Aims. Patient dissatisfaction is not uncommon following primary total knee arthroplasty. One proposed method to alleviate this is by improving knee kinematics. Therefore, we aimed to answer the following research question: are there significant differences in knee kinematics based on the design of the tibial insert (cruciate-retaining (CR), ultra-congruent (UC), or medial congruent (MC))?. Methods. Overall, 15 cadaveric knee joints were examined with a CR implant with three different tibial inserts (CR, UC, and MC) using an established knee joint simulator. The effects on coronal alignment, medial and lateral femoral roll back, femorotibial rotation, bony rotations (femur, tibia, and patella), and patellofemoral length ratios were determined. Results. No statistically significant differences were found regarding coronal alignment (p = 0.087 to p = 0.832). The medial congruent insert demonstrated restricted femoral roll back (mean medial 37.57 mm; lateral 36.34 mm), while the CR insert demonstrated the greatest roll back (medial 42.21 mm; lateral 37.88 mm; p < 0.001, respectively). Femorotibial rotation was greatest with the CR insert with 2.45° (SD 4.75°), then the UC insert with 1.31° (SD 4.15°; p < 0.001), and lowest with the medial congruent insert with 0.8° (SD 4.24°; p < 0.001). The most pronounced patella shift, but lowest patellar rotation, was noted with the CR insert. Conclusion. The MC insert demonstrated the highest level of constraint of these inserts. Femoral roll back, femorotibial rotation, and single bony rotations were lowest with the MC insert. The patella showed less shifting with the MC insert, but there was significantly increased rotation. While the medial congruent insert was found to have highest constraint, it remains uncertain if this implant recreates native knee kinematics or if this will result in improved patient satisfaction. Cite this article: Bone Jt Open 2024;5(7):592–600

Aims. This study aimed to determine outcomes of isolated tibial insert exchange (ITIE) during revision total knee arthroplasty (TKA). Methods. From 1985 to 2016, 270 ITIEs were performed at one institution for instability (55%, n = 148), polyethylene wear (39%, n = 105), insert fracture/dissociation (5%, n = 14), or stiffness (1%, n = 3). Patients with component loosening, implant malposition, infection, and extensor mechanism problems were excluded. Results. Survivorship free of any re-revision was 68% at ten years. For the indication of insert wear, survivorship free of any re-revision at ten years was 74%. Re-revisions were more frequent for index diagnoses other than wear (hazard ratio (HR) 1.9; p = 0.013), with ten-year survivorships of 69% for instability and 37% for insert fracture/dissociation. Following ITIE for wear, the most common reason for re-revision was aseptic loosening (33%, n = 7). For other indications, the most common reason for re-revision was recurrence of the original diagnosis. Mean Knee Society Scores improved from 54 (0 to 94) preoperatively to 77 (38 to 94) at ten years. Conclusion. After ITIE, the risk and reasons for re-revision correlated with preoperative indications. The best results were for polyethylene wear. For other diagnoses, the re-revision rate was higher and the failure mode was most commonly recurrence of the original indication for the revision TKA. Cite this article: Bone Joint J 2021;103-B(6):1103–1110

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. Mobile-bearing unicompartmental knee arthroplasty (UKA) with a flat tibial plateau has not performed well in the lateral compartment, leading to a high rate of dislocation. For this reason, the Domed Lateral UKA with a biconcave bearing was developed. However, medial and lateral tibial plateaus have asymmetric anatomical geometries, with a slightly dished medial and a convex lateral plateau. Therefore, the aim of this study was to evaluate the extent at which the normal knee kinematics were restored with different tibial insert designs using computational simulation. Methods. We developed three different tibial inserts having flat, conforming, and anatomy-mimetic superior surfaces, whereas the inferior surface in all was designed to be concave to prevent dislocation. Kinematics from four male subjects and one female subject were compared under deep knee bend activity. Results. The conforming design showed significantly different kinematics in femoral rollback and internal rotation compared to that of the intact knee. The flat design showed significantly different kinematics in femoral rotation during high flexion. The anatomy-mimetic design preserved normal knee kinematics in femoral rollback and internal rotation. Conclusion. The anatomy-mimetic design in lateral mobile UKA demonstrated restoration of normal knee kinematics. Such design may allow achievement of the long sought normal knee characteristics post-lateral mobile UKA. However, further in vivo and clinical studies are required to determine whether this design can truly achieve a more normal feeling of the knee and improved patient satisfaction. Cite this article: Bone Joint Res 2020;9(7):421–428

Components from 73 failed knee replacements (TKRs) consisting of rotating-platform, mobile-bearing and fixed-bearing implants were examined to assess the patterns of wear. The patterns were divided into low-grade (burnishing, abrasion and cold flow) and high-grade (scratching, pitting/metal embedding and delamination) to assess the severity of the wear of polyethylene. The rotating-platform group had a higher incidence of low-grade wear on the upper surface compared with the fixed-bearing group. By contrast, high-grade wear comprising scratching, pitting and third-body embedding was seen on the lower surface. Linear regression analysis showed a significant correlation of the wear scores between the upper and lower surfaces of the tibial insert (R. 2. = 0.29, p = 0.04) for the rotating-platform group, but no significant correlation was found for the fixed-bearing counterpart. This suggests that high-grade wear patterns on the upper surface are reduced with the rotating-platform design. However, the incidence of burnishing, pitting/third-body embedding and scratching wear patterns on the lower surface was higher compared with that in the fixed-bearing knee

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

Aims. This study aims to investigate the effects of posterior tibial slope (PTS) on knee kinematics involved in the post-cam mechanism in bi-cruciate stabilized (BCS) total knee arthroplasty (TKA) using computer simulation. Methods. In total, 11 different PTS (0° to 10°) values were simulated to evaluate the effect of PTS on anterior post-cam contact conditions and knee kinematics in BCS TKA during weight-bearing stair climbing (from 86° to 6° of knee flexion). Knee kinematics were expressed as the lowest points of the medial and lateral femoral condyles on the surface of the tibial insert, and the anteroposterior translation of the femoral component relative to the tibial insert. Results. Anterior post-cam contact in BCS TKA was observed with the knee near full extension if PTS was 6° or more. BCS TKA showed a bicondylar roll forward movement from 86° to mid-flexion, and two different patterns from mid-flexion to knee extension: screw home movement without anterior post-cam contact and bicondylar roll forward movement after anterior post-cam contact. Knee kinematics in the simulation showed similar trends to the clinical in vivo data and were almost within the range of inter-specimen variability. Conclusion. Postoperative knee kinematics in BCS TKA differed according to PTS and anterior post-cam contact; in particular, anterior post-cam contact changed knee kinematics, which may affect the patient’s perception of the knee during activities. Cite this article: Bone Joint Res 2020;9(11):761–767

Objectives. Unicompartmental knee arthroplasty (UKA) is an alternative to total knee arthroplasty for patients who require treatment of single-compartment osteoarthritis, especially for young patients. To satisfy this requirement, new patient-specific prosthetic designs have been introduced. The patient-specific UKA is designed on the basis of data from preoperative medical images. In general, knee implant design with increased conformity has been developed to provide lower contact stress and reduced wear on the tibial insert compared with flat knee designs. The different tibiofemoral conformity may provide designers the opportunity to address both wear and kinematic design goals simultaneously. The aim of this study was to evaluate wear prediction with respect to tibiofemoral conformity design in patient-specific UKA under gait loading conditions by using a previously validated computational wear method. Methods. Three designs with different conformities were developed with the same femoral component: a flat design normally used in fixed-bearing UKA, a tibia plateau anatomy mimetic (AM) design, and an increased conforming design. We investigated the kinematics, contact stress, contact area, wear rate, and volumetric wear of the three different tibial insert designs. Results. Conforming increased design showed a lower contact stress and increased contact area. In addition, increased conformity resulted in a reduction of the wear rate and volumetric wear. However, the increased conformity design showed limited kinematics. Conclusion. Our results indicated that increased conformity provided improvements in wear but resulted in limited kinematics. Therefore, increased conformity should be avoided in fixed-bearing patient-specific UKA design. We recommend a flat or plateau AM tibial insert design in patient-specific UKA. Cite this article: Y-G. Koh, K-M. Park, H-Y. Lee, K-T. Kang. Influence of tibiofemoral congruency design on the wear of patient-specific unicompartmental knee arthroplasty using finite element analysis. Bone Joint Res 2019;8:156–164. DOI: 10.1302/2046-3758.83.BJR-2018-0193.R1

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. Results. A-XLPE inserts had higher rates of burnishing and lower rates of pitting and scratching compared with XLPE. There were no differences in the density of crosslinking at loaded and unloaded regions. A-XLPE showed higher oxidation indices in the unloaded surface region compared with XLPE. There were no differences in the levels of oxidation in the loaded regions. Conclusion. Retrieval analysis of A-XLPE did not reflect a clinically relevant difference in surface damage, density of crosslinking, or oxidation compared with XLPE tibial inserts at short-term evaluation. Cite this article: Bone Joint J 2018;100-B:1330–5

Aims. Commonly performed unicompartmental knee arthroplasty (UKA) is not designed for the lateral compartment. Additionally, the anatomical medial and lateral tibial plateaus have asymmetrical geometries, with a slightly dished medial plateau and a convex lateral plateau. Therefore, this study aims to investigate the native knee kinematics with respect to the tibial insert design corresponding to the lateral femoral component. Methods. Subject-specific finite element models were developed with tibiofemoral (TF) and patellofemoral joints for one female and four male subjects. Three different TF conformity designs were applied. Flat, convex, and conforming tibial insert designs were applied to the identical femoral component. A deep knee bend was considered as the loading condition, and the kinematic preservation in the native knee was investigated. Results. The convex design, the femoral rollback, and internal rotation were similar to those of the native knee. However, the conforming design showed a significantly decreased femoral rollback and internal rotation compared with that of the native knee (p < 0.05). The flat design showed a significant difference in the femoral rollback; however, there was no difference in the tibial internal rotation compared with that of the native knee. Conclusion. The geometry of the surface of the lateral tibial plateau determined the ability to restore the rotational kinematics of the native knee. Surgeons and implant designers should consider the geometry of the anatomical lateral tibial plateau as an important factor in the restoration of native knee kinematics after lateral UKA. Cite this article: Bone Joint Res 2019;8:593–600

Aims. Knee arthroplasty surgery is a highly effective treatment for arthritis and disorders of the knee. There are a wide variety of implant brands and types of knee arthroplasty available to surgeons. As a result of a number of highly publicized failures, arthroplasty surgery is highly regulated in the UK and many other countries through national registries, introduced to monitor implant performance, surgeons, and hospitals. With time, the options available within many brand portfolios have grown, with alternative tibial or femoral components, tibial insert materials, or shapes and patella resurfacings. In this study we have investigated the effect of the expansion of implant brand portfolios and where there may be a lack of transparency around a brand name. We also aimed to establish the potential numbers of compatible implant construct combinations. Methods. Hypothetical implant brand portfolios were proposed, and the number of compatible implant construct combinations was calculated. Results. A simple knee portfolio with cemented cruciate-retaining (CR) and posterior-stabilized (PS) components, with and without a patella, has four combinations. If there are two options available for each component, the numbers double for each option, resulting in 32 combinations. The effect of adding a third option multiplies the number by 1.3. Introducing compatible uncemented options, with the effect of hybrids, multiplies the number by 4. An implant portfolio with two femoral components (both in CR and PS), with two insert options and a patella, all in cemented and uncemented versions leads to 192 possible compatible implant construct combinations. There are implant brands available to surgeons with many more than two options. Conclusion. This study demonstrates that the addition of multiple variants within a knee brand portfolio leads to a large number (many hundreds) of compatible implant construct combinations. Revision rates of implant combinations are not currently reviewed at this level of granularity, leading to the risk of camouflage of true outcomes. Cite this article: Bone Joint J 2021;103-B(10):1555–1560

Aims. The material and design of knee components can have a considerable effect on the contact characteristics of the tibial post. This study aimed to analyze the stress distribution on the tibial post when using different grades of polyethylene for the tibial inserts. In addition, the contact properties of fixed-bearing and mobile-bearing inserts were evaluated. Methods. Three different grades of polyethylene were compared in this study; conventional ultra high molecular weight polyethylene (UHMWPE), highly cross-linked polyethylene (HXLPE), and vitamin E-stabilized polyethylene (VEPE). In addition, tibial baseplates with a fixed-bearing and a mobile-bearing insert were evaluated to understand differences in the contact properties. The inserts were implanted in neutral alignment and with a 10° internal malrotation. The contact stress, von Mises stress, and equivalent plastic strain (PEEQ) on the tibial posts were extracted for comparison. Results. The stress and strain on the tibial post for the three polyethylenes greatly increased when the insert was placed in malrotation, showing a 38% to 56% increase in von Mises stress and a 335% to 434% increase in PEEQ. The VEPE insert had the lowest PEEQ among the three materials. The mobile-bearing design exhibited a lower increase in stress and strain around the tibial posts than the fixed-bearing design. Conclusion. Using VEPE for the tibial component potentially eliminates the risk of material permanent deformation. The mobile-bearing insert can help to avoid a dramatic increase in plastic strain around the tibial post in cases of malrotation. The mobility allows the pressure to be distributed on the tibial post and demonstrated lower stresses with all three polyethylenes simulated. Cite this article: Bone Joint Res 2020;9(11):768–777

Aims. We propose a state-of-the-art temporary spacer, consisting of a cobalt-chrome (CoCr) femoral component and a gentamicin-eluting ultra-high molecular weight polyethylene (UHMWPE) tibial insert, which can provide therapeutic delivery of gentamicin, while retaining excellent mechanical properties. The proposed implant is designed to replace conventional spacers made from bone cement. Methods. Gentamicin-loaded UHMWPE was prepared using phase-separated compression moulding, and its drug elution kinetics, antibacterial, mechanical, and wear properties were compared with those of conventional gentamicin-loaded bone cement. Results. Gentamicin-loaded UHMWPE tibial components not only eradicated planktonic Staphylococcus aureus, but also prevented colonization of both femoral and tibial components. The proposed spacer possesses far superior mechanical and wear properties when compared with conventional bone cement spacers. Conclusion. The proposed gentamicin-eluting UHMWPE spacer can provide antibacterial efficacy comparable with currently used bone cement spacers, while overcoming their drawbacks. The novel spacer proposed here has the potential to drastically reduce complications associated with currently used bone cement spacers and substantially improve patients’ quality of life during the treatment. Cite this article: Bone Joint J 2020;102-B(6 Supple A):151–157

Objectives. Little biomechanical information is available about kinematically aligned (KA) total knee arthroplasty (TKA). The purpose of this study was to simulate the kinematics and kinetics after KA TKA and mechanically aligned (MA) TKA with four different limb alignments. Materials and Methods. Bone models were constructed from one volunteer (normal) and three patients with three different knee deformities (slight, moderate and severe varus). A dynamic musculoskeletal modelling system was used to analyse the kinematics and the tibiofemoral contact force. The contact stress on the tibial insert, and the stress to the resection surface and medial tibial cortex were examined by using finite element analysis. Results. In all bone models, posterior translation on the lateral side and external rotation in the KA TKA models were greater than in the MA TKA models. The tibiofemoral force at the medial side was increased in the moderate and severe varus models with KA TKA. In the severe varus model with KA TKA, the contact stress on the tibial insert and the stress to the resection surface and to the medial tibial cortex were increased by 41.5%, 32.2% and 53.7%, respectively, compared with MA TKA, and the bone strain at the medial side was highest among all models. Conclusion. Near normal kinematics was observed in KA TKA. However, KA TKA increased the contact force, stress and bone strain at the medial side for moderate and severe varus knee models. The application of KA TKA for severe varus knees may be inadequate. Cite this article: S. Nakamura, Y. Tian, Y. Tanaka, S. Kuriyama, H. Ito, M. Furu, S. Matsuda. The effects of kinematically aligned total knee arthroplasty on stress at the medial tibia: A case study for varus knee. Bone Joint Res 2017;6:43–51. DOI: 10.1302/2046-3758.61.BJR-2016-0090.R1

Objectives. Bone void fillers are increasingly being used for dead space management in arthroplasty revision surgery. The aim of this study was to investigate the influence of calcium sulphate bone void filler (CS-BVF) on the damage and wear of total knee arthroplasty using experimental wear simulation. Methods. A total of 18 fixed-bearing U2 total knee arthroplasty system implants (United Orthopedic Corp., Hsinchu, Taiwan) were used. Implants challenged with CS-BVF were compared with new implants (negative controls) and those intentionally scratched with a diamond stylus (positive controls) representative of severe surface damage (n = 6 for each experimental group). Three million cycles (MC) of experimental simulation were carried out to simulate a walking gait cycle. Wear of the ultra-high-molecular-weight polyethylene (UHMWPE) tibial inserts was measured gravimetrically, and damage to articulating surfaces was assessed using profilometry. Results. There was no significant difference (p  >  0.05) between the wear rate of implants challenged with CS-BVF (3.3 mm. 3. /MC (95% confidence interval (CI) 1.8 to 4.8)) and the wear rate of those not challenged (2.8 mm. 3. /MC (95% CI 1.3 to 4.3)). However, scratching the cobalt-chrome (CoCr) significantly (p < 0.001) increased the wear rate (20.6 mm. 3. /MC (95% CI 15.5 to 25.7)). The mean surface roughness of implants challenged with CS-BVF was equivalent to negative controls both after damage simulation (p = 0.98) and at the conclusion of the study (p = 0.28). Conclusion. When used close to articulating surfaces, a low-hardness, high-purity CS-BVF had no influence on wear. When trapped between the articulating surfaces of a total knee arthroplasty, CS-BVF did not scratch the surface of CoCr femoral components, nor did it increase the wear of UHMWPE tibial inserts compared with undamaged negative controls. Cite this article: R. M. Cowie, S. S. Aiken, J. J. Cooper, L. M. Jennings. The influence of a calcium sulphate bone void filler on the third-body damage and polyethylene wear of total knee arthroplasty. Bone Joint Res 2019;8:65–72. DOI: 10.1302/2046-3758.82.BJR-2018-0146.R1

Aims. Neither a surgeon’s intraoperative impression nor the parameters of computer navigation have been shown to be predictive of the outcomes following total knee arthroplasty (TKA). The aim of this study was to determine whether a surgeon, with robotic assistance, can predict the outcome as assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain (KPS), one year postoperatively, and establish what factors correlate with poor KOOS scores in a well-aligned and balanced TKA. Methods. A total of 134 consecutive patients who underwent TKA using a dynamic ligament tensioning robotic system with a tibia first resection technique and a cruciate sacrificing ultracongruent TKA system were enrolled into a prospective study. Each TKA was graded based on the final mediolateral ligament balance at 10° and 90° of flexion: 1) < 1 mm difference in the thickness of the tibial insert and that which was planned (n = 75); 2) < 1 mm difference (n = 26); 3) between 1 mm to 2 mm difference (n = 26); and 4) > 2 mm difference (n = 7). The mean one-year KPS score for each grade of TKA was compared and the likelihood of achieving an KPS score of > 90 was calculated. Finally, the factors associated with lower KPS despite achieving a high-grade TKA (grade A and B) were analyzed. Results. Patients with a grade of A or B TKA had significantly higher mean one-year KPS scores compared with those with C or D grades (p = 0.031). There was no difference in KPS scores in grade A or B TKAs, but 33% of these patients did not have a KPS score of > 90. While there was no correlation with age, sex, preoperative deformity, and preoperative KOOS and Patient-Reported Outcomes Measurement Information System (PROMIS) physical scores, patients with a KPS score of < 90, despite a grade A or B TKA, had lower PROMIS mental health scores compared with those with KPS scores of > 90 (54.1 vs 50.8; p = 0.043). Patients with grade A and B TKAs with KPS > 90 were significantly more likely to respond with “my expectations were too low”, and with “the knee is performing better than expected” compared with patients with these grades of TKA who had a KPS score of < 90 (40% vs 22%; p = 0.004). Conclusion. A TKA balanced with robotic assistance to within 1 mm of difference between the medial and lateral sides in both flexion and extension had a higher KPS score one year postoperatively. Despite accurate ligament balance information, a robotic system could not guarantee excellent pain relief. Patient expectations and mental status also significantly affected the perceived success of TKA. Cite this article: Bone Joint J 2021;103-B(6 Supple A):67–73

Aims. A retrospective longitudinal study was conducted to compare directly volumetric wear of retrieved polyethylene inserts to predicted volumetric wear modelled from individual gait mechanics of total knee arthroplasty (TKA) patients. Methods. In total, 11 retrieved polyethylene tibial inserts were matched with gait analysis testing performed on those patients. Volumetric wear on the articular surfaces was measured using a laser coordinate measure machine and autonomous reconstruction. Knee kinematics and kinetics from individual gait trials drove computational models to calculate medial and lateral tibiofemoral contact paths and forces. Sliding distance along the contact path, normal forces and implantation time were used as inputs to Archard’s equation of wear to predict volumetric wear from gait mechanics. Measured and modelled wear were compared for each component. Results. Volumetric wear rates on eight non-delaminated components measured 15.9 mm. 3. /year (standard error (SE) ± 7.7) on the total part, 11.4 mm. 3. /year (SE ± 6.4) on the medial side and 4.4 (SE ± 2.6) mm. 3. /year on the lateral side. Volumetric wear rates modelled from patient gait mechanics predicted 16.4 mm. 3. /year (SE 2.4) on the total part, 11.7 mm. 3. /year (SE 2.1) on the medial side and 4.7 mm. 3. /year (SE 0.4) on the lateral side. Measured and modelled wear volumes correlated significantly on the total part (p = 0.017) and the medial side (p = 0.012) but not on the lateral side (p = 0.154). Conclusion. In the absence of delamination, patient-specific knee mechanics during gait directly affect wear of the tibial component in TKA. Cite this article: Bone Joint J 2020;102-B(6 Supple A):129–137

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

Introduction. Wear of polyethylene inserts plays an important role in failure of total knee replacement and can be monitored in vivo by measuring the minimum joint space width in anteroposterior radiographs. The objective of this retrospective cross-sectional study was to compare the accuracy and precision of a new model-based method with the conventional method by analysing the difference between the minimum joint space width measurements and the actual thickness of retrieved polyethylene tibial inserts. . Method. Before revision, the minimum joint space width values and their locations on the insert were measured in 15 fully weight-bearing radiographs. These measurements were compared with the actual minimum thickness values and locations of the retrieved tibial inserts after revision. . Results. The mean error in the model-based minimum joint space width measurement was significantly smaller than the conventional method for medial condyles (0.50 vs 0.94 mm, p < 0.01) and for lateral condyles (0.06 vs 0.34 mm, p = 0.02). The precision (standard deviation of the error) of the methods was similar (0.84 vs 0.79 mm medially and both 0.46 mm laterally). The distance between the true minimum joint space width locations and the locations from the model-based measurements was less than 10 mm in the medial direction in 12 cases and less in the lateral direction in 13 cases. Conclusion. The model-based minimum joint space width measurement method is more accurate than the conventional measurement with the same precision. Cite this article: Bone Joint Res 2014;3:289–96

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

Aims. We sought to establish whether an oxidised zirconium (OxZr) femoral component causes less loss of polyethylene volume than a cobalt alloy (CoCr) femoral component in total knee arthroplasty. Materials and Methods. A total of 20 retrieved tibial inserts that had articulated with OxZr components were matched with 20 inserts from CoCr articulations for patient age, body mass index, length of implantation, and revision diagnosis. Changes in dimensions of the articular surfaces were compared with those of pristine inserts using laser scanning. The differences in volume between the retrieved and pristine surfaces of the two groups were calculated and compared. Results. The loss of polyethylene volume was 122 mm. 3. (standard deviation (. sd. ) 87) in the OxZr group and 170 mm. 3. (. sd. 96) in the CoCr group (p = 0.033). The volume loss in the OxZr group was also lower in the medial (72 mm. 3 . (. sd. 67) versus 92 mm. 3 . (. sd. 60); p = 0.096) and lateral (49 mm. 3 . (. sd. 36) versus 79 mm. 3 . (. sd. 61); p = 0.096) compartments separately, but these differences were not significant. Conclusion. Our results corroborate earlier findings from in vitro testing and visual retrieval analysis which suggest that polyethylene volume loss is lower with OxZr femoral components. Since both OxZr and CoCr are hard surfaces that would be expected to create comparable amounts of polyethylene creep, the differences in volume loss may reflect differences in the in vivo wear of these inserts. Cite this article: Bone Joint J 2017;99-B:793–8

Aims. The aims of this study were to determine the proportion of patients with outlier varus or valgus alignment in kinematically aligned total knee arthroplasty (TKA), whether those with outlier varus or valgus alignment have higher forces in the medial or lateral compartments of the knee than those with in-range alignment and whether measurements of the alignment of the limb, knee and components predict compartment forces. Patients and Methods. The intra-operative forces in the medial and lateral compartments were measured with an instrumented tibial insert in 67 patients who underwent a kinematically aligned TKA during passive movement. The mean of the forces at full extension, 45° and 90° of flexion determined the force in the medial and lateral compartments. Measurements of the alignment of the limb and the components included the hip-knee-ankle (HKA) angle, proximal medial tibial angle (PMTA), and distal lateral femoral angle (DLFA). Measurements of the alignment of the knee and the components included the tibiofemoral angle (TFA), tibial component angle (TCA) and femoral component angle (FCA). Alignment was measured on post-operative, non-weight-bearing anteroposterior (AP) scanograms and categorised as varus or valgus outlier or in-range in relation to mechanically aligned criteria. Results. The proportion of patients with outlier varus or valgus alignment was 16%/24% for the HKA angle, 55%/0% for the PMTA, 0%/57% for the DLFA, 25%/12% for the TFA, 100%/0% for the TCA, and 0%/64% for the FCA. In general, the forces in the medial and lateral compartments of those with outlier alignment were not different from those with in-range alignment except for the TFA, in which patients with outlier varus alignment had a mean paradoxical force which was 6 lb higher in the lateral compartment than those with in-range alignment. None of the measurements of alignment of the limb, knee and components predicted the force in the medial or lateral compartment. Conclusion. Although kinematically aligned TKA has a high proportion of varus or valgus outliers using mechanically aligned criteria, the intra-operative forces in the medial and lateral compartments of patients with outlier alignment were comparable with those with in-range alignment, with no evidence of overload of the medial or lateral compartment of the knee. Cite this article: Bone Joint J 2017;99-B:1319–28

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Mid-level constraint designs for total knee arthroplasty (TKA) are intended to reduce coronal plane laxity. Our aims were to compare kinematics and ligament forces of the Zimmer Biomet Persona posterior-stabilized (PS) and mid-level designs in the coronal, sagittal, and axial planes under loads simulating clinical exams of the knee in a cadaver model.

Aims

The aim of this study was to compare a bicruciate-retaining (BCR) total knee arthroplasty (TKA) with a posterior cruciate-retaining (CR) TKA design in terms of kinematics, measured using fluoroscopy and stability as micromotion using radiostereometric analysis (RSA).

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The purpose of this study was to assess mid-term survivorship following primary total knee arthroplasty (TKA) with Optetrak Logic components and identify the most common revision indications at a single institution.

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This study compared patient-reported outcomes of three total knee arthroplasty (TKA) designs from one manufacturer: one cruciate-retaining (CR) design, and two cruciate-sacrificing designs, anterior-stabilized (AS) and posterior-stabilized (PS).

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Total knee arthroplasty (TKA) with a highly congruent condylar-stabilized (CS) articulation may be advantageous due to increased stability versus cruciate-retaining (CR) designs, while mitigating the limitations of a posterior-stabilized construct. The aim was to assess ten-year implant survival and functional outcomes of a cemented single-radius TKA with a CS insert, performed without posterior cruciate ligament sacrifice.

Aims. The aim of this study was to establish the results of isolated exchange of the tibial polyethylene insert in revision total knee arthroplasty (RTKA) in patients with well-fixed femoral or tibial components. We report on a series of RTKAs where only the polyethylene was replaced, and the patients were followed for a mean of 13.2 years (10.0 to 19.1). Patients and Methods. Our study group consisted of 64 non-infected, grossly stable TKA patients revised over an eight-year period (1998 to 2006). The mean age of the patients at time of revision was 72.2 years (48 to 88). There were 36 females (56%) and 28 males (44%) in the cohort. All patients had received the same cemented, cruciate-retaining patella resurfaced primary TKA. All subsequently underwent an isolated polyethylene insert exchange. The mean time from the primary TKA to RTKA was 9.1 years (2.2 to 16.1). Results. At final follow-up, 13 patients had died, leaving 51 patients for study. Only seven of these patients had required re-operation. Knee Society scores (KSS) prior to RTKA were a mean of 78.4 (24 to 100). By six weeks post-revision, the mean total KSS was 93.5 (38 to 100) and at final follow-up, they had a mean of 91.6 (36 to 100). Conclusion. In appropriate circumstances, where the femoral and tibial components are satisfactorily aligned and well fixed, and where the soft tissues can be balanced, a polyethylene exchange alone can provide a durable solution for these RTKA patients. Cite this article: Bone Joint J 2019;101-B(7 Supple C):104–107

We report on the long-term results of 163 bicruciate-retaining Hermes 2C total knee replacements in 130 patients at a mean follow-up of 22.4 years (20.3 to 23.5). Even when the anterior cruciate ligament had a partially degenerative appearance it was preserved as long as the knee had a normal anterior drawer and Lachman’s test pre-operatively. The description and surgical technique of this minimally constrained prosthesis were published in 1983 and the ten-year clinical results in 1999. A total of 12% of the knees (20 of 163) in this study were revised because of wear of the polyethylene tibial insert. Excellent stability was achieved and the incidence of aseptic component loosening was 4.3% (seven of 163). The survival rate using revision for any reason as the endpoint was 82% (95% confidence interval 76.2 to 88.0). Although this series included a relatively small number of replacements, it demonstrated that the anterior cruciate ligament, even when partially degenerated at the time of TKR, remained functional and provided adequate stability at a long-term follow-up. Cite this article: Bone Joint J 2013;95-B:917–22

The April 2023 Hip & Pelvis Roundup³⁶⁰ looks at: Do technical errors determine outcomes of operatively managed femoral neck fractures in younger adults?; Single-stage or two-stage revision for hip prosthetic joint infection (INFORM); Fixation better than revision in type B periprosthetic fractures of taper slip stems; Can you maximize femoral head size at the expense of liner thickness?; Plasma D-dimer for periprosthetic joint infection?; How important is in vivo oxidation?; Total hip arthroplasty for HIV patients with osteonecrosis.

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.

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To explore the clinical efficacy of using two different types of articulating spacers in two-stage revision for chronic knee periprosthetic joint infection (kPJI).

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The surgical target for optimal implant positioning in robotic-assisted total knee arthroplasty remains the subject of ongoing discussion. One of the proposed targets is to recreate the knee’s functional behaviour as per its pre-diseased state. The aim of this study was to optimize implant positioning, starting from mechanical alignment (MA), toward restoring the pre-diseased status, including ligament strain and kinematic patterns, in a patient population.

Periprosthetic joint infection (PJI) remains an extremely challenging complication. We have focused on this issue more over the last decade than previously, but there are still many unanswered questions. We now have a workable definition that everyone should align to, but we need to continue to focus on identifying the organisms involved. Surgical strategies are evolving and care is becoming more patient-centred. There are some good studies under way. There are, however, still numerous problems to resolve, and the challenge of PJI remains a major one for the orthopaedic community. This annotation provides some up-to-date thoughts about where we are, and the way forward. There is still scope for plenty of research in this area.

Cite this article: Bone Joint J 2022;104-B(11):1193–1195.

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The mid-term results of kinematic alignment (KA) for total knee arthroplasty (TKA) using image derived instrumentation (IDI) have not been reported in detail, and questions remain regarding ligamentous stability and revisions. This paper aims to address the following: 1) what is the distribution of alignment of KA TKAs using IDI; 2) is a TKA alignment category associated with increased risk of failure or poor patient outcomes; 3) does extending limb alignment lead to changes in soft-tissue laxity; and 4) what is the five-year survivorship and outcomes of KA TKA using IDI?

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During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing.

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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.

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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.

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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.

We describe the survivorship of the Medial Rotation total knee replacement (TKR) at ten years in 228 cemented primary replacements implanted between October 1994 and October 2006, with their clinical and radiological outcome. This implant has a highly congruent medial compartment, with the femoral component represented by a portion of a sphere which articulates with a matched concave surface on the medial side of the tibial insert. There were 78 men (17 bilateral TKRs) and 111 women (22 bilateral TKRs) with a mean age of 67.9 years (28 to 90). All the patients were assessed clinically and radiologically using the American Knee Society scoring systems. The mean follow-up was for six years (1 to 13) with only two patients lost to follow-up and 34 dying during the period of study, one of whom had required revision for infection. There were 11 revisions performed in total, three for aseptic loosening, six for infection, one for a periprosthetic fracture and one for a painful but well-fixed replacement performed at another centre. With revision for any cause as the endpoint, the survival at ten years was 94.5% (95% CI 85.1 to 100), and with aseptic loosening as the endpoint 98.4% (95% CI 93 to 100). The mean American Knee Society score improved from 47.6 (0 to 88) to 72.2 (26 to 100) and for function from 45.1 (0 to 100) to 93.1 (45 to 100). Radiological review failed to detect migration in any of the surviving knees. The clinical and radiological results of the Medial Rotation TKR are satisfactory at ten years. The increased congruence of the medial compartment has not led to an increased rate of loosening and continued use can be supported

Debate has raged over whether a cruciate retaining (CR) or a posterior stabilised (PS) total knee replacement (TKR) provides a better range of movement (ROM) for patients. Various sub-sets of CR design are frequently lumped together when comparing outcomes. Additionally, multiple factors have been proven to influence the rate of manipulation under anaesthetic (MUA) following TKR. The purpose of this study was to determine whether different CR bearing insert designs provide better ROM or different MUA rates. All primary TKRs performed by two surgeons between March 2006 and March 2009 were reviewed and 2449 CR-TKRs were identified. The same CR femoral component, instrumentation, and tibial base plate were consistently used. In 1334 TKRs a CR tibial insert with 3° posterior slope and no posterior lip was used (CR-S). In 803 there was an insert with no slope and a small posterior lip (CR-L) and in 312 knees the posterior cruciate ligament (PCL) was either resected or lax and a deep-dish, anterior stabilised insert was used (CR-AS). More CR-AS inserts were used in patients with less pre-operative ROM and greater pre-operative tibiofemoral deformity and flexion contracture (p < 0.05). The mean improvement in ROM was highest for the CR-AS inserts (5.9° (-40° to 55°) vs CR-S 3.1° (-45° to 70°) vs CR-L 3.0° (-45° to 65°); p = 0.004). There was a significantly higher MUA rate with the CR-S and CR-L inserts than CR-AS (Pearson rank 6.51; p = 0.04). Despite sacrificing or not substituting for the PCL, ROM improvement was highest, and the MUA rate was lowest in TKRs with a deep-dish, anterior-stabilised insert. Substitution for the posterior cruciate ligament (PCL) in the form of a PS design may not be necessary even when the PCL is deficient. . Cite this article: Bone Joint J 2013;95-B, Supple A:129–32

We retrospectively reviewed 35 cemented unicompartmental knee replacements performed for medial unicompartmental osteoarthritis of the knee in 31 patients ≤50 years old (mean 46, 31 to 49). Patients were assessed clinically and radiologically using the Knee Society scores at a mean follow-up of 9.7 years (5 to 16) and survival at 12 years was calculated. The mean Knee Society Function Score improved from 54 points (25 to 64) pre-operatively to 89 (80 to 100) post-operatively (p < 0.0001). Six knees required revision, four for polyethylene wear treated with an isolated exchange of the tibial insert, one for aseptic loosening and one for progression of osteoarthritis. The 12-year survival according to Kaplan-Meier was 80.6% with revision for any reason as the endpoint. Despite encouraging clinical results, polyethylene wear remains a major concern affecting the survival of unicompartmental knee replacement in patients younger than 50

Our purpose was to determine the mechanism which allows the maximum knee flexion in vivo after a posterior-cruciate-ligament (PCL)-retaining total knee arthroplasty. Using three-dimensional computer-aided design videofluoroscopy of deep squatting in 29 patients, we determined that in 72% of knees, direct impingement of the tibial insert posteriorly against the back of the femur was the factor responsible for blocking further flexion. In view of this finding we defined a new parameter termed the ‘posterior condylar offset’. In 150 consecutive arthroplasties of the knee, the magnitude of posterior condylar offset was found to correlate with the final range of flexion

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The aims of this study were to evaluate wear on the surface of cobalt-chromium (CoCr) femoral components used in total knee arthroplasty (TKA) and compare the wear of these components with that of ceramic femoral components.

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It is unknown whether gap laxities measured in robotic arm-assisted total knee arthroplasty (TKA) correlate to load sensor measurements. The aim of this study was to determine whether symmetry of the maximum medial and lateral gaps in extension and flexion was predictive of knee balance in extension and flexion respectively using different maximum thresholds of intercompartmental load difference (ICLD) to define balance.

We studied the kinetics of the knee in 20 patients (22 knees) 12 months after total knee arthroplasty (TKA), by using three-dimensional radiostereometry and film-exchanger techniques. Eleven knees had a concave (constrained) tibial implant and 11 a posterior-stabilised prosthesis. Eleven normal knees served as a control group. In the posterior-stabilised knees there was less proximal and posterior displacement of the centre of the tibial plateau during extension from 45° to 15°, with a decrease in the anterior translation of the femoral condyles of 4 mm at 45°. There was less internal tibial rotation and increased distal positioning of the centre of the tibial plateau with both designs when compared with the normal knees, and in both the centre of the plateau was displaced posteriorly by more than 1 cm. Increased AP translation has been recorded in all prosthetic designs so far studied by radiostereometry. The use of a posterior-stabilised design of tibial insert could reduce this translation but not to that of the normal knee

A consecutive series of 235 total knee arthroplasties using the PFC system was followed prospectively for at least ten years in 186 patients. The operation was for osteoarthritis in 150 knees, for rheumatoid arthritis in 83, and for Paget’s disease and femoral osteonecrosis in one knee each. At the latest review 56 patients had died, fi ve were too ill to assess and three could not be traced. The PFC knee replacement utilised was a nonconforming posterior-cruciate-retaining prosthesis with a polyethylene insert which is fl at in the sagittal plane. The patella was resurfaced using a metal-backed component in 170 cases, but later in the series we used an all-polyethylene component in 22 knees; 43 patellae were not resurfaced. The survival without need for reoperation for any reason was 90% at ten years. Nineteen revisions were component-related due to failure of nine metal-backed patellae, nine polyethylene inserts, and one unresurfaced patella; two reoperations were for synovectomy (one for recurrent haemarthrosis and one for recurrent rheumatoid synovitis) and three were for metastatic joint infection. There were no revisions for aseptic loosening of femoral or tibial components, or the all-polyethylene patellar replacement. The PFC system provides good and predictable results in tricompartmental arthritis of the knee. Loosening appeared to be negligible, but there were wear-related problems in 8%. The change from a metal-backed patella and an increase in the contact area of the tibial insert should provide further improvement by minimising wear

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To describe the risk of periprosthetic joint infection (PJI) and reoperation in patients who have an acute, traumatic wound dehiscence following total knee arthroplasty (TKA).

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Surgeons commonly resect additional distal femur during primary total knee arthroplasty (TKA) to correct a flexion contracture, which leads to femoral joint line elevation. There is a paucity of data describing the effect of joint line elevation on mid-flexion stability and knee kinematics. Thus, the goal of this study was to quantify the effect of joint line elevation on mid-flexion laxity.

We investigated the characteristics of patients who achieved Japanese-style deep flexion (seiza-sitting) after total knee replacement (TKR) and measured three-dimensional positioning and the contact positions of the femoral and tibial components. Seiza-sitting was achieved after surgery by 23 patients (29 knees) of a series of 463 TKRs in 341 patients. Pre-operatively most of these patients were capable of seiza-sitting, had a lower body mass index and a favourable attitude towards the Japanese lifestyle (27 of 29 knees). According to two-/three-dimensional image registration analysis in the seiza-sitting position, flexion, varus and internal rotation angles of the tibial component relative to the femoral component had means of 148° (. sd. 8.0), 1.9° (. sd. 3.2) and 13.4° (. sd. 5.9), respectively. Femoral surface contact positions tended to be close to the posterior edge of the tibial polyethylene insert, particularly in the lateral compartment, but only 8.3% (two of 24) of knees showed femoral subluxation over the posterior edge. The mean contact positions of the femoral cam on the tibial post were located 7.8 mm (. sd. 1.5) proximal to the lowest point of the polyethylene surface and 5.5 mm (. sd. 0.9) medial to the centre of the post, indicating that the post-cam contact position translated medially during seiza-sitting, but not proximally. Collectively, the seiza-sitting position seems safe against component dislocation, but the risks of posterior edge loading and breakage of the tibial polyethylene post remain. Cite this article: Bone Joint J 2013;95-B:782–7