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The Journal of Arthroplasty 31 (2016) 290–294

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The Journal of Arthroplasty


journal homepage: www.arthroplastyjournal.org

Comparison of Tibial Insert Polyethylene Damage in Rotating Hinge and


Highly Constrained Total Knee Arthroplasty: A Retrieval Analysis
Kamal Bali, MBBS, MS, DNB a, Douglas D. Naudie, MD, FRCSC a, James L. Howard, MD, MSc, FRCSC a,
Richard W. McCalden, MD, MPhil(Edin), FRCSC a,
Steven J. MacDonald, MD, FRCSC a, Matthew G. Teeter, PhD a,b,c
a
Division of Orthopaedic Surgery, Department of Surgery, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada
b
Department of Medical Biophysics, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada
c
Surgical Innovation Program, Lawson Health Research Institute, London, ON, Canada

a r t i c l e i n f o a b s t r a c t

Article history: This study compared the damage scores and damage patterns in 19 tibial inserts from rotating hinge (RH)
Received 25 May 2015 implants with 19 inserts from highly constrained (HC) implants. Each insert was divided into 16 damage
Accepted 8 July 2015 zones and each zone was subjectively graded from a scale of 0–3 for seven different damage modes. The overall
damage scores were comparable for the two groups (RH: 64.1 ± 15.4; HC: 66.1 ± 29.0; P = 0.59). The HC group,
Keywords:
however, had greater post damage (compared to the post-hole of RH) while the RH group had greater backside
polyethylene wear
rotating hinge
damage. The pattern of damage was also different, with burnishing and cold flow being more common in HC
constrained liner group while pitting, scratching and embedded debris were more common in the RH group.
damage © 2016 Elsevier Inc. All rights reserved.
instability

Total knee arthroplasty (TKA) has generally shown good patient retrieval studies have reported post wear in 100% of the posterior stabilized
satisfaction and very high survivorship rates after implantation, even for implants [14]. This is perhaps even more relevant for HC implants charac-
young patients [1–3]. Tibial insert wear continues to be problem however, terized by a more robust and larger tibial posts compared to posterior
and can result in mechanical and biological complications leading to even- stabilized implants. For RH implants, backside wear and post-hole wear
tual failure of TKA [4–6]. Although multiple factors can influence wear in are potential additional sources of polyethylene debris [22].
TKA [6–11], prosthetic design has increasingly been shown to be an The wear characteristics of the articular side of tibial polyethylene
important factor for wear generation in TKA [12–16]. This may be parti- inserts of less constrained implants (posterior stabilized, PS or cruciate
cularly relevant with increased degree of constraint as in rotating hinge retaining, CR) have been reported extensively by retrieval studies
(RH) and unlinked highly constrained (HC) implant designs [17–19]. [22–26]. However, there is very little published on wear in implants
With rising need of TKA, RH and HC implants will likely be used with with increased constraint (RH and HC). The patterns and amount of
increasing frequency in years to come. Although most surgeons tend to damage for these inserts with increased constraint associated with RH
use HC type of implants for medial-lateral instability, this can also be and HC implants may be entirely different as compared to the inserts
addressed with an RH implant [17–20]. However, it is important to under- for primary TKA. Wear analysis of retrieved inserts from HC and RH
stand that a high degree of coronal instability combined with a significant type of TKAs may help predict specific wear patterns such as pitting
mismatch of flexion-extension gaps during revision TKA is an indication and delamination resulting from material fatigue or scratching caused
for RH type of implant instead of the HC implant [19]. Medial collateral by embedded debris. This information may be useful to understand
ligament insufficient that is non-reconstructable is also an indication for possible failure mechanisms of these inserts, and may aid in improving
an RH implant instead of the HC implant [20]. As these implants become the design of these implants in the future.
more popular, polyethylene wear is likely to ensue [21]. It is likely that Furthermore, although rotating platform TKAs have shown no wear
the tibial post will remain a major source of polyethylene wear as some related [22,27–30] or clinical [31–34] benefits over fixed bearing TKA in
primary setting, there exists no published study comparing the clinical
One or more of the authors of this paper have disclosed potential or pertinent conflicts or wear related differences between RH and fixed bearing HC tibial de-
of interest, which may include receipt of payment, either direct or indirect, institutional signs. Therefore, the objective of this retrieval study was to evaluate the
support, or association with an entity in the biomedical field which may be perceived to patterns of tibial insert damage in mobile bearing RH and fixed bearing
have potential conflict of interest with this work. For full disclosure statements refer to
HC implants to allow comparison with respect to articular, backside, and
http://dx.doi.org/10.1016/j.arth.2015.07.007.
Reprint requests: Matthew G. Teeter, PhD, Surgical Innovation Program, Lawson tibial post polyethylene damage. Our hypothesis was that, by virtue of
Health Research Institute, 339 Windermere Road, London, ON N6A 5A5 Canada. their design differences, there would be significant differences in the

http://dx.doi.org/10.1016/j.arth.2015.07.007
0883-5403/© 2016 Elsevier Inc. All rights reserved.
K. Bali et al. / The Journal of Arthroplasty 31 (2016) 290–294 291

pattern and/or amount of polyethylene damage between retrieved HC for no damage, 1 for b 10% area affected, 2 for 10–50% area affected
and RH inserts. and 3 for N50% of area affected. The scoring system was based on previously
established protocols for damage scoring in retrieved polyethylene
Methods specimens [13,23,35]. The maximum possible damage score by this
method was 336. The mean score for the two observers for each insert
The study involved visual damage scoring of all the fixed bearing HC was used for analysis of the results.
and mobile bearing RH tibial polyethylene inserts from our institutional Statistical analysis was performed with SPSS (Statistical Package for
review board approved implant retrieval laboratory. These inserts had the Social Sciences) software (version 11.0; SPSS, Chicago, IL). Univariate
been collected during revision TKA surgeries performed at our institu- analysis was performed with chi-square or the Fischer's exact test for
tion between 1996 and 2013. Demographic data were obtained from comparison of proportions between two categorical data. The Mann–
patient records for each retrieved tibial polyethylene insert. The following Whitney U test was used to compare the non-parametric data between
variables were collected: age at the time of revision, patient gender, two independent samples. P b 0.05 was considered significant.
operative side, time in vivo (TIV) for the inserts, body mass index (BMI)
and the number of revision at the time of retrieval of the tibial insert. Results
A total of 22 HC and 26 RH inserts were available for damage scoring.
Inserts that had been implanted for less than 6 months were excluded The demographic profile of the two groups of inserts is summarized
from the analysis. This included 3 HC inserts and 4 RH inserts. Nineteen in Table 1. Both the RH and HC groups were matched for TIV (mean 3.0
retrieved HC inserts were matched to a similar cohort of 19 RH inserts for RH vs 4.1 for HC, P = 0.335) and BMI (mean 31.1 for RH vs 32.3 for
based on BMI and TIV. Due to limited numbers of available inserts, we HC, P = 0.731). The mean age of the patients was higher in the HC group
included inserts from three different manufacturing companies and (69.3 years in HC vs 61.5 years in RH, P = 0.034) while the RH group had
therefore did not restrict the study to any single implant manufacturer. a higher number of revision procedures at the time of retrieval (mean
All 19 HC implants were Smith and Nephew designs (Smith and 3.7 in RH vs 2.5 in HC, P = 0.019). There were more male patients in
Nephew, Memphis, TN), manufactured with conventional GUR 1050 the RH group (84%) compared to the HC group (53%) (P b 0.0001).
polyethylene sterilized with ethylene oxide. Of the 19 RH implants, 12 Reasons for revision were similar in both groups, with the RH group
were Stryker designs (Howmedica, Rutherford, NJ), and 7 were Biomet having more revisions due to implant fracture or failure, and the HC
designs (Biomet, Warsaw, IN). Both designs were manufactured with group having more revisions due to instability.
conventional polyethylene and sterilized with gamma irradiation. Visual Analysis of mean visual damage scores revealed comparable total
damage scoring was therefore performed on a total of 38 tibial inserts. damage in both the groups (64.1 for RH vs 66.1 for HC, P = 0.549). Dis-
Two independent examiners were blinded to the demographic data tribution of the visual damage has been summarized in Table 2. The HC
of patients and performed damage scoring of the polyethylene inserts. group was found to have higher post damage (Fig. 2A) as compared to
The tibial inserts were divided into 16 zones for damage scoring. This the damage in the post-hole of the RH (8.8 in RH vs 21.7 in HC,
was similar to that previously used by published retrieval studies P b 0.0001). For the post of HC inserts, maximum damage was observed
[13,23]. The medial and lateral articulating surfaces were divided into on the posterior aspect of the post. The damage scores were slightly
4 quadrants. The backside (inferior) surface of the insert was divided higher in the RH group (Fig. 2B) in the medial articular zones (19.5 for
into 4 quadrants. The tibial post (for HC implants) or post-hole (for RH vs 15.8 for HC, P = 0.023) but comparable for the lateral articular
RH implant) was divided into anterior, posterior, medial and lateral zones (19.1 for RH vs 20.5 for HC, P = 0.515). Damage scores on the
zones (Fig. 1). backside were higher in the RH group (Fig. 2C) as compared to the HC
Each zone was subjectively graded from a scale of 0–3 for seven dif- group (16.7 in RH vs 8.2 in HC, P = 0.001).
ferent damage modes (burnishing, abrasion, cold flow, scratching, Table 3 summarizes the damage scores in both the groups based on
pitting, delamination and embedded debris). The damage score was 0 damage modes in the tibial inserts. The most common damage mode

Fig. 1. The sixteen zones used for damage scoring on the retrieved polyethylene inserts. (A) Articular surface of the constrained inserts. (B) Backside surface of the constrained inserts.
(C) Articular surface of the hinged inserts. (D) Backside surface of the hinged inserts.
292 K. Bali et al. / The Journal of Arthroplasty 31 (2016) 290–294

Table 1 plastic deformation. Burnishing (usually seen on the articular side) is a


Summary of Demographic Profile of Two Groups of Inserts. function of the area of contact and the sliding distance. Although the
Demographic Rotating Hinge, Highly Constrained, P Value area of contact of the articular aspect of fixed bearing type HC implant
Variable Mean + SD (Range) Mean + SD (Range) is less than the highly conforming mobile bearing RH, the sliding of
Number 19 19 – the insert (especially of the post in the case of imperfect centralization
Age 61.5 ± 10.1 (47–85) 69.3 ± 11.6 (46–88) 0.034a of the post within the box of femoral component) can contribute to
Time in vivo 3.0 ± 3.1 (0.5–13.9) 4.1 ± 3.3 (0.5–11.0) 0.335 high burnishing on the articular side of the HC implants. The use of an
Revision number 3.7 ± 2.0 (2–8) 2.5 ± 0.8 (1–4) 0.019a
HC implant implies low coronal instability, which may decrease the bal-
BMI 31.1 ± 6.6 (23.4–45.3) 32.3 ± 9.7 0.731
(21.6–58.8) ance of the joint, leading to irregular force distribution. Similarly, cold
Percent male 84 % 53 % b0.0001a flow, which was found to be higher in the HC implants as compared to
Reason for Infection (n = 10) Infection (n = 10) – the RH implants, can result from plastic deformation of the post. Cold
revision Loosening (n = 4) Loosening (n = 5) flow does not lead to volumetric loss of polyethylene and, along with
Implant failure (n = 3) Instability (n = 3)
abrasion and burnishing, is also classified as low-grade wear. However,
Pain (n = 1) Pain (n = 1)
Periprosthetic fracture this low-grade wear may produce large amount of smaller and granular
(n = 1) particles that can trigger a biological response leading to osteolysis
SD = standard deviation. [36,37].
a
Significant. For the RH inserts, pitting and scratching were found to be the most
common mode of damage. This was similar to findings by Stoner et al
[27], Lu et al [28] and Engh et al [29] who found higher pitting and
was pitting for RH inserts and burnishing for the HC inserts. Detailed scratching in the mobile bearing inserts as compared to the fixed bearing
analysis revealed higher “low grade wear patterns” (burnishing and inserts. Embedded debris on the backside of the RH implants was also
cold flow) in HC inserts and more “high grade wear patterns” much higher than the HC implants and was most likely a result of
(scratching, pitting and embedded debris) in the RH inserts. Abrasion trapped debris in the backside articulation and post-hole area of the RH
and delamination were equivalent between the two groups of inserts. implants. The pitting and scratching in the RH implants most likely
represent wear due to third body debris. These are all forms of high-
Discussion grade wear, which produces larger polyethylene particles and great
volumetric loss of polyethylene. While high grade wear may not always
Multiple factors influence wear in polyethylene tibial inserts and lead to osteolysis [36] it can lead to rapid severe polyethylene wear
these include patient, implant and surgical variables [6–11]. Although resulting in failure of the implant.
prosthetic design has been shown to be an important factor for wear In the current study, the overall total damage scores for both RH type
generation in TKA [12–16], there is a lack of retrieval studies comparing and HC type of tibial inserts were comparable (64.1 for RH vs 66.1 for
hinged and unlinked highly constrained implants. HC, P = 0.549). There have been a few studies that have calculated
From a design point of view, the RH and HC types of implants are dif- damage scoring in PS type implants using the same scoring system uti-
ferent. A more robust post as compared to the traditional posterior sta- lized in the current study [13,38]. In comparison to previously reported
bilized implants characterizes the fixed bearing HC tibial insert. In HC mean damage scorings in PS type inserts, this current study demon-
implants, a snugger fit within the femoral box resists varus-valgus de- strated significantly higher scores for both the RH and HC inserts. In par-
formity and limits rotation to a few degrees. This increased constraint ticular, the mean damage score of conventionally sterilized tibial inserts
can lead to high contact stresses at the post and potentially higher PS type inserts was 55 in a study by Medel et al [38] while in a previous
post damage. In contrast, the RH type implants are characterized by a study from our institution [13], the mean damage score for traditional
metal post attached to the femoral component by means of a metal PS type inserts was 49.2. In both these studies [13,38], the time in vivo
axle and polyethylene bushing. In addition, a separate polyethylene for the implants and demographic profile was similar to our current
bumper inserted in the anterior aspect of the tibial component is de- study. These findings clearly support the concept that the wear and
signed to prevent hyperextension. Apart from the articular surface, damage in tibial inserts increase as the level of constraint increases
other potential sites of polyethylene wear for the RH type of insert are from a PS type to HC or RH type of implant.
the backside and the post-hole area of inserts. While the fixed bearing The study by Padgett et al [18], in which they reported on a retrieval
HC type of inserts has less conforming articular geometry, the mobile analysis of 56 constrained tibial inserts (HC type) after primary total
bearing RH type inserts usually have a highly conforming articulating knee arthroplasty, represents the only work that allows direct compar-
geometry. As the HC and RH type implants are structurally very different, ison to our study of HC inserts. However, their study had a significantly
the patterns of wear and the contact stresses would clearly be very shorter mean TIV (21 months vs. 49 months) and the zones for damage
different. This fact is confirmed in the findings of our study and thus scoring on the post were different and they did not evaluate back-side
confirms our hypothesis. damage scores. However, the methodology of articular surface scoring
The different wear patterns observed between the RH and HC inserts in their study was similar to our study in which they reported a mean
carry different significance. Burnishing, most commonly seen in the HC articular surface damage score of 54, compared to only 36.3 in our
implants in the current study, is a low grade type of wear and appears as study. Although the authors did not comment on the mean age of the
smooth or brightened surface without visible scratches, fracture or patients, a higher activity level (by virtue of all the patients having

Table 2
Summary of Damage Scores for the Two Groups Based on Damage Location.

Damage Location Rotating Hinge, Mean + SD (Range) Highly Constrained, Mean + SD (Range) P Value

Lateral articular 19.1 ± 5.6 (12–31) 20.5 ± 7.6 (8–37) 0.515


Medial articular 19.5 ± 5.1 (12–28) 15.8 ± 8.8 (4–38) 0.023a
Post or post-hole 8.8 ± 5.9 (0–23) 21.7 ± 11 (6–55) b0.0001a
Backside 16.7 ± 6.9 (4–32) 8.2 ± 6.3 (1–25) 0.001a
Total 64.1 ± 15.4 (37–96) 66.1 ± 29.0 (23–147) 0.549

SD = standard deviation.
a
Significant.
K. Bali et al. / The Journal of Arthroplasty 31 (2016) 290–294 293

Fig. 2. Examples of damage seen on the retrieved polyethylene inserts. (A) Damage to the post of a constrained insert. (B) Damage on the articular surface of a hinged insert. (C) Damage on
the backside of a hinged insert.

received a primary TKA) may explain their observed higher damage may been used in patients with greater coronal plane laxity (and as such
score. Nevertheless, similar to our study, these authors found a higher could not be managed with an HC insert). The total articular wear was
level of insert damage with increased constraint and discouraged the comparable for the two designs. Although there are no studies in litera-
overuse of constrained implants in primary TKA. ture comparing RH with HC inserts, these findings are very similar to the
Studies on retrieval analysis of hinged implants are also limited. retrieval studies comparing mobile bearing with fixed bearing tibial in-
Kester et al [19] evaluated 12 tibial inserts from the Noiles hinge type serts in primary TKA [22,27–30]. In these studies, the damage scores are
implant (Depuy, Warsaw, IN). The authors found significant polyethy- reported higher on the post of the fixed bearing inserts. Furthermore,
lene deterioration on the tibial stem and tibial plateau bearing polyethy- similar to our study, the total damage scores and the articular sided
lene components. They noted two types of wear. The most marked was damage scores are comparable between the mobile bearing and fixed
gall wear, exemplified by deep ruts (greater than 1 mm) in the poly- bearing inserts [22,27–30].
ethylene and was principally seen along the parameters of articulating Of note, the two groups in our study were matched with respect to
surfaces. The second type, composed of small pits (100–300 μm) and BMI and TIV. While higher BMI and increased TIV have been shown to
scratches, was noted to occur where metal articulated with the be associated with higher damage scores [15,30], we attempted to con-
polyethylene on the stem and bearing surfaces. Although a formal trol for these factors, thus allowing meaningful comparison of the two
damage scoring was not performed in this study, the study showed groups. However, male sex and patient age were not similar between
very high polyethylene damage in older hinge type designs. Recently, groups, where there was a preponderance of males and younger pa-
Lee et al [17] described repeated early hyperextension failure of the tients in the RH group. This is a potential limitation of the current
RH type Zimmer Segmental Knee System (ZSKS). Retrieved polyethy- study as male sex and younger age have been shown to be associated
lenes in their study showed deformation, both along the circular contact with higher activity levels and higher damage scores in other retrieved
area with the axle and anteriorly where it was designed to resist inserts [15,27].
recurvatum. The authors identified the “one piece” post system of the Some other limitations of the current study should also be noted.
ZSKS, as different to traditional RH designs, and attributed this system Firstly, we calculated damage scores using a visual scaling method.
design as responsible for the repeated failures observed in their series While an accepted methodology, this method accesses only two-
and the high damage observed in their retrieved inserts. dimensional damage and thus the damage scores may not accurately re-
In our current study, with respect to the location of the damage, flect the actual volumetric wear. Also, as not all the primary TKAs were
there was much higher post damage in HC inserts as compared to the performed at our institution and these implants have continued to
post-holes of RH inserts. As discussed previously, rubbing or sliding of evolve over years, we do not have complete manufacturing information
the post within the box and against the cam mechanism in a fixed for the inserts especially with respect to the sterilization technique,
bearing varus-valgus constrained design can lead to increased low- shelf life or storage. These factors have been shown to influence the
grade type of wear of the post and therefore explains these results. wear characteristics of polyethylene in vivo [8–10,38]. Further, the
Conversely, backside damage scores were much higher for RH implants wear patterns found in the current study were limited to a few designs
compared to HC inserts. This is almost certainly a result of the additional of the knee and may not completely represent design features of diverse
articulating surface (by virtue of mobile bearing nature of the RH implant designs available for revision TKA. Additionally, of the implants
design) and the likelihood of entrapment of debris in this region leading evaluated, we did not take into account factors like femoral component
to third body high grade backside wear. We cannot easily explain the designs variation and thickness of the polyethylene insert, which may
finding that the medial sided articular wear was slightly higher in the affect the type and distribution of damage [6,7,11]. Furthermore, some
RH inserts as compared to HC inserts, except to say that the RH implants of the inserts in this study would have been removed at the time of re-
vision surgery for mechanical failure and may not be representative of
well functioning implants. We also did not have clinical and radiological
Table 3 data (like osteolysis/bone loss) to correlate with the amount and type of
Summary of Damage Scores for the Two Groups Based on Damage Mode.
damage observed in the inserts.
Damage Mode Rotating Hinge, Highly Constrained, P Value Nevertheless, this retrieval study is the first to directly compare
Mean + SD (Range) Mean + SD (Range) damage in RH and HC implants. As such, it provides important informa-
Burnishing 13.6 ± 7.3 (0–23) 27.9 ± 5.2 (18–35) b0.0001a tion regarding wear in knee implants with differing levels of constraint.
Abrasion 13.8 ± 5.9 (7–30) 12.8 ± 8.1 (1–27) 0.578 These data can be used to better understand the various failure mecha-
Cold flow 2.1 ± 2.5 (0–8) 4.6 ± 4.5 (0–16) 0.038a
nisms associated with specific design features of these inserts.
Scratching 13.4 ± 5.3 (6–24) 8.9 ± 7.0 (2–25) 0.007a
Pitting 17.0 ± 10.2 (4–44) 10.7 ± 8.0 (1–27) 0.042a
In summary, the tibial inserts with increased constraint (HC or RH)
Embedded debris 3.4 ± 3.9 (0–14) 0.8 ± 2.4 (0–10) 0.0003a show higher damage when compared to previous published results on
Delamination 1.1 ± 2.6 (0–11) 0.6 ± 2.3 (0–10) 0.219 damage scoring for lesser-constrained (PS or CR type) inserts in TKA. Al-
Total 64.1 ± 15.4 (37–96) 66.1 ± 29.0 (23–147) 0.549 though the overall damage scores are comparable in both the groups,
SD = standard deviation. the location and pattern of damage are very different. Mobile bearing
a
Significant. RH inserts are associated with much higher backside wear while the
294 K. Bali et al. / The Journal of Arthroplasty 31 (2016) 290–294

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