Original Article

Proc IMechE Part H:

J Engineering in Medicine
2021, Vol. 235(5) 515–522
Total knee replacement wear during Ó IMechE 2021
Article reuse guidelines:
simulated gait with mechanical and sagepub.com/journals-permissions
DOI: 10.1177/0954411921991269

anatomic alignments journals.sagepub.com/home/pih

Chase Maag , Ioan Cracaoanu, Jason Langhorn and Mark Heldreth

Abstract
Total knee replacements (TKR) have historically been implanted perpendicular to the mechanical axis of the knee joint,
with a commensurate external rotation of the femur in flexion relative to the posterior condylar axis (PCA). Although
this mechanical alignment (MA) method has typically offered good long-term survivorship of implants, it may result in
alignment of the implant that departs significantly from the native Joint Line (JL) in extension and flexion for a consider-
able portion of the patient population. There is a growing interest with surgeons to implant TKR components more
closely aligned to the natural JL (Anatomic Alignment-AA) of the patient’s knee joint to reduce the need for soft tissue
releases during surgery, potentially improving knee function and patient satisfaction. Using a previously-validated finite
element model of the lower extremity, implant- and alignment-specific loading conditions were developed and applied in
a wear experiment via a six-degree-of-freedom joint simulator. MA was defined as 0° Joint Line (JL), 0° varus hip-knee-
ankle (HKA) angle, and 3° external femoral rotation. AA was defined as 5° varus JL, 3° varus HKA, and 0° femoral rota-
tion. The experiment returned wear rates of 3.76 6 0.51 mg/million cycles (Mcyc) and 2.59 6 2.11 mg/Mcyc for
ATTUNEÒ cruciate-retaining (CR) fixed bearing (FB) in MA and AA, respectively. For ATTUNE posterior-stabilized (PS)
FB in AA, the wear rate was 0.97 6 1.11 mg/Mcyc. For ATTUNE CR rotating platform (RP), the wear rates were
0.23 6 0.19 mg/Mcyc, 0.48 6 1.02 mg/Mcyc in MA and AA respectively. Using a two-way ANOVA, it was determined that
there was no significantly difference in the wear rates between AA and MA (p = 0.144) nor the wear rate of ATTUNE PS
FB in AA significantly different from either ATTUNE CR FB or ATTUNE CR RP.

Keywords
Total knee replacement, wear testing, experimental simulator, kinematics, load control

Date received: 13 July 2020; accepted: 6 January 2021

Introduction degrees-of-freedom (DOF) possible in the knee joint;

Total knee replacement (TKR) is a surgical process in
which a patient’s damaged knee joint is replaced with a
prosthetic implant. Approximately 700,000 TKR sur-
geries are performed annually in the United States; this
number is projected to grow due to the increased preva-
lence of degenerative joint diseases such as arthritis,
and the success of prosthetic knee implants in improv-
ing a patient’s function and quality of life.1,2 Predictive
wear testing is a necessary pre-clinical screening test to
ensure the efficacy of these total joint replacement
devices. Joint replacement wear testing is typically per-
formed in vitro on experimental simulators with inputs
derived to reproduce normal human gait and published
by international standards organizations such as ISO
and ASTM.3–5
Inputs for the wear testing of TKR, defined in ISO
14243-1:2009 and 14243-3:2014, include four of the six
flexion, anterior-posterior (A-P) displacement, interior-
exterior (I-E) rotation, and vertical load leaving the
other two axes uncontrolled (Varus-Valgus (V-V) and
Medial-Lateral (M-L)).3,4 By only controlling four axes
these protocols are only valid for testing implants in a
simulation of mechanical alignment (MA), with com-
ponents aligned perpendicular to the neutral mechani-
cal axis of the human knee in extension (0° Hip-Knee-
Ankle (HKA) alignment, 0° Joint Line (JL)) and
femoral posterior condyles parallel to the insert during
flexion (Figure 1). With improvements in materials,
DePuy Synthes Joint Reconstruction, Warsaw, IN, USA
Corresponding author:
Chase Maag, DePuy Synthes Joint Reconstruction, 700 Orthopaedic Dr,
Warsaw, IN 46582-3994, USA.
Email: cmaag@its.jnj.com
516
Figure 1. Mechanical alignment diagram (top) and anatomic
alignment diagram (bottom) (Depuy-Synthes surgical technique
DSUS/JRC/0617/2179).
process, and design, implant wear has become increas-
ingly robust to the standard ISO wear protocol. This
has led to the need for more clinically relevant wear
loading profiles to be developed in order to exercise
devices outside of these standardized gait profiles.6 An
effective and efficient way to produce these loading
profiles has not yet been documented.
In TKR, MA has been historically considered the
most ideal alignment for implant survivorship due to its
low reported revision rates in well aligned implants.7 In
contrast to MA which aligns the implants perpendicu-
lar to the neutral mechanical axis of the knee, an ana-
tomic alignment (AA) surgical technique aims to more
closely recreate the patient’s natural JL.8 Implementing
the AA surgical technique in a varus knee typically
results in a more varus tibial component and a more
valgus femoral component to maintain the HKA align-
ment within 0° to 3° overall varus. In addition, the
rotation of the femoral component in flexion is based
upon restoring the posterior condyles parallel to the
PCA. This rotation in flexion maintains harmony with
the more natural JL. It is hypothesized that the AA sur-
gical technique may also reduce the amount of soft tis-
sue releases required to effectively balance the knee,
and studies have shown that the reduction in soft tissue
release leads to reduced pain and improved function.9,10
As such, the AA surgical technique has recently been
gaining popularity with TKR surgeons. AA technique
should not be confused with kinematics alignment
(KA). Kinematic alignment is a different technique that
has a different focus and will not be discussed in this
paper.
Finite element (FE) models and their application to
experimental simulators are important in understand-
ing and advancement of joint replacement devices.
Advanced FE models such as the Kansas knee simula-
tor model and Denver lower-limb model have provided
insight into the loading and kinematics of TKRs.11,12
Proc IMechE Part H: J Engineering in Medicine 235(5)
Figure 2. Attune constructs - CR fixed bearing (top left), PS
fixed bearing (TOP RIGHT), CR rotating platform (bottom
center).
Telemetric implants such as those developed by the
Charité Universitätsmedizin, Berlin have also provided
a point of comparison for these models.13 While tele-
metric implants have generated insight into the loading
of a single implant, they have the limitation of repre-
senting a single alignment scenario in vivo. As such an
advanced lower-limb FE model described by
Fitzpatrick et al.12 was used to produce implant and
alignment specific loading conditions. A cruciate-
retaining (CR) TKR design in both fixed bearing (FB)
and rotating platform (RP) were evaluated for wear
using MA and AA alignments (Figure 2). Additionally,
a posterior stabilized (PS) FB TKR design was evalu-
ated for wear in AA and compared to the previously
stated wear experiments. The purpose of this study was
to compare the loading conditions and the resulting
wear of MA to that of AA in a CR FB and a CR RP
design and to compare the AA loading and wear of the
CR FB design to a PS FB design. A representation of
the experimental flow can be seen in Figure 3.
Methods
Defining AA parameters
Anatomic alignment surgical cut parameters were
defined as 3° varus HKA angle, 5° varus JL, and 0°
femoral rotation (Figure 1). The implant manufactur-
er’s ATTUNEÒ Knee System Femur First measured
resection AA surgical technique, as well as the
ATTUNE Knee System Tibia First balanced approach
Maag et al. 517

Figure 3. Computational/experimental flow chart.

patient specific alignment surgical technique, expressly

limit this technique to a maximum of 3° varus HKA
angle, no more than 3° varus JL and femoral rotation
is recommended to be held at 0°. A 5° varus JL was
chosen for this study to simulate inadvertent surgical
variation using conventional surgical instruments.14–17
These parameters are believed to produce a worst-case
implant orientation using this technique.

Computational simulation
Gait loading data (K1L-110108_1_86p) was retrieved
from the Charité Universitätsmedizin Berlin database
(Orthoload), collated and trimmed to a single cycle for
further analysis at DePuy Synthes (Warsaw, IN). It is
noted that raw data collected by Orthoload does not
describe the knee flexion/extension during activity, and
as such the flexion was measured at DePuy Synthes via
the video record of the activity undertaken by the
patient.13 Implant loads and kinematics were then pro-
cessed for Abaqus/Explicit (SIMULIA, Providence,
RI) using a custom MATLAB (MathWorks, Natick,
MA) script. This custom MATLAB script moved the
data into a useable form for the Abaqus/Explicit solver
to read. Using the previously described lower limb
model of Fitzpatrick et al.12 (Figure 4) physiological
hip, ankle, and muscle loading conditions were calcu-
lated for the gait cycle described above (Figure 5).
These physiological hip, ankle, and muscle loading con-
ditions were then applied through the same lower limb
model to an ATTUNE CR TKR in MA (0° HKA, 0°
JL, 3° femoral rotation), as well as AA (3° HKA, 5°
JL, 0° femoral rotation) and to an ATTUNE PS TKR
in the same AA alignment. All geometry was meshed
using rigid triangular elements with fundamental ele- Figure 4. Finite element model representation of the lower
ment length of 1 to 1.2 mm, which has been demon- limb.12
strated to be sufficiently fine for mesh convergence.18,19
Contact was modeled using a calibrated pressure over-
closure model detailed in Fitzpatrick et al.12 and a fric- kinematics were extracted from the simulation model.
tional coefficient of 0.04. Components were modeled as Measured kinetics and kinematics were then processed
rigid and as such have no material properties attributed through a custom MATLAB script to develop the
to them. After completion of the FE simulations the 6- implant and alignment specific joint level loading con-
DOF loads measured at the tibial interface and ditions. These loading conditions were then applied
518 Proc IMechE Part H: J Engineering in Medicine 235(5)

Figure 5. Input waveforms (load and kinematics) used on AMTI VIVO 6-DOF joint simulator.

Figure 6. AMTI vivo simulator (Top), experimental test setup-fixed bearing CR (bottom left) rotating platform CR (bottom right).

through an AMTI VIVO 6-DOF joint simulator
(AMTI, Watertown, MA) for experimental wear
testing.
Experimental testing
Gravimetric wear testing was performed by means of
an AMTI VIVO 6-DOF joint simulator (AMTI,
Watertown, MA) using production finished size 5
ATTUNE CR and PS implants (Figure 6). For each of
the load cases determined for measurement (ATTUNE
CR FB and RP MA, ATTUNE CR FB and RP AA,
and ATTUNE PS FB AA) four implant sets (femur,
tibial base, and polyethylene insert) were used; three
wear sample sets and one loaded soak sample. The
physical wear simulation was run in five axis force con-
trol, with flexion being the only displacement-
controlled axis, at a clinically relevant gait frequency of
Maag et al. 519

Table 1. Results.

Implant design/alignment Wear rates (mg/Mcyc)

ATTUNE CR FB MA 3.76 6 0.51

ATTUNE CR FB AA 2.59 6 2.11
ATTUNE PS FB AA 0.97 6 1.11
ATTUNE CR RP MA 0.23 6 0.19
ATTUNE CR RP AA 0.48 6 1.02

0.8 Hz. Test lubricant was bovine calf serum with a

protein concentration of approximately 17.25 g/L sup-
plemented with sodium azide (0.2%) for bacteria
growth retardation and EDTA (20 mM) to prevent cal-
cium precipitation. The temperature of the serum was
maintained at 37°C 6 2°C throughout the duration of
the test to simulate in vivo test conditions. Gravimetric
wear of the tibial inserts was quantified following meth-
ods detailed in ISO 14243-2:2009 with measurement
points being at test commencement and every 0.5 mil-
lion cycles (Mcyc) thereafter.20 Wear rates were calcu-
lated via linear regression of the gravimetric loss.

Figure 7. Average wear rate (top) and average wear (bottom)

Statistical analysis
Statistical analysis is undertaken using a two-way
ANOVA with interaction term and a confidence interval
of 0.95. The factors of implant design and alignment
were used in the analysis. If the interaction term is
deemed to be insignificant it will be removed, and analy-
sis will proceed using a two-way ANOVA. Additionally,
in-order to understand how the implant designs compare
a Tukey pairwise comparison will be done.
Results
Computational simulation
Using the lower limb model previously described, inde-
pendent implant and alignment loading profiles were
created for the AMTI VIVO joint simulator. These
independent loading profiles can be found in Figure 5.
The lower limb model was successfully used to translate
telemetric implant data to the specific implant and
alignments being used in the wear experiment.
Experimental testing
The AMTI VIVO 6-DOF joint simulator was observed
to effectively reproduce the loading profiles generated
by the lower limb model procedure described above.
Following 4.5 million cycles (Mcyc) of wear testing the
linear wear rates were calculated to be 3.76 6 0.51 mg/
Mcyc, 2.59 6 2.11 mg/Mcyc, 0.23 6 0.19 mg/Mcyc,
0.48 6 1.02 mg/Mcyc, and 0.97 6 1.11 mg/Mcyc for
ATTUNE CR FB MA, ATTUNE CR FB AA,
ATTUNE CR RP MA, ATTUNE CR RP AA, and
ATTUNE PS FB AA; respectively (Table 1). Average
wear for all sample groups can be seen in Figure 7. It is
noted that one of the ATTUNE CR FB MA femoral
of mechanical alignment CR FB, anatomic alignment CR FB,
mechanical alignment CR RP, anatomic alignment CR RP and
anatomic alignment PS FB.
components was found to be scratched during the one
Mcyc measurement interval. It is believed that this was
caused by a fluid containment failure that inadvertently
happened during one of the testing intervals. This led
to increased wear of this sample set and as such wear
rates were calculated using the two remaining samples
rather than all three.
Statistical analysis
Initially the interaction of implant design and alignment
were checked for significance, the p value was greater
than 0.05 and found to not be significant. As such, the
interaction term of the two-way ANOVA was removed
from the final analysis. The analysis determined that
there is no significant difference between MA and AA
(p = 0.144) while there was a significant difference
between implant designs (p = 0.003). Investigating the
implant design differences via a Tukey pairwise com-
parison, CR RP had significantly lower wear rates than
CR FB while both CR FB and CR RP did not have sig-
nificant differences with PS FB. Wear scars were photo-
graphed at the end of testing and can be found in
Table 2.
Discussion
Testing of orthopaedic knee implants in alignments
other than MA have not been extensively reported in
literature. It is believed that this is a consequence of the
inherent difficulty running in vitro testing in alignments
520 Proc IMechE Part H: J Engineering in Medicine 235(5)

Table 2. Sample group wear scars.

Sample group Wear scar

Medial Lateral

Mechanical
alignment CR FB

Figure 8 Comparison of compartmental loading based on

percent medial loading.

Anatomic
other than MA. Utilizing a computational model to
alignment CR FB calculate loading at the interface of the tibial implant
enabled the 6-DOF simulator to induce the change in
alignment from MA to AA without changing the physi-
cal fixturing. This study has shown that a combination
of computational and experimental techniques can be
readily used to better understand the wear and loading
of different alignments in the knee joint. Coupling com-
putational and experimental in this fashion may aid in
reducing design phase iterations, and better understand
how variations in implant orientation may affect per-
Anatomic formance in vivo.
alignment PS FB Wears scars presented in Table 2 give insight into
how the different implants and alignments effect wear
on the polymer inserts. One of the first comparisons
that can be drawn from the wear scars are changes
between mechanical and anatomic alignment of the CR
FB implants. It can be seen from that wear scar outline
that the anatomic alignment wear scar has much more
lateral movement when compared to the mechanical
alignment wear scar. This is an expected outcome when
changing the alignment methods (Figure 8). Anatomic
Mechanical alignment targets the patients pre-operative state and as
alignment CR RP such this implant alignment produces kinematics more
similar to the natural knee. It is noted that the natural
knee tends to have an increased medial pivot move-
ment, where the medial condyle experiences less A-P
movement than the lateral condyle.8,21,22 When com-
paring wear scars between MA and AA alignment for
the CR RP inserts, a similar pattern is found. Anatomic
alignment PS inserts do not seem to exhibit the same
wear pattern, and it is surmised that this may be due to
PCL removal in the finite element simulations and/or
Anatomic post-cam interactions in the PS design.
alignment CR RP
It is noted that this technique would make it possible
to produce loading profiles for additional alignment sce-
narios or additional activities and investigate other
potential consequences of implant alignment such as
implant fixation. This technique may also offer insight
on the effect of implant alignment on ligamentous struc-
tures in the knee joint. While in this study the ligamen-
tous structure insertion points were held constant, it may
be possible to perturb these locations to see the effects
on tibial loads with difference alignments and implants.
Maag et al.
These aspects will be investigated in future studies.
Another application of this technique that is not dis-
cussed is investigation into mal-alignment. Implants may
not always be perfectly aligned when initially implanted
or may migrate after implantation. As such there may be
an interest in studying the effects of mal-alignment on
the implant. Mal-alignment is suspect for early fixation
failure, increased wear, and other early revision factors.
Mal-alignment was not being directly investigated in this
study but using this technique it is possible to implant in
any alignment position to see the outcome in the joint.
Ligamentous structure information could be extracted
from the model, along with tibial interface loading and
its effects on the cement mantle. Investigation and better
understanding of the joint effects of mal-alignment may
be studied in the future.
This technique, as all do, has its limitations; the pri-
mary example being it is limited to only being able to
produce loading profiles from already recorded in vivo
measured tibial plateau loads. Though this limitation is
present, if external boundary conditions for an activity
were known for an activity one could apply those to the
model to find the loads at the tibial interface. There is
also an assumption that the external boundary condi-
tions of the Denver lower-limb model do not change
when switching implants and alignments. This assump-
tion is justified by the fact that if the same patient per-
forms that activity (with a different implant/different
alignment) then the external boundary conditions allow
that activity to be achieved. One could argue that as the
alignment of the implants change, the body (external
boundary conditions) will realign to reduce the inherit
force balances in the joint. This possibility is acknowl-
edged, however by not rebalancing for the new align-
ment these conditions would be more of a ‘‘worse’’ case
condition. In the lower limb model the knee insert is
considered a rigid body to reduce computation time
necessary to execute. In the situation where kinematics
and kinetics are of interest rather than wear metrics this
is an appropriate simplification.
From the results detailed in this publication it can
be concluded that AA, as defined in this study, does
not adversely affect the wear rates of ATTUNE CR
FB or RP when compared to MA and measured using
the AMTI VIVO 6-DOF simulator. Additionally, it
was found that ATTUNE CR RP had a significantly
lower wear rate than that of ATTUNE CR FB; this
may be a result of decoupling the internal-external
rotational torque in the RP implants. It can also be
concluded that the wear rate of ATTUNE PS FB in
AA not significantly different from either ATTUNE
CR FB or ATTUNE CR RP.
Author contributions
Chase Maag: Formal Analysis, Project Administration,
Software, Methodology, Investigation, Data Curation,
Visualization
521
Ioan Cracaoanu: Investigation, Formal Analysis, Data
Curation
Jason Langhorn: Writing – Review & Editing,
Supervision, Resources
Mark Heldreth: Conceptualization, Project administra-
tion, Writing – Review & Editing
All Authors have read and approved the final sub-
mitted manuscript.
Declaration of conflicting interests
The author(s) declared the following potential conflicts
of interest with respect to the research, authorship, and/
or publication of this article: Four of the authors (CM,
IC, JL, MH) are employees of DePuy Synthes.
Funding
The author(s) received no financial support for the
research, authorship, and/or publication of this article.
ORCID iD
Chase Maag https://orcid.org/0000-0003-1246-987X
References
1. Williams SN, Wolford ML and Bercovitz A. Hospitaliza-
tion for total knee replacement among inpatients aged 45
and over: United States, 2000–2010. NCHS data brief, no
210. 2015. Hyattsville, MD: National Center for Health
Statistics.
2. American Academy of Orthopaedic Surgeons. ‘‘98 percent
of total knee replacement patients return to life, work fol-
lowing surgery.’’ ScienceDaily, www.sciencedaily.com/
releases/2013/03/130321082857.htm (2013, accessed 10
March 2020).
3. ISO 14243:2009. Implants for surgery -wear of total
knee-joint prosteheses. Part 1: loading and displacement
parameters for wear-testing machines with load control
and corresponding environmental conditions for test.
4. ISO 14243:2014. Implants for surgery -wear of total
knee-joint prosteheses. Part 3: loading and displacement
parameters for wear-testing machines with displacement
control and corresponding environmental conditions for
tests.
5. ASTM F3141-17a, Standard guide for total knee replacement
loading profiles. West Conshohocken, PA: ASTM Interna-
tional. https://www.astm.org/Standards/F3141.htm (2017).
6. Reinders J, Sonntag R, Vot L, et al. Wear testing of
moderate activities of daily living using in vivo measured
knee joint loading. Plos One 2015; 10(3): e0123155.
7. Bonner TJ, Eardley WGP, Patterson P, et al. The effect
of post-operative mechanical axis alignment on the sur-
vival of primary total knee replacements after a follow-
up of 15 years. J Bone Joint Surg 2011; 93-B: 1217–1222.
8. Cherian J, Kapadia B, Banerjee S, et al. Mechanical,
anatomical, and kinematic axis in TKA: concepts and
practical applications. Curr Rev Musculoskelet Med 2014;
7: 89–95.
9. Dossett HG, Estrada NA, Swartz GJ, et al. A rando-
mized controlled trial of kinematically and mechanically
522
aligned total knee replacements. Bone Joint J 2014; 96-B:
907–913.
10. Howell SM, Papadopoulos S, Kuznik KT, et al. Accu-
rate alignment and high function after kinematically
aligned TKA performed with generic instruments.
Knee Surg Sports Traumatol Arthrosc 2013b; 21: 2271–
2280.
11. Baldwin MA, Clary CW, Fitzpatrick CK, et al. Dynamic
finite element knee simulation for evaluation of knee
replacement mechanics. J Biomech 2012; 45: 474–483.
12. Fitzpatrick CK, Baldwin MA, Clary CW, et al. Evaluat-
ing knee replacement mechanics during ADL with PID-
controlled dynamic finite element analysis. Comput Meth-
ods Biomech Biomed Eng 2012; 17: 360–369.
13. Bergmann G (Ed.) Charite-Universitaetsmedizin Berlin
(2008) ‘‘Orthoload’’. http://Orthoload.com (2008,
accessed 1 July 2011).
14. Barrett W, Hoeffel D, Dalury D, et al. In-vivo alignment
comparing patient specific instrumentation with both
conventional and Computer Assisted Surgery (CAS)
instrumentation in total knee arthroplasty. J Arthroplasty
2014; 29: 343–347.
Proc IMechE Part H: J Engineering in Medicine 235(5)
15. Bankes MJ, Back DL, Cannon SR, et al. The effect of
component malalignment on the clinical and radiological
outcome of the kinemax total knee replacement. Knee
2003; 10: 55–60.
16. Depuy-Synthes surgical technique DSUS/JRC/0617/2179
17. Depuy-Synthes surgical technique 097081-181130
18. Godest AC, Beaugonin M, Haug E, et al. Simulation of
a knee joint replacement during a gait cycle using explicit
finite element analysis. J Biomech 2002; 35: 267–275.
19. Halloran JP, Petrella AJ and Rullkoetter PJ. Explicit
finite element modeling of total knee replacement
mechanics. J Biomech 2005a; 38: 323–331.
20. ISO 14243:2009. Implants for surgery -wear of total knee-
joint prosteheses. Part 2: methods of measurement.
21. Lee YS, Howell SM, Won YY, et al. Kinematic align-
ment is a possible alternative to mechanical alignment in
total knee arthroplasty. Knee Surg Sports Traumatol
Arthrosc 2017; 25(11): 3467–3479.
22. Roussot MA, Vles GF and Oussedik S. Clinical out-
comes of kinematic alignment versus mechanical align-
ment in total knee arthroplasty: a systematic review.
EFFORT Open Rev 2020; 5: 486–497.