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.

Influence of radiation conditions on the wear behaviour of Vitamin E treated UHMWPE gliding components for total knee arthroplasty after extended artificial aging and simulated daily patient activities.

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.

Metal ion release barrier function and biotribological evaluation of a zirconium nitride multilayer coated knee implant under highly demanding activities wear simulation.

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 ±â€¯0.29 mg/million cycles) in comparison with the uncoated group (2.89 ±â€¯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.

Vitamin E stabilised polyethylene for total knee arthroplasty evaluated under highly demanding activities wear simulation.

As total knee arthroplasty (TKA) patients are getting more active, heavier and younger and structural material fatigue and delamination of tibial inserts becomes more likely in the second decade of good clinical performance it appears desirable to establish advanced pre-clinical test methods better characterizing the longterm clinical material behaviour. The questions of our study were 1) Is it possible to induce subsurface delamination and striated pattern wear on standard polyethylene TKA gliding surfaces? 2) Can we distinguish between γ-inert standard polyethylene (PEstand.30kGy) as clinical reference and vitamin E stabilised materials (PEVit.E30kGy & PEVit.E50kGy)? 3) Is there an influence of the irradiation dose (30vs 50kGy) on oxidation and wear behaviour? Clinical relevant artificial ageing (ASTM F2003; 2weeks) of polyethylene CR fixed TKA inserts and oxidation index measurements were performed by Fourier transform infrared spectroscopy prior testing. The oxidation index was calculated in accordance with ISO 5834-4:2005 from the area ratio of the carbonyl peak (between 1650 and 1850cm-1) to the reference peak for polyethylene (1370cm-1). Highly demanding patient activities (HDA) measured in vivo were applied for 5million knee wear cycles in a combination of 40% stairs up, 40% stairs down, 10% level walking, 8% chair raising and 2% deep squatting with up to 100° flexion. After 3.0mc all standard polyethylene gliding surfaces developed noticeable areas of progressive delamination. Cumulative gravimetric wear was 355.9mg for PEstand.30kGy, 28.7mg for PEVit.E30kGy and 26.5mg for PEVit.E50kGy in HDA knee wear simulation. Wear rates were 12.4mg/mc for PEstand.30kGy in the linear portion (0-2mc), 5.6mg/mc for PEVit.E30kGy and 5.3mg/mc for PEVit.E50kGy. In conclusion, artificial ageing of standard polyethylene to an oxidation index of 0.7-0.95 in combination with HDA knee wear simulation, is able to create subsurface delamination, structural material fatigue in vitro, whereas for the vitamin-E-blended materials no evidence of progressive wear, fatigue or delamination was found. STATEMENT OF SIGNIFICANCE: As total knee arthroplasty patients are getting more active, heavier and younger and structural material fatigue and delamination of polyethylene tibial inserts becomes more likely in the second decade of good clinical performance, it appears desirable to establish advanced pre-clinical test methods better characterizing the longterm clinical material behaviour. Various studies reported in literature attempted to artificially create delamination during in vitro knee wear simulation. We combined artificial ageing to clinically observed oxidation of gamma inert and vitamin E stabilised polyethylene inserts and highly demanding patient activities knee wear simulation based on in vivo load data. With this new method we were able to create clinically relevant subsurface delamination and structural material fatigue on standard polyethylene inserts in vitro.

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.

CR TKA UHMWPE wear tested after artificial aging of the vitamin E treated gliding component by simulating daily patient activities.

The wear behaviour of total knee arthroplasty (TKA) is dominated by two wear mechanisms: the abrasive wear and the delamination of the gliding components, where the second is strongly linked to aging processes and stress concentration in the material. The addition of vitamin E to the bulk material is a potential way to reduce the aging processes. This study evaluates the wear behaviour and delamination susceptibility of the gliding components of a vitamin E blended, ultra-high molecular weight polyethylene (UHMWPE) cruciate retaining (CR) total knee arthroplasty. Daily activities such as level walking, ascending and descending stairs, bending of the knee, and sitting and rising from a chair were simulated with a data set received from an instrumented knee prosthesis. After 5 million test cycles no structural failure of the gliding components was observed. The wear rate was with 5.62 ± 0.53 mg/million cycles falling within the limit of previous reports for established wear test methods.

Biotribology of a mobile bearing posterior stabilised knee design--effect of motion restraint on wear, tibio-femoral kinematics and particles.

The objective of our study was to evaluate the impact of a biphaseal anterior-posterior (AP) and internal-external (IE) motion restraint system on the wear behaviour, tibio-femoral kinematics and particle release of a mobile bearing posterior stabilised knee design in comparison to the widely used linear restraint. in vitro wear simulation was performed using a posterior stabilised total knee replacement with a mobile rotating platform gliding surface design to compare the standard ISO 14243-1:2002 (E) protocol with a linear AP and IE motion restraint and the new ISO 14243-1:2009 (E) protocol with a biphaseal AP and IE motion restraint. For the mobile gliding surfaces, an increase in wear rate by more than a magnitude was measured applying the biphaseal protocol (8.5±1.6 mg/million cycles) in a direct comparison to the linear protocol (0.33±0.07 mg/million cycles), with statistically significant difference. The amplitudes of AP displacement were 3.22±0.47 mm for the biphaseal test, compared to 1.97±0.22 mm in the linear test and the amplitudes of the IE rotation angle had mean values of 7.32°±0.91° under the biphaseal setup, compared to 1.97°±0.14° under linear motion restraint test conditions. From our observations, we conclude that the changes in AP translation and IE rotation motion restraints from ISO linear to ISO biphaseal test conditions highly impact the knee joint kinematics and wear behaviour of a mobile bearing posterior stabilised knee design.

Knee wear simulation under conditions of highly demanding daily activities--influence on an unicompartmental fixed bearing knee design.

The objectives of our in vitro study were to evaluate a knee wear simulation based on patient daily activities in combination with artificial ageing of polyethylene inserts to create an optimised simulation of in vivo wear modes. A wear simulation was performed on fixed bearing unicompartmental knee arthroplasty (UKA) devices in a direct comparison of level walking (as given by the ISO 14243-1:2002(E) profiles) and in a customised test configuration based on activities for level walking (10%), stairs ascending (40%), stairs descending (40%), chair rising (8%) and deep squatting (2%). The cumulative gravimetric wear was estimated to be 15.3mg for level walking (ISO) and 69.6 mg for high demanding activities (HDA). The gravimetric wear rate of the ISO group was 3.0mg/million cycles, compared to 11.7 mg/million cycles for the HDA protocol. Level walking wear testing conditions (ISO) and artificial ageing alone is not sufficient to reproduce in vivo failure modes. After 3 million cycles all gliding surfaces of the HDA group developed in the tibio-femoral articulation markable areas of structural material fatigue and delamination. In conclusion a combination of artificial ageing to clinical relevant oxidation grades and a sequence of various high demanding daily patient activities is necessary to represent a revised in vitro behaviour of abrasive-adhesive wear and delamination in artificial knee replacements.

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.

Definition and evaluation of testing scenarios for knee wear simulation under conditions of highly demanding daily activities.

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.

Effect of anterior-posterior and internal-external motion restraint during knee wear simulation on a posterior stabilised knee design.

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.

Biotribology of alternative bearing materials for unicompartmental knee arthroplasty.

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.

Alternative bearing materials for intervertebral disc arthroplasty.

The objective of our study was to test alternative polymer-on-polymer articulations for cervical total disc arthroplasty with favourable biotribological properties and the benefit of radiolucency in comparison to the clinically well established metal-on-polyethylene coupling. In vitro wear simulation was performed according to ISO 18192-1:2008 (E) with the clinically introduced activ C cervical artificial disc (Aesculap AG Tuttlingen, Germany) made of UHMWPE/CoCr29Mo6 in a direct comparison to experimental disc articulations made of PEEK, CFR-PEEK and PEK. Each material combination was tested for 10 million cycles with a customised 6 station spinal wear simulator (EndoLab Thansau, Germany). Gravimetric and geometric wear assessment, optical surface characterisation and an estimation of particle size and morphology were performed. The gravimetric wear rate of the clinical reference polyethylene-on-cobalt-chromium was 1.0+/-0.1 mg/million cycles, compared to 1.4+/-0.4 mg/million cycles for PEEK, to 0.02+/-0.02 mg/million cycles for CFR-PEEK and 0.8+/-0.1 mg/million cycles for PEK. In conclusion, a number of different candidate materials for total cervical disc arthroplasty were compared using the same disc design. Whereas the polymer-on-polymer articulation of PEK showed no substantial benefit in comparison to polyethylene-on-cobalt-chromium and whereas natural PEEK tends towards pitting and delamination, the carbon fibre reinforced PEEK demonstrated an excellent wear behaviour with a reduction in order of a magnitude. Therefore, the CFR-PEEK based polymer-on-polymer articulations may be an alternative to polyethylene-on-metal and have a high potential for next generation disc replacements.

Fixed bearing knee congruency -- influence on contact mechanics, abrasive wear and kinematics.

The objective of our study was to evaluate the in vitro wear behavior of fixed bearing designs for total knee arthroplasty in relation to contact mechanics and resultant kinematics for different degrees of congruency. a finite element model was created for three knee articulations with increasing degrees of tibio-femoral congruency (flat, curved, and dished design). For the three different knee design configurations, in vitro wear simulation was performed according to iso 14243-1. Contact areas increased with increasing knee congruency, whereas the peak surface contact stresses decreased. The wear rates for the knee design configurations differed substantially between the three test groups (flat, curved, and dished). our observations demonstrate that increased congruency in conjunction with decreased surface contact stresses significantly contributes to reducing wear in fixed bearing knee articulations.

Biotribological evaluation of artificial disc arthroplasty devices: influence of loading and kinematic patterns during in vitro wear simulation.

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.