Aims. Total knee arthroplasty (TKA) is a common and safe orthopaedic procedure. Zimmer Biomet's NexGen is the second most popular brand of implant used in the UK. The primary cause of revision after the first year is aseptic loosening. We present our experience of using this implant, with significant concerns around its performance with regards early aseptic loosening of the tibial component. Methods. A retrospective, single-surgeon review was carried out of all of the NexGen Legacy Posterior Stabilized (LPS) TKAs performed in this institute. The specific model used for the index procedures was the NexGen Complete Knee System (Legacy Knee-Posterior Stabilized LPS-Flex Articular Surface, LPS-Flex Femoral Component Option, and Stemmed Nonaugmentable Tibial Component Option). Results. Between 2013 and 2016, 352 NexGen TKAs were carried out on 331 patients. A total of 62 TKAs have been revised to date, giving an all-cause revision rate of 17.6% at a minimum of five years. Three of these revisions were due to infection. Overall, 59 of the revisions were performed for aseptic loosening (16.7%) of the tibial component. The tibial component was removed intraoperatively without instrumentation due to significant tibial debonding between the implant-cement interface. Conclusion. While overall, we believe that early aseptic loosening is multi-factorial in nature, the significantly high aseptic revision rate, as seen by an experienced fellowship-trained arthroplasty surgeon, has led us to believe that there is a fundamental issue with this NexGen implant design. Continued implant surveillance and rigorous review across all regions using this particular implant is warranted based on the concerning findings described here. Cite this article: Bone Jt Open 2022;3(6):495–501

Abstract. Introduction. At our national explant retrieval unit, we identified an unusual pattern of backside-deformation on polyethylene (PE) inserts of contemporary total-knee-replacements (TKRs). The PE backside's margins were inferiorly deformed in TKRs with central-locking trays. We reported that this backside-deformation appeared to be linked to tray debonding. Moreover, recent studies have shown high-rate of tray debonding in PS NexGen TKRs. Therefore, we hypothesised that backside deformation on PS inserts may be more than on CR inserts. Methodology. We used peer-reviewed techniques to analyse changes in the bearing (wear rate) and backside surfaces (deformation) of PE inserts using coordinate measuring machines [N=61 NexGen (CR-39 and PS-22) TKRs with non-augmented-trays]. Multiple regression was used to determine which variable had the greatest influence on backside-deformation. The amount of cement cover on trays was quantified as a %of the total surface using Image-J software. Results. There was no statistically significant difference (p=0.238) in median (IQR) wear rate of the CR PEs 18 (12–28) mm. 3. /year and PS PEs 14 (8–20) mm. 3. /year. The PE backside-deformation median (IQR) of PS [297(242–333) µm] was significantly higher (p=0.011), when compared with CR [241(161–259) µm]. Multiple regression modelling showed that duration in-vivo (p=0.037), central-clearance between insert and tray (p<0.001) and constraint (p=0.003) were significantly associated with PE backside-deformation. 27(69%) of CR and 20(91%) PS exhibited ≤10% of cement cover on tray. Conclusion. This explant study showed backside-deformation on PS inserts was more than on CR inserts. Therefore, indicating a high-rate of tibial tray debonding in PS compared to CR NexGen TKRs

We carried out a prospective study to assess the clinical outcome, complications and survival of the NexGen Legacy posterior-stabilised-Flex total knee replacement (TKR) in a consecutive series of 278 knees between May 2003 and February 2005. Mean follow-up for 259 TKRs (98.2%) was 3.8 years (3.0 to 4.8). Annual follow-up showed improvement in the Knee Society scores (paired t-test, p < 0.05). At the last follow-up, the mean maximum flexion was 135° (110° to 150°). Two knees showed radiolucent lines, but revision was not required because the patients were asymptomatic. Revision was required in one case because of infection, but there were no prosthesis-related revisions. There were no other complications. The estimated survival rate at four years with revision for any reason and prosthesis-related problems was 99.6% and 100%, respectively. This relatively large study indicates that the legacy posterior stabilised-Flex design provides excellent short-term outcome but warrants ongoing evaluation to confirm the long-term durability and functioning of the implant

Modifications in the design of knee replacements have been proposed in order to maximise flexion. We performed a prospective double-blind randomised controlled trial to compare the functional outcome, including maximum knee flexion, in patients receiving either a standard or a high flexion version of the NexGen legacy posterior stabilised total knee replacement. A total of 56 patients, half of whom received each design, were assessed pre-operatively and at one year after operation using knee scores and analysis of range of movement using electrogoniometry. For both implant designs there was a significant improvement in the function component of the knee scores (p < 0.001) and the maximum range of flexion when walking on the level, ascending and descending a slope or stairs (all p < 0.001), squatting (p = 0.020) and stepping into a bath (p = 0.024). There was no significant difference in outcome, including the maximum knee flexion, between patients receiving the standard and high flexion designs of this implant

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

Aims. The mean age of patients undergoing total knee arthroplasty (TKA) has reduced with time. Younger patients have increased expectations following TKA. Aseptic loosening of the tibial component is the most common cause of failure of TKA in the UK. Interest in cementless TKA has re-emerged due to its encouraging results in the younger patient population. We review a large series of tantalum trabecular metal cementless implants in patients who are at the highest risk of revision surgery. Methods. A total of 454 consecutive patients who underwent cementless TKA between August 2004 and December 2021 were reviewed. The mean follow-up was ten years. Plain radiographs were analyzed for radiolucent lines. Patients who underwent revision TKA were recorded, and the cause for revision was determined. Data from the National Joint Registry for England, Wales, Northern Island, the Isle of Man and the States of Guernsey (NJR) were compared with our series. Results. No patients in our series had evidence of radiolucent lines on their latest radiological assessment. Only eight patients out of 454 required revision arthroplasty, and none of these revisions were indicated for aseptic loosening of the tibial baseplate. When compared to data from the NJR annual report, Kaplan-Meier estimates from our series (2.94 (95% confidence interval (CI) 1.24 to 5.87)) show a significant reduction in cumulative estimates of revision compared to all cemented (4.82 (95% CI 4.69 to 4.96)) or cementless TKA (5.65 (95% CI 5.23 to 6.10)). Our data (2.94 (95% CI 1.24 to 5.87)) also show lower cumulative revision rates compared to the most popular implant (PFC Sigma Cemented Knee implant fixation, 4.03 (95% CI 3.75 to 4.33)). The prosthesis time revision rate (PTIR) estimates for our series (2.07 (95% CI 0.95 to 3.83)) were lower than those of cemented cases (4.53 (95% CI 4.49 to 4.57)) from NJR. Conclusion. The NexGen trabecular (tantalum) cementless implant has lower revision rates in our series compared to all cemented implants and other types of cementless implants, and its use in younger patients should be encouraged. Cite this article: Bone Jt Open 2024;5(4):277–285

Aims. The outcomes of total knee arthroplasty (TKA) depend on many factors. The impact of implant design on patient-reported outcomes is unknown. Our goal was to evaluate the patient-reported outcomes and satisfaction after primary TKA in patients with osteoarthritis undergoing primary TKA using five different brands of posterior-stabilized implant. Patients and Methods. Using our institutional registry, we identified 4135 patients who underwent TKA using one of the five most common brands of implant. These included Biomet Vanguard (Zimmer Biomet, Warsaw, Indiana) in 211 patients, DePuy/Johnson & Johnson Sigma (DePuy Synthes, Raynham, Massachusetts) in 222, Exactech Optetrak Logic (Exactech, Gainesville, Florida) in 1508, Smith & Nephew Genesis II (Smith & Nephew, London, United Kingdom) in 1415, and Zimmer NexGen (Zimmer Biomet) in 779 patients. Patients were evaluated preoperatively using the Knee Injury and Osteoarthritis Outcome Score (KOOS), Lower Extremity Activity Scale (LEAS), and 12-Item Short-Form Health Survey questionnaire (SF-12). Demographics including age, body mass index, Charlson Comorbidity Index, American Society of Anethesiologists status, sex, and smoking status were collected. Postoperatively, two-year KOOS, LEAS, SF-12, and satisfaction scores were compared between groups. Results. Outcomes were available for 4069 patients (98%) at two years postoperatively. In multiple regression analysis, which separately compared each implant group with the aggregate of all others, there were no clinically significant differences in the change of KOOS score from baseline to two-year follow-up between any of the groups. More than 80% of patients in each group were satisfied at this time in all domains. In a multivariate regression model, patients in the NexGen group were the most likely to be satisfied (odds ratio (OR) 1.63; p = 0.006) and Optetrak Logic patients were the least likely to be satisfied (OR 0.60; p < 0.001). Conclusion. TKA provides improvement in function and satisfaction regardless of the type of implant. We could not demonstrate superiority of one design above others across these groups of implants, and any price premium for one above the other systems may not be justified. Healthcare administrators may find these similarities in outcomes helpful when negotiating purchasing contracts. Cite this article: Bone Joint J 2019;101-B(7 Supple C):48–54

We measured the contact areas and contact stresses at the post-cam mechanism of a posterior-stabilised total knee arthroplasty when a posterior force of 500 N was applied to the Kirschner Performance, Scorpio Superflex, NexGen LPS Flex Fixed, and NexGen LPS Flex Mobile knee systems. Measurements were made at 90°, 120°, and 150° of flexion both in neutral rotation and 10° of internal rotation of the tibial component. Peak contact stresses at 90°, 120°, and 150° were 24.0, 33.9, and 28.8 MPa, respectively, for the Kirschner; 26.0, 32.4, and 22.1 MPa, respectively, for the Scorpio; and 34.1, 31.5, and 32.5 MPa, respectively, for the NexGen LPS Flex Fixed. With an internally rotated tibia, the contact stress increased significantly with all the fixed-bearing arthroplasties but not with the NexGen LPS Flex Mobile arthroplasty. The post-cam design should be modified in order to provide a larger contact area whilst avoiding any impingement and edge loading

We compared the performance of uncemented trabecular metal tibial components in total knee replacement with that of cemented tibial components in patients younger than 60 years over two years using radiostereophotogrammetric analysis (RSA). A total of 22 consecutive patients (mean age 53 years, 33 to 59, 26 knees) received an uncemented NexGen trabecular metal cruciate-retaining monobloc tibial component and 19 (mean 53 years, 44 to 59, 21 knees) a cemented NexGen Option cruciate-retaining modular tibial component. All the trabecular metal components migrated during the initial three months and then stabilised. The exception was external rotation, which did not stabilise until 12 months. Unlike conventional metal-backed implants which displayed a tilting migration comprising subsidence and lift-off from the tibial tray, most of the trabecular metal components showed subsidence only, probably due to the elasticity of the implant. This pattern of subsidence is regarded as being beneficial for uncemented fixation

We undertook a study in which 138 female patients with a mean age of 71.2 years (51 to 82) received a standard NexGen CR-flex prosthesis in one knee and a gender-specific NexGen CR-flex prosthesis in the other. The mean follow-up period was 3.25 years (3.1 to 3.5). The aspect ratios of the standard and gender-specific prostheses were compared with that of the distal femur. The mean post-operative Knee Society knee scores were 94 (70 to 100) and 93 (70 to 100) points and the function scores were 83 (60 to 100) and 84 (60 to 100) points for the standard implants and the gender-specific designs, respectively. The mean post-operative Western Ontario and McMaster Universities score was 26.4 points (0 to 76). Patient satisfaction, the radiological results and the complication rates were similar in the two groups. In those with a standard prosthesis, the femoral component was closely matched in 80 knees (58.0%), overhung in 14 (10.1%) and undercovered the bone in 44 (31.9%). In those with a gender-specific prosthesis, it was closely matched in 15 knees (10.9%) and undercovered the bone in 123 (89.1%). Since we found no significant differences between the two groups with regard to the clinical and radiological results, patient satisfaction or complication rate, the goal of the design of the gender-specific CR-flex prosthesis to improve the outcome was not achieved in our patients

Mechanical failure because of wear or fracture of the polyethylene tibial post in posteriorly-stabilised total knee replacements has been extensively described. In this study of 12 patients with a clinically and radiologically successful NexGen LPS posteriorly-stabilised prosthesis impingement of the anterior tibial post was evaluated in vivo in three dimensions during gait using radiologically-based image-matching techniques. Impingement was observed in all images of the patients during the stance phase, although the NexGen LPS was designed to accommodate 14° of hyperextension of the component before impingement occurred. Impingement arises as a result of posterior translation of the femur during the stance phase. Further attention must therefore be given to the configuration of the anterior portion of the femoral component and the polyethylene post when designing posteriorly-stabilised total knee replacements

Introduction. Hip and knee replacements are being performed at increasing rates and currently account for one of the largest procedure expenditures in the Medicare budget. Outcomes of total knee replacement (TKR) depend on surgeon, patient and implant factors. The impact that the specific implants might have on patient-reported outcomes is unknown. The primary purpose of this study was to evaluate the patient-reported functional outcomes and satisfaction after primary total knee arthroplasty in patients with osteoarthritis who underwent TKR using five different brands of posterior-stabilized implants. Specifically, the aim was to evaluate for any difference in patient-reported outcomes based on implant brand used. The hypothesis was that there would be no difference in functional outcome that could be attributed to the implant used in primary TKR. Methods. Using our institution's total joint arthroplasty registry, we identified 4,135 patients who underwent total knee replacement (TKR) using one of the five most common implant brands used at our institution. These included Biomet Vanguard (N=211 patients), Depuy/Johnson&Johnson Sigma (N=221), Exactech OptetrakLogic (N=1,507), Smith & Nephew Genesis II (N=1,414), and Zimmer NexGen (N=779). Only posterior-stabilized primary TKRs in patients with osteoarthritis were included. Patients were evaluated preoperatively using the Knee Osteoarthritis Outcomes Score (KOOS), Lower Extremity Activity Scale (LEAS), and Short Form-12 (SF-12). Demographics including age, body mass index (BMI), Charleston Comorbidity Index (CCI), ASA physical status classification, sex, and smoking status were collected. Postoperatively, 2-year KOOS, LEAS, SF-12, and satisfaction scores were compared between implant groups. Results. At 2-year follow-up, patient-reported outcome scores were available for a total of 4,069 patients. In multiple regression analysis which separately compared each implant group to the aggregate of all others, after accounting for age, BMI, CCI, ASA status, and sex, there were no clinically significant differences in KOOS score changes from baseline to 2-year follow-up between any of the implants. In 2-year satisfaction, >80% of patients in each implant group were satisfied in all domains measured. In the multivariate regression model, patients in the NexGen group had the highest likelihood of being satisfied (OR 1.63, p=0.006) and OptetrakLogic patients had the lowest likelihood of being satisfied (OR 0.60, P<0.001) although these differences were below the minimal clinically important thresholds. Conclusion. TKR provides patient satisfaction and improvement in function regardless of implant type. While some implant systems had higher outcome scores than others, these differences were all below clinically significant thresholds. Whether these differences are a function of surgeon expertise or implant design is unknown. Future research should focus on identifying specific design elements that contribute to improved patient outcomes. Healthcare administrators may find the similarities in clinical outcomes to be a useful consideration when negotiating implant purchasing contracts

The outcome of total knee replacement (TKR) using components designed to increase the range of flexion is not fully understood. The short- to mid-term risk of aseptic revision in high flexion TKR was evaluated. The endpoint of the study was aseptic revision and the following variables were investigated: implant design (high flexion vs non-high flexion), the thickness of the tibial insert (≤ 14 mm vs > 14 mm), cruciate ligament (posterior stabilised (PS) vs cruciate retaining), mobility (fixed vs rotating), and the manufacturer (Zimmer, Smith & Nephew and DePuy). Covariates included patient, implant, surgeon and hospital factors. Marginal Cox proportional hazard models were used. In a cohort of 64 000 TKRs, high flexion components were used in 8035 (12.5%). The high flexion knees with tibial liners of thickness > 14 mm had a density of revision of 1.45/100 years of observation, compared with 0.37/100 in non-high flexion TKR with liners ≤ 14 mm thick. Relative to a standard fixed PS TKR, the NexGen (Zimmer, Warsaw, Indiana) Gender Specific Female high flexion fixed PS TKR had an increased risk of revision (hazard ratio (HR) 2.27 (95% confidence interval (CI) 1.48 to 3.50)), an effect that was magnified when a thicker tibial insert was used (HR 8.10 (95% CI 4.41 to 14.89)). Surgeons should be cautious when choosing high flexion TKRs, particularly when thicker tibial liners might be required. Cite this article: Bone Joint J 2014;96-B:217–23

We evaluated the impact of pre-coating the tibial component with polymethylmethacrylate (PMMA) on implant survival in a cohort of 16 548 primary NexGen total knee replacements (TKRs) in 14 113 patients. In 13 835 TKRs a pre-coated tray was used while in 2713 TKRs the non-pre-coated version of the same tray was used. All the TKRs were performed between 2001 and 2009 and were cemented. TKRs implanted with a pre-coated tibial component had a lower cumulative survival than those with a non-pre-coated tibial component (p = 0.01). After adjusting for diagnosis, age, gender, body mass index, American Society of Anesthesiologists grade, femoral coupling design, surgeon volume and hospital volume, pre-coating was an independent risk factor for all-cause aseptic revision (hazard ratio 2.75, p = 0.006). Revision for aseptic loosening was uncommon for both pre-coated and non-pre-coated trays (rates of 0.12% and 0%, respectively). Pre-coating with PMMA does not appear to be protective of revision for this tibial tray design at short-term follow-up. Cite this article: Bone Joint J 2013;95-B:367–70

We have examined the results obtained with 72 NexGen legacy posterior stabilised-flex fixed total knee replacements in 47 patients implanted by a single surgeon between March 2003 and September 2004. Aseptic loosening of the femoral component was found in 27 (38%) of the replacements at a mean follow-up of 32 months (30 to 48) and 15 knees (21%) required revision at a mean of 23 months (11 to 45). We compared the radiologically-loose and revised knees with those which had remained well-fixed to identify the factors which had contributed to this high rate of aseptic loosening. Post-operatively, the mean maximum flexion was 136° (110° to 140°) in the loosened group and 125° (95° to 140°) in the well-fixed group (independent t-test, p = 0.022). Squatting, kneeling, or sitting cross-legged could be achieved by 23 (85%) of the loosened knees, but only 22 (49%) of the well-fixed knees (chi-squared test, p = 0.001). The loosened femoral components were found to migrate into a more flexed position, but no migration was detected in the well-fixed group. These implants allowed a high degree of flexion, but showed a marked rate of early loosening of the femoral component, which was associated with weight-bearing in maximum flexion

Aims

Conflicting clinical results are reported for the ATTUNE Total Knee Arthroplasty (TKA). This randomized controlled trial (RCT) evaluated five-year follow-up results comparing cemented ATTUNE and PFC-Sigma cruciate retaining TKAs, analyzing component migration as measured by radiostereometric analysis (RSA), clinical outcomes, patient-reported outcome measures (PROMs), and radiological outcomes.

Aims

This systematic review and meta-analysis aimed to compare the influence of patellar resurfacing following cruciate-retaining (CR) and posterior-stabilized (PS) total knee arthroplasty (TKA) on the incidence of anterior knee pain, knee-specific patient-reported outcome measures, complication rates, and reoperation rates.

This study used CT analysis to determine the rotational alignment of 39 painful and 26 painless fixed-bearing total knee replacements (TKRs) from a cohort of 740 NexGen Legacy posterior-stabilised and cruciate-retaining prostheses implanted between May 1996 and August 2003. The mean rotation of the tibial component was 4.3° of internal rotation (25.4° internal to 13.9° external rotation) in the painful group and 2.2° of external rotation (8.5° internal to 18.2° external rotation) in the painfree group (p = 0.024). In the painful group 17 tibial components were internally rotated more than 9° compared with none in the painfree group (p < 0.001). Additionally, six femoral components in the painful group were internally rotated more than 6° compared with none in the painfree group (p = 0.017). External rotational errors were not found to be associated with pain. Overall, 22 (56.4%) of the painful TKRs had internal rotational errors involving the femoral, the tibial or both components. It is estimated that at least 4.6% of all our TKRs have been implanted with significant internal rotational errors

Aims

Metal particles detached from metal-on-metal hip prostheses (MoM-THA) have been shown to cause inflammation and destruction of tissues. To further explore this, we investigated the histopathology (aseptic lymphocyte-dominated vasculitis-associated lesions (ALVAL) score) and metal concentrations of the periprosthetic tissues obtained from patients who underwent revision knee arthroplasty. We also aimed to investigate whether accumulated metal debris was associated with ALVAL-type reactions in the synovium.

Aims

The aim of this study was to investigate the distribution of phenotypes in Asian patients with end-stage osteoarthritis (OA) and assess whether the phenotype affected the clinical outcome and survival of mechanically aligned total knee arthroplasty (TKA). We also compared the survival of the group in which the phenotype unintentionally remained unchanged with those in which it was corrected to neutral.