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Aims. The primary objective of this study was to compare the five-year tibial component migration and wear between highly crosslinked polyethylene (HXLPE) inserts and conventional polyethylene (PE) inserts of the uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary objectives included clinical outcomes and patient-reported outcome measures (PROMs). Methods. A double-blinded, randomized study was conducted including 96 TKAs. Tibial component migration and insert wear were measured with radiostereometric analysis (RSA) at three, six, 12, 24, and 60 months postoperatively. PROMS were collected preoperatively and at all follow-up timepoints. Results. There was no clinically relevant difference in terms of tibial component migration, insert wear, and PROMs between the HXLPE and PE groups. The mean difference in tibial component migration (maximal total point migration (MTPM)) was 0.02 mm (95% confidence interval (CI) -0.07 to 0.11), which is below the value of 0.2 mm considered to be clinically relevant. Wear after five years for HXLPE was 0.16 mm (95% CI 0.05 to 0.27), and for PE was 0.23 mm (95% CI 0.12 to 0.35). The mean difference in wear rate was 0.01 mm/year (95% CI -0.02 to 0.05) in favour of the HXLPE group. Wear is mainly present on the medial side of the insert. Conclusion. There is no clinically relevant difference in tibial component migration and insert wear for up to five years between the HXLPE conventional PE inserts. For the implant studied, the potential advantages of a HXLPE insert remain to be proven under clinical conditions at longer-term follow-up. Cite this article: Bone Joint J 2023;105-B(5):518–525


Bone & Joint Research
Vol. 13, Issue 5 | Pages 226 - 236
9 May 2024
Jürgens-Lahnstein JH Petersen ET Rytter S Madsen F Søballe K Stilling M

Aims. Micromotion of the polyethylene (PE) inlay may contribute to backside PE wear in addition to articulate wear of total knee arthroplasty (TKA). Using radiostereometric analysis (RSA) with tantalum beads in the PE inlay, we evaluated PE micromotion and its relationship to PE wear. Methods. A total of 23 patients with a mean age of 83 years (77 to 91), were available from a RSA study on cemented TKA with Maxim tibial components (Zimmer Biomet). PE inlay migration, PE wear, tibial component migration, and the anatomical knee axis were evaluated on weightbearing stereoradiographs. PE inlay wear was measured as the deepest penetration of the femoral component into the PE inlay. Results. At mean six years’ follow-up, the PE wear rate was 0.08 mm/year (95% confidence interval 0.06 to 0.09 mm/year). PE inlay external rotation was below the precision limit and did not influence PE wear. Varus knee alignment did not influence PE wear (p = 0.874), but increased tibial component total translation (p = 0.041). Conclusion. The PE inlay was well fixed and there was no relationship between PE stability and PE wear. The PE wear rate was low and similar in the medial and lateral compartments. Varus knee alignment did not influence PE wear. Cite this article: Bone Joint Res 2024;13(5):226–236


Aims. The aim of this study was to compare the migration of the femoral component, five years postoperatively, between patients with a highly cross-linked polyethylene (HXLPE) insert and those with a conventional polyethylene (PE) insert in an uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary aims included clinical outcomes and patient-reported outcome measures (PROMs). We have previously reported the migration and outcome of the tibial components in these patients. Methods. A double-blinded randomized controlled trial was conducted including 96 TKAs. The migration of the femoral component was measured with radiostereometry (RSA) at three and six months and one, two, and five years postoperatively. PROMs were collected preoperatively and at all periods of follow-up. Results. There was no clinically relevant difference in terms of migration of the femoral component or PROMs between the HXLPE and PE groups. The mean difference in migration (maximum total point motion), five years postopeatively, was 0.04 mm (95% CI -0.06 to 0.16) in favour of the PE group. Conclusion. There was no clinically relevant difference in migration of the femoral component, for up to five years between the two groups. These findings will help to establish a benchmark for future studies on migration of femoral components in TKA. Cite this article: Bone Joint J 2024;106-B(8):826–833


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1791 - 1801
1 Dec 2021
Bhalekar RM Nargol ME Shyam N Nargol AVF Wells SR Collier R Pabbruwe M Joyce TJ Langton DJ

Aims. The aim of this study was to investigate whether wear and backside deformation of polyethylene (PE) tibial inserts may influence the cement cover of tibial trays of explanted total knee arthroplasties (TKAs). Methods. At our retrieval centre, we measured changes in the wear and deformation of PE inserts using coordinate measuring machines and light microscopy. The amount of cement cover on the backside of tibial trays was quantified as a percentage of the total surface. The study involved data from the explanted fixed-bearing components of four widely used contemporary designs of TKA (Attune, NexGen, Press Fit Condylar (PFC), and Triathlon), revised for any indication, and we compared them with components that used previous generations of PE. Regression modelling was used to identify variables related to the amount of cement cover on the retrieved trays. Results. A total of 114 explanted fixed-bearing TKAs were examined. This included 76 used with contemporary PE inserts which were compared with 15 used with older generation PEs. The Attune and NexGen (central locking) trays were found to have significantly less cement cover than Triathlon and PFC trays (peripheral locking group) (p = 0.001). The median planicity values of the PE inserts used with central locking trays were significantly greater than of those with peripheral locking inserts (205 vs 85 microns; p < 0.001). Attune and NexGen inserts had a characteristic pattern of backside deformation, with the outer edges of the PE deviating inferiorly, leaving the PE margins as the primary areas of articulation. Conclusion. Explanted TKAs with central locking mechanisms were significantly more likely to debond from the cement mantle. The PE inserts of these designs showed characteristic patterns of deformation, which appeared to relate to the manufacturing process and may be exacerbated in vivo. This pattern of deformation was associated with PE wear occurring at the outer edges of the articulation, potentially increasing the frictional torque generated at this interface. Cite this article: Bone Joint J 2021;103-B(12):1791–1801


The Bone & Joint Journal
Vol. 103-B, Issue 11 | Pages 1695 - 1701
1 Nov 2021
Currier JH Currier BH Abdel MP Berry DJ Titus AJ Van Citters DW

Aims. Wear of the polyethylene (PE) tibial insert of total knee arthroplasty (TKA) increases the risk of revision surgery with a significant cost burden on the healthcare system. This study quantifies wear performance of tibial inserts in a large and diverse series of retrieved TKAs to evaluate the effect of factors related to the patient, knee design, and bearing material on tibial insert wear performance. Methods. An institutional review board-approved retrieval archive was surveyed for modular PE tibial inserts over a range of in vivo duration (mean 58 months (0 to 290)). Five knee designs, totalling 1,585 devices, were studied. Insert wear was estimated from measured thickness change using a previously published method. Linear regression statistical analyses were used to test association of 12 patient and implant design variables with calculated wear rate. Results. Five patient-specific variables and seven implant-specific variables were evaluated for significant association with lower insert wear rate. Six were significant when controlling for other factors: greater patient age, female sex, shorter duration in vivo, polished tray, highly cross-linked PE (HXLPE), and constrained knee design. Conclusion. This study confirmed that knee wear rate increased with duration in vivo. Older patients and females had significantly lower wear rates. Polished modular tibial tray surfaces, HXLPE, and constrained TKA designs were device design factors associated with significantly reduced wear rate. Cite this article: Bone Joint J 2021;103-B(11):1695–1701


The Bone & Joint Journal
Vol. 104-B, Issue 3 | Pages 376 - 385
1 Mar 2022
Gramlich Y Hofmann L Kress S Ruckes C Kemmerer M Klug A Hoffmann R Kremer M

Aims. This study compared the cobalt and chromium serum ion concentration of patients treated with two different metal-on-metal (MoM) hinged total knee arthroplasty (TKA) systems, as well as a titanium nitride (TiN)-coated variant. Methods. A total of 63 patients (65 implants) were treated using either a MoM-coated (n = 29) or TiN-coated (n = 7) hinged TKA (GenuX mobile bearing, MUTARS; Implantcast, Germany) versus the BPKS (Brehm, Germany) hinged TKA (n = 27), in which the weight placed on the MoM hinge is diffused through a polyethylene (PE) inlay, reducing the direct load on the MoM hinge. Serum cobalt and chromium ion concentrations were assessed after minimum follow-up of 12 months, as well as functional outcome and quality of life. Results. No differences in mean age (69 years, 40 to 86), mean age adapted Charlson Comorbidity Index (3.1 (SD 1.4)), mean BMI (29.2 kg/m. 2. (SD 5.8)), or number of other implants were observed between groups. Significant improvements in outcome scores and pain levels were achieved for all groups, and there was no difference in quality of life (12-Item Short-Form Health Survey questionnaire (SF-12)). Mean cobalt and chromium ion levels were significantly higher for the GenuX versus the BPKS hinged TKA (GenuX vs BPKS: cobalt: 16.3 vs 9.4 µg/l; chromium: 9.5 vs 5.2 µg/l). The TiN-coated implants did not appear to confer improvement in the metal ion levels. Metal ion concentrations above 7 µg/l were detected in 81%(29/36) of GenuX patients versus 41% (11/27) in the BPKS group. No GenuX patients had normal levels under 2 µg/l, versus 22% of BPKS patients. No significant reduction in outcome scores was observed regardless of the metal ion levels, whereas higher work-related activity was correlated with higher chromium concentrations. Conclusion. Hinged TKA, using MoM hinges, resulted in critically high cobalt and chromium ion concentrations. The BPKS hinged TKA showed significantly lower metal ion concentrations compared with the GenuX TKA. No benefits were observed using TiN coating. The different weightbearing mechanics might influence the wear of the component materials. Higher workloads and physical activity could influence chromium levels. Cite this article: Bone Joint J 2022;104-B(3):376–385


The Bone & Joint Journal
Vol. 101-B, Issue 11 | Pages 1348 - 1355
1 Nov 2019
Gascoyne T Parashin S Teeter M Bohm E Laende E Dunbar M Turgeon T

Aims. A retrospective study was conducted to measure short-term in vivo linear and volumetric wear of polyethylene (PE) inserts in 101 total knee arthroplasty (TKA) patients using model-based radiostereometric analysis (MBRSA). Patients and Methods. Nonweightbearing supine RSA exams were performed postoperatively and at six, 12, and 24 months. Weightbearing standing RSA exams were performed on select patients at 12 and 24 months. Wear was measured both linearly (joint space) and volumetrically (digital model overlap) at each available follow-up. Precision of both methods was assessed by comparing double RSA exams. Patient age, sex, body mass index, and Oxford Knee Scores were analyzed for any association with PE wear. Results. Linear wear occurred at 0.015 mm/year (supine) and 0.220 mm/year (standing). Volumetric wear occurred at 10.3 mm. 3. /year (supine) and 39.3 mm. 3. /year (standing). Wear occurred primarily on the medial side of the joint. Weightbearing imaging greatly improved the reliability of measurement. Clinical precision of volumetric wear was 34 mm. 3. No significant associations were found between patient demographics or function scores and measured wear. Conclusion. In vivo volumetric wear of TKAs can be assessed at short-term follow-up using MBRSA. Cite this article: Bone Joint J 2019;101-B:1348–1355


The Bone & Joint Journal
Vol. 99-B, Issue 8 | Pages 996 - 1002
1 Aug 2017
Brown TS Van Citters DW Berry DJ Abdel MP

Advances in polyethylene (PE) in total hip arthroplasty have led to interest and increased use of highly crosslinked PE (HXLPE) in total knee arthroplasty (TKA). Biomechanical data suggest improved wear characteristics for HXLPE inserts over conventional PE in TKA. Short-term results from registry data and few clinical trials are promising. Our aim is to present a review of the history of HXLPEs, the use of HXLPE inserts in TKA, concerns regarding potential mechanical complications, and a thorough review of the available biomechanical and clinical data. Cite this article: Bone Joint J 2017;99-B:996–1002


Bone & Joint Research
Vol. 7, Issue 1 | Pages 20 - 27
1 Jan 2018
Kang K Son J Suh D Kwon SK Kwon O Koh Y

Objectives. Patient-specific (PS) implantation surgical technology has been introduced in recent years and a gradual increase in the associated number of surgical cases has been observed. PS technology uses a patient’s own geometry in designing a medical device to provide minimal bone resection with improvement in the prosthetic bone coverage. However, whether PS unicompartmental knee arthroplasty (UKA) provides a better biomechanical effect than standard off-the-shelf prostheses for UKA has not yet been determined, and still remains controversial in both biomechanical and clinical fields. Therefore, the aim of this study was to compare the biomechanical effect between PS and standard off-the-shelf prostheses for UKA. Methods. The contact stresses on the polyethylene (PE) insert, articular cartilage and lateral meniscus were evaluated in PS and standard off-the-shelf prostheses for UKA using a validated finite element model. Gait cycle loading was applied to evaluate the biomechanical effect in the PS and standard UKAs. Results. The contact stresses on the PE insert were similar for both the PS and standard UKAs. Compared with the standard UKA, the PS UKA did not show any biomechanical effect on the medial PE insert. However, the contact stresses on the articular cartilage and the meniscus in the lateral compartment following the PS UKA exhibited closer values to the healthy knee joint compared with the standard UKA. Conclusion. The PS UKA provided mechanics closer to those of the normal knee joint. The decreased contact stress on the opposite compartment may reduce the overall risk of progressive osteoarthritis. Cite this article: K-T. Kang, J. Son, D-S. Suh, S. K. Kwon, O-R. Kwon, Y-G. Koh. Patient-specific medial unicompartmental knee arthroplasty has a greater protective effect on articular cartilage in the lateral compartment: A Finite Element Analysis. Bone Joint Res 2018;7:20–27. DOI: 10.1302/2046-3758.71.BJR-2017-0115.R2


Bone & Joint Research
Vol. 5, Issue 11 | Pages 552 - 559
1 Nov 2016
Kang K Koh Y Son J Kwon O Baek C Jung SH Park KK

Objectives. Malrotation of the femoral component can result in post-operative complications in total knee arthroplasty (TKA), including patellar maltracking. Therefore, we used computational simulation to investigate the influence of femoral malrotation on contact stresses on the polyethylene (PE) insert and on the patellar button as well as on the forces on the collateral ligaments. Materials and Methods. Validated finite element (FE) models, for internal and external malrotations from 0° to 10° with regard to the neutral position, were developed to evaluate the effect of malrotation on the femoral component in TKA. Femoral malrotation in TKA on the knee joint was simulated in walking stance-phase gait and squat loading conditions. Results. Contact stress on the medial side of the PE insert increased with internal femoral malrotation and decreased with external femoral malrotation in both stance-phase gait and squat loading conditions. There was an opposite trend in the lateral side of the PE insert case. Contact stress on the patellar button increased with internal femoral malrotation and decreased with external femoral malrotation in both stance-phase gait and squat loading conditions. In particular, contact stress on the patellar button increased by 98% with internal malrotation of 10° in the squat loading condition. The force on the medial collateral ligament (MCL) and the lateral collateral ligament (LCL) increased with internal and external femoral malrotations, respectively. Conclusions. These findings provide support for orthopaedic surgeons to determine a more accurate femoral component alignment in order to reduce post-operative PE problems. Cite this article: K-T. Kang, Y-G. Koh, J. Son, O-R. Kwon, C. Baek, S. H. Jung, K. K. Park. Measuring the effect of femoral malrotation on knee joint biomechanics for total knee arthroplasty using computational simulation. Bone Joint Res 2016;5:552–559. DOI: 10.1302/2046-3758.511.BJR-2016-0107.R1


The Bone & Joint Journal
Vol. 104-B, Issue 10 | Pages 1126 - 1131
1 Oct 2022
Hannon CP Kruckeberg BM Pagnano MW Berry DJ Hanssen AD Abdel MP

Aims

We have previously reported the mid-term outcomes of revision total knee arthroplasty (TKA) for flexion instability. At a mean of four years, there were no re-revisions for instability. The aim of this study was to report the implant survivorship and clinical and radiological outcomes of the same cohort of of patients at a mean follow-up of ten years.

Methods

The original publication included 60 revision TKAs in 60 patients which were undertaken between 2000 and 2010. The mean age of the patients at the time of revision TKA was 65 years, and 33 (55%) were female. Since that time, 21 patients died, leaving 39 patients (65%) available for analysis. The cumulative incidence of any re-revision with death as a competing risk was calculated. Knee Society Scores (KSSs) were also recorded, and updated radiographs were reviewed.


The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 635 - 640
1 Jun 2023
Karczewski D Siljander MP Larson DR Taunton MJ Lewallen DG Abdel MP

Aims

Knowledge on total knee arthroplasties (TKAs) in patients with a history of poliomyelitis is limited. This study compared implant survivorship and clinical outcomes among affected and unaffected limbs in patients with sequelae of poliomyelitis undergoing TKAs.

Methods

A retrospective review of our total joint registry identified 94 patients with post-polio syndrome undergoing 116 primary TKAs between January 2000 and December 2019. The mean age was 70 years (33 to 86) with 56% males (n = 65) and a mean BMI of 31 kg/m2 (18 to 49). Rotating hinge TKAs were used in 14 of 63 affected limbs (22%), but not in any of the 53 unaffected limbs. Kaplan-Meier survivorship analyses were completed. The mean follow-up was eight years (2 to 19).


Bone & Joint Research
Vol. 11, Issue 7 | Pages 494 - 502
20 Jul 2022
Kwon HM Lee J Koh Y Park KK Kang K

Aims

A functional anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) has been assumed to be required for patients undergoing unicompartmental knee arthroplasty (UKA). However, this assumption has not been thoroughly tested. Therefore, this study aimed to assess the biomechanical effects exerted by cruciate ligament-deficient knees with medial UKAs regarding different posterior tibial slopes.

Methods

ACL- or PCL-deficient models with posterior tibial slopes of 1°, 3°, 5°, 7°, and 9° were developed and compared to intact models. The kinematics and contact stresses on the tibiofemoral joint were evaluated under gait cycle loading conditions.


The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 610 - 621
1 Jun 2023
Prodromidis AD Chloros GD Thivaios GC Sutton PM Pandit H Giannoudis PV Charalambous CP

Aims

Loosening of components after total knee arthroplasty (TKA) can be associated with the development of radiolucent lines (RLLs). The aim of this study was to assess the rate of formation of RLLs in the cemented original design of the ATTUNE TKA and their relationship to loosening.

Methods

A systematic search was undertaken using the Cochrane methodology in three online databases: MEDLINE, Embase, and CINAHL. Studies were screened against predetermined criteria, and data were extracted. Available National Joint Registries in the Network of Orthopaedic Registries of Europe were also screened. A random effects model meta-analysis was undertaken.


Bone & Joint Open
Vol. 2, Issue 8 | Pages 576 - 582
2 Aug 2021
Fuchs M Kirchhoff F Reichel H Perka C Faschingbauer M Gwinner C

Aims

Current guidelines consider analyses of joint aspirates, including leucocyte cell count (LC) and polymorphonuclear percentage (PMN%) as a diagnostic mainstay of periprosthetic joint infection (PJI). It is unclear if these parameters are subject to a certain degree of variability over time. Therefore, the aim of this study was to evaluate the variation of LC and PMN% in patients with aseptic revision total knee arthroplasty (TKA).

Methods

We conducted a prospective, double-centre study of 40 patients with 40 knee joints. Patients underwent joint aspiration at two different time points with a maximum period of 120 days in between these interventions and without any events such as other joint aspirations or surgeries. The main indications for TKA revision surgery were aseptic implant loosening (n = 24) and joint instability (n = 11).


The Bone & Joint Journal
Vol. 102-B, Issue 11 | Pages 1527 - 1534
3 Nov 2020
Orita K Minoda Y Sugama R Ohta Y Ueyama H Takemura S Nakamura H

Aims

Vitamin E-infused highly cross-linked polyethylene (E1) has recently been introduced in total knee arthroplasty (TKA). An in vitro wear simulator study showed that E1 reduced polyethylene wear. However there is no published information regarding in vivo wear. Previous reports suggest that newly introduced materials which reduce in vitro polyethylene wear do not necessarily reduce in vivo polyethylene wear. To assist in the evaluation of the newly introduced material before widespread use, we established an in vivo polyethylene wear particle analysis for TKA. The aim of this study was to compare in vivo polyethylene wear particle generation between E1 and conventional polyethylene (ArCom) in TKA.

Methods

A total of 34 knees undergoing TKA (17 each with ArCom or E1) were investigated. Except for the polyethylene insert material, the prostheses used for both groups were identical. Synovial fluid was obtained at a mean of 3.4 years (SD 1.3) postoperatively. The in vivo polyethylene wear particles were isolated from the synovial fluid using a previously validated method and examined by scanning electron microscopy.


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 338 - 346
1 Feb 2021
Khow YZ Liow MHL Lee M Chen JY Lo NN Yeo SJ

Aims

This study aimed to identify the tibial component and femoral component coronal angles (TCCAs and FCCAs), which concomitantly are associated with the best outcomes and survivorship in a cohort of fixed-bearing, cemented, medial unicompartmental knee arthroplasties (UKAs). We also investigated the potential two-way interactions between the TCCA and FCCA.

Methods

Prospectively collected registry data involving 264 UKAs from a single institution were analyzed. The TCCAs and FCCAs were measured on postoperative radiographs and absolute angles were analyzed. Clinical assessment at six months, two years, and ten years was undertaken using the Knee Society Knee score (KSKS) and Knee Society Function score (KSFS), the Oxford Knee Score (OKS), the 36-Item Short-Form Health Survey questionnaire (SF-36), and range of motion (ROM). Fulfilment of expectations and satisfaction was also recorded. Implant survivorship was reviewed at a mean follow-up of 14 years (12 to 16). Multivariate regression models included covariates, TCCA, FCCA, and two-way interactions between them. Partial residual graphs were generated to identify angles associated with the best outcomes. Kaplan-Meier analysis was used to compare implant survivorship between groups.


Bone & Joint Research
Vol. 9, Issue 9 | Pages 593 - 600
1 Sep 2020
Lee J Koh Y Kim PS Kang KW Kwak YH Kang K

Aims

Unicompartmental knee arthroplasty (UKA) has become a popular method of treating knee localized osteoarthritis (OA). Additionally, the posterior cruciate ligament (PCL) is essential to maintaining the physiological kinematics and functions of the knee joint. Considering these factors, the purpose of this study was to investigate the biomechanical effects on PCL-deficient knees in medial UKA.

Methods

Computational simulations of five subject-specific models were performed for intact and PCL-deficient UKA with tibial slopes. Anteroposterior (AP) kinematics and contact stresses of the patellofemoral (PF) joint and the articular cartilage were evaluated under the deep-knee-bend condition.


The Bone & Joint Journal
Vol. 100-B, Issue 10 | Pages 1330 - 1335
1 Oct 2018
Ponzio DY Weitzler L deMeireles A Esposito CI Wright TM Padgett DE

Aims

The aim of this study was to evaluate the surface damage, the density of crosslinking, and oxidation in retrieved antioxidant-stabilized highly crosslinked polyethylene (A-XLPE) tibial inserts from total knee arthroplasty (TKA), and to compare the results with a matched cohort of standard remelted highly crosslinked polyethylene (XLPE) inserts.

Materials and Methods

A total of 19 A-XLPE tibial inserts were retrieved during revision TKA and matched to 18 retrieved XLPE inserts according to the demographics of the patients, with a mean length of implantation of 15 months (1 to 42). The percentage areas of PE damage on the articular surfaces and the modes of damage were measured. The density of crosslinking of the PE and oxidation were measured at loaded and unloaded regions on these surfaces.


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1477 - 1481
1 Nov 2017
Hernandez NM Taunton MJ Perry KI Mara KC Hanssen AD Abdel MP

Aims

Patients with flexion instability after total knee arthroplasty (TKA) often present with a recurrent effusion, which may be a haemarthrosis. While the radiographic factors contributing to flexion instability have been elucidated, the clinical diagnosis remains challenging. Our aim, in this study, was to determine the mean white cell count and differential profile in pre-operative aspirations of synovial fluid in a consecutive series of patients undergoing revision TKA for flexion instability.

Patients and Methods

Between 2000 and 2010, 60 patients undergoing aseptic revision TKA for flexion instability were identified. The results of the pre-operative aspiration of synovial fluid were available for 53 patients (88%). These patients were 1:2 matched to 106 patients who underwent aseptic TKA for indications other than flexion instability. The mean age of the patients at revision TKA was 65 years (44 to 82) and 55% were women. The mean follow-up was 4.3 years (2 to 10.2).