Aims

Oxidized zirconium (OxZi) and highly cross-linked polyethylene (HXLPE) were developed to minimize wear and risk of osteolysis in total hip arthroplasty (THA). However, retrieval studies have shown that scratched femoral heads may lead to runaway wear, and few reports of long-term results have been published. The purpose of this investigation is to report minimum ten-year wear rates and clinical outcomes of THA with OxZi femoral heads on HXLPE, and to compare them with a retrospective control group of cobalt chrome (CoCr) or ceramic heads on HXLPE.

Abstract. BACKGROUND. Hemi-arthroplasty (HA) as a treatment for fractured neck of femur has slightly increased since 2019 and remarkably after the COVID pandemic. The main drawback of the treatment is ongoing cartilage deterioration that may require revision to THR. OBJECTIVE. This study assessed cartilage surface damage in hip HA by reproducing anatomical motion and loading conditions in a hip simulator. METHODS. Experimental design. HA tests were conducted using porcine acetabula and CoCr femoral heads. Five groups (n=4) were included: a control group comprising natural tissue and four HA groups where the acetabula were paired with metal heads to allow radial clearance (RC) classed as small (RC<0.6mm), large (2mm<RC<4mm), extra-large (4mm<RC), and oversized (RC<−0.6mm). Tests were carried out in an anatomical hip simulator that reproduced a simplified twin peak gait cycle, adapted for porcine hip joints, from the ISO 14242 standard for wear of THR prostheses (peak load of 900N). The test length was 6 hours, with photogrammetry taken at 1-hour intervals. Ringers solution was used as a lubricant. RESULTS. No changes were observed in the control group. However, cartilage surface changes were observed in all hemi-arthroplasty groups. Discolouration on the cartilage surface was noticeable at the posterior-superior part of the acetabulum after 1-hour (extra-large and oversized groups). Damage severity and location were characteristic of each clearance group. Of all the groups, the oversized group showed more significant damage. No labrum separation was seen after the simulation. CONCLUSIONS. These results are relevant to understand the effect of femoral head clearance on cartilage damage risk after HA. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest

Advances in total hip and knee replacement technologies have heretofore been largely driven by corporate marketing hype with each seeming advancement accompanied by a cost increase often out in front of peer-reviewed reports documenting their efficacy or not. As example, consider the growing use of ceramic femoral heads in primary total hip arthroplasty (THA). The question to consider is “Can an upcharge of $350 for a ceramic femoral head in primary THA be justified?” The answer to this question lies in an appreciation of whether the technology modifies the potential for costly revision arthroplasty procedures. Peer-Reviewed Laboratory & Clinical Review - According to the 2022 Australian National Joint Replacement Registry, the four leading causes of primary THA failure requiring revision are: 1.) infection, 2.) dislocation/instability, 3.) periprosthetic fracture and 4.) loosening, which constitute 87.5% of the reported reasons for revision. Focusing on these failure modes, hip simulator findings report that ceramic femoral heads dramatically reduce wear debris generation, decreasing the potential for osteolytic response leading to loosening. Further, ceramic materials enable the utilization of larger head sizes, avoiding the potential for dislocation. The overall mid- to long-term survival rate reported in the peer-reviewed, clinical literature for these bearings has exceeded 95% with virtually no osteolysis. Also, could bearing surface choice influence periprosthetic joint infection (PJI)? A study on a total of more than 10,500 primary THA procedures reported a confirmed PJI incidence of 2.4% for cobalt-chrome and 1.6% for ceramic femoral heads, suggesting that the employ of a ceramic bearing surface may also play a role in decreasing the potential for infection. Review of the clinical data available for ceramic bearings justifies that it is better to “pay me now than to pay orders of magnitude later”, if in fact a revision THA can be avoided, significantly reducing the overall financial burden to the healthcare system

Non-optimal clinical alignment of components in total hip replacements (THRs) may lead to edge loading of the acetabular cup liner. This has the potential to cause changes to the liner rim not accounted for in standard wear models. A greater understanding of the material behaviours could be beneficial to design and surgical guidance for THR devices. The aim of this research was to combine finite element (FE) modelling and experimental simulation with microstructural assessment to examine material behaviour changes during edge loading. A dynamic deformable FE model, matching the experimental conditions, was created to simulate the stress strain environment within liners. Five liners were tested for 4Mc (million cycles) of standard loading (ISO14242:1) followed by 3Mc of edge loading with dynamic separation (ISO14242:4) in a hip simulator. Microstructural measurements by Raman spectroscopy were taken at unloaded and highly loaded rim locations informed by FE results. Gravimetric and geometric measurements were taken every 1Mc cycles. Under edge loading, peak Mises stress and plastic deformation occur below the surface of the rim during heel strike. After 7Mc, microstructural analysis determined edge loaded regions had an increased crystalline mass fraction compared to unloaded regions (p<0.05). Gravimetric wear rates of 12.5mm. 3. /Mc and 22.3mm. 3. /Mc were measured for standard and edge loading respectively. A liner penetration of 0.37mm was measured after 7Mc. Edge loading led to an increase in gravimetric wear rate indicating a different wear mechanism is occurring. FE and Raman results suggest that changes to material behaviour at the rim could be possible. These methods will now be used to assess more liners and over a larger number of cycles. They have potential to explore the impact of edge loading on different surgical and patient variables

Hip joint biomechanics can be altered by abnormal morphology of the acetabulum and/or femur. This may affect load distribution and contact stresses on the articular surfaces, hence, leading to damage and degradation of the tissue. Experimental hip joint simulators have been used to assess tribology of total hip replacements and recently methods further developed to assess the natural hip joint mechanics. The aim of this study was to evaluate articular surfaces of human cadaveric joints following prolonged experimental simulation under a standard gait cycle. Four cadaveric male right hips (mean age = 62 years) were dissected, the joint disarticulated and capsule removed. The acetabulum and femoral head were mounted in an anatomical hip simulator (Simulation Solutions, UK). A simplified twin peak gait cycle (peak load of 3kN) was applied. Hips were submerged in Ringers solution (0.04% sodium azide) and testing conducted at 1 Hertz for 32 hours (115,200 cycles). Soft tissue degradation was recorded using photogrammetry at intervals throughout testing. All four hips were successfully tested. Prior to simulation, two samples exhibited articular surface degradation and one had a minor scalpel cut and a small area of cartilage delamination. The pre-simulation damage got slightly worse as the simulation continued but no new areas of damage were detected upon inspection. The samples without surface degradation, showed no damage during testing and the labral sealing effect was more obvious in these samples. The fact that no new areas of damage were detected after long simulations, indicates that the loading conditions and positioning of the sample were appropriate, so the simulation can be used as a control to compare mechanical degradation of the natural hip when provoked abnormal conditions or labral tissue repairs are simulated

Variations in component positioning of total hip replacements can lead to edge loading of the liner, and potentially affect device longevity. These effects are evaluated using ISO 14242:4 edge loading test results in a dynamic system. Mediolateral translation of one of the components during testing is caused by a compressed spring, and therefore the kinematics will depend on the spring stiffness and damping coefficient, and the mass of the translating component and fixture. This study aims to describe the sensitivity of the liner plastic strain to these variables, to better understand how tests using different simulator designs might produce different amounts of liner rim deformation.

A dynamic explicit deformable finite element model with 36mm Pinnacle metal-on-polyethylene bearing geometry (DePuy Synthes, Leeds, UK) was used with material properties for conventional UHMWPE. Setup was 65° clinical inclination, 4mm mismatch, 70N swing phase load, and 100N/mm spring. Fixture mass was varied from 0.5-5kg, spring damping coefficient was varied from 0-2Ns/mm. They were changed independently, and in combination.

Maximum separation values were relatively insensitive to changes in the mass, damping coefficient, or both. The sensitivity of peak plastic strain, to this range of inputs, was similar to changing the swing phase load from 70N to approximately 150N – 200N. Increasing the fixture mass and/or damping coefficient increased the peak plastic strain, with values from 0.15-0.19.

Liner plastic deformation was sensitive to the spring damping and fixture mass, which may explain some of the differences in fatigue and deformation results in UHMWPE liners tested on different machines or with modified fixtures. These values should be described when reporting the results of ISO14242:4 testing.

Acknowledgements

Funded by EPSRC grant EP/N02480X/1; CAD supplied by DePuy Synthes.

Aims

A significant reduction in wear at five and ten years was previously reported when comparing Durasul highly cross-linked polyethylene with nitrogen-sterilized Sulene polyethylene in total hip arthroplasty (THA). We investigated whether the improvement observed at the earlier follow-up continued, resulting in decreased osteolysis and revision surgery rates over the second decade.

Aims

Head-taper corrosion is a cause of failure in total hip arthroplasty (THA). Recent reports have described an increasing number of V40 taper failures with adverse local tissue reaction (ALTR). However, the real incidence of V40 taper damage and its cause remain unknown. The aim of this study was to evaluate the long-term incidence of ALTR in a consecutive series of THAs using a V40 taper and identify potentially related factors.

Aims

The aim of this study was to evaluate the performance of first-generation annealed highly cross-linked polyethylene (HXLPE) in cementless total hip arthroplasty (THA).

Abstract. Objectives. Dual mobility (DM) hip implants whereby the polyethylene liner is “free-floating” are being used increasingly clinically. The motion of the liner is not well understood and this may provide insight into failure mechanisms; however, there are no published methods on tracking liner motion while testing under clinically relevant conditions. The aim was to develop and evaluate a bespoke inertial tracking system for DM implants that could operate submerged in lubricant without line-of-sight and provide 3D orientation information. Methods. Trackers (n=5) adhered to DM liners were evaluated using a robotic arm and a six-degree of freedom anatomical hip simulator. Before each set of testing the onboard sensor suites were calibrated to account for steady-state and non-linearity errors. The trackers were subjected to ranges of motion from ±5° to ±25° and cycle frequencies from 0.35Hz to 1.25Hz and the outputs used to find the absolute error at the peak angle for each principle axis. In total each tracker was evaluated for ten unique motion profiles with each sequence lasting 60 cycles. Results. Across all test conditions the angular error was consistently less than 1.1 ± 1.8° (mean ± SD) per principle axis with no relationship found between range of motion or cycle frequency and measurement error. Rotations about the trackers X and Y axes produced more repeatable results with a maximum spread of 5.5°, where as rotations about Z spread by up to 10.1°. Conclusions. The results of this study show that a system for monitoring DM liner motion without line of sight is possible, going forward this will be used to determine the effects of different loading and kinematic conditions on liner motions in a hip simulator

Aims. This study investigates head-neck taper corrosion with varying head size in a novel hip simulator instrumented to measure corrosion related electrical activity under torsional loads. Methods. In all, six 28 mm and six 36 mm titanium stem-cobalt chrome head pairs with polyethylene sockets were tested in a novel instrumented hip simulator. Samples were tested using simulated gait data with incremental increasing loads to determine corrosion onset load and electrochemical activity. Half of each head size group were then cycled with simulated gait and the other half with gait compression only. Damage was measured by area and maximum linear wear depth. Results. Overall, 36 mm heads had lower corrosion onset load (p = 0.009) and change in open circuit potential (OCP) during simulated gait with (p = 0.006) and without joint movement (p = 0.004). Discontinuing gait’s joint movement decreased corrosion currents (p = 0.042); however, wear testing showed no significant effect of joint movement on taper damage. In addition, 36 mm heads had greater corrosion area (p = 0.050), but no significant difference was found for maximum linear wear depth (p = 0.155). Conclusion. Larger heads are more susceptible to taper corrosion; however, not due to frictional torque as hypothesized. An alternative hypothesis of taper flexural rigidity differential is proposed. Further studies are necessary to investigate the clinical significance and underlying mechanism of this finding. Cite this article: Bone Jt Open 2021;2(11):1004–1016

Abstract. Objectives. The importance of cup position on the performance of total hip replacements (THR) has been demonstrated in in vitro hip simulator tests and clinically. However, how cup position changes during gait has not been considered and may affect failure scenarios. The aim of this study was to assess dynamic cup version using gait data. Methods. Pelvic movement data for walking for 39 unilateral THR patients was acquired (Leeds Biomedical Research Centre). Patient's elected walking speed was used to group patients into high- and low-functioning (mean speed, 1.36(SD 0.09)ms. −1. and 0.85(SD 0.08)ms. −1. respectively). A computational algorithm (Python3.7) was developed to calculate cup version during gait cycle. Inputs were pelvic angles and initial cup orientation (assumed to be 45° inclination and 7° version, anterior pelvic plane was parallel to radiological frontal plane). Outputs were cup version angles during a gait cycle (101 measurements/cycle). Minimum, maximum and average cup version during gait cycle were measured for each patient. Two-sample t-test (p=0.05) was used to compare groups. Results. Over a gait cycle the mean minimum, maximum and average version angles for the high-functioning group were −4.5(SD 4.4)°, 5.0(SD 4.3)°, 9.5(SD 4.0)° and for low-functioning group 2.0(SD 3.7)°, 6.2(SD 2.9)°, 8.1(SD 3.2)°. There were no significant differences for the minimum, maximum and average version angles between the two groups. Conclusions. The study shows that dynamic acetabular cup version changes substantially during gait and this must be considered clinically and in pre-clinical testing. There was no significant difference between the two groups; however, dynamic cup version was more negative in high-functioning compared to low-functioning patients. Further studies on a larger cohort are required to determine whether patients’ profiles can be stratified to provide enhanced inputs for pre-clinical THR testing. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

Abstract. OBJECTIVES. Abnormal joint mechanics have been proposed as adversely affecting natural hip joint tribology, whereby increased stress on the articular cartilage from abnormal loading leads to joint degeneration. The aim of this project was to assess the damage caused by different loading conditions on the articular surfaces of the porcine hip joint in an experimental simulator. METHODS. Porcine hip joints were dissected and mounted in a single station hip simulator (SimSol, UK) and tested under loading scenarios (that corresponded to equivalent of different body mass index's’ (BMI) in humans), as follows:“Normal” (n=4), the loading cycle consisted of a simplified gait cycle based on a scaled version of a simplified twin-peak human gait cycle, the peak load was 900N (representative of a healthy BMI). Representative of an “Overweight” BMI (n=3), as the normal cycle with a peak load of 1,130N Representative of an “Obese” BMI (n=1), as the normal cycle with a peak load of 1,340N Tests were conducted at 1Hz for 14,400 cycles in Ringers solution; photogrammetry was used to characterise the appearance of the cartilage and labrum pre, during and post simulation. the appearance and location of damage was recorded. RESULTS. No significant damage was observed for samples tested under normal conditions. Following “overweight” condition testing, tears and detachment of the labrum were observed during testing in two (of three) samples. In addition to damaged observed in “overweight” tested samples the “obese” showed similar damage and also cartilage bruising and wear tracks on the articular surface of the acetabulum. DISCUSSION. The absence of damage in “normal” loading provides evidence that this is an appropriate methodology and loading regime for porcine hips. Increased damage with increasing loads demonstrates the potential to develop further this experimental simulation to assess adverse loading in natural hip joints. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

Abstract. Objectives. Impingement of total hip replacements (THRs) can cause rim damage of polyethylene liners, and lead to dislocation and/or mechanical failure of liner locking mechanisms[1]. A geometric model of a THR in situ was previously developed to predict impingement for different component orientations and joint motions of activities[2]. However, the consequence of any predicted impingement is unknown. This study aimed to develop an in-vitromethod to investigate the effects of different impingement scenarios. Method. A ProSim electro-mechanical single-station hip simulator (Simulation Solutions) was used, and the 32mm diameter metal-on-polyethylene THRs (DePuy Synthes) were assessed. The THR was mounted in an inverted orientation, and the input (motion and loading) applied simulated a patient stooping over to pick an object from the floor[3]. The impingement severity was varied by continuing motion past the point of impingement by 2.5° or 5°, and compressive load applied in the medial-lateral direction was varied from 100N to 200N. Each test condition was applied for 40,000 cycles (n=3). Rim penetration was assessed using a CMM and component separation was measured during the tests. Results. Varying the impingement severity from 2.5° to 5° increased rim penetration two-fold (by >0.05mm) and increased medial-lateral component separation three-fold (by >0.3mm) (both p<0.001). Increasing the medial-lateral load had less effect on the rim penetration and component separation, with exception of rim penetration with the higher impingement severity condition. Conclusion. The impingement severity influenced the medial-lateral component separation, suggesting that increasing the impingement severity could increase the risk of dislocation. The impingement severity, which could be predicted from geometric modelling, was also found to significantly affect rim penetration, meaning this method could be used alongside geometric modelling to predict impingement severity in a range of scenarios. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest

Introduction. Femoral neck impingement occurs clinically in total hip replacements (THR) when the acetabular liner articulates against the neck of a femoral stem prosthesis. This may occur in vivo due to factors such as prostheses design, patient anatomical variation, and/or surgical malpositioning, and may be linked to joint instability, unexplained pain, and dislocation. The Standard Test Method for Impingement of Acetabular Prostheses, ASTM F2582 −14, may be used to evaluate acetabular component fatigue and deformation under repeated impingement conditions. It is worth noting that while femoral neck impingement is a clinical observation, relative motions and loading conditions used in ASTM F2582-14 do not replicate in vivo mechanisms. As written, ASTM F2582-14 covers failure mechanism assessment for acetabular liners of multiple designs, materials, and sizes. This study investigates differences observed in the implied and executed kinematics described in ASTM F2582-14 using a Prosim electromechanical hip simulator (Simulation Solutions, Stockport, Greater Manchester) and an AMTI hydraulic 12-station hip simulator (AMTI, Watertown, MA). Method. Neck impingement testing per ASTM F2582-14 was carried out on four groups of artificially aged acetabular liners (per ASTM F2003-15) made from GUR 1020 UHMWPE which was re-melted and cross-linked at 7.5 Mrad. Group A (n=3) and B (n=3) consisted of 28mm diameter femoral heads articulating on 28mm ID × 44mm OD acetabular liners. Group C (n=3) and D (n=3) consisted of 40mm diameter femoral heads articulating on lipped 40mm ID × 56mm OD 10° face changing acetabular liners. All acetabular liners were tested in production equivalent shell-fixtures mounted at 0° initial inclination angle. Femoral stems were potted in resin to fit respective simulator test fixtures. Testing was conducted in bovine serum diluted to 18mg/mL protein content supplemented with sodium azide and EDTA. Groups A and C were tested on a Prosim; Groups B and D were tested on an AMTI. Physical examination and coordination measurement machine (CMM) analyses were conducted on all liners pre-test and at 0.2 million cycle intervals to monitor possible failure mechanisms. Testing was conducted for 1.0 million cycles or until failure. An Abaqus/Explicit model was created to investigate relative motions and contact areas resulting from initial impingement kinematics for each test group. Results. Effects of kinematic differences in the execution of ASTM F2582-14 were observed in the four groups based on simulator type (Figure 1) and liner design. The Abaqus/Explicit FEA model revealed notable differences in relative motions and contact points (Figure 2) between specimen components i.e. acetabular liner, femoral head, and femoral stem throughout range of motion. Acetabular liner angular change within shell-fixtures, rim deformation, crack propagation, and metal-on-metal contact between acetabular shell-fixtures and femoral stems were observed as potential failure mechanisms (Figure 3) throughout testing. These mechanisms varied in severity by group due to differing contact stresses and simulator constraints. Significance. Investigating failure mechanisms caused by altered kinematics of in-vitro neck impingement testing, due to influences of simulator type and acetabular liner design, may aid understanding of failure mechanisms involved when assessing complaints/retrievals and influence future prosthetic designs. For any figures or tables, please contact the authors directly

Introduction. Retrieval investigations have shown that cracking or rim failure of polyethylene hip liners may occur at the superior aspect of the liner, in the area that engages the locking ring of the shell. 1. Failure could occur due to acetabular liner/stem impingement and/or improper cup position. Other contributing factors may include high body mass index, patient activity and design characteristics such as polyethylene material properties, thin liner rim geometry and cup rim design. Currently no standard multi-axis simulator methodology exists for high angle rim fatigue testing, although tests have been developed using static uniaxial load frames. 2. The purpose of this study was to develop a technique to create a clinically relevant rim crack/fracture event on a 4-axis hip simulator, and to understand the contribution of component design and loading and motion parameters. Method. A method for creating rim fracture in vitro was developed to evaluate implant design features and polyethylene liner materials. Liners were secured into acetabular shells, fixtured in resin mounted at a 55° (in vitro; 65° in vivo) inclination to ensure high load/stress was at the area of interest. Ranges of kinematic and maximum applied load profiles were investigated (parameters summarized in Table 1). Testing was conducted on an AMTI 12-station hip simulator for 0.25–1.0 million cycles or until fracture (lubrication maintained with lithium grease). At completion, liners were cleaned and examined for crack propagation/fracture. Inspection of the impingement site on the opposite rim was also analyzed. Additional assessments included liner disassociation/rock out, deformation of characteristics such as anti-rotation devices and microscopic inspection of high-stress regions. Results/Discussion. This study summarizes testing on hip wear simulators to create rim cracking/fracture in vitro. Results indicate that cup/stem angles must be controlled to ensure contact areas are reproducible, and therefore on a multi-station machine (i.e. AMTI), only one test station can/should be run at a time to ensure repeatability. Component design characteristics, such as head size and liner material had a marked effect on the results. It is noted that the kinematics, load and cycle count must be adjusted per the component design to create rim fracture in the high-risk region. Finite element analysis modeling may help identify the high-stress region(s) prior to simulator testing. Deformation of the rim opposite the fracture region (rim/taper impingement) was observed due to the high angle of inclination combined with the abduction/adduction angles. Conclusion. Rim fractures similar in location and morphology to those seen in retrieval studies can be created using a multi-axis hip simulator in vitro. It is noted, however, that the factors presented in this study must be considered and controlled to assure a repeatable method, as the differences in component design investigated and simulator inputs were seen significantly affect the outcome. This study was limited and did not attempt to reproduce rim damage seen in all implant retrievals (e.g. lateralized liners, high offset implants, etc.). These design inputs are being investigated and will be reported upon in the future. For any figures or tables, please contact the authors directly

Introduction. Acetabular component loosening has been one of the factors of revision of total hip arthroplasty (THA). Inadequate mechanical fixation or load transfer may contribute to this loosening process. Several reports showed the load transfer in the acetabulum by metal components. However, there is no report about the influence of the joint surface on the load transfer. We developed a novel acetabular cross-linked polyethylene (CLPE) liner with graft biocompatible phospholipid polymer(MPC) on the surface. The MPC polymer surface had high lubricity and low friction. We hypothesized the acetabular component with MPC polymer surface (MPC-CLPE) may reduce load transfer in the acetabulum compared to that of the by CLPE acetabular component without MPC. Methods. We fixed the three cement cup with MPC-CLPE (Group M; sample No.1–3) and three cement cup with CLPE (Group C; sample No.4–6) placed in the synthetic bone block with bone cement with a 0.10mm thick arc-shaped piezoresistive force sensor, which can measure the dynamic load transfer(Tekscan K-scan 4400; Boston). (Fig 1) A hip simulator (MTS Systems Corp., Eden Prairie, MN) was used for the load transfer test performed according to the ISO Standard 14242-1. Both groups had same inner and outer diameter s of 28 and 50mm, respectively. A Co–Cr alloy femoral head with a diameter of 28 mm (K-MAXs HH-02; KYOCERA Medical Corp.) was used as the femoral component. A biaxial rocking motion was applied to the head/cup interface via an offset bearing assembly with an inclined angle of +20. Both the loading and motion were synchronized at 1 Hz. According to the double-peaked Paul-type physiologic hip load, the applied peak loads were 1793 and 2744 N described in a previous study. The simulator was run 3 cycles. We recorded both the peak of the contact force and the accumulation of the six times load in total. Secondly, we calculated the mean change of the load transfer. We used the Student t-test. P value < 0.05 was used to determine statistical significance. We used EZR for statistical analysis. Results. The mean of total accumulation of the load transfer in the group M is significantly lower than that of in the group C. (7037±508 N vs 11019±1290 N, P<0.0001). The peak of load in the group M was also significantly lower than that in the group C. (1024±166 N vs 1557±395 N) (Fig 2)The mean of the change of the load transfer in the group M is significantly lower than that of in the group C. (2913±112 N vs 4182±306 N) (Fig 3). Conclusion. The acetabular component with MPC surface could reduce and prevent the radical load transfer change toward to the acetabulum compared to CLPE acetabular component without MPC. For any figures or tables, please contact the authors directly

Introduction. Adverse local tissue reactions (ALTR) can result in devastating soft tissue and osseous destruction, while potentially increasing the risk of concomitant periprosthetic joint infection (PJI). The aims of this study were to evaluate cobalt (Co) and chromium (Cr) levels generated in simulators from metal-on-polyethylene (MoP) and ceramic-on-polyethylene (CoP) constructs, and determine their impact on native tissues and PJI risk through evaluation of human adipose-derived mesenchymal stem cells (AMSCs) and Staphylococcus epidermidis isolates. Methods. Ten hip simulator constructs were assembled with 36-mm high-offset femoral heads, highly cross-linked polyethylene liners, and titanium stems. Five constructs used CoCr femoral heads and five used ceramic. Constructs were submerged in bovine serum (BS) and run for 1,000,000 cycles. Samples of BS were collected and evaluated for CoCr concentration. Various concentrations of CoCr were chosen for further assessment of cytotoxicity and growth impact on AMSCs and S. epidermidis and compared to inert SiO2. Results. After 1,000,000 cycles, mean MoP and CoP Co concentration was 2264 ng/mL and 0.6 ng/mL, respectively (p<0.001). Mean MoP and CoP Cr concentration was 217 ng/mL and 4.3 ng/mL, respectively (p<0.001). Mean MoP Co:Cr ratio was 10. Co nanoparticles were significantly more toxic to human AMSCs than control SiO2 in a dose-response manner (p<0.001). S. epidermidis growth was not significantly impacted by Co concentrations derived from the simulators. Conclusions. MoP constructs built in ideal conditions generated substantial CoCr debris, highlighting a baseline risk with these implants that may be exacerbated by host factors or imperfect surgical technique. Evaluation of impact on AMSCs suggests that debris levels produced under ideal conditions can be cytotoxic. Additionally, these concentrations did not potentiate or inhibit S. epidermidis growth, suggesting elevated PJI rates with ALTR may be related to other factors potentially associated with tissue necrosis. For any tables or figures, please contact the authors directly

INTRODUCTION. There is great potential for the use of computational tools within the design and test cycle for joint replacement devices. The increasing need for stratified treatments that are more relevant to specific patients, and implant testing under more realistic, less idealised, conditions, will progressively increase the pre-clinical experimental testing work load. If the outcomes of experimental tests can be predicted using low cost computational tools, then these tools can be embedded early in the design cycle, e.g. benchmarking various design concepts, optimising component geometrical features and virtually predicting factors affecting the implant performance. Rapid, predictive tools could also allow population-stratified scenario testing at an early design stage, resulting in devices which are better suited to a patient-specific approach to treatment. The aim of the current study was to demonstrate the ability of a rapid computational analysis tool to predict the behaviour of a total hip replacement (THR) device, specifically the risk of edge loading due to separation under experimental conditions. METHODS. A series of models of a 36mm BIOLOX. ®. Delta THR bearing (DePuy Synthes, Leeds, UK) were generated to match an experimental simulator study which included a mediolateral spring to cause lateral head separation due to a simulated mediolateral component misalignment of 4mm. A static, rigid, frictionless model was implemented in Python (PyEL, runtime: ∼1m), and results were compared against 1) a critically damped dynamic, rigid, FE model (runtime: ∼10h), 2) a critically damped dynamic, rigid, FE model with friction (µ = 0.05) (runtime: ∼10h), and 3) kinematic experimental test data from a hip simulator (ProSim EM13) under matching settings (runtime: ∼6h). Outputs recorded were the variation of mediolateral separation and force with time. RESULTS/DISCUSSION. The low cost PyEL model successfully replicated experimental trends in maximum separation with changing swing phase load. PyEL provided a good estimate of the high separation values which resulted from lower swing phase loads, but overestimated the separation resulting from higher swing phase loads. The separation verses time curve of the dynamic rigid FE (with and without friction) closely matched that of the PyEL model. Inertia caused a small delay when moving into and out of the cup (peak delay ∼0.025s). Therefore there was no substantial advantage to the more costly dynamic finite element models as a predictive design tool for hard-on-hard bearings

Introduction and Aims. A recent submission to ASTM, WK28778 entitled “Standard test method for determination of friction torque and friction factor for hip implants using an anatomical motion hip simulator”, describes a proposal for determining the friction factor of hip implant devices. Determination of a friction factor in an implant bearing couple using a full kinematic walking cycle as described in ISO14242-1 may offer designers and engineers valuable input to improve wear characteristics, minimize torque and improve long term performance of hip implants. The aim of this study was to investigate differences in friction factors between two commercially available polyethylene materials using the procedure proposed. Methods. Two polyethylene acetabular liner material test groups were chosen for this study: commercially available Marathon. ®. (A) and AltrX. ®. (B). All liners were machined to current production specifications with an inner diameter of 36mm and an outer diameter of 56mm. Surface roughness (Ra) of the liner inner diameters were measured using contact profilometry in the head-liner contact area, before and after 3Mcyc of wear testing. Liners were soaked in bovine serum for 48 hours prior to testing. Friction factor measurements were taken per ASTM WK28778 prior to, and after wear testing using an external six degrees of freedom load cell (ATI Industrial Automation) and a reduced maximum vertical load of 1900N. Friction factor and wear testing was conducted in bovine serum (18mg/mL total protein concentration) supplemented with 0.056% sodium azide (preservative) and 5.56mM EDTA (calcium stabilizer) on a 12-station AMTI (Watertown, MA) ADL hip simulator with load soak controls per ISO 14242-1:2014(E). The liners were removed from the machine, cleaned and gravimetric wear determined per ISO 14242-2:2000(E) every 0.5 million cycles (MCyc) through a total of 3Mcyc to evaluate wear. Results. It was observed that although measured wear rates were significantly different between the Marathon. ®. (10.3 ± 2.2mg/Mcyc) and AltrX. ®. (1.7 ± 0.2mg/Mcyc) test groups, the measured friction factors were not significantly different between groups; 0.094 ± 0.015 Marathon. ®. and 0.095 ± 0.007 AltrX. ®. pre wear, and 0.103 ± 0.001 Marathon. ®. and 0.106 ± 0.006 AltrX. ®. post wear. The increase in friction factor observed following wear in of the polyethylene liners is expected. Average friction factors were calculated from data measured in the region from heel strike through toe-off of the gait cycle (the 1. st. 60% of the kinematics cycle described in ISO 14242). It is observed that the resultant friction curves for untested bearing couples had a larger spread across the 4 measured samples than those following 3Mcyc of standard wear, most likely due to variations in polyethylene roughness, contact area and clearances between the bearing couples in the as received state. Conclusions. It is concluded from this study that the draft ASTM protocol proposed is capable of measuring frictional effects in MoP hip bearing couples, and for the polyethylene materials tested herein there is no significant difference between the average measured friction factors when all other parameters (i.e. design and gait cycle) are controlled