Introduction. Total knee arthroplasty (TKA) designs evolve as evidence accumulates on natural and prosthetic knee function. TKA designs based upon a medially conforming tibiofemoral articulation seek to reproduce essential aspects of normal knee stability and have enjoyed good clinical success and high patient satisfaction for over two decades. Fluoroscopic kinematic studies on several medially conforming knee designs show extremely stable knee function, but very small ranges of tibial axial rotation compared to healthy knees. The GMK Sphere TKA is a recent evolution in medially-conforming TKA designs that adopts a sagittally unconstrained lateral tibiofemoral articulation to allow more natural tibial rotation. This study was conducted to quantify motions in knees with this prosthesis to address two questions:. Does the medially conforming GMK Sphere design provide an AP-stable articulation that provides for tibiofemoral translations that are comparable to, but not larger than, translations measured in natural knees?. Does the medially conforming GMK Sphere design provide sufficient rotatory laxity to allow tibiofemoral rotations comparable to, but not larger than, rotations measured in natural knees?. Materials and Methods. Fifteen patients (9 females), mean age 65 years and mean BMI of 30 ±3, consented to participate. Sixteen knees received the GMK Sphere TKA. Mean Oxford Knee Score (OKS) improved significantly from 19±7 to 40±3 six months post surgery (P< 0.0001). On the day of the study, the mean OKS, Knee Society Score, EQ5D and Heath status scores were 40, 87, 0.83 and 85 respectively. Mean ROM from active maximum extension till maximum supine flexion was 108°±8°. Motions in 16 knees were observed using pulsed-fluoroscopy during a range of activities. Subjects were observed in maximum flexion kneeling and lunging positions, and in stepping up/down on a 22cm step. Model-image registration methods were used to quantify three-dimensional knee motions from digitized fluoroscopic images. Results. Tibial internal rotation averaged 8° during lunge and kneeling activities. During lunging, the medial and lateral condyles were an average of 2mm and 8mm posterior to the tibial sulcus, respectively, and 2mm and 9mm posterior to the tibial sulcus during kneeling. During the stair-stepping activity, the medial condyle did not translate significantly, while the lateral condyle moved 5mm posteriorly with flexion, accompanying 5° tibial internal rotation. Discussion. The GMK Sphere TKA was designed to provide intrinsic stability through a medially conforming articulation, and provide for more natural tibial rotation with an unconstrained lateral articulation. Fluoroscopic observation of these knees during lunge, kneel and stair-stepping activities showed a stable medial articulation with little translation, and a lateral articulation translating in direct relation to tibial rotation. Tibial rotation during kneeling (8° average) was approximately twice that observed in knees with an earlier medially conforming TKA design (Moonot et al., Knee Surg Sports Traumatol Arthrosc, 2009) and similar to that observed in natural knees with medial osteoarthritis (Hamai et al., J Orthop Res, 2009). At only six months follow-up, knees with the GMK Sphere arthroplasty show functional kinematics that are AP stable and have more natural tibial rotation, consistent with the implant design intent

Introduction. Despite consequent advancement in Total Knee Arthroplasty (TKA) up to 20% of patients are not satisfied after having been operated. Beside correct implantation, the design of the TKA-system is supposed to be a key factor of a successful TKA. Consequently it has been tried to restore natural kinematics by the design of the prosthesis. A medially stabilized design therefore is supposed to allow a lateral translation with a medial pivot. Objectives. Our study compared posterior stabilized (PS) with medially stabilized (MS) TKA-design in terms of kinematics, femorotibial and patellofemoral contact patterns in vitro. Methods. Twelve fresh frozen human knee specimen (8 male, 4 female, Ø 63.9 y) were tested in a knee rig under natural condition and after TKA with the two different types of TKA systems (GMK PS; GMK MS Sphere; Medacta International, Switzerland). The knee rig simulated a loaded squat from approximately 20°−120° of flexion with a ground reaction force of 50 N. An ultrasound 3D-motion analysis system (Zebris, CMS 10, Germany) measured complete knee kinematics and pressure sensitive foils (Tekscan Inc. US) analysed the femorotibial and patellofemoral contact patterns. By having the same bone cuts for the PS and MS knee system the direct comparison within every single knee specimen could be performed. For stastics mixed effects models were applied by utilizing random intercept per specimen to compare PS and MS during the whole squat. P < 0.05 represented statistical differences. Results. Femorotibial kinematics of MS design showed a significant reduction of medial femorotibial translation compared to PS design. At 120° of flexion the PS design displayed a mean posterior translation of the femur related to the tibia of 15.62 mm, while the MS design translated medially only an average of 3.45 mm in the same direction. In the lateral compartment both designs showed a posterior translation of the femur in relation to the tibia. At 120° of flexion the femur of the PS design translated 19.00 mm posteriorly compared to the MS design with 14.73 mm (p<0.01). In the medial femorotibial compartment of MS design we observed an enlarged contact area (+175.6 mm2) and lower peak pressure (−1.83 MPa), in contrast in the lateral compartment there was a reduced contact area (−19.68mm2) and increased peak pressure (+0.63 MPa) compared to PS design (p<0.01). The retropatellar peak pressure increased significantly after TKA. The contact area at 120° flexion showed no difference between GMK Sphere and the natural knees. The PS had a lower contact area. Retropatellar mean pressure increased for the PS compared to MS and natural knee. There was no significant difference of the retropatellar peak pressure between MS and PS. Conclusion. Neither of the two designs seems to replicate completely the physiological movement of the knee. However, the MS TKA system provided a lateral translation with a medial stable compartment, which is supposed to provide a-p stability and restore the physiological knee kinematics in the active arc of flexion. In terms of retropatellar contact patterns MS restored natural conditions better than PS

Introduction. The alternative kinematic alignment (KA) technique for total knee arthroplasty (TKA) aims at restoring the native joint line orientation and laxity of the knee. The goal is to generate a more physiological prosthetic knee enabling higher functional performance and satisfaction for the patient. KA TKA have only been reported so far with cruciate retaining and posterior-stabilised designs. Similarly, medial pivot design for TKA has been recently developed to enable more natural knee kinematics and antero-posterior stability. The superiority of KA technique and medial pivot implant design is still controversial when compared to current practice. Our study aims to assess the value of KA TKA when performed with medial pivot implants. Methods. We conducted a retrospectively matched case-control study. Clinical data was prospectively collected on patients as part of an ongoing ODEP study. Thirty-three non-selected consecutive KA TKAs performed by the lead author were matched to a control group of 33 measured resection with mechanically aligned (MA) TKAs performed by other consultant surgeons. Patients were matched for sex, age, BMI and pre-operative Oxford Knee Score (OKS). Pre-operative median OKS was 21 points (max 48), mean age was 69, mean BMI 31, and there were 21 female patients in both arms. The medial pivot GMK Sphere implant (Medacta, Switzerland) was used in all cases. OKS and EQ-5D scores were measured pre-operatively and at 1-year post-op. Patient outcome satisfaction scores were assessed at 1-year follow-up using a visual analogic scale (VAS). Pre- and post-operative knee radiographs were analysed using TraumaCad software. Results. No reoperation or revision was recorded in either group. KA patients were found to have higher OKS (median 44 Vs 42, p=0.78), satisfaction (median 99/100 Vs 90/100, p=0.28), and EQ-5D improvement (mean 0.34 Vs 0.28, p=0.21) compared to MA patients; however, none of the differences discovered were statistically significant. In addition, KA patients had a femoral component that was on average, 3.5° more valgus orientated (aLDFA 84° Vs 80°, p<0.05) and 2.1° more flexed (4.4° Vs 2.3°, p=NS), and a tibial component with 3.6° (aMPTA 86° Vs 89.6°, p<0.05) and 3.9° (5.5° Vs 1.6°, p<0.05) increased varus orientation and posterior slope, respectively. Conclusion/Discussion. KA TKA performed with medial pivot implant design has shown good safety and efficacy at early-term. The physiological implantation provided by the KA technique seems to be clinically beneficial compared to MA implantation, although, the measured differences did not show statistical significance. Having a low study power and high ceiling effect of outcome measure tools may partly explain our results. Early results for KA TKA are encouraging and longer follow-up is warranted to assess longevity of results. For any figures or tables, please contact authors directly

Background. In the late 1980's Michael Freeman conceived the idea that knee replacement would most closely replicate the natural knee joint, if the medial Tibio-Femoral articulation was configured as a “ball-in-socket”. Over the last three decades, medial rotation and medial pivot designs have proved successful in clinical use. Freeman's final iteration of the medial ball-in-socket concept was the Medial Sphere knee. We report the three-year survivorship, clinical outcomes, patient reported outcome measures (PROMs) and radiographic analysis of this implant in a multi-centre, multi-surgeon, prospective observational study. Methods. Patients awaiting total knee replacement were recruited by four centres. They had no medical contraindication to surgery, were able to provide informed consent and were available for follow-up. Primary outcome was implant survival at six months, one, two, three and five years. Secondary outcomes were patient reported outcome measures: Oxford Knee Score (OKS), Euroqol (EQ-5D), International Knee Society Score (IKSS), IKSS Functional score and Health State score, complications and radiographic outcomes. Radiographic analysis was undertaken using the TraumaCad software and data analysis was undertaken using SPSS. Results. To date, 328 female and 202 male patients with a mean age 66.9 years and mean body mass index 30.0 were recruited. Three year Kaplan-Meier survivorship analysis of cumulative failure showed an implant survival of 99.46% (95% confidence interval 100 – 96.74), when deaths and withdrawals were treated as censored data. Twelve patients withdrew (2.26%), seven died (1.32%) and two knees were revised (0.38%). The mean EQ5D, Health State Scores, OKS, IKSS & IKSS Function scores at three years improved significantly from pre- operative scores (Health State Score: 9.91 (65.59 pre-op to 75.50); OKS: 18.82 (19.90 pre-op to 38.72); IKSS: 39.87 (44.39 pre-op to 92.09); IKSS Function Score: 35.03 (49.42 pre-op to 84.45). The mean improvement of EQ5D at three years was: 0.34 (0.48 pre-op to 0.82). Discussion. Survival of the GMK Sphere to three years in this study was over 99%. Risk of revision compares favourably with UK National Joint Registry (NJR) data. The improvements that are seen in patient reported outcome measures reflect an enhancement in patient function and quality of life. Conclusion. At three years follow-up, the implant demonstrates satisfactory survival and outcomes. Patient matching and evaluation of more cases, at more time points will allow outcome comparison with other implant options

Introduction. There is current debate concerning the most biomechanically advantageous knee implant systems, and there is also currently great interest in improving patient satisfaction after knee arthroplasty. Additionally, there is no consensus whether a posterior-stabilized (PS) total knee device is superior to a more congruent, cruciate-substituting, medially-stabilized device (MS). This study compared the clinical outcomes of two such devices. The primary hypothesis was that the clinical outcomes, and specifically the patient satisfaction as measured by the Forgotten Joint Score, would be better in the MS group. Methods. This prospective, randomized, blinded Level 1 study compared the outcomes of 100 patients who received a Medacta GMK PS device and 101 patients who received a Medacta GMK medially-stabilized Sphere device (Medacta Intl., Lugano, Switzerland). All patients undergoing elective primary total knee arthroplasty were eligible for participation. Institutional Review Board approval and informed consent from participants were obtained. The devices were implanted using an anatomic alignment/calipered- measured resection surgical approach. Clinical and radiographic assessments were performed preoperatively, 6 weeks, 6 months, and annually. Data were compared using T-test with a significance level of 0.05. Results. The minimum follow-up period is 2 years. There were no statistically significant differences in demographic characteristics and preoperative scores; tourniquet time was 7.24% longer for the PS group (40.28 min vs 37.56 min, P < .0086). Alignment was not different between the groups (preoperative or postoperative). There were significant differences between groups for the 1 year and 2 years postop Knee Society scores, Forgotten Joint Score, and ROM; in every case where there was a statistically significant difference, the results were better in the MS group. For example, the FJS was 65.72 in the MS group at 2 years, 54.33 in the PS group (p=0.02). The maximum active flexion at 2 years was 129.75º in the MS group, in the PS group it was 122.27º (p=0.03). Conclusion. The clinical outcomes of the MS group at 1 and 2 years, including the Forgotten Joint Score and flexion, were better statistically, and there was a statistically longer tourniquet time for the PS group. At the minimum 2-year follow-up, the results demonstrate superiority of the medially-stabilized device in terms of multiple clinical outcomes, including patient satisfaction as measured by the Forgotten Joint Score. These findings support the use of a medially-stabilized knee implant system, and support the conclusion that this design, in conjunction with an anatomic alignment, calipered-measured resection surgical technique, offers improved biomechanics and kinematics