THEKNE-02974; No of Pages 5

The Knee xxx (xxxx) xxx

Contents lists available at ScienceDirect

The Knee

Revisiting the role of isolated polyethylene exchange for aseptic

failures in total knee arthroplasty
Ian Duensing, Christopher E. Pelt, Mike B. Anderson, Jill Erickson,
Jeremy Gililland, Christopher L. Peters ⁎
University of Utah, Department of Orthopaedics, 590 Wakara Way, Salt Lake City, UT 84108, USA

a r t i c l e i n f o

Article history: Background: Controversy continues to exist regarding the advisability of isolated polyethylene
Received 22 August 2019
exchange (IPE) following total knee arthroplasty (TKA) for aseptic indications. We sought to
Received in revised form 7 December 2019
compare the difference in the cumulative incidence of reoperation after IPE specifically for
Accepted 5 January 2020
Available online xxxx aseptic failure and to evaluate risk factors for failure.
Methods: We performed a retrospective cohort study of 122 knees revised for aseptic failure.
Reasons for IPE in aseptic knees included: instability, polyethylene wear, arthrofibrosis, patella
Keywords:
fracture, patellar resurfacing, patellar maltracking, extensor mechanism failure, patellectomy,
Arthroplasty
Revision
and a custom polyethylene for correction of valgus deformity. The relatively high rate of mor-
Polyethylene tality warranted a competing risk model to evaluate the cumulative incidence reoperation.
Exchange Follow-up time was defined by years from IPE to date of reoperation or last follow-up. Gener-
Survivorship alized estimating equations were used for comparisons.
Knee Results: Our analysis demonstrated an 87% (95% CI, 78–92%) survivorship free of reoperation at
five years. Re-revision was secondary to aseptic failure, infection, and patellar malalignment.
IPE for polyethylene wear was found to be protective and less likely to require reoperation
(SHR 0.121 95% CI: 0.016–0.896, p = 0.039).
Conclusions: The current study suggests that when done for carefully selected indications, IPE
may be an acceptable procedure and helpful alternative for aseptic TKA revisions, particularly
when the pre-operative diagnosis is polyethylene wear. This is in contrast to prior reports
and may represent a need to re-visit the role of isolated polyethylene exchange.
© 2020 Elsevier B.V. All rights reserved.

1. Introduction

Despite the reliability and reproducible success of total knee arthroplasty (TKA), the number of revision surgeries are rising [1].
Reasons for failure are varied and the complexity of revision surgery is inconsistent. Aseptic loosening is certainly the predomi-
nant reason for revision arthroplasty [2] followed by peri-prosthetic joint infection. Adding the non-specific categories of instabil-
ity, stiffness, and pain, 80% to 90% of the causes of revision arthroplasties are accounted for [2,3]. Since the advent of modularity in
arthroplasty components in the 1980s, the option for isolated polyethylene exchange (IPE) has been a source of controversy and
debate. Specifically, reports on survivorship and outcomes vary widely with evidence to both support and condemn isolated tibial
polyethylene exchange in the available literature. Several groups report high rates of failure and re-revision after isolated tibial

⁎ Corresponding author.
E-mail addresses: ian.duensing@hsc.utah.edu, (I. Duensing), chris.pelt@hsc.utah.edu, (C.E. Pelt), mike.anderson@hsc.utah.edu, (M.B. Anderson),
jill.erickson@hsc.utah.edu, (J. Erickson), jeremy.gililland@hsc.utah.edu, (J. Gililland), chris.peters@hsc.utah.edu. (C.L. Peters).

https://doi.org/10.1016/j.knee.2020.01.002
0968-0160/© 2020 Elsevier B.V. All rights reserved.

Please cite this article as: I. Duensing, C.E. Pelt, M.B. Anderson, et al., Revisiting the role of isolated polyethylene exchange for asep-
tic failures in total knee arthroplast..., The Knee, https://doi.org/10.1016/j.knee.2020.01.002
2 I. Duensing et al. / The Knee xxx (xxxx) xxx

polyethylene insert exchange [4–6] and caution against this approach for most knee revision indications. Several more recent
studies have published support for IPEs in well indicated patients with appropriate techniques and sterilization methods [7–9].
Data published in 2010 shows whole implant revision being performed more than three times as frequently than one- or two-
component exchange (35% whole component) with IPE performed only nine percent [3]. This, however, does not include IPE for
infection. Septic failures undergoing IPE present and are treated with much greater heterogeneity and, therefore, are difficult to
compare outcomes, reoperation rates, and longevity to aseptic failures. As such, septic failures after TKA should be considered dif-
ferently than aseptic failures which, in contrast, allows for a more standardized cohort. Studies focusing on aseptic failures allow
for a more nuanced evaluation of mechanical reasons for failure, mainly instability, malalignment, and polyethylene wear.
With this degree of variability in the literature, it becomes apparent that more data is needed with a focus on survivorship and
patient characteristics favorable for survival in aseptic failures. The purpose of this observational study was to compare the differ-
ence in the cumulative incidence of reoperation after IPE five years after index surgery, specifically focusing on failure for aseptic
etiologies at a single academic institution. Additionally, we sought to evaluate risk factors for failure in aseptic cases.

2. Methods

After approval from an institutional review board, we performed a retrospective cohort study on a consecutive series of pa-
tients who underwent IPE between September 2000 and April 2016. Our cohort was established by querying our institution's en-
terprise data warehouse for all cases that underwent revision TKA of a single component using current procedural terminology
code 27816 (revision of TKA, with or without allograft, one component). After the initial data query was complete, the electronic
medical records (EPIC, Verona, Wisconsin, USA) was reviewed to identify IPE as the component revised (214 patients, 224 knees),
the procedure date was confirmed, follow-up visits were determined, and additional data regarding complications were obtained.
The initial query included patient characteristics (age, sex, body mass index [BMI], and the American Society of Anesthesiologists
physical status classification [ASA score]), diagnoses, and a deceased flag. Forty-one patients underwent IPE for septic indications
and were excluded. Sixty-one knees (33%) lacked a minimum two-year follow-up and were excluded leaving 122 knees (119 pa-
tients) for analysis. To more precise the proportion of aseptic IPE, there were 1361 revision cases performed at our institution dur-
ing this time period including the aforementioned 224 IPEs. Aseptic IPE (122 cases) at our institution is performed infrequently
indicated by a low percentage of overall revision cases (nine percent). Prior to exclusion, the Social Security Death index was
reviewed for all patients lacking follow-up in order to determine if the patients had expired. Forty-two patients were found to
have expired during the study period. Five (12%) of the deceased patients were revised prior to death.
In general, the major indications for isolated poly exchange in aseptic cases were instability and polyethylene wear. Impor-
tantly, of the 122 knees included in the analysis, 14 of these were performed in the revision setting. The remaining group of
IPE (108/122) was following the primary or index surgery. In all cases, IPE was considered effectively as a procedure of exclusion.
It was deemed appropriate only in patients who demonstrated clinically neutral alignment without physical exam findings to sug-
gest excessive instability in the antero-posterior or varus valgus planes. This was determined by four experienced adult recon-
struction surgeons, all with similar approaches and criteria for IPE. Radiographically, there must be clear evidence of
appropriate femoral and tibial component alignment and fixation without the presence of aseptic loosening or radiographically
evident osteolysis. Plain radiographs were the principle means of investigation during this study period to evaluate component
and osseous integrity with advanced three-dimensional imaging not routinely utilized. For cases of instability, the indications
were antero-posterior instability, indicated only in knees containing cruciate retaining implants, generally attributed in these pa-
tients to posterior cruciate ligament incompetence, or mild global varus–valgus laxity in both flexion and extension gaps. Extreme
varus–valgus instability, determined by the evaluating surgeon, was a contraindication for IPE. Unbalanced laxity, most often en-
countered in flexion or mid-flexion, was almost never indicated for IPE unless, in the rare circumstance, that the extension gap
was likely to accommodate added poly thickness without the creation of excessive extension tightness and a flexion contracture.
IPE for polyethylene wear was diagnosed radiographically, showing asymmetric narrowing of either medial or lateral tibiofemoral
compartments without radiographic osteolysis or aseptic loosening. IPE for polyethylene wear was considered if the implant man-
ufacturer made available appropriate polyethylene for posterior stabilization (posterior stabilized, anterior stabilized, or ultra-
congruent). The other indications for IPE (e.g. arthrofibrosis, patella fracture or resurfacing) were dependent on exchanging the
polyethylene at the time of correcting other problems with the TKA.
Data are summarized using descriptive statistics. A Kaplan–Meier Analysis was used to determine the survivorship of the index
polyethylene exchange with failure defined as reoperation involving polyethylene exchange or removal, for any reason. Mean
follow-up was 5.2 years, range 0.08–16.9. Patients were censored at time of reoperation following IPE, death or last follow-up.

Table 1
Patient characteristics of aseptic IPEs.

Characteristic Aseptic, n = 115

Agea, mean ± sd (range) 65 ± 12 (28–88)

Male, n (%) 51 (42%)
BMIb, mean ± sd (range) 33.4 ± 7.2 (19.6–52.2)
ASA, median (IQR) 2 (2–3)
a
Age in years.
b
BMI in kg/m2.

Please cite this article as: I. Duensing, C.E. Pelt, M.B. Anderson, et al., Revisiting the role of isolated polyethylene exchange for asep-
tic failures in total knee arthroplast..., The Knee, https://doi.org/10.1016/j.knee.2020.01.002
 I. Duensing et al. / The Knee xxx (xxxx) xxx 3

A modified Poisson regression was used to evaluate risk factor for failure. All analyses were performed using commercially avail-
able statistical software (Stata v. 14.2, College Station, TX, USA). Significance for risk factors were evaluated at p b 0.05.

3. Results

The mean age of this cohort was 65 ± 12 years (range, 28–88 years), and the majority of these patients were male (58%,
Table 1). In this aseptic failure cohort, the reasons for IPE varied but most commonly were revised for instability (64/122) and
polyethylene wear (41/122). Less common indications included in the aseptic cohort were arthrofibrosis (7/122), patella fracture
(5/122), patellar resurfacing (2/122), and one each for patellar maltracking, extensor mechanism failure, patellectomy, and a cus-
tom polyethylene for correction of valgus deformity. For the latter and less common indications, polyethylene exchange was per-
formed at the same time as the additional procedures for which these patients were indicated for and therefore were not truly
isolated in nature. However, these cases were kept in the final cohort as these did fall under the category of polyethylene revision
without whole component exchange. Otherwise, demographics for this group were unremarkable with a mean body mass index
of 33 (range 19.6–52.2) and an average ASA class of 2.
The Kaplan–Meier analysis demonstrated an 87% (95% Confidence Interval (CI), 78–92%) survivorship free of reoperation at
five years (Figure 1). There were 15 failures identified in this group during this time period, and these 15 failures required re-re-
vision. Indications for re-revision varied but included seven (47%) revision TKAs for repeat aseptic failure, seven (47%) stage-one
revisions for infection, and one (seven percent) subsequent IPE for patellar malalignment.
Results of the regression analysis looked at risk factors for failure and favorable indications that might be protective from re-
operation. The analysis showed knees that underwent IPE for polyethylene wear were actually found to be protective in this co-
hort with sub-hazard ratios suggesting these patients were less likely than other indications to require reoperation (sub-hazard
ratios (SHR) 0.121, 95% CI: 0.016–0.896, p = 0.039). The other major indication in this group, instability, did not show a favorable
SHR possibly indicating that these patients, as a group, treated with IPE do not do as well in mid- to long-term follow-up as those
revised for polyethylene wear. A number of other preoperative variables were evaluated in the analysis, but none were associated
with failure (all, p N 0.05, Table 2). That said, the numbers available for analysis of other risk factors were quite small and there-
fore may not have been robust enough to be adequately powered or draw conclusions from. With the numbers available, we were
unable to identify any other preoperative risk factor for failure of IPE.

4. Discussion

This study evaluated a single institution's experience with IPE in revision total knees for aseptic pathology. Revision TKAs are
treated with varying procedures; isolated modular polyethylene component exchange is utilized in a relatively small percentage
of cases with revision of one or more components representing a much more likely scenario. Much of this lack of enthusiasm of
IPE has come from prior studies that question the role of IPE in the setting of revision TKA due to poor outcomes. Our data sug-
gests that when IPE is done for aseptic reasons, reoperation rates at five years are acceptable with a cumulative incidence of 13%,
which is similar to reoperation rates following revision TKA in general. When compared to the existing literature, the current
study offers a much larger patient cohort with favorable reoperation rates. This is consistent with more recent literature
[7,8,14] and stands in contrast to the grim picture painted by literature in the early 2000s [4,5,15,16]. Importantly, to emphasize
again, the distinction between IPE for aseptic vs septic scenarios should be noted. These patients and situations should not be con-
sidered equal as IPE for septic failure is associated with an extremely high reoperation rate, often due to persistent infection.
Strict selection criteria must be identified and followed to maximize chance of successful outcomes. In our study, IPE was per-
formed only in the absence of other identifiable reasons for failure. Patients were examined critically in clinic for overall limb

Figure 1. Kaplan-Meier curve for survivorship free from reoperation.

Please cite this article as: I. Duensing, C.E. Pelt, M.B. Anderson, et al., Revisiting the role of isolated polyethylene exchange for asep-
tic failures in total knee arthroplast..., The Knee, https://doi.org/10.1016/j.knee.2020.01.002
4 I. Duensing et al. / The Knee xxx (xxxx) xxx

Table 2
Risk factors for failure following aseptic IPE, presented as sub-hazard ratios (SHR).

Preoperative risk factor n (%) Unadjusted SHR (95% CI) p value

Instability as preoperative diagnosis 64/122 (52%) 2.26 (0.81–6.32) 0.121

Polyethylene wear as preoperative diagnosis 41/122 (34%) 0.121 (0.016–0.896) 0.039
Obesitya 98/122 (80%) 0.95 (0.28–3.29) 0.938
Age – 0.99 (0.96–1.03) 0.846
Male sex 51/122 (42%) 1.42 (0.54–3.74) 0.479
ASA N 2 46/122 (38%) 1.10 (0.40–3.05) 0.853
Mental healtha 12/122 (10%) 0.60 (0.08–4.40) 0.613
Diabetesa 12/122 (10%) 0.55 (0.07–4.24) 0.570
Chronic paina 3/122 (2.5%) 4.98 (0.56–44.4) 0.151
History of tobacco usea 10/122 (8.2%) 0.88 (0.11–7.22) 0.906
Anti-coagulation therapya 5/122 (4.1%) 1.67 (0.21–12.3) 0.646
Hypertensiona 41/122 (34%) 0.47 (0.13–1.67) 0.236
a
Obtained from preoperative comorbidity diagnoses.

alignment, and length, laxity on examination in both flexion and extension, as well as other possible concomitant sources of pa-
thology from other anatomic areas. Radiographically, TKA components were evaluated for evidence of loosening, osteolysis, or
asymmetric joint space narrowing. As mentioned previously, patients demonstrating clinically neutral alignment with antero-
posterior instability in cruciate-retaining knees or mild global or varus–valgus laxity in both flexion and extension gaps were con-
sidered candidates for IPE, while those with excessive or unbalanced laxity were not. Radiographically, clear evidence of appro-
priate component positioning and fixation without the presence of aseptic loosening or radiographically evident osteolysis
were criteria for being considered for IPE. Prior reports show varying success rates and efficacy of IPE [4,5,7,15,16] with a wide
range of failure rates, 11% to 59% [14]. The majority of the available literature on this topic included IPE for a variety of failure
mechanisms (stiffness, instability, polyethylene wear, etc.), which may influence success of the procedure, and a recent report
by Cooper et al. demonstrated non-inferiority to component revision when pre- and intra-operative criteria were met [14].
Their analysis included 90 knees with varying levels of constraint diagnosed with instability without malalignment that were
treated with isolated tibial polyethylene insert exchange and were compared to group undergoing component exchange when
these criteria were not met. They found no difference in Knee Society Scores, overall arc of motion, and failure rates between
groups. The authors did note that re-revision rates were significantly lower when the level of polyethylene insert constraint
was increased. Prior to this, Konrads et al. evaluated their series of 62 TKAs revised with IPE for aseptic failure with similarly
good results [7]. Polyethylene insert thickness was increased by an average of two millimeters and was primarily revised for in-
stability and polyethylene wear. Their results show that the overall survival of IPE was 72.2% at 6.25 years of follow-up with only
an 11% failure rate due to re-revision. Additionally, Baker et al. evaluated another 45 failed aseptic TKA treated with IPE and, at a
mean follow-up of 58 months, only four patients (nine percent) were re-revised [8]. The study by Cooper et al., our present study,
as well as the additional cited studies demonstrate a more positive outlook of IPE for well-selected patients with aseptic failure
than has been previously documented.
Given the varying success of selective component revision, the critical comparison is between IPE and one, two, and whole
component revisions. Comparing efficacy of a less morbid, smaller and relatively simpler procedure to whole implant exchange
is an important distinction to make and the underlying question being addressed in the present study. Overall survival rates
for revision knee arthroplasty 10 years from index surgery has been cited between 52% and 97% [17]. Data from the Norwegian
Joint Registry [17] reviewed failure rates of revised total knee arthroplasties for aseptic failures between the dates of January 1994
and December 2011. Indications for revision included loosening, pain, instability, patellar maltracking, malalignment,
arthrofibrosis, and peri-prosthetic fracture. All septic failures were excluded in this study. One thousand and one hundred sixteen
TKAs were included for analysis and were treated with component exchange, most commonly femoral or tibial component ex-
change, exchange of the entire prosthesis, and IPE. Overall survivorship analysis demonstrated 85% (82–87%) five-year survival,
78% (75–82%) 10-year survival, and 71% (62–80%) 15-year survival. The most common cause of re-revision was deep infection,
and they found better implant survivability with whole implant exchange than single component revision including IPE (adjusted
Risk Ratio (RR) (95% CI) 1.5 (0.9–2.3)). To contrast this, comparison of our data at minimum two-year follow-up of only IPE for
aseptic failures found a lower failure rate when compared to IPE or single component exchange in the referenced study and a
similar failure rate compared to whole implant exchange. Another review of revision total knees by Riaz and Umar in 2006 rec-
ommended against selective revision following TKA aseptic failure [18]. The present study makes the argument that, perhaps, the
rates of re-revision are less disheartening than previously reported.
We recognize several limitations to the present study. First, this is a retrospective observational study and is therefore subject
to the inherent limitations and biases associated with this study design. Unfortunately, to capture the large number of patients in
this study, a retrospective review was necessary and unavoidable. In addition, lack of follow-up in 31% of the cases and exclusion
of 41 patients for septic failures may have resulted in retrospective selection bias, and the outcomes should be considered with
this in mind. Further, in order to establish the large number of patients included in the present study, IPE for all causes were in-
cluded. Approaching the data in this manner may have influenced the overall success of the procedure, however, including all pa-
tients in the analysis gives a truer representation of the success of IPE and is more encouraging given the overall lower rates of
revision compared to prior studies [4,5,15,16]. Indications for IPE may have varied slightly between evaluating surgeons, although

Please cite this article as: I. Duensing, C.E. Pelt, M.B. Anderson, et al., Revisiting the role of isolated polyethylene exchange for asep-
tic failures in total knee arthroplast..., The Knee, https://doi.org/10.1016/j.knee.2020.01.002
 I. Duensing et al. / The Knee xxx (xxxx) xxx 5

the low rates of IPE at this institution and review of the clinical records suggest that this procedure was performed relatively un-
commonly with closely evaluated, narrow patient/case-based indications and selection criteria. That said, there were no definitive
criteria used universally to appropriate patients to IPE for either instability or polyethylene wear. Additionally, at our institution, it
is common during IPE to upsize the polyethylene liner by one size to address instability and achieve congruent fit, occasionally
requiring upsizing of the insert by two sizes. However, given the retrospective nature of the data extraction, the exact proportion
of cases requiring increasing thickness was not available and is considered a limitation of this review. Our data collection was har-
vested from a broad study period, during which protocols and treatment algorithms may have changed. There were a large pro-
portion of our patients who had expired prior to the end of the study dates, and although appropriate statistical evaluation was
employed using a competing risk model, this has the potential for imperfect data analysis. Finally, despite being the largest series
in the literature, the available numbers are still small. Despite this, and the relatively low frequency of IPE cases in general, we feel
our data still supports the use of IPE in select TKA patients with aseptic failure.

5. Conclusion

Results of the present study suggest that when done for carefully selected indications, IPE may be an acceptable procedure and
helpful alternative for aseptic TKA revisions, particularly when the pre-operative diagnosis is polyethylene wear. This is in contrast
to prior reports and may represent a need to re-visit the role of isolated polyethylene exchange.

Funding source

This research did not receive any specific grant or financial support from funding agencies in the public, commercial, or not-
for-profit sectors.

Declaration of competing interest

Several authors report financial interests outside of the scope of this study. Two authors (CEP, CLP) receive royalties, institu-
tional research support, and/or consult for Zimmer Biomet. One author (CLP) has stock options in CoNextions Medical and Muve
Health. One author (CEP) is a paid consultant for Total Joint Orthopaedics and Acelity, Inc. One author (MBA) consults for and has
equity interest in OrthoGrid Systems, Inc.

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Please cite this article as: I. Duensing, C.E. Pelt, M.B. Anderson, et al., Revisiting the role of isolated polyethylene exchange for asep-
tic failures in total knee arthroplast..., The Knee, https://doi.org/10.1016/j.knee.2020.01.002