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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.)

Modularity of femoral stems and neck components has become a more frequently used tool for an optimized restoration of the hip joint center and improvement of patient biomechanics. The additional taper interface increases the risk of mechanical failure due to fretting and crevice corrosion. Several failures of titanium alloy neck adapters have been documented in case-reports. An experimental fretting device was developed in this study to systematically investigate the effect of micromotion and contact pressure on fretting damage in contact situations similar to taper interfaces of modular hip prostheses under cyclic loading representative of in vivo load conditions. As a first application, the fretting behavior of Ti-6Al-4V titanium alloy components was investigated. Micromotions were varied between 10μm and 50μm, maximum contact pressures between 400 and 860N/mm(2). All modes of fretting damage were observed: Fretting wear was found for high micromotions in combination with low contact pressures. Fretting fatigue occurred with reduced movement or increased contact pressures. With small micromotions or high normal pressures, low fretting damage was observed. The developed device can be used to evaluate taper design (and especially contact geometry) as well as different materials prior to clinical use., (Copyright © 2012 IPEM. Published by Elsevier Ltd. All rights reserved.)

The objective of our study was the definition of testing scenarios for knee wear simulation under various highly demanding daily activities of patients after total knee arthroplasty. This was mainly based on a review of published data on knee kinematics and kinetics followed by the evaluation of the accuracy and precision of a new experimental setup. We combined tibio-femoral load and kinematic data reported in the literature to develop deep squatting loading profiles for simulator input. A servo-hydraulic knee wear simulator was customised with a capability of a maximum flexion of 120°, a tibio-femoral load of 5000N, an anterior-posterior (AP) shear force of ±1000N and an internal-external (IE) rotational torque of ±50Nm to simulate highly demanding patient activities. During the evaluation of the newly configurated simulator the ability of the test machine to apply the required load and torque profiles and the flexion kinematics in a precise manner was examined by nominal-actual profile comparisons monitored periodically during subsequent knee wear simulation. For the flexion kinematics under displacement control a delayed actuator response of approximately 0.05s was inevitable due to the inertia of masses in movement of the coupled knee wear stations 1-3 during all applied activities. The axial load and IE torque is applied in an effective manner without substantial deviations between nominal and actual load and torque profiles. During the first third of the motion cycle a marked deviation between nominal and actual AP shear load profiles has to be noticed but without any expected measurable effect on the latter wear simulation due to the fact that the load values are well within the peak magnitude of the nominal load amplitude. In conclusion the described testing method will be an important tool to have more realistic knee wear simulations based on load conditions of the knee joint during activities of daily living., (Copyright © 2012 IPEM. Published by Elsevier Ltd. All rights reserved.)

The objective of our study was to examine the effect of biphaseal AP translation and IE rotation restraint, using a system defined specifically for posterior stabilised knee designs, on wear, kinematics and particle release in comparison to linear motion restraint as required by the established ISO 14243-1:2002(E) protocol. In the ISOlinear groups, an AP motion restraint of 30 N/mm and an IE rotation restraint of 0.6 Nm/° were applied in the knee wear simulation. In the ISOgap biphaseal groups with PCL sacrificing implants, the restraining AP force was zero in a ±2.5mm range with, externally, a constant of 9.3N/mm applied proportionally to the AP translation of the tibia plateau, whereas the restraining IE torque was zero in a ±6° range with, externally, a constant of 0.13 Nm/° applied proportionally to the IE rotation of the tibia plateau. Using the ISOgap biphaseal protocol on a posterior stabilised knee design, we found an increase of 41% in AP translation and of 131% in IE rotation, resulting in a 3.2-fold higher wear rate compared to the results obtained using the ISOlinear protocol. Changes in AP translation and IE rotation ligament motion restraints have a high impact on knee joint kinematics and wear behaviour of a fixed bearing posterior stabilised knee design., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

The unicompartmental knee prosthesis is an attractive alternative to total knee arthroplasty. Current UKP devices can be subdivided into two groups based on different design principles: fixed bearing knees, where the ultra-high molecular weight polyethylene meniscal component snap or press fits into the tibial tray, and mobile bearing designs which facilitate movement of the insert relative to the tray. The present study was aimed at comparing the in-vitro wear behaviour of fixed and mobile unicompartmental knee menisci under two configurations: the femoral components were cemented into a custom-made metallic block or, as a novelty of the present study, into a synthetic femur (i.e. under conditions which should better reproduce the in-vivo behaviour). Analyses were performed using a displacement-control knee wear simulator with "three-plus-one" stations. All the kinematics tests were set in accordance with the ISO 14243-1,2,3. Fixed and mobile polyethylene menisci showed a different wear behaviour: the fixation-frame influenced directional load transfer through each component in a qualitative and quantitative way. In fact, gravimetric results showed that under the metal block holder fixation, mobile components worn more than fixed components (weight losses of 8.7±2.0 mg and 2.6±1.09 mg, respectively); on the other hand, under the synthetic femur configuration, differences in wear behaviour were less pronounced and mobile menisci underwent a slightly lower weight loss than fixed components (4.5±2.2 mg vs. 6.7±1.4 mg). This different trend was explained in relation to the kinematic schemes of the two fixation methods. Raman spectroscopy, used to evaluate the UHMWPE crystallinity changes induced by mechanical stress, showed that mobile menisci specimens were more affected than the fixed components in both their superior and inferior surfaces, independent of the fixation-frame. In conclusion, if tested under conditions which should better reproduce the in-vivo behaviour, mobile UKPs did not show a worse wear behaviour than fixed components in terms of weight losses, although UHMWPE changes at the molecular scale could be detrimental., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Poly(ether ether ketone) (PEEK) and its composites are recognized as alternative bearing materials for use in arthroplasty because of their mechanical properties. The objective of this project was to evaluate the biological response of two different kinds of carbon fiber-reinforced (CFR) PEEK compared with ultra-high molecular weight polyethylene (UHMWPE) in vivo as a standard bearing material. Wear particles of the particulate biomaterials were injected into the left knee joint of female BALB/c mice. Assessment of the synovial microcirculation using intravital fluorescence microscopy as well as histological evaluation of the synovial layer were performed 7 days after particle injection. Enhanced leukocyte-endothelial cell interactions and an increase in functional capillary density as well as histological investigations revealed that all tested biomaterials caused significantly (P < 0.05) increased inflammatory reactions compared with control animals (injected with sterile phosphate-buffered saline), without any difference between the tested biomaterials (P > 0.05). These data suggest that wear debris of CFR-PEEK is comparable with UHMWPE in its biological activity. Therefore, CFR-PEEK represents an alternative bearing material because of its superior mechanical and chemical behavior without any increased biological activity of the wear particles, compared with a standard bearing material., (Copyright © 2010 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.)

The objective of our wear simulator study was to evaluate the suitability of two different carbon fibre-reinforced poly-ether-ether-ketone (CFR-PEEK) materials for fixed bearing unicompartmental knee articulations with low congruency. In vitro wear simulation was performed according to ISO 14243-1:2002 (E) with the clinically introduced Univation F fixed bearing unicompartmental knee design (Aesculap AG, Tuttlingen, Germany) made of UHMWPE/CoCr29Mo6 in a direct comparison to experimental gliding surfaces made of CFR-PEEK pitch and CFR-PEEK PAN. Gliding surfaces of each bearing material (n=6+2) were gamma-irradiated, artificially aged and tested for 5 million cycles with a customized four-station knee wear simulator (EndoLab, Thansau, Germany). Volumetric wear assessment, optical surface characterization and an estimation of particle size and morphology were performed. The volumetric wear rate of the reference PE1-6 was 8.6 +/- 2.17 mm(3) per million cycles, compared to 5.1+/-2.29 mm(3) per million cycles for PITCH1-6 and 5.2 +/- 6.92 mm(3) per million cycles for PAN1-6; these differences were not statistically significant. From our observations, we conclude that CFR-PEEK PAN is obviously unsuitable as a bearing material for fixed bearing knee articulations with low congruency, and CFR-PEEK pitch also cannot be recommended as it remains doubtful wether it reduces wear compared to polyethylene. In the fixed bearing unicompartmental knee arthroplasty examined, application threshold conditions for the biotribiological behaviour of CFR-PEEK bearing materials have been established. Further in vitro wear simulations are necessary to establish knee design criteria in order to take advantage of the biotribiological properties of CFR-PEEK pitch for its beneficial use to patients., (2010 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.)

Wear simulation is an essential pre-clinical method to predict the mid- and long-term clinical wear behavior of newly introduced devices for total disc arthroplasty. The main requirement of a suitable method for spinal wear simulation has to be the ability to distinguish between design concepts and allow for a direct comparison of predicate devices. The objective of our study was to investigate the influence of loading and kinematic patterns based on two different protocols for spinal wear simulation (ISO/FDIS 18192-1 (2006) and ASTM F2423-05). In vitro wear simulation was performed with six activ L lumbar artificial disc devices (Aesculap Tuttlingen, Germany). The applied kinematic pattern of movement was multidirectional for ISO (elliptic track) and unidirectional with a curvilinear shape for ASTM. Testing was done for 10 million cycles in the ISO loading mode and afterwards with the same specimens for 5 million cycles according to the ASTM protocol with a customized six-station servohydraulic spinal wear simulator (EndoLab Thansau, Germany). Gravimetrical and geometrical wear assessment, a slide track analysis correlated to an optical surface characterization, and an estimation of particle size and morphology were performed. The gravimetric wear rate for the first 10 million cycles was ISO(initial) = 2.7 +/- 0.3 mg/million cycles. During the ASTM test period (10-15 million cycles) a gravimetric wear rate of 0.14 +/- 0.06 mg/million cycles was estimated. The wear rates between the ISO and ASTM driven simulations differ substantially (approximately 20-fold) and statistical analysis demonstrates a significant difference (p < 0.001) between the test groups. The main explanation of divergency between ISO and ASTM driven wear simulations is the multidirectional pattern of movement described in the ISO document resulting in a cross-shear stress on the polyethylene material. Due to previous retrieval observations, it seems to be very unlikely that a lumbar artificial disc is loaded with a linear wear path.Testing according to ASTM F2423-05 with pure unidirectional motion does not reflect the kinematics of TDA patients' daily activities. Based on our findings it seems to be more reliable to predict the clinical wear behavior of an artificial disc replacement using the ISO/FDIS 18192-1 method.

Calf specimens from the L3-4 and L5-6 levels were used for in vitro stability testing of a new transforaminal lumbar interbody fusion (TLIF) implant. Results were compared with those of the conventional posterior lumbar interbody fusion (PLIF) technique using two cuboid spacers. The specimens were loaded with pure moments of 10 Nm in flexion, extension, lateral bending, and axial rotation without any axial preload. They were allowed to move freely and unconstrained in all directions. In extension the PLIF implants showed slightly higher degrees of stiffness than the TLIF implant. While the conventional PLIF technique results in an increased range of motion by a factor of 2.5 after implant insertion, the TLIF approach prevents segmental destabilization in axial rotation. The facet joint arthrodesis using resorbable pins reveals biomechanically interesting results and will therefore be investigated in further studies.