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The use of inertial measurement units (IMUs) as an alternative to optical marker-based systems has the potential to make gait analysis part of the clinical standard of care. Previously, an IMU-based system leveraging Rauch-Tung-Striebel smoothing to estimate knee angles was assessed using a six-degrees-of-freedom joint simulator. In a clinical setting, however, accurately measuring abduction/adduction and external/internal rotation of the knee joint is particularly challenging, especially in the presence of soft tissue artefacts. In this study, the in vivo IMU-based joint angles of 40 asymptomatic knees were assessed during level walking, under two distinct sensor placement configurations: (1) IMUs fixed to a rigid harness, and (2) IMUs mounted on the skin using elastic hook-and-loop bands (from here on referred to as "skin-mounted IMUs"). Estimates were compared against values obtained from a harness-mounted optical marker-based system. The comparison of these three sets of kinematic signals (IMUs on harness, IMUs on skin, and optical markers on harness) was performed before and after implementation of a REference FRame Alignment MEthod (REFRAME) to account for the effects of differences in coordinate system orientations. Prior to the implementation of REFRAME, in comparison to optical estimates, skin-mounted IMU-based angles displayed mean root-mean-square errors (RMSEs) up to 6.5°, while mean RMSEs for angles based on harness-mounted IMUs peaked at 5.1°. After REFRAME implementation, peak mean RMSEs were reduced to 4.1°, and 1.5°, respectively. The negligible differences between harness-mounted IMUs and the optical system after REFRAME revealed that the IMU-based system was capable of capturing the same underlying motion pattern as the optical reference. In contrast, obvious differences between the skin-mounted IMUs and the optical reference indicated that the use of a harness led to fundamentally different joint motion being measured, even after accounting for reference frame misalignments. Fluctuations in the kinematic signals associated with harness use suggested the rigid device oscillated upon heel strike, likely due to inertial effects from its additional mass. Our study proposes that optical systems can be successfully replaced by more cost-effective IMUs with similar accuracy, but further investigation (especially in vivo and upon heel strike) against moving videofluoroscopy is recommended.

Background: Despite advances in total knee arthroplasty, many patients are still unsatisfied with the functional outcome. Multibody simulations enable a more efficient exploration of independent variables compared to experimental studies. However, to what extent numerical models can fully reproduce knee joint kinematics is still unclear. Hence, models must be validated with different test scenarios before being applied to biomechanical questions., Methods: In our feasibility study, we analyzed a human knee specimen on a six degree of freedom joint simulator, applying a passive flexion and different laxity tests with sequential states of ligament resection while recording the joint kinematics. Simultaneously, we generated a subject-specific multibody model of the native tibiofemoral joint considering ligaments and contact between articulating cartilage surfaces., Results: Our experimental data on the sequential states of ligament resection aligned well with the literature. The model-based knee joint kinematics during passive flexion showed good agreement with the experiment, with root-mean-square errors of less than 1.61 mm for translations and 2.1° for knee joint rotations. During laxity tests, the experiment measured up to 8 mm of anteroposterior laxity, while the numerical model allowed less than 3 mm., Conclusion: Although the multibody model showed good agreement to the experimental kinematics during passive flexion, the validation showed that ligament parameters used in this feasibility study are too stiff to replicate experimental laxity tests correctly. Hence, more precise subject-specific ligament parameters have to be identified in the future through model optimization., (© 2024. The Author(s).)

This study aims to evaluate and compare the properties of a biomedical clinically established zirconium nitride (ZrN) multilayer coating prepared using two different techniques: pulsed magnetron sputtering and cathodic arc deposition. The investigation focuses on the crystalline structure, grain size, in-vitro oxidation behaviour and tribological performance of these two coating techniques. Experimental findings demonstrate that the sputter deposition process resulted in a distinct crystalline structure and smaller grain size compared to the arc deposition process. Furthermore, in vitro oxidation caused oxygen to penetrate the surface of the sputtered ZrN top layer to a depth of 700 nm compared to 280 nm in the case of the arc-deposited coating. Finally, tribological testing revealed the improved wear rate of the ZrN multilayer coating applied by sputter deposition.

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.

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., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Three of the authors (EMS, CS, TMG) are employees of Aesculap AG, a manufacturer of orthopedic implants. RT and AG are paid consultants for Aesculap AG. AG is receiving royalties from Aesculap AG and is an unpaid consultant for DePuy Synthes. He is member of the Austrian Orthopaedic Society and of ”AE – Arbeitsgemeinschaft Endoprothetik”. RT is receiving royalties from Conformis and is a paid consultant for this company. RT has stock or stock options in OnPoint Surgical and receives support from Conformis and ZimmerBiomet as Principal Investigator. TMG is scientific member of the working group „Evaluations & Studies“ of the German National Joint Registry „Endoprothesenregister Deutschland“ (EPRD), Advisory Board Member of the EU Consortium SPINNER “Next generation of repair materials & techniques for spine surgery” and Chair of working group I “Introduction of Innovations” of the ”European Federation of National Associations of Orthopaedics and Traumatology” (EFORT) “Implant & Patient Safety Initiative”. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Sporer et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

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.

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., Competing Interests: Author AM and TG were employed by Aesculap AG. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Guo, Smith, Schütz, Trepczynski, Moewis, Damm, Maas, Grupp, Taylor and Hosseini Nasab.)

Objectives: The aim of this study was to determine the resistance to impingement damage of three different artificially aged UHMWPE materials used for total hip joint replacement. The results obtained can be used as a basis for an acceptance criterion for testing according to ASTM F2582-20., Methods: Three different polyethylene liner materials, standard polyethylene (UHMWPE), moderately crosslinked (XLPE) and vitamin E stabilized crosslinked (XLPE-VE) polyethylene of the same design and manufacturer were tested up to one million impingement cycles according to ASTM F2582-20. The liners were artificially oxygen aged for two and three weeks according to ASTM F2003-02. The wear volumes of the liner, acetabular shells, and hip endoprosthesis stems were determined. Each of the six impingement test groups consisted of three samples. For each test group, a reference group was subjected to the same conditioning and loading conditions but without impingement between the hip stem and the liner. The force needed to disassemble the liner from the acetabular shell (push-out force) was determined according to ASTM F1820-22 for the test and the reference groups., Results: XLPE and XLPE-VE polyethylene groups showed less impingement wear when compared to the standard UHMWPE material. Similarly, the protective function of the liner against direct metal-on-metal contact was greater, resulting in less wear on the acetabular shell and the stem neck. The three weeks aged standard UHMWPE group showed early onset of fatigue delamination wear. The push-out values remained unchanged for all XLPE liners and the 3-week aged XLPE-VE liners. The aged UHMWPE liners showed low push-out strength due to component shrinkage caused by aging in combination with the tapered fixation used for this specific design., Significance: The largest polyethylene wear volume measured of XLPE and XLPE-VE polyethylene aged for two and three weeks was 15.05 mm³ (SD 0.56 mm³). The corresponding metal wear volume was 1.23 mm³ (SD 0.19 mm³) for the acetabular cup and 1.33 mm³ (SD 0.20 mm³) for the stem neck. Those values can support the definition of an acceptance criteria for impingement testing. The results of the push-out test required by ASTM F2582-20 should be evaluated with respect to geometry changes caused by aging. The protective effect of the polyethylene liner against metal-on-metal contact should be considered in the implant design phase in order to avoid implant failure due to metal debris., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

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.

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.

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.

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., (© 2023. The Author(s).)

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., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

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.

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., (Copyright © 2022 Elsevier Inc. All rights reserved.)

End-of-stem pain of the femur 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. The aim of this prospective study was to find out how the stem is positioned in the medullary canal, how the femoral geometry changes due to implantation, and whether the results are influenced by the diameter of the trial. We implanted 16 rotating hinge knee implants into 16 fresh-frozen human femora using the hybrid fixation technique and comparing two reaming protocols. We created 3-dimensional models of the specimens before and after implantation using CT-scans and calculated the differences. The main contact between stem and bone was found at the proximal 30 mm of the stem, especially anterior. We observed two different contact patterns of stem and bone. The cortical thickness was reduced especially at the anterior tip of the stem with a maximum reduction of 1405 ± 501  μ m in the standard group and 980 ± 447  μ m in the small&#95;trial group, which is a relative reduction of 34 ± 14% (standard group) and 26 ± 14% (small&#95;trial group). The bone experienced a deformation to posterior and lateral. We conclude that the tip of the stem is an important biomechanical region. Different contact patterns between stem and bone as well as the reduction in cortical thickness at the tip of the stem may play a role in the development of end-of-stem pain., Competing Interests: Four of the authors (EMS, AS, CS, and TMG) are employees of Aesculap AG, a manufacturer of orthopedic implants. RJT and AG are paid consultants for Aesculap AG. AG is receiving royalties from Aesculap AG and is an unpaid consultant for DePuy Synthes. He is member of the Austrian Orthopaedic Society and of “AE—Arbeitsgemeinschaft Endoprothetik.” RJT is receiving royalties from Conformis and is a paid consultant for this company. RJT has stock or stock options in OnPoint Surgical and receives support from Conformis and ZimmerBiomet as Principal Investigator. TMG is scientific member of the working group “Evaluations & Studies” of the German National Joint Registry “Endoprothesenregister Deutschland” (EPRD), Advisory Board Member of the EU Consortium SPINNER “Next generation of repair materials & techniques for spine surgery,” and Chair of working group I “Introduction of Innovations” of the “European Federation of National Associations of Orthopaedics and Traumatology” (EFORT) “Implant & Patient Safety Initiative.”, (Copyright © 2022 Elisabeth M. Sporer et al.)

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., (© 2022. The Author(s).)

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., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

A correlation between patellar kinematics and anterior knee pain is widely accepted. However, there is no consensus on how they are connected or what profile of patellar kinematics would minimize anterior knee pain. Nevertheless, answering this question by merging existing studies is further complicated by the variety of ways to describe patellar kinematics. Therefore, this study describes the most frequently used conventions for defining patellar kinematics, focusing on the rotations. The similarities and differences between the Cardan sequences and angles calculated by projecting axes are analyzed. Additionally, a tool is provided to enable the conversion of kinematic data between definitions in different studies. The choice of convention has a considerable impact on the absolute values and the clinical characteristics of the patello-femoral angles. In fact, the angles that result from using different mathematical conventions to describe a given patello-femoral rotation from our analyses differ up to a Root Mean Squared Error of 111.49° for patellar flexion, 55.72° for patellar spin and 35.39° for patellar tilt. To compare clinical kinematic patello-femoral results, every dataset must follow the same convention. Furthermore, researchers should be aware of the used convention's implications to ensure reproducibility when interpreting and comparing such data.

The long term performance of total knee arthroplasty (TKA) with regards to the bearing materials is related to the aging behaviour of these materials. The use of highly crosslinked materials in hip arthroplasty improved the clinical outcome. Nevertheless, the outcome for these materials compared to conventional UHMWPE (ultra-high molecular weight polyethylene) remains controversial in TKA and alternative bearing materials may be advantageous to improve its outcome in the second and third decade. The aim of this study is the evaluation of the influence of radiation conditions on the wear behaviour of Vitamin E blended UHMWPE gliding components for TKA by simulation of extended aging and high demanding daily patient activities. For a medium radiation dose (30 kGy), the influence of the irradiation type (E-beam or Gamma radiation) and the thermal conditions (room temperature (RT) or heated to 115 °C) are evaluated in comparison to non-irradiated material. Significant influences on the wear behaviour were found for the radiation source and temperature during irradiation. Furthermore, no relevant degradation of the tested materials was observed after extended artificial aging. There was a good correspondence between the wear pattern in this study and retrievals., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Cementless total knee arthroplasty (TKA) implants rely on interference fit to achieve initial stability. However, the optimal interference fit is unknown. This study investigates the effect of using different interference fit on the initial stability of tibial TKA implants. Experiments were performed on human cadaveric tibias using a low interference fit of 350 μm of a clinically established cementless porous-coated tibial implant and a high interference fit of 700 μm. The Orthoload peak loads of gait and squat were applied to the specimens with a custom-made load applicator. Micromotions and gaps opening/closing were measured at the bone-implant interface using Digital Image Correlation (DIC) in 6 regions of interest (ROIs). Two multilevel linear mixed-effect models were created with micromotions and gaps as dependent variables. The results revealed no significant differences for micromotions between the two interference fits (gait p = 0.755, squat p = 0.232), nor for gaps opening/closing (gait p = 0.474, squat p = 0.269). In contrast, significant differences were found for the ROIs in the two dependent variables (p < 0.001), where more gap closing was seen in the posterior ROIs than in the anterior ROIs during both loading configurations. This study showed that increasing the interference fit from 350 to 700 μm did not influence initial stability., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

The objectives of this study were to (a) assess primary stability of a press-fit cup in a simplified acetabular defect model, filled with compacted cancellous bone chips, and (b) to compare the results with primary stability of a press-fit cup combined with two different types of bone graft substitute in the same defect model. A previously developed acetabular test model made of polyurethane foam was used, in which a mainly medial contained defect was implemented. Three test groups (N = 6 each) were prepared: Cancellous bone chips (bone chips), tricalciumphosphate tetrapods + collagen matrix (tetrapods + coll), bioactive glass S53P4 + polyethylene glycol-glycerol matrix (b.a.glass + PEG). Each material was compacted into the acetabulum and a press-fit cup was implanted. The specimens were loaded dynamically in the direction of the maximum resultant force during level walking. Relative motion between cup and test model was assessed with an optical measurement system. At the last load step (3000 N), inducible displacement was highest for bone chips with median [25th percentile; 75th percentile] value of 113 [110; 114] µm and lowest for b.a.glass + PEG with 91 [89; 93] µm. Migration at this load step was highest for b.a.glass + PEG with 868 [845; 936] µm and lowest for tetrapods + coll with 491 [487; 497] µm. The results show a comparable behavior under load of tetrapods + coll and bone chips and suggest that tetrapods + coll could be an attractive alternative to bone chips. However, so far, this was found for one specific defect type and primary stability should be further investigated in additional/more severe defects., (© 2020 The Authors. Journal of Orthopaedic Research® published by Wiley Periodicals LLC on behalf of Orthopaedic Research Society.)

The German Arthroplasty registry (EPRD) has shown that different prosthesis systems have different rates of secondary patellar resurfacing: four years after implantation, the posterior-stabilized (PS) Vega prosthesis has a 3.2% risk of secondary patellar resurfacing compared to the cruciate-retaining (CR) Columbus prosthesis at 1.0% (both Aesculap AG, Tuttlingen, Germany). We hypothesized that PS implants have increased retropatellar pressure and a decreased retropatellar contact area compared to a CR design, which may lead to an increased likelihood of secondary patellar resurfacing. Eight fresh frozen specimens (cohort 1) were tested with an established knee rig. In addition, a possible influence of the registry-based patient collective (cohort 2) was investigated. No significant differences were found in patient data-cohort 2-(sex, age). A generally lower number of PS system cases is noteworthy. No significant increased patella pressure could be detected with the PS design, but a lower contact area was observed (cohort 1). Lower quadriceps force (100°-130° flexion), increased anterior movement of the tibia (rollback), greater external tilt of the patella, and increasing facet pressure in the Vega PS design indicate a multifactorial cause for a higher rate of secondary resurfacing which was found in the EPRD patient cohort and might be related to the PS' principle function.

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., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Cementless femoral total knee arthroplasty (TKA) components use a press-fit (referred to as interference fit) to achieve initial fixation. A higher interference fit could lead to a superior fixation, but it could also introduce more damage to the bone during implantation. The purpose of the current study was to investigate the effect of interference fit on the micromotions and gap opening/closing at the bone-implant interface. Experimental tests were performed in six pairs of cadaveric femurs implanted with femoral components using a low interference fit of 350 μm and a high interference fit of 700 μm. The specimens were subjected to the peak loads of gait and squat, based on the Orthoload dataset. Digital Image Correlation (DIC) was used to measure the micromotions and opening/closing in different regions of interest (ROIs). Two linear mixed-effect statistical models were created with micromotions and gap opening/closing as dependent variables. ROIs, loading conditions, and implant designs as independent variables, and cadaver specimens as random intercepts. The results revealed no significant difference between the two interference fit implants for micromotions (p = 0.837 for gait and p = 0.065 for squat), nor for the gap opening/closing (p = 0.748 for gait and p = 0.561 for squat). In contrast, significant differences were found between loading and most of the ROIs in both dependent variables (p < 0.0001). Additionally, no difference in bone deformation was found between low and high interference fit. Changing interference between either 350 μm or 700 μm did not affect the primary stability of a femoral TKA component. There could be an interference fit threshold beyond which fixation does not further improve., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

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.

Hip implant failure is mainly due to aseptic loosening of the cotyle and is typically accompanied by defects in the acetabular region. Revision surgery aims to repair such defects before implantation by means of reconstruction materials, whose morselized bone graft represents the gold standard. Due to the limited availability of bone tissue, synthetic substitutes are also used. The aim of this study was to evaluate if a synthetic fully resorbable tri-calcium phosphate-based substitute can provide adequate mechanical stability when employed to restore severe, contained defects, in comparison with morselized bone graft. Five cadaveric pelvises were adopted, one side was reconstructed with morselized bone graft and the other with the synthetic substitute, consisting of dense calcium phosphate granules within a collagen matrix. During the biomechanical test, cyclic load packages of increasing magnitude were applied to each specimen until failure. Bone/implant motions were measured through Digital Image Correlation and were expressed in terms of permanent and inducible translations and rotations. The reconstruction types exhibited a similar behavior, consisting of an initial settling trend followed by failure as bone fracture (i.e., no failure of the reconstruction material). When 2.2 Body Weight was applied, the permanent translations were not significantly different between the two reconstructions ( p = 0.06-1.0) and were below 1.0 mm. Similarly, the inducible translations did not differ significantly ( p = 0.06-1.0) and were below 0.160 mm. Rotations presented the same order of magnitude but were qualitatively different. Overall, the synthetic substitute provided adequate mechanical stability in comparison with morselized bone graft, thus representing a reliable alternative to treat severe, contained acetabular defects.

The objectives of this study were to develop a simplified acetabular bone defect model based on a representative clinical case, derive four bone defect increments from the simplified defect to establish a step-wise testing procedure, and analyze the impact of bone defect and bone defect filling on primary stability of a press-fit cup in the smallest defined bone defect increment. The original bone defect was approximated with nine reaming procedures and by exclusion of specific procedures, four defect increments were derived. The smallest increment was used in an artificial acetabular test model to test primary stability of a press-fit cup in combination with bone graft substitute (BGS). A primary acetabular test model and a defect model without filling were used as reference. Load was applied in direction of level walking in sinusoidal waveform with an incrementally increasing maximum load (300 N/1000 cycles from 600 to 3000 N). Relative motions (inducible displacement, migration, and total motion) between cup and test model were assessed with an optical measurement system. Original and simplified bone defect volume showed a conformity of 99%. Maximum total motion in the primary setup at 600 N (45.7 ± 5.6 µm) was in a range comparable to tests in human donor specimens (36.0 ± 16.8 µm). Primary stability was reduced by the bone defect, but could mostly be reestablished by BGS-filling. The presented method could be used as platform to test and compare different treatment strategies for increasing bone defect severity in a standardized way., (© 2020 The Authors. Journal of Orthopaedic Research® published by Wiley Periodicals, Inc. on behalf of Orthopaedic Research Society.)

The influence of X-ray cross-linking compared with electron beam cross-linking on the mechanical and thermal properties of UHMWPE blended with 0.1 wt% vitamin E was investigated. Two X-ray doses (80 and 100 kGy) and two irradiation temperatures (RT: room temperature; 100 °C: warm) were considered. The reference was Vitelene® a vitamin E stabilized UHMWPE cross-linked with 80 kGy e-beam at 100°C. Uniaxial tensile and small punch testing were conducted. The Izod impact strength and the thermal properties were determined. The yield, ultimate tensile strength and elongation were 21.7 MPa, 48 MPa, and 393% for Vitelene® and 21.7 MPa, 47 MPa, and 402% for X (80 kGy)-warm, respectively. The peak load, ultimate displacement, and work to failure accounted for 63 N, 5.7 mm and 331 mJ for Vitelene® and 65 N, 5.6 mm, and 322 mJ for X (80 kGy)-warm respectively. The Izod impact strength of Vitelene® amounted to 81 kJ/m 2 , that of X (80 kGy)-warm to 82 kJ/m 2 . Crystallinity of both was 52%. The melt temperature of Vitelene® was 140 °C, that of X (80 kGy)-warm 139°C. In conclusion, using the same irradiation temperature (100 °C) and dose (80 kGy), the different radiation sources e-beam and X-rays resulted in equivalent thermal and mechanical properties., (© 2020 The Authors. Journal of Biomedical Materials Research Part B: Applied Biomaterials published by Wiley Periodicals, Inc.)

Patellofemoral (PF) disorders are considered a major clinical complication after total knee replacement (TKR). Malpositioning and design of the patellar component impacts knee joint dynamics, implant fixation and wear propagation. However, only a limited number of studies have addressed the biomechanical impact of the patellar component on PF dynamics and their results have been discussed controversially. To address these issues, we implemented a musculoskeletal multibody simulation (MMBS) study for the systematical analysis of the patellar component's thickness and positioning on PF contact forces and kinematics during dynamic squat motion with virtually implanted unconstrained cruciate-retaining (CR)-TKR. The patellar button thickness clearly increased the contact forces in the PF joint (up to 27%). Similarly, the PF contact forces were affected by superior-inferior positioning (up to 16%) and mediolateral positioning (up to 8%) of the patellar button. PF kinematics was mostly affected by the mediolateral positioning and the thickness of the patellar component. A medialization of 3 mm caused a lateral patellar shift by up to 2.7 mm and lateral patellar tilt by up to 1.6°. However, deviations in the rotational positioning of the patellar button had minor effects on PF dynamics. Aiming at an optimal intraoperative patellar component alignment, the orthopedic surgeon should pay close attention to the patellar component thickness in combination with its mediolateral and superior-inferior positioning on the retropatellar surface. Our generated MMBS model provides systematic and reproducible insight into the effects of patellar component positioning and design on PF dynamics and has the potential to serve as a preoperative analysis tool.

Previous studies have shown that increased cross-link density, reduced free radicals, and increased antioxidant grafting resulting from electron-beam irradiation at elevated temperatures improved the wear performance and the oxidative stability of vitamin E blended UHMWPE. The current study explores the impact of elevated irradiation temperature on vitamin E blended UHMWPE using X-ray. We hypothesize that the effects of temperature would be similar to those observed after electron-beam irradiation due to the relatively high dose rate of X-rays. Two X-ray doses of 80 and 100 kGy and two irradiation temperatures, that is, room temperature and 100°C were considered. The reference was Vitelene®, a vitamin E stabilized polyethylene cross-linked with 80 kGy by e-beam at 100°C. Oxidation index and oxidation induction time, as well as cross-link density, gel fraction, and trans -vinylene index, were determined, as the oxidative and network properties are decisive for the long-term implant performance. Gel fraction and oxidation induction time were significantly improved subsequently to warm irradiation in comparison with the material irradiated at room temperature. In conclusion, X-ray irradiation at elevated temperatures resulted in an increase of cross-linking and oxidative resistance of vitamin E stabilized polyethylene comparable to those of e-beam irradiated UHMWPE., Competing Interests: The authors are employees of Aesculap AG Tuttlingen, a manufacturer of orthopedic implants., (Copyright © 2020 M. A. Mulliez et al.)

How to proceed with a clinically asymptomatic modular Metha ® Ti alloy stem with dual taper CoCr neck adapter in case of acetabular revision? To systematically answer this question the status of research and appropriate diagnostic methods in context to clinically symptomatic and asymptomatic dual taper stem-neck couplings has been evaluated based on a systematic literature review. A retrieval analysis of thirteen Metha ® modular dual taper CoCr/Ti alloy hip stems has been performed and a rational decision making model as basis for a clinical recommendation was developed. From our observations we propose that in cases of acetabular revision, that for patients with a serum cobalt level of > 4 µg/L and a Co/Cr ratio > 3.6, the revision of the modular dual taper stem may be considered. Prior to acetabular revision surgery a systematic diagnostic evaluation should be executed, using specific tests such as serum metal (Co, Cr) ion analysis, plain antero-posterior and lateral radiographs and cross-sectional imaging modalities (Metal Artefact Reduction Sequence Magnetic Resonance Imaging). For an asymptomatic Metha ® dual taper Ti alloy/CoCr stem-neck coupling at the stage of acetabular revision careful clinical decision making according to the proposed model should be followed and overreliance on any single examination should be avoided, considering the complete individual differential diagnosis and patient situation.

Background: Unicompartmental knee arthroplasty (UKA) offers good long-term survivorship and superior kinematics and function compared with total knee arthroplasty (TKA). However, revision rates are higher with aseptic loosening representing a major cause. Biomechanical stability depends on cement penetration. The goal of this study was to analyze the influence of cement morphology and bone density on primary stability of tibial UKA under physiological loading conditions in human tibiae., Methods: Thirty-six tibial trays were implanted in fresh-frozen human cadaver knees and tested for primary stability using dynamic compression-shear testing. Prior to implantation, bone density had been quantified for all 18 tibiae. Postoperatively, cement penetration has been assessed on frontal cuts based on eight predefined parameters. The influence of bone density and cement morphology on biomechanical stability was determined using correlation and linear regression analysis., Results: Mean failure load was 2691 ± 832.9 N, mean total cement thickness was 2.04 ± 0.37 mm, mean cement penetration was 1.54 ± 0.33 mm and mean trabecular bone mineral density (BMD) was 107.1 ± 29.3 mg/ml. There was no significant correlation between failure load and cement morphology (P > .05). Failure load was significantly positive correlated with trabecular BMD (r = 0.843; P < .0001) and cortical BMD (r = 0.432; P = .0136)., Conclusions: Simulating physiological loading conditions, the failure load of tibial UKA is linearly dependent on the trabecular BMD. The observed parameters of cementation morphology seem capable of preventing failure at the bone-cement interface before inherent bone stability is reached. Further research is required to assess the usefulness of a preoperative assessment of bone quality for patient selection in UKA., Competing Interests: Declaration of competing interest P.E.M. received research funding in correlation with Aesculap R&D project and is an advising surgeon of Aesculap R&D projects. M.F.P. and P.E.M. received payments for lectures and instructional courses in knee/shoulder arthroscopy. There are no other relationships/conditions/circumstances that present a potential conflict of interest. T.M.G. is an employee of Aesculap (manufacturer of orthopedic implants)., (Copyright © 2020 Elsevier B.V. All rights reserved.)

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., (Copyright © 2019 The Author(s). Published by Elsevier Inc. All rights reserved.)

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.

Bone graft substitutes in orthopedic applications have to fulfill various demanding requirements. Most calcium phosphate (CaP) bone graft substitutes are highly porous to achieve bone regeneration, but typically lack mechanical stability. This study presents a novel approach, in which a scaffold structure with appropriate properties for bone regeneration emerges from the space between specifically shaped granules. The granule types were tetrapods (TEPO) and pyramids (PYRA), which were compared to porous CaP granules (CALC) and morselized bone chips (BC). Bulk materials of the granules were mechanically loaded with a peak pressure of 4 MP; i.e., comparable to the load occurring behind an acetabular cup. Mechanical loading reduced the volume of CALC and BC considerably (89% and 85%, respectively), indicating a collapse of the macroporous structure. Volumes of TEPO and PYRA remained almost constant (94% and 98%, respectively). After loading, the porosity was highest for BC (46%), lowest for CALC (25%) and comparable for TEPO and PYRA (37%). The pore spaces of TEPO and PYRA were highly interconnected in a way that a virtual object with a diameter of 150 µm could access 34% of the TEPO volume and 36% of the PYRA volume. This study shows that a bulk of dense CaP granules in form of tetrapods and pyramids can create a scaffold structure with load capacities suitable for the regeneration of an acetabular bone defect.

Background: Unicompartmental knee arthroplasty is an established treatment option for anteromedial osteoarthritis. However, large registry studies report higher rates of aseptic loosening compared to total knee arthroplasty. The objective of this study was to assess the impact of bone density on morphological cement penetration. Moreover, an alternative regional bone density measuring technique was validated against the established bone mineral density assessment., Methods: Components were implanted on the medial side of 18 fresh-frozen cadaver knees using a minimally invasive approach. Bone density has been quantified prior to implantation using Hounsfield units and bone mineral density. Morphological cement penetration has been assessed in different areas and was correlated with local bone density., Findings: A highly significant correlation between Hounsfield units and trabecular bone mineral density was detected (r = 0.93; P < 0.0001), and local bone density was significantly increased in the anterior and posterior area (P = 0.0003). The mean cement penetration depth was 1.5 (SD 0.5 mm), and cement intrusion into trabecular bone was interrupted in 31.8% (SD 23.7%) of the bone-cement interface. Bone density was correlated significantly negative with penetration depth (r = - 0.31; P = 0.023) and positive with interruptions of horizontal interdigitating (r = + 0.33; P = 0.014). Cement penetration around the anchoring peg was not significantly correlated with bone density., Interpretation: Areas with high bone density were characterized by significantly lower penetration depths and significantly higher areas without cement penetration. Anchoring pegs facilitate cement intrusion mechanically. Regional quantification of bone density using Hounsfield units is a simple but valuable extension to the established determination of bone mineral density.

Objectives: Acetabular bone defect quantification and classification is still challenging. The objectives of this study were to suggest and define parameters for the quantification of acetabular bone defects, to analyze 50 bone defects and to present the results and correlations between the defined parameters., Methods: The analysis was based on CT-data of pelvises with acetabular bone defects and their reconstruction via a statistical shape model. Based on this data, bone volume loss and new bone formation were analyzed in four sectors (cranial roof, anterior column, posterior column, and medial wall). In addition, ovality of the acetabulum, lateral center-edge angle, implant migration, and presence of wall defects were analyzed and correlations between the different parameters were assessed., Results: Bone volume loss was found in all sectors and was multidirectional in most cases. Highest relative bone volume loss was found in the medial wall with median and [25, 75]-percentile values of 72.8 [50.6, 95.0] %. Ovality, given as the length to width ratio of the acetabulum, was 1.3 [1.1, 1.4] with a maximum of 2.0, which indicated an oval shape of the defect acetabulum. Lateral center-edge angle was 30.4° [21.5°, 40.4°], which indicated a wide range of roof coverage in the defect acetabulum. Total implant migration was 25.3 [14.8, 32.7] mm, whereby cranial was the most common direction. 49/50 cases showed a wall defect in at least one sector. It was observed that implant migration in cranial direction was associated with relative bone volume loss in cranial roof (R = 0.74) and ovality (R = 0.67)., Conclusion: Within this study, 50 pelvises with acetabular bone defects were successfully analyzed using six parameters. This could provide the basis for a novel classification concept which would represent a quantitative, objective, unambiguous, and reproducible classification approach for acetabular bone defects., Competing Interests: We have read the journal's policy and the authors of this manuscript have the following competing interests: Three of the authors (RS, GH, TG) are employees of B.Braun Aesculap AG Tuttlingen, a manufacturer of orthopedic implants. Four of the authors (HG, VJ, MR, FT) are advising surgeons in Aesculap R&D projects and three authors (VJ, MR, PW) are getting institutional support. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

The objective of the study was to suggest a novel quantitative assessment of acetabular bone defects based on a statistical shape model, validate the method, and present preliminary results. Two exemplary CT-data sets with acetabular bone defects were segmented to obtain a solid model of each defect pelvis. The pathological areas around the acetabulum were excluded and a statistical shape model was fitted to the remaining healthy bone structures. The excluded areas were extrapolated such that a solid model of the native pelvis per specimen resulted (i.e., each pelvis without defect). The validity of the reconstruction was tested by a leave-one-out study. Validation results showed median reconstruction errors of 3.0 mm for center of rotation, 1.7 mm for acetabulum diameter, 2.1° for inclination, 2.5° for anteversion, and 3.3 mm 3 for bone volume around the acetabulum. By applying Boolean operations on the solid models of defect and native pelvis, bone loss and bone formation in four different sectors were assessed. For both analyzed specimens, bone loss and bone formation per sector were calculated and were consistent with the visual impression. In specimen&#95;1 bone loss was predominant in the medial wall (10.8 ml; 79%), in specimen&#95;2 in the posterior column (15.6 ml; 46%). This study showed the feasibility of a quantitative assessment of acetabular bone defects using a statistical shape model-based reconstruction method. Validation results showed acceptable reconstruction accuracy, also when less healthy bone remains. The method could potentially be used for implant development, pre-clinical testing, pre-operative planning, and intra-operative navigation. © 2018 The Authors. Journal of Orthopaedic Research® Published by Wiley Periodicals, Inc. on behalf of Orthopaedic Research Society. J Orthop Res 9999:1-9, 2018., (© 2018 The Authors. Journal of Orthopaedic Research® Published by Wiley Periodicals, Inc. on behalf of Orthopaedic Research Society.)

Total knee arthroplasty is a well established treatment for degenerative joint disease, which is also performed as a treatment in younger and middle-aged patients who have a significant physical activity and high life expectancy. However, complications may occur due to biological responses to wear particles, as well as local and systemic hypersensitivity reactions triggered by metal ions and particles such as cobalt, chromium and molybdenum. The purpose of the study was to perform a highly demanding activities (HDA) knee wear simulation in order to compare the wear characteristics and metal ion release barrier function of a zirconium nitride (ZrN) coated knee implant, designed for patients with suspected metal ion hypersensitivity, against an uncoated knee implant made out of CoCrMo. The load profiles were applied for 5 million HDA cycles, which represent 15-30 years of in vivo service depending on the activity level of the patient. Results showed a significant wear rate reduction for the coated group (1.01 ± 0.29 mg/million cycles) in comparison with the uncoated group (2.89 ± 1.04 mg/million cycles). The zirconium nitride coating showed no sign of scratches nor delamination during the wear simulation, whereas the uncoated femurs showed characteristic wear scratches in the articulation areas. Furthermore, the metal ion release from the coated implants was reduced up to three orders of magnitude in comparison with the uncoated implants. These results demonstrate the efficiency of zirconium nitride coated knee implants to reduce wear as well as to substantially reduce metal ion release in the knee joint., (Copyright © 2018 Elsevier Ltd. All rights reserved.)