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

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

Recent publications have drawn attention to the fact that some brands of joint replacement may contain variants which perform significantly worse (or better) than their ‘siblings’. As a result, the National Joint Registry has performed much more detailed analysis on the larger families of knee arthroplasties in order to identify exactly where these differences may be present and may hitherto have remained hidden. The analysis of the Nexgen knee arthroplasty brand identified that some posterior-stabilized combinations have particularly high revision rates for aseptic loosening of the tibia, and consequently a medical device recall has been issued for the Nexgen ‘option’ tibial component which was implicated. More elaborate signal detection is required in order to identify such variation in results in a routine fashion if patients are to be protected from such variation in outcomes between closely related implant types. Cite this article: Bone Joint J 2023;105-B(3):221–226

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

Aims. This study aimed to identify the effect of anatomical tibial component (ATC) design on load distribution in the periprosthetic tibial bone of Koreans using finite element analysis (FEA). Methods. 3D finite element models of 30 tibiae in Korean women were created. A symmetric tibial component (STC, NexGen LPS-Flex) and an ATC (Persona) were used in surgical simulation. We compared the FEA measurements (von Mises stress and principal strains) around the stem tip and in the medial half of the proximal tibial bone, as well as the distance from the distal stem tip to the shortest anteromedial cortical bone. Correlations between this distance and FEA measurements were then analyzed. Results. The distance from the distal stem tip to the shortest cortical bone showed no statistically significant difference between implants. However, the peak von Mises stress around the distal stem tip was higher with STC than with ATC. In the medial half of the proximal tibial bone: 1) the mean von Mises stress, maximum principal strain, and minimum principal strain were higher with ATC; 2) ATC showed a positive correlation between the distance and mean von Mises stress; 3) ATC showed a negative correlation between the distance and mean minimum principal strain; and 4) STC showed no correlation between the distance and mean measurements. Conclusion. Implant design affects the load distribution on the periprosthetic tibial bone, and ATC can be more advantageous in preventing stress-shielding than STC. However, under certain circumstances with short distances, the advantage of ATC may be offset. Cite this article: Bone Joint Res 2022;11(5):252–259

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

One of the most controversial issues in total knee replacement is whether or not to resurface the patella. In order to determine the effects of different designs of femoral component on the conformity of the patellofemoral joint, five different knee prostheses were investigated. These were Low Contact Stress, the Miller-Galante II, the NexGen, the Porous-Coated Anatomic, and the Total Condylar prostheses. Three-dimensional models of the prostheses and a native patella were developed and assessed by computer. The conformity of the curvature of the five different prosthetic femoral components to their corresponding patellar implants and to the native patella at different angles of flexion was assessed by measuring the angles of intersection of tangential lines. The Total Condylar prosthesis had the lowest conformity with the native patella (mean 8.58°; 0.14° to 29.9°) and with its own patellar component (mean 11.36°; 0.55° to 39.19°). In the other four prostheses, the conformity was better (mean 2.25°; 0.02° to 10.52°) when articulated with the corresponding patellar component. The Porous-Coated Anatomic femoral component showed better conformity (mean 6.51°; 0.07° to 9.89°) than the Miller-Galante II prosthesis (mean 11.20°; 5.80° to 16.72°) when tested with the native patella. Although the Nexgen prosthesis had less conformity with the native patella at a low angle of flexion, this improved at mid (mean 3.57°; 1.40° to 4.56°) or high angles of flexion (mean 4.54°; 0.91° to 9.39°), respectively. The Low Contact Stress femoral component had the best conformity with the native patella (mean 2.39°; 0.04° to 4.56°). There was no significant difference (p > 0.208) between the conformity when tested with the native patella or its own patellar component at any angle of flexion. The geometry of the anterior flange of a femoral component affects the conformity of the patellofemoral joint when articulating with the native patella. A more anatomical design of femoral component is preferable if the surgeon decides not to resurface the patella at the time of operation

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

The purpose of this prospective, randomised study was to evaluate the clinical and radiological results comparing the identical cemented or cementless NexGen total knee prostheses implanted bilaterally in the same patient. Sequential simultaneous bilateral total knee replacements were performed in 50 patients (100 knees). There were 39 women and 11 men with a mean age of 58.4 years (51 to 67) who received a cemented prosthesis in one knee and a cementless prosthesis in the other. The mean follow-up was 13.6 years (13 to 14). At final review, the mean Knee Society scores (96.2 (82 to 100) versus 97.7 (90 to 100)), the mean Western Ontario and McMaster Universities osteoarthritis index (34.5 (4 to 59) versus 35.6 (5 to 51)), the mean ranges of knee movement (124° (100° to 140°) versus 128° (110° to 140°)), mean patient satisfaction (8.1 (. sd. 1.9) versus 8.3 (. sd. 1.7)), and radiological results were similar in both groups. The rate of survival of the femoral components was 100% in both groups at 14 years. The rate of survival of the cemented tibial component was 100% and 98% in the cementless tibial component. No osteolysis was identified in either group. Our data have shown no advantage of cementless over cemented components in total knee replacement

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