyethylene according
to ISO 5834-1 and 5834-2. The humeral heads had a diameter of
54 mm. Regarding the metal group, original Turon heads made of
a cobalt-chromium-molybdenum alloy according to ISO 5832-4 were
used. In the ceramic group, identically designed heads have been
manufactured from zirconia-toughened alumina ceramics (Biolox
delta; CeramTec, Plochingen, Germany). The radial mismatch
between the heads and glenoid components was 8 mm in the anterior-
posterior direction and 12 mm in the SI direction.
Testing conditions
Calf serum (Biochrom GmbH, Berlin, Germany) was used as test
medium according to ISO 14243-1:2009.25 The serum, diluted with
deionized water and filtered through a 2-µm filter, had a protein con-
centration of 20 g/L; 1.85 g/L of sodium azide and 5.85 g/L of
ethylenediaminetetraacetic acid were used as additives to the calf
serum to prevent bacterial growth and to minimize calcium phos-
phate films on the implant surface. Wear testing was carried out in
sealed chambers. Each chamber was filled with 250 mL of calf serum,
maintained at37°C. The frequency of the simulation for 1 cycle was
1 ± 0.1 Hz, and each wear test was conducted until 3 × 106 loading
cycles had been completed.
Wear analysis
Before simulation, the glenoid components were presoaked in the
serum until the incremental mass change of the inserts waswhich is about 25% lower than the current results.57
It is known that the biologic reaction to wear particles is
also related to the size, morphology, and number of wear
particles.18,22 In terms of size and morphology, the analyzed
particles are in a similar range compared with particles ob-
tained by knee wear simulations.49 As only small differences
in wear particle size, morphology, and number of particles
were observed in this study, the following considerations are
focused only on the wear rates.
In comparison to other joint replacements, the reported wear
amount determined here and by Wirth et al57 seems to be high
in aTSA. Using conventional polyethylene, wear rates of ap-
proximately 1-9 mg/106 cycles in total knee
arthroplasties19,32,46,48 and approximately 12 mg/106 cycles
(ceramic heads)59 to 35 mg/106 cycles (metallic heads)30,50 in
total hip joint replacements have been reported. However, di-
rectly comparing the different types of joints should be done
with caution. Regarding the number of loading cycles per year,
different values have to be considered as the activity varies
among shoulder, hip, and knee prostheses. For hips and knees,
it has been reported that approximately 5000-7000 steps are
performed per day, which would result in about 2.2 million
loading cycles per year.29 For shoulder joints, only limited
data regarding activity are available. Depending on the ve-
locity and direction, Coley et al reported approximately 50
motions per hour in abduction-adduction.11 Considering 16
hours of daily activity, this would correspond to approxi-
mately 800 motions per day. A similar value has been reported
by Duc et al.13 Out of these numbers, a yearly activity of about
0.3 million loading cycles could be expected for the shoul-
der joint, which is far below the activity of hip and knee joints.
Thus, the yearly amount of released polyethylene wear in the
shoulder joint might be in a similar range compared with knee
joint replacements.
The results of this study are limited to the investigated com-
ponents and should not be generalized. Furthermore, there
are also some limitations in this study. First, only conven-
tional polyethylene has been studied, and it can be assumed
that the wear rates would have been lower if cross-linked poly-
ethylene had been used.57 Second, the polyethylene has not
been artificially aged, and material oxidation also takes part
in the degradation process of polyethylene.3 Third, only a single
activity has been chosen for the test, although the shoulder
joint has a huge variety of activities. Interestingly, the applied
loadings and kinematics in the testing setup led to wear scars
that are similar in dimension and location to retrieved
components.7
Conclusion
Although only a single activity has been chosen, a good
replication of the clinical wear situation could be ex-
pected. The analyzed aTSA could clearly benefit from a
ceramic humeral head in terms of reduced polyethylene
wear. As there is potential to improve the wear perfor-
mance of aTSA, further research is required. This could
be supported by the developed experimental wear testing
method presented in this study.
Acknowledgments
The authors would like to thank the manufacturer CeramTec
GmbH, Plochingen, Germany, for financial support and
for providing the prosthesis components. We gratefully ac-
knowledge further support from the Deutsche Arthrose-
Hilfe e.V. Foundation.
Disclaimer
The authors, their immediate families, and any research
foundations with which they are affiliated have not re-
ceived any financial payments or other benefits from any
commercial entity related to the subject of this article.
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	 Influence of humeral head material on wear performance in anatomic shoulder joint arthroplasty
	 Materials and methods
	 Biomechanical rationale
	 Testing setup
	 Determination of forces and kinematics on the shoulder joint
	 Soft tissue restraint system
	 Analyzed components
	 Testing conditions
	 Wear analysis
	 Results
	 Discussion
	 Conclusion
	 Acknowledgments
	 Disclaimer
	 References