Validation of Inertial-Measurement-Unit-Based Ex Vivo Knee Kinematics during a Loaded Squat before and after Reference-Frame-Orientation Optimisation.

Recently, inertial measurement units have been gaining popularity as a potential alternative to optical motion capture systems in the analysis of joint kinematics. In a previous study, the accuracy of knee joint angles calculated from inertial data and an extended Kalman filter and smoother algorithm was tested using ground truth data originating from a joint simulator guided by fluoroscopy-based signals. Although high levels of accuracy were achieved, the experimental setup leveraged multiple iterations of the same movement pattern and an absence of soft tissue artefacts. Here, the algorithm is tested against an optical marker-based system in a more challenging setting, with single iterations of a loaded squat cycle simulated on seven cadaveric specimens on a force-controlled knee rig. Prior to the optimisation of local coordinate systems using the REference FRame Alignment MEthod (REFRAME) to account for the effect of differences in local reference frame orientation, root-mean-square errors between the kinematic signals of the inertial and optical systems were as high as 3.8° ± 3.5° for flexion/extension, 20.4° ± 10.0° for abduction/adduction and 8.6° ± 5.7° for external/internal rotation. After REFRAME implementation, however, average root-mean-square errors decreased to 0.9° ± 0.4° and to 1.5° ± 0.7° for abduction/adduction and for external/internal rotation, respectively, with a slight increase to 4.2° ± 3.6° for flexion/extension. While these results demonstrate promising potential in the approach's ability to estimate knee joint angles during a single loaded squat cycle, they highlight the limiting effects that a reduced number of iterations and the lack of a reliable consistent reference pose inflicts on the sensor fusion algorithm's performance. They similarly stress the importance of adapting underlying assumptions and correctly tuning filter parameters to ensure satisfactory performance. More importantly, our findings emphasise the notable impact that properly aligning reference-frame orientations before comparing joint kinematics can have on results and the conclusions derived from them.

Endurance Behavior of Cemented Tibial Tray Fixation Under Anterior Shear and Internal-External Torsional Shear Testing: A New Methodological Approach.

BACKGROUND: Early total knee arthroplasty failures continue to surface in the literature. Cementation technique and implant design are two of the most important scenarios that can affect implant survivorship. Our objectives were to develop a more suitable preclinical test to evaluate the endurance of the implant-cement-bone interface under anterior shear and internal-external (I/E) torsional shear testing condition in a biomechanical sawbones. METHODS: Implants tested included the AS VEGA System PS and the AS Columbus CR/PS (Aesculap AG, Germany), with zirconium nitride (ZrN) coating. Tibial implants were evaluated under anterior shear and I/E torsional shear conditions with 6 samples in 4 test groups. For the evaluation of the I/E torsional shear endurance behavior, a test setup was created allowing for clinically relevant I/E rotation with simultaneous high axial/tibio-femoral load. The test was performed with an I/E displacement of ±17.2°, for 1 million cycles with an axial preload of 3,000 N. RESULTS: After the anterior shear test an implant-cement-bone fixation strength for the AS VEGA System tibial tray of 2,674 ± 754 N and for the AS Columbus CR/PS tibial tray of 2,177 ± 429 N was determined (P = .191). After I/E rotational shear testing an implant-cement-bone fixation strength for the AS VEGA System PS tray of 2,561 ± 519 N and for the AS Columbus CR/PS tray of 2,824 ± 515 N was resulted (P = .39). CONCLUSION: Both methods had varying degrees of failure modes from debonding to failure of the sawbones foam. These two intense biomechanical loading tests are more strenuous and more representative of clinical activity.

A Framework for Analytical Validation of Inertial-Sensor-Based Knee Kinematics Using a Six-Degrees-of-Freedom Joint Simulator.

The success of kinematic analysis that relies on inertial measurement units (IMUs) heavily depends on the performance of the underlying algorithms. Quantifying the level of uncertainty associated with the models and approximations implemented within these algorithms, without the complication of soft-tissue artefact, is therefore critical. To this end, this study aimed to assess the rotational errors associated with controlled movements. Here, data of six total knee arthroplasty patients from a previously published fluoroscopy study were used to simulate realistic kinematics of daily activities using IMUs mounted to a six-degrees-of-freedom joint simulator. A model-based method involving extended Kalman filtering to derive rotational kinematics from inertial measurements was tested and compared against the ground truth simulator values. The algorithm demonstrated excellent accuracy (root-mean-square error ≤0.9°, maximum absolute error ≤3.2°) in estimating three-dimensional rotational knee kinematics during level walking. Although maximum absolute errors linked to stair descent and sit-to-stand-to-sit rose to 5.2° and 10.8°, respectively, root-mean-square errors peaked at 1.9° and 7.5°. This study hereby describes an accurate framework for evaluating the suitability of the underlying kinematic models and assumptions of an IMU-based motion analysis system, facilitating the future validation of analogous tools.

Impact of femoro-tibial size combinations and TKA design on kinematics.

INTRODUCTION: The variability in patients' femoral and tibial anatomy requires to use different tibia component sizes with the same femoral component size. These size combinations are allowed by manufacturers, but the clinical impact remains unclear. Therefore, the goals of our study were to investigate whether combining different sizes has an impact on the kinematics for two well-established knee systems and to compare these systems' kinematics to the native kinematics. MATERIALS AND METHODS: Six fresh frozen knee specimens were tested in a force controlled knee rig before and after implantation of a cruciate retaining (CR) and a posterior-stabilized (PS) implant. Femoro-tibial kinematics were recorded using a ultrasonic-based motion analysis system while performing a loaded squat from 30° to 130°. In each knee, the original best fit inlay was then replaced by different inlays simulating a smaller or bigger tibia component. The kinematics obtained with the simulated sizes were compared to the original inlay kinematics using descriptive statistics. RESULTS: For all size combinations, the difference to the original kinematics reached an average of 1.3 ± 3.3 mm in translation and - 0.1 ± 1.2° in rotation with the CR implant. With the PS implant, the average differences reached 0.4 ± 2.7 mm and  - 0.2 ± 0.8°. Among all knees, no size combination consistently resulted in significantly different kinematics. Each knee showed a singular kinematic pattern. For both knee systems, the rotation was smaller than in the native knee, but the direction of the rotation was preserved. The PS showed more rollback and the CR less rollback than the native knee. CONCLUSION: TKA systems designed with a constant tibio-femoral congruency among size combinations should enable to combine different sizes without having substantial impact on the kinematics. The rotational pattern was preserved by both TKA systems, while the rollback could only be maintained by the PS design.

Ceramic Coating in Cemented Primary Total Knee Arthroplasty is Not Associated With Decreased Risk of Revision due to Early Prosthetic Joint Infection.

BACKGROUND: Prosthetic joint infection (PJI) is one of the most frequent and devastating causes of short-term revision total knee arthroplasty (TKA). In vitro evidence suggests ceramic surfaces demonstrate resistance to biofilm, but the clinical effect of bearing surface modifications on the risk of PJI remains unclear. This premier registry-based study examines the influence of ceramic bearing surface coatings on the outcome in cemented primary TKA. METHODS: In total, 117,660 cemented primary TKAs in patients with primary osteoarthritis recorded in the German arthroplasty registry since 2012 were followed up for a maximum of 3 years. The primary endpoint was risk of revision for PJI on ceramic coated and uncoated cobalt-chromium-molybdenum femoral components. Propensity score matching for age, gender, obesity, diabetes mellitus, depression and Elixhauser comorbidity index, and substratification on common design twins with and without coating was performed. RESULTS: In total, 4637 TKAs (85.1% female) with a ceramic-coated femoral component were identified, 42 had been revised for PJI and 122 for other reasons at 3 years. No survival advantage due to the risk of revision for PJI could be determined for ceramic-coated components. Revision for all other reasons demonstrated a significant higher rate for TKAs with ceramic-coated components. However, the results of this were confounded by a strong prevalence (20.7% vs 0.3%) of metal sensitivity in the ceramic-coated group. CONCLUSION: No evidence of reduced risk for PJI due to ceramic-coated implants in cemented primary TKA was found. Further analysis for revision reasons other than PJI is required.

Tibial Implant Fixation Behavior in Total Knee Arthroplasty: A Study With Five Different Bone Cements.

BACKGROUND: The objectives of this study are to (1) evaluate if there is a potential difference in cemented implant fixation strength between tibial components made out of cobalt-chromium (CrCoMo) and of a ceramic zirconium nitride (ZrN) multilayer coating and to (2) test their behavior with 5 different bone cements in a standardized in vitro model for testing of the implant-cement-bone interface conditions. We also analyzed (3) whether initial fixation strength is a function of timing of the cement apposition and component implantation by an early, mid-term, and late usage within the cement-specific processing window. METHODS: An in vitro study using a synthetic polyurethane foam model was performed to investigate the implant fixation strength after cementation of tibial components by a push-out test. A total of 20 groups (n = 5 each) was used: Vega PS CrCoMo tibia and Vega PS ZrN tibia with the bone cements BonOs R, SmartSet HV, Cobalt HV, Palacos R, and Surgical Simplex P, respectively, using mid-term cement apposition. Three different cement apposition times-early, mid-term, and late usage-were tested with a total of 12 groups (n = 5 each) with the bone cements BonOs R and SmartSet HV. RESULTS: There was no significant difference in implant-cement-bone fixation strength between CrCoMo and ZrN multilayer-coated Vega tibial trays tested with 5 different commonly used bone cements. CONCLUSION: Apposition of bone cements and tibial tray implantation in the early to mid of the cement-specific processing window is beneficial in regard to interface fixation in TKA.

Vitamin E-blended highly cross-linked polyethylene liners in total hip arthroplasty: a randomized, multicenter trial using virtual CAD-based wear analysis at 5-year follow-up.

BACKGROUND: Progressive oxidation of highly cross-linked ultra-high molecular weight (UHMPWE-X) liners is considered to be a risk factor for material failure in THA. Antioxidants such as vitamin E (alpha-tocopherol) (UHMWPE-XE) were supplemented into the latest generation of polyethylene liners. To prevent inhomogenous vitamin E distribution within the polymer, blending was established as an alternative manufacturing process to diffusion. The purpose of the present study was to investigate the in vivo wear behavior of UHMWPE-XE in comparison with conventional UHMWPE-X liners using virtual CAD-based radiographs. METHODS: Until now, 94 patients from a prospective, randomized, controlled, multicenter study were reviewed at 5-year follow-up. Of these, 51 (54%) received UHMWPE-XE and 43 (46%) UHMWPE-X liners. Anteroposterior pelvic radiographs were made immediately after surgery and at 1 and 5 years postoperatively. The radiographs were analyzed using the observer-independent analysis software RayMatch® (Raylytic GmbH, Leipzig, Germany). RESULTS: The mean wear rate was measured to be 23.6 µm/year (SD 13.7; range 0.7-71.8 µm). There were no significant differences between the two cohorts (UHMWPE-X: 23.2 µm/year vs. UHMWPE-XE: 24.0 µm/year, p = 0.73). Cup anteversion significantly changed within the 1st year after implantation independent from the type of polyethylene liner [UHMWPE-X: 18.2-23.9° (p = 0.0001); UHMWPE-XE: 21.0-25.5° (p = 0.002)]. No further significant changes of cup anteversion in both groups were found between year 1 and 5 after implantation [UHMWPE-X (p = 0.46); UHMWPE-XE (p = 0.56)]. CONCLUSION: The present study demonstrates that the addition of vitamin E does not adversely affect the midterm wear behavior of UHMWPE-X. The antioxidative benefit of vitamin E is expected to become evident in long-term follow-up. Cup anteversion increment by 5° within the 1st year is likely a result of the released hip flexion contracture resulting in an enhanced posterior pelvic tilt. Therefore, a reassessment of target values in acetabular cup placement might be considered.

Impact of a double-layer cementing technique on the homogeneity of cementation and the generation of loose bone cement fragments in tibial unicompartmental knee arthroplasty.

BACKGROUND: The objective of this study was to evaluate the impact of a single- vs. double-layer cementing technique on morphological cementation and the generation of microscopic cement layers or loose cement fragments in unicompartmental knee arthroplasty (UKA). METHODS: UKAs were implanted in 12 cadaver knees. The specimens were divided into two groups of comparable bone mineral density. Six UKAs were implanted using a single-layer cementing technique (group A) and six UKAs were implanted using a double-layer cementing technique (group B). Morphological cementation was assessed on nine cuts through the implant-cement-bone interface in the frontal plane. Loose bone cement fragments and the microscopically quality of layer formation were evaluated. RESULTS: Contact between bone and prosthesis was observed in 45.4% of interfaces in group A and 27.8% in group B (p = 0.126). The significant increase of areas without visible cement interlocking in the anteroposterior direction in group A (p = 0.005) was not evident in group B (p = 0.262). Penetration around the peg tended to occur more frequently in group B (67.5% vs. 90.6% p = 0.091). Scanning electron microscopy identified no evidence of fissure formations within the bilaminar cement mantle. Free bone cement fragments were documented in 66.7% in both groups with no difference concerning mass (p = 1.0). CONCLUSIONS: This in-vitro study showed a tendency towards a more homogenous cementation of tibial UKAs using a double-layer cementing technique, although most of the differences did not reach the level of significance. However, theoretical downsides of the double-layer cementing technique such as an increased formation of free bone fragments or a microscopically fissure formation within the cement layer could not be detected either.

Evaluation of impingement behaviour in lumbar spinal disc arthroplasty.

INTRODUCTION: The objective of our in vitro study was to introduce a test method to evaluate impingement in lumbar spinal disc arthroplasty in terms of wear, contact pattern, metal ion concentration and particle release. MATERIAL AND METHOD: Impingement wear simulation was performed on a 6-station spinal wear simulator (Endolab, Germany) on a lumbar spinal disc system (activ L Aesculap AG, Germany) using four different protocols specific to impingement in flexion, in extension, in lateral bending and in combined flexion bending. Impingement contact stress is intentionally created by applying an angular displacement of +2° in addition to the intended range of motion in the impingement direction, whereas a bending moment of 8 Nm remains constant during the impingement phase (plateau). RESULTS: An average volumetric wear rate of 0.67 mm(3)/million cycles was measured by impingement under flexion, of 0.21 mm(3)/million cycles under extension, of 0.06 mm(3)/million cycles under lateral bending and of 1.44 mm(3)/million cycles under combined flexion bending. The particle size distribution of the cobalt-chromium wear particles released by impingement in flexion (anterior), extension (posterior), lateral bending (lateral) and combined flexion bending (antero-lateral) revealed that most of the detected cobalt-chromium particles were in a size range between 0.2 and 2 µm. CONCLUSION: The impingement wear simulation introduced here proved to be suitable to predict in vivo impingement behaviour in regard to contact pattern seen on retrieved devices of the activ L lumbar disc arthroplasty design in a pre-clinical test.

A New Methodology for the Accurate Measurement of Tibiofemoral Kinematics in Human Cadaveric Knees: An Evaluation of the Anterior-Posterior Laxity Pre- and Post-Cruciate Ligament Resection.

Anterior-posterior (AP) stability is an important measure of knee performance after total knee arthroplasty (TKA). To improve the stabilizing effect of implants designed to compensate for the loss of the cruciate ligaments, it is important to understand the tibiofemoral contact situation within the native ligamentous situation of the knee and how it changes after cruciate ligament resection. This in vitro study introduces a new approach to accurately measure the tibiofemoral kinematics in a six-degrees-of-freedom joint motion simulator by tracking landmark-based coordinate systems and their corresponding bone geometries. The tibiofemoral contact situation was investigated by projecting the medial and lateral flexion facet centers onto the tibial plateau under AP shear forces across various flexion angles in thirteen knees. Tests were conducted pre- and post-cruciate ligament resection. Post-cruciate ligament resection, the femoral condyles shifted closer to or even exceeded the posterior border of the tibial plateau, but only slightly closer to the anterior border. This study presents a new methodology for measuring the tibiofemoral kinematics that can be applied to multiple loading profiles. It provides a basis for further investigations, including passive or active muscle forces, to enhance the design of total knee protheses and improve surgical outcomes.

Strains on the human femur after revision total knee arthroplasty: An in vitro study using digital image correlation.

Pain at the tip of the stem of a knee prosthesis (End-of-Stem Pain) is a common problem in revision total knee arthroplasty (TKA). It may be caused by a problematic interaction between stem and bone, but the exact biomechanical correlate is still unknown. On top of this, there is no biomechanical study investigating End-of-Stem Pain at the distal femur using human specimens. Aim of this study was to find out whether the implantation of a revision total knee implant leads to high femoral surface strains at the tip of the stem, which the authors expect to be the biomechanical correlate of End-of-Stem Pain. We implanted 16 rotating hinge knee implants into 16 fresh-frozen human femora using the hybrid fixation technique and comparing two reaming protocols. Afterwards, surface strains on these femora were measured under dynamic load in two different load scenarios (climbing stairs and chair rising) using digital image correlation (DIC) and fracture patterns after overcritical load were analysed. Peak surface strains were found at the tip of the stem in several measurements in both load scenarios. There were no significant differences between the two compared groups (different trial sizes) regarding surface strains and fracture patterns. We conclude that implantation of a long intramedullary stem in revision TKA can lead to high surface strains at the tip of the stem that may be the correlate of femoral End-of-Stem Pain. This finding might allow for a targeted development of future stem designs that can lead to lower surface strains and therefore might reduce End-of-Stem Pain. Digital Image Correlation proved valid for the measurement of surface strains and can be used in the future to test new stem designs in vitro.

Posterior tibial slope influences joint mechanics and soft tissue loading after total knee arthroplasty.

As a solution to restore knee function and reduce pain, the demand for Total Knee Arthroplasty (TKA) has dramatically increased in recent decades. The high rates of dissatisfaction and revision makes it crucially important to understand the relationships between surgical factors and post-surgery knee performance. Tibial implant alignment in the sagittal plane (i.e., posterior tibia slope, PTS) is thought to play a key role in quadriceps muscle forces and contact conditions of the joint, but the underlying mechanisms and potential consequences are poorly understood. To address this biomechanical challenge, we developed a subject-specific musculoskeletal model based on the bone anatomy and precise implantation data provided within the CAMS-Knee datasets. Using the novel COMAK algorithm that concurrently optimizes joint kinematics, together with contact mechanics, and muscle and ligament forces, enabled highly accurate estimations of the knee joint biomechanics (RMSE <0.16 BW of joint contact force) throughout level walking and squatting. Once confirmed for accuracy, this baseline modelling framework was then used to systematically explore the influence of PTS on knee joint biomechanics. Our results indicate that PTS can greatly influence tibio-femoral translations (mainly in the anterior-posterior direction), while also suggesting an elevated risk of patellar mal-tracking and instability. Importantly, however, an increased PTS was found to reduce the maximum tibio-femoral contact force and improve efficiency of the quadriceps muscles, while also reducing the patellofemoral contact force (by approximately 1.5% for each additional degree of PTS during walking). This study presents valuable findings regarding the impact of PTS variations on the biomechanics of the TKA joint and thereby provides potential guidance for surgically optimizing implant alignment in the sagittal plane, tailored to the implant design and the individual deficits of each patient.

The influence of third-body particles on wear rate in unicondylar knee arthroplasty: a wear simulator study with bone and cement debris.

The reduced intraoperative visibility of minimally invasive implanted unicondylar knee arthroplasty makes it difficult to remove bone and cement debris, which have been reported on the surface of damaged and retrieved bearings. Therefore, the aim of this study was to analyze the influence of bone and cement particles on the wear rate of unicompartmental knee prostheses in vitro. Fixed bearing unicompartmental knee prostheses were tested using a knee-wear-simulator according to the ISO standard 14243-1:2002(E) for 5.0 million cycles. Afterwards bone debris (particle size 671 ± 262 µm) were added to the test fluid in a concentration of 5 g/l for 1.5 million cycles, followed by 1.5 million cycles blended with cement debris (particle size 644 ± 186 µm) in the same concentration. Wear rate, knee-kinematics and wear-pattern were analyzed. The wear rate reached 12.5 ± 1.0 mm³/million cycles in the running-in and decreased during the steady state phase to 4.4 ± 0.91 mm³/million cycles. Bone particles resulted in a wear rate of 3.0 ± 1.27 mm³/million cycles with no influence on the wear rate compared to the steady state phase. Cement particles, however, lead to a significantly higher wear rate (25.0 ± 16.93 mm³/million cycles) compared to the steady state phase. The careful removal of extruded cement debris during implantation may help in reducing wear rate. Bone debris are suggested to have less critical influence on the prostheses wear rate.

Computer-based analysis of different component positions and insert thicknesses on tibio-femoral and patello-femoral joint dynamics after cruciate-retaining total knee replacement.

BACKGROUND: Positioning of the implant components and tibial insert thickness constitute critical aspects of total knee replacement (TKR) that influence the postoperative knee joint dynamics. This study aimed to investigate the impact of implant component positioning (anterior-posterior and medio-lateral shift) and varying tibial insert thickness on the tibio-femoral (TF) and patello-femoral (PF) joint kinematics and contact forces after cruciate-retaining (CR)-TKR. METHOD: A validated musculoskeletal multibody simulation (MMBS) model with a fixed-bearing CR-TKR during a squat motion up to 90° knee flexion was deployed to calculate PF and TF joint dynamics for varied implant component positions and tibial insert thicknesses. Evaluation was performed consecutively by comparing the respective knee joint parameters (e.g. contact force, quadriceps muscle force, joint kinematics) to a reference implant position. RESULTS: The PF contact forces were mostly affected by the anterior-posterior as well as medio-lateral positioning of the femoral component (by 3 mm anterior up to 31 % and by 6 mm lateral up to 14 %). TF contact forces were considerably altered by tibial insert thickness (24 % in case of + 4 mm increase) and by the anterior-posterior position of the femoral component (by 3 mm posterior up to 16 %). Concerning PF kinematics, a medialised femoral component by 6 mm increased the lateral patellar tilt by more than 5°. CONCLUSIONS: Our results indicate that regarding PF kinematics and contact forces the positioning of the femoral component was more critical than the tibial component. The positioning of the femoral component in anterior-posterior direction on and PF contact force was evident. Orthopaedic surgeons should strictly monitor the anterior-posterior as well as the medio-lateral position of the femoral component and the insert thickness.

A frame orientation optimisation method for consistent interpretation of kinematic signals.

In clinical movement biomechanics, kinematic data are often depicted as waveforms (i.e. signals), characterising the motion of articulating joints. Clinically meaningful interpretations of the underlying joint kinematics, however, require an objective understanding of whether two different kinematic signals actually represent two different underlying physical movement patterns of the joint or not. Previously, the accuracy of IMU-based knee joint angles was assessed using a six-degrees-of-freedom joint simulator guided by fluoroscopy-based signals. Despite implementation of sensor-to-segment corrections, observed errors were clearly indicative of cross-talk, and thus inconsistent reference frame orientations. Here, we address these limitations by exploring how minimisation of dedicated cost functions can harmonise differences in frame orientations, ultimately facilitating consistent interpretation of articulating joint kinematic signals. In this study, we present and investigate a frame orientation optimisation method (FOOM) that aligns reference frames and corrects for cross-talk errors, hence yielding a consistent interpretation of the underlying movement patterns. By executing optimised rotational sequences, thus producing angular corrections around each axis, we enable a reproducible frame definition and hence an approach for reliable comparison of kinematic data. Using this approach, root-mean-square errors between the previously collected (1) IMU-based data using functional joint axes, and (2) simulated fluoroscopy-based data relying on geometrical axes were almost entirely eliminated from an initial range of 0.7°-5.1° to a mere 0.1°-0.8°. Our results confirm that different local segment frames can yield different kinematic patterns, despite following the same rotation convention, and that appropriate alignment of reference frame orientation can successfully enable consistent kinematic interpretation.

Musculoskeletal Rehabilitation: New Perspectives in Postoperative Care Following Total Knee Arthroplasty Using an External Motion Sensor and a Smartphone Application for Remote Monitoring.

BACKGROUND: The number of total knee replacements performed annually is steadily increasing. Parallel options for postoperative care are decreasing, which reduces patient satisfaction. External devices to support physical rehabilitation and health monitoring will improve patient satisfaction and postoperative care. METHODS: In a prospective, international multicenter study, patients were asked to use an external motion sensor and a smartphone application during the postoperative course of primary total knee arthroplasty. The collected data were transferred to a data platform, allowing for the real-time evaluation of patient data. RESULTS: In three participating centers, 98 patients were included. The general acceptance of using the sensor and app was high, with an overall compliance in study participation rate of up to 76%. The early results showed a significant improvement in the overall quality of life (p < 0.001) and significant reductions in pain (p < 0.01) and depression (p < 0.001). CONCLUSIONS: The early results of this clinical and multicenter study emphasize that there is a high interest in and acceptance of digital solutions in patients' treatment pathways. Motion sensor and smartphone applications support patients in early rehabilitation.

1st EFORT European Consensus "Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices": Background, Delphi Methodology & Consensus process.

The objectives of the 1st EFORT European Consensus on 'Medical and Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices' were foremost to focus on patient safety by establishing performance requirements for medical devices. The 1st EFORT European Consensus applied an a priori-defined, modified Delphi methodology to produce unbiased, high-quality recommendation statements, confirmed by consensus voting of a European expert panel. Intended key outcomes are practical guidelines justified by the current stage of knowledge and based on a broad European Expert Consensus, to maintain innovation and optimisation of orthopaedic devices within the boundaries of MDR 2017/745. Twenty-one main research areas of relevance were defined relying on input from the EFORT IPSI WG1 'Introduction of Innovation' recommendations and a related survey. A modified Delphi approach with a preparatory literature review and work in small groups were used to prepare answers to the research questions in the form of 32 draft Consensus statements. A Consensus Conference in a hybrid format, on-site in the Carl Gustav Carus University of Dresden was organised to further refine the draft statements and define consensus within the complete group of participants by final voting, intended to further quantify expert opinion knowledge. The modified Delphi approach provides practical guidelines for hands-on orientation for orthopaedic surgeons, research institutes and laboratories, orthopaedic device manufacturers, patient representatives, Notified Bodies, National Institutes and authorities. For the first time, initiated by the EFORT IPSI (WG1 'Introduction of Innovation'), knowledge of all related stakeholders was combined in the 1st EFORT European Consensus to develop guidelines and result in a comprehensive set of recommendations.

Introduction of innovations in joint arthroplasty: Recommendations from the 'EFORT implant and patient safety initiative'.

With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process. The EFORT Implant and Patient Safety Initiative WG1 'Introduction of Innovation', combined knowledge of orthopaedic surgeons, research institutes, orthopaedic device manufacturers, patient representatives and regulatory authorities to develop a comprehensive set of recommendations for the introduction of innovations in joint arthroplasty within the boundaries of MDR 2017/745. Recommendations have been developed to address key questions about pre-clinical and clinical requirements for the introduction of new implants and implant-related instrumentation with the participation of a steering group, invited by the EFORT Board in dialogue with representatives from European National Societies and Speciality Societies. Different degrees of novelty and innovation were described and agreed on in relation to when surgeons can start, using implants and implant-related instrumentation routinely. Before any clinical phase of a new implant, following the pre-market clinical investigation or the equivalent device PMCF pathway, it is a common understanding that all appropriate pre-clinical testing (regulatory mandatory and evident state of the art) - which has to be considered for a specific device - has been successfully completed. Once manufacturers receive the CE mark for a medical device, it can be used in patients routinely when a clinical investigation has been conducted to demonstrate the conformity of devices according to MDR Article 62 or full equivalence for the technical, biological and clinical characteristics has been demonstrated (MDR, Annex XIV, Part A, 3.) and a PMCF study has been initiated.

Isolated effects of patellar resurfacing in total knee arthroplasty and their relation to native patellar geometry.

The isolated effects of patellar resurfacing on patellar kinematics are rarely investigated. Nonetheless, knowing more about these effects could help to enhance present understanding of the emergence of kinematic improvements or deteriorations associated with patellar resurfacing. The aim of this study was to isolate the effects of patellar resurfacing from a multi-stage in vitro study, where kinematics after total knee arthroplasty before and after patellar resurfacing were recorded. Additionally, the influence of the native patellar geometry on these effects was analysed. Eight fresh frozen specimens were tested successively with different implant configurations on an already established weight bearing knee rig. The patello-femoral kinematics were thereby measured using an ultrasonic measurement system and its relation to the native patellar geometries was analysed. After patellar resurfacing, the specimen showed a significantly medialized patellar shift. This medialization of the patellar tracking was significantly correlated to the lateral facet angle of the native patella. The patellar shift after patellar resurfacing is highly influenced by the position of the patellar button and the native lateral patellar facet angle. As a result, the ideal medio-lateral position of the patellar component is affected by the geometry of the native patella.