Introduction. Edge loading in acetabular hip implants is generally due to mal-orientation or low tissue tension. It is known that edge loading of metal-on-metal THA may lead to higher metal wear and ion release with corresponding adverse body reactions. The inclination angle of the acetabular cup has been positively correlated with the wear rate of explanted components . 1. However, no data published is known about wear rates of edge loaded hard – soft hip bearings. Methods. For the hip simulator study, seleXys cup inlays, size 28/EE, (Mathys Ltd Bettlach, Switzerland) were used. Standard PE parts and vitamys® inlays (highly cross-linked, vitamin E stabilised UHMWPE) were tested in the same run. PE inlays were machined out of sintered GUR 1020 slabs, packaged and gamma-sterilised in inert atmosphere at 30 kGy. The vitamys® material was made in-house by adding 0.1 wt.-% of vitamin E to GUR 1020 powder from Ticona GmbH, Kelsterbach/Germany. Cross-linking used 100 (±10) kGy gamma-irradiation and the final sterilisation was gas plasma. Cup inclination was varied: besides the protocol of ISO 14242-1 with an inclination angle corresponding to 45 ° in the medial-lateral plane, a steep cup position corresponding to 75 ° was tested, too. To our knowledge, this is the highest inclination angle ever tested in a hip simulator. The testing was conducted in a servo-hydraulic six-station hip simulator (Endolab, Thansau/Rosenheim, Germany) at a temperature of 37±1°C. Tests were run at the RMS Foundation (Bettlach / Switzerland) for five million cycles. The test fluid was based on bovine serum diluted to a protein concentration of 30 g/l and stabilised with sodium azide and EDTA. At lubricant change interval of 500,000 cycles, the inlays were measured gravimetrically with an accuracy of 0.01 mg. Results. The wear rate of the standard UHMWPE inlays tested with an inclination of 75° was 16% lower than those of the inlays with 45 ° inclination. For the vitamys® inlays, wear rates were about the same for both inclination angles (cf. Figure 1). After the test, the 75 ° inlays were polished tribologically on the caudal wall of the inlays while on the pole the tool-marks were still present (Figure 2, vitamys®). The polished surface of the 45 ° inclination samples was lager and covered about 2/3 of the articulation surface (vitamys®, Figure 3) or almost the whole articulation (standard PE). Hence, the hard – soft bearings tested showed no significant effect of inclination angle on the wear rate. This is true for a position as steep as 75 °, just before subluxation would occur. Conclusions. Based on the present hip simulator study, it seems that metal-on-polyethylene bearings are exempt of accelerated wear rate when subjected to edge loading conditions. Using the newest generation of HXLPE, stabilised with vitamin E, combines superior oxidation resistance . 2. , low wear and highest forgiveness for component mal-orientation

Introduction. The bearing surfaces of ceramic-on-ceramic (CoC) total hip replacements (THR) show a substantially lower wear rate than metal-on-polyethylene (MoP) THR in-vitro. However, revision rates for CoC THR are comparable with MoP. Our hypothesis that an explanation could be adverse reaction to metal debris (ARMD) from the trunnion led us to investigate the wear at both the bearing surfaces and the taper-trunnion interface of a contemporary CoC THR in an in-vitro study. Methods. Three 36mm CoC hips were tested in a hip simulator for 5 million cycles (Mc). BIOLOX. ®. delta ceramic femoral heads were mounted on 12/14 titanium (Ti6Al4V) trunnions. Wear of femoral heads, acetabular liners and trunnions was determined gravimetrically using the analytical balance. Roughness measurements (Sa) were taken on the articulating surfaces (pre and post-test) and on the trunnion surfaces (worn and unworn). Furthermore, Energy Dispersive X-ray Spectroscopy (EDX) was used to identify and quantify the wear debris present in the lubricant using scanning electron microscope (SEM). Results and Discussion. The total volumetric wear was 0.25 mm. 3. for CoC joints and 0.29 mm. 3. for titanium trunnions. The total wear volume of the titanium trunnions was in agreement with an explant study (Kocagoz et al, 2016, CORR) which quantified the volumetric material loss from retrieved trunnions with the total wear ranging from 0.0–0.74 mm. 3. The Sa values, pre-and post-test, for heads were 0.003 ± 0.002 and 0.004 ± 0.001 µm and for liners were 0.005 ± 0.001 and 0.005 ± 0.001 µm. Pre-and post-test measurements for Sa of heads (p = 0.184) and liners (p = 0.184) did not show a statistically significant change. The Sa of the trunnions on the unworn and worn areas showed a statistically significant decrease from 0.558 ± 0.060 to 0.312 ± 0.028 µm respectively (p < 0.001). Analysis of wear debris within the lubricant confirmed the presence of titanium. A recent clinical study (Matharu et al, 2016, BMC Musc Dis) found more ARMD in CoC hips than MoP hips. This is despite there being fewer metallic components in a CoC hip than a MoP hip. This in vitro study has shown that one source of metal debris in a CoC hip is the taper-trunnion junction. Conclusion. An explanation for wear related failures in ceramic-on-ceramic hip arthroplasty, despite the low wear arising at the articulating surfaces, may now exist; namely that titanium wear particles are generated from the trunnion. No other long-term hip simulator studies have measured wear at the taper-trunnion junction

Introduction. Osteolysis and aseptic loosening in total hip replacement (THR) is often associated with polyethylene (PE) wear. This caused interest in alternative bearing surfaces. Since the mid nineties, research focused on hard-hard bearings like metal-on-metal (MOM) or ceramic-on-ceramic (COC). However, concerns remain about biological reactions to metallic wear debris or failure of the ceramic components. A new approach to reduce wear with a minimized risk of failure may be the use of a metallic cup in combination with a ceramic head, the so called ceramic-on-metal bearing (COM). The aim of this study was to estimate the wear behaviour at an early stage of this COM bearing type in comparison to COC bearings using a hip simulator. Material and Methods. Simulator studies were carried out on a single station hip simulator (MTS 858 Mini Bionix II, Eden Prairie, USA) in accordance to ISO 14242-1. Bovine serum was used as the test medium. Four COM and four COC bearings were used, both 36mm in diameter. The heads were made of a mixed-oxid ceramic (Biolox Delta(r)) paired with a high carbon wrought CoCrMo cup in the COM group whereas both components were made of Biolox Delta(r) in the COC group. Simulation was run to a total of 2.4×10. 6. cycles. Wear measurements were performed in intervals of 0.2x10. 6. cycles using a gravimetric method (Sartorius Genius ME235S, measuring solution: 15 μg, Sartorius, Göttingen, Germany). Results. Wear of the COM and COC pairings is shown in Figure 1. During the first 200,000 cycles a mean wear rate of 0.16mm. 3. /10. 6. cycles was found followed by a decreased wear rate of 0.04mm. 3. /10. 6. cycles for the COC bearings. The overall wear ranged from 0.08mm. 3. to 0.17mm. 3. , with a mean of 0.12 mm. 3. There was found a high variability in the wear progression between the four COM implants (Figure 1). A mean wear rate of 0.13mm. 3. /10. 6. cycles was determined during the first 200,000 cycles followed by a decreased wear rate of 0.05mm. 3. /10. 6. cycles. The overall wear of the COM implants ranged from 0.02mm. 3. to 0.21mm. 3. , with a mean of 0.13 mm. 3. All ceramic heads from the COM bearings showed metallic material transfer in form of stripes whereas no visible wear traces were found on the COC heads. Discussion and Conclusion. The COM implants showed very low wear levels that were similar to the COC bearings and far below wear levels of conventional MOM bearings. However, there was a spreading up to the thirteen fold between lowest and highest wear volume of the COM at the end of the study. Concerning COM implants such high variability was also seen by other investigators. The simulator conditions are highly reproducible (as seen for the COC bearings). Considering the high variations in patients demand, the influence of patient related activity parameters should be further investigated in terms of wear. Moreover, this study was performed without implementing subluxation, impingement or malalignment which might also increase wear. These effects together with the influence of third body wear needs to be further considered

Burroughs et al showed that frictional torque increases with increasing head size in a simple in vitro model and showed differences in frictional torque with different polyethylene materials [1]. Therefore, the purpose of this study was to evaluate the influence of bearing material and bearing size on the frictional torque of hip bearings utilizing a more physiologically relevant hip simulator model. A total of four hip bearing combinations (Crosslinked PE/CoCr, Conventional PE/CoCr, Crosslinked PE/Delta and Alumina /Alumina) with various bearing sizes were evaluated. The sizes tested in this study range from 22 mm to 44 mm; it is important to note that the study only evaluated bearing combinations (size and material combination) currently commercially available. A total of three samples per bearing combination were tested, with the exception of conventional PE, which included a total of 4 samples. A MTS hip joint simulator was used. All components were oriented anatomically with the femoral head mounted below on a rotating angled block which imparts a 23° biaxial rocking motion onto the head. Loading was held constant at each load level (500N, 1000N, 1500N, 2000N, 2450N) for at least two rotational cycles while all 3 axes of load and all 3 axes of moments were measured at 10 khz. Fresh Alpha Calf Fraction serum was utilized as a lubricant. Results show that frictional torque increases with the increase of head size regardless of head material for all polyethylene combinations (p > 0.05), as shown in Figure 1 and 2. However, results showed no change in frictional behavior for the Alumina/Alumina combination regardless of the bearing size. The results of this test did not show any significant difference between crosslinked PE and conventional PE materials for sizes 28 mm and 32 mm when paired against a CoCr head (p > 0.05) (Figure 3). The Alumina/Alumina bearing combination had the lowest frictional torque among all the bearing material combinations evaluated in this study. This data suggests that there is a strong correlation between increased head size and increased frictional torque (R. 2. = 0.6906, 0.8847) for the polyethylenes evaluated here regardless of head material. No correlation can be concluded for the Alumina /Alumina bearing combination (R. 2. = 0.0217). The combination of Alumina /Alumina seems to have the most favorable frictional properties. This data also suggests no effect on frictional properties regardless of the polyethylene material (crosslinked and conventional) for sizes 28 mm and 32 mm. The frictional torque values recorded in this study are different than those published by Burroughs et al [1]. This difference may be attributed to the testing methodology. The current study utilizes a hip simulator, which closely mimics the natural joint providing a more physiologically relevant model whereas the Burroughs et al study utilizes a single axis machine. It is important to understand that frictional behavior in hip bearings may be highly sensitive to bearing clearance, cup thickness, and stiffness, which may outweight the effect of head diameter. Further evaluation is necessary to isolate and investigate those parameters

INTRODUCTION. The reported revision rate for THA is below 10% at 10 years. Major factors for revision are aseptic loosening or dislocation of the articulating components. CoC bearings in total hip arthroplasty (THA) have demonstrated very low wear rates. Due to producing the least number of wear particles of any articular bearing used for THA, osteolysis is very rarely observed. Zirconia-platelet toughened alumina (ZPTA) has improved toughness and bending strength while maintaining all other advantageous properties of alumina. Consequently, its clinical fracture rate is minimal and wear resistance is superior to alumina. OBJECTIVES. Since a trend exists towards the usage of larger bearings the aim of this study was to compare the tribological behavior of different ZPTA/ZPTA THAs with respect to their ball head diameter. METHODS. Wear tests according to ISO14242-1 were performed in a servo-hydraulic hip simulator with ZPTA bearings from 28 to 48mm up to 5 million cycles (mc). Wear was measured every mc and surfaces were inspected at 5mc. The tests were carried out in 20g/l protein serum. RESULTS. All ZPTA articulations showed a characteristic running in period followed by a steady decrease in wear rate up to 5mc. The 48mm bearing showed highest running in wear. For all bearing sizes wear decreased to about 0.05mm³/mc or less throughout the testing period. For all couplings minimal differences in the wear rate was found. CONCLUSION. The current study supports the extremely low wear rates for ZPTA/ZPTA bearings and showed that increasing the diameter up to 48mm has only a small influence on the wear rate when tested under ISO14242-1 conditions. Larger diameter bearings increase the range of motion and joint stability and reduce the risk of impingement or dislocation. Thus, larger diameter ZPTA bearings seem a safe solution for active patients due to higher dislocation resistance and reduced wear. Other loading conditions such as subluxation are known to contribute to the clinical wear rate and will be investigated in future tests

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

Introduction. Over 40-years the dominant form of implant fixation has been bone cement (PMMA). However the presence of circulating PMMA debris represents a 3rd-body wear mechanism for metal-on-polyethylene (MPE). Wear studies using PMMA slurries represent tests of clinical relevance (Table 1). Cup designs now use many varieties of highly-crosslinked polyethylene (HXPE) of improved wear resistance. However there appears to be no adverse wear studies of vitamin-E blended cups.1–4 The addition of vitamin E as an anti-oxidant is the currently preferred method to preserve mechanical properties and ageing resistance of HXPE. Therefore the present study examined the response of vitamin-E blended liners to PMMA abrasion combined with CoCr and ceramic heads. The hip simulator wear study was run in two phases to compare wear with, (i) clean lubricants and (ii) PMMA slurries. Methods. The vitamin-e blended polyethylene liners (HXe+) were provided by DJO Surgical (Austin, TX) with 40mm CoCr and ceramic femoral heads (Biolox-delta). Polyethylene liners were run in standard “Inverted” test. (Table 1) All cups were run in ‘clean’ serum lubricant for 6-million load cycles (6Mc)5 and in a debris slurry (PMMA: 5mg/ml concentration) for 2Mc.4 A commercial bone cement powder was used as “abrasive” (Biomet, Warsaw, IN). PMMA slurries were added at test intervals 6, 6.5, 7 and 7.5Mc.4 Wear was assessed gravimetrically and characterized by linear regression. Bearing roughness was analyzed by interferometry and SEM. Results. The acetabular cups showed low wear-rates to 6Mc duration with both ceramic and CoCr heads (Fig. 1). The debris slurries created much higher wear-rates, whereas control liners continued as before (Table 2). Discussion. This is the 1st study of vitamin-E blended polyethylene under 3rd-body wear conditions. With clean lubricant conditions, CPE combination wore approximately 50% less than MPE combination. Under abrasive lubricant conditions, CPE and MPE combinations wore at approximately same rate but more than an order of magnitude greater than the clean test phase. This was typical of such PMMA abrasion tests (Table 1). However there are no guidelines as to optimal choice of particulate type, morphology, dosage, frequency of injection or duration of test intervals (Table 1). The production of particulates in vivo is an unpredictable phenomenon and consequently laboratory simulation is fraught with uncertainties.6 On completion of the abrasive challenge (6–8Mc duration), our study will continue under clean conditions to 10Mc to define the important recovery phase of the vitamin-E blended polyethylene.3

Damage to metallic femoral heads can occur in vivo. Testing of hip prostheses under abrasive conditions is one among various efforts needed towards more realistic and harsher testing. Abrasion likely increases both wear and friction at the head/liner interface. This study investigates if our novel friction measurement technique can detect damage to femoral heads during extended wear testing of metal-on-plastic (MOP) THRs of various material combinations using both scratched and as-new femoral heads. Friction was measured based on equilibrium of forces and moments measured by a 6-DOF load cell on each test station of an AMTI hip simulator. The force and moment data from the load cells was utilized to calculate the frictional torque about each of three rotational axes (flexion/extension, abduction/adduction and internal/external rotation). The frictional torques were transformed to account for the offset in load cell position from the hip center and were then vector summed to yield an overall frictional torque about the femoral head. The friction factor was then computed by dividing the overall frictional torque by the applied compressive load and the femoral head radius. The waveforms specified in ISO-14242-1 were used. Diluted bovine serum at 37°C with 30 g/L protein concentration lubricated the specimens. Twelve UHMWPE liners (40 mm I.D.) were tested against CoCrMo femoral heads. Liners were of three materials: a) Three conventional (GUR1020, gamma-sterilized 3.5 Mrad), b) Three highly cross-linked (HXL) (GUR 1020, 10 Mrad, annealed, EtO-sterilized, artificially aged), and c) Six HXL w/vitamin-E (GUR 1020, 12 Mrad, annealed, EtO-sterilized, aged). The test consisted of three phases were as follows: . –. Phase-I: Standard clean (non-abrasive) test for 5 Mc. –. Phase-II: Pulverized PMMA was added to serum at 700 mg/L (to introduce abrasive conditions); however, effects were minimal after 2 Mc (7 Mc total). –. Phase-III: Femoral heads were scratched using a technique developed in house to create latitudinal and longitudinal scratches similar to what is seen on retrievals. Phase-III lasted for 1 Mc, for a total of 8 Mc. The friction results are shown in Fig. 1. Friction factors of the three THR types tested were similar for the first 5 Mc (0.062 ± 0.0084) and increased only marginally after the PMMA powder was added (0.066 ± 0.0066). The PMMA powder did not appear to damage the heads much visually, and therefore the insignificant increase was not surprising. However, once heads were intentionally scratched at 7 Mc, the friction factor rose on all three THR types: a) 0.11 ± 0.0077, b) 0.082 ± 0.0049, c) 0.087 ± 0.022. This friction technique successfully detected when femoral head damage had occurred. Higher friction was clearly observed after femoral heads had been scratched

Introduction. Metal-on-polyethylene (MoP) is the most commonly used bearing couple in total hip replacements (THRs). Retrieval studies (Cooper et al, 2012, JBJS, Lindgren et al, 2011, JBJS) report adverse reactions to metal debris (ARMD) due to debris produced from the taper-trunnion junction of the modular MoP THRs. A recent retrospective observational study (Matharu et al, 2016, BMC Musc Dis) showed that the risk of ARMD revision surgery is increasing in MoP THRs. To the authors' best knowledge, no hip simulator tests have investigated material loss from the taper-trunnion junction of contemporary MoP THRs. Methods. A 6-station anatomical hip joint simulator was used to investigate material loss at the articulating and taper-trunnion surfaces of 32mm diameter metal-on-cross-linked polyethylene (MoXLPE) joints for 5 million cycles (Mc) with a sixth joint serving as a dynamically loaded soak control. Commercially available cobalt-chromium-molybdenum (CoCrMo) femoral heads articulating against XLPE acetabular liners (7.5Mrad) were used with a diluted new-born-calf-serum lubricant. Each CoCrMo femoral head was mounted on a 12/14 titanium alloy trunnion. The test was stopped every 0.5Mc, components were cleaned and gravimetric measurements performed following ISO 14242-2 and the lubricant was changed. Weight loss (mg) obtained from gravimetric measurements was converted into volume loss (mm. 3. ) and wear rates were calculated from the slopes of the linear regression lines in the volumetric loss versus number of cycles plot for heads, liners and trunnions. Additionally, volumetric measurements of the head tapers were obtained using a coordinate measuring machine (CMM) post-test. The surface roughness (Sa) of all heads and liners was measured pre and post-test. At the end of the test, the femoral heads were cut and the roughness of the worn and unworn area was measured. Statistical analysis was performed using a paired-t-test (for roughness measurements) and an independent sample t-test (for wear rates). Results and Discussion. The mean volumetric wear rates for CoCrMo heads, XLPE liners and titanium trunnions were 0.019, 2.74 and 0.013 mm. 3. /Mc respectively. There was a statistically significant decrease (p<0.001) in the Sa of the liners post-test. This is in contrast to the femoral heads roughness in which no change was observed (p = 0.338). This head roughness result matches with a previous MoP in vitro test (Saikko, 2005, IMechE-H). The Sa of the head tapers on the worn area showed a statistically significant increase (p<0.001) compared with unworn, with an associated removal of the original machining marks. The mean volumetric wear rate of the head tapers obtained using the CMM (0.028 ± 0.016 mm. 3. /Mc) was not statistically different (p=0.435) to the mean volumetric wear rate obtained gravimetrically (0.019 ± 0.020 mm. 3. /Mc) for the femoral heads. Therefore, wear of the heads arose mainly from the internal taper. The mean wear rates of the CoCrMo taper and titanium trunnion are in agreement with a MoP explant study (Kocagoz et al, 2016, CORR). Conclusion. This is the first long-term hip simulator study to report wear generated from the taper-trunnion junction of MoP hips

Is is believed that 3rd-body wear of polyethylene, be it from particles of bone, bone-cement (PMMA), or metal, is an unavoidable risk in total hip arthroplasty (THA). Simulator studies have demonstrated that wear in conventional polyethylene (CXPE) and highly crosslinked polyethylene (HXPE) cups increased 6 and 20-fold respectively when challenged by circulating 3^rd-body PMMA particulates. There was no corresponding change in head roughness, i.e. the PMMA did not roughen CoCr surfaces. Many contemporary cup designs now use the vitamin-E process combined with higher crosslinking dosage (VEPE). However, little if anything is known about the VEPE debris. Therefore in this study we analyzed the morphology of VEPE particles from cups that had been run in, a) standard simulator test mode and b) adverse PMMA debris-challenge mode. The aim of this study was to determine how a clinically relevant challenge, such as addition of PMMA particles affected the wear debris. This had not been attempted previously due to contamination polyethylene by PMMA debris. The hypotheses were that, a) during the ‘clean’ test, VEPE would yield smaller debris of standard globular shape compared to controls (XPE) and b) in adverse PMMA challenge mode, VEPE debris size would increase and become more flake-like.

The XPE and vitamin-E blended cups (VEPE) cups were gamma-irradiated at 7.5 Mrad and 15 Mrad, respectively. Cups were run Inverted and mated with ceramic femoral heads of diameter 44 mm (Biolox-delta, Ceramtec). The three test phases included; ‘clean’ for 6 million cycles (6 Mc), abrasive slurry 6–8 Mc (concentration 10g/L), and ‘clean’ 8–10 Mc. The debris was isolated using standard procedure for ‘clean’ tests and a modified procedure for the abrasive slurries. Particles were imaged using SEM and the micrographs analyzed (Image J). Approximately 600 particles were analyzed from each sample (4.5 Mc and 8 Mc) and morphology defined via aspect ratio (AR), equivalent circular diameter (ECD), and circular shape factor (CSF).

The clean test revealed slight differences in shape factors for XPE and VEPE (AR, CSF within 30%: p <0.0001) but none with regard to size (p > 0.9999). The median ECD for both XPE and VEPE was approximately 0.55 μm. The abrasive test revealed a statistical difference (p < 0.0001) in shape compared to the clean test, but varied less than 25%. The greater change in debris morphology between the abrasive test and clean test was size, which increased 3.6 fold for VEPE particles (ECD = 2.0 μm) and 4.3 fold for XPE particles (ECD = 2.3 μm).

It was determined that addition of vitamin E to the PE did not change the size, but did change the shape of PE debris particles up to 30%. This study was the first to isolate debris particles during an abrasive slurry test and determine morphology under such conditions. Debris particles formed in abrasive conditions were found to be 4-fold larger in diameter, suggesting a larger volume of shreds in comparison to the mostly submicron population observed under standard testing conditions.

Figure 1: Boxplot of equivalent circular diameter values.

Figure 2: Boxplot of aspect ratio values.

Figure 3: Boxplot of circular shape factor values.

Introduction

Significant reduction in the wear of current orthopaedic bearing materials has made it challenging to isolate wear debris from simulator lubricants. Ceramics such as silicon nitride (SiN), as well as ceramic-like surface coatings on metal substrates have been explored as potential alternatives to conventional implant materials. Current isolation methods were designed for isolating conventional metal, UHMWPE and ceramic wear debris. The objective of this study was to develop methodology for isolation and characterisation of modern ceramic or ceramic-like coating particles and metal wear particles from serum lubricants under ultra-low wearing conditions. Sodium polytungstate (SPT) was used as a novel density gradient medium due to its properties, such as high water solubility, the fact that it is non-toxic and acts as a protein denaturant, coupled with a large density range of 1.1–3.0 g/cm3 in water.

1. Introduction. Metal-on-metal (MOM) hip joints have regained a favor in arthroplasty since they own excellent wear resistance. In this study, wear tests by using a hip joint simulator were conducted with MOM bearings of specified 40 mm femoral heads. The influence of clearance on the wear behavior was investigated. Furthermore, an optimized radial clearance was estimated by lubricant film thickness and contact pressure analysis. 2. Materials and methods. Co-27Cr-5Mo-0.13N-0.05C (hereafter CCMN) alloy (mass %) was used. The ingots were vacuum induction melted, homogenized and hot forged successively. The microstructure shows equiaxed crystal grains with abundant annealing twins but no carbides. Two groups of bearings, indicated as cr 1 and cr 2, were designed. The radial clearances for cr 1 and cr 2 were 37.9 and 148.7 μm, respectively. Wear tests were conducted in a hip joint simulator (INSTRON 8870) in Hanks' solution at 37±2°f. The force and 3-axile angle of movement were applied on the articulation according to ISO 14242-1 for 1.5 million cycles (Mc). The contact pressures on the hip joints were also analyzed by using ABAQUS. The femoral heads were set 40 mm with radial clearances of 0–200 μm. Half models were set up and only the maximum force of 3 kN converted as pressure was applied as boundary condition. 3. Results and discussion. In general, the wear scratches paralleling to the flexion-extension direction tend to the greatest [Fig. 1]. For cr 1, shallow scratches and few plowing-grooves were observed. While for cr 2, deep plowing-grooves (5–10 μm) with obvious plastic deformation were generated in large quantities by abrasive wear. The wear rate [Fig. 2] for cr 2 was approximately 29.5 mm. 3. /Mc more than the one for cr 1, probable caused by different lubrication mode and contact pressure for different clearances. From the prediction of the lubricant film thickness, the lubrication regime transformed from full film lubrication to boundary lubrication for cr 1 and mixed film lubrication to boundary lubrication for cr 2. The simulation results [Fig. 3] also show that as the clearance increase, the contact pressure would increase leading to aggravating wear. On the other hand, if the clearance is too small, the contact pressure also increases by wedging and equatorial contact of the articulation. For a MOM articulation with a 40 mm femoral head, there is a minimum contact pressure when the radial clearance is between 40 and 50 μm. 4. Conclusions. To summarize, for a 40 mm diameter MOM articulation, abrasive wear was the dominant wear mechanism. The wear decreased as the radial clearance decreased, due to a thicker lubricant film thickness which can separate the surfaces' direct contact. However, the function of the contact pressure and radial clearance was not monotonous. It could be concluded that an optimized radial clearance ranging in 40–50 μm is appropriate for this MOM hip joint

Introduction and Aims. Clinically many factors such as variations in surgical positioning, and patients' anatomy and biomechanics can affect the occurrence and severity of edge loading which may have detrimental effect on the wear and durability of the implant. Assessing wear of hundreds of combinations of conditions would be impractical, so a preclinical testing approach was followed where the occurrence and severity of edge loading can be determined using short biomechanical tests. Then, selected conditions can be chosen under which the wear can be determined. If a wear correlation with the magnitude of dynamic separation or the severity of edge loading can be shown, then an informed decision can be made based upon the biomechanical results to only select important variables under which the tribological performance of the implant can be assessed. The aim of this study was to determine the relationship between the wear of ceramic-on-ceramic bearings and the (1) magnitude of dynamic separation, (2) the maximum force reached during edge loading and (3) the severity of edge loading resulting from component translational mismatch between the head and cup centres. Methods. The Leeds II hip joint simulator with a standard walking cycle and 36mm diameter ceramic-on-ceramic bearings (BIOLOX. ®. delta, DePuy Synthes Joint Reconstruction, Leeds, UK.) were used. The study was in two parts. Part one: a biomechanical study where the dynamic separation, the maximum load during edge loading, and the duration of edge loading alongside the magnitude of forces under edge loading (severity of edge loading) were assessed. Part two; a wear study where the wear rates of the bearing surfaces were assessed under a series of input conditions. These input testing conditions included inclining the acetabular cups at 45° and 65° cup inclination angle (in-vivo equivalent), with 2, 3, and 4mm medial-lateral component mismatch between the centres of the head and the cup. This equated to six conditions being assessed, each with three repeats for the biomechanical test, and six repeats completed for the wear study. The severity of edge loading was assessed as described in Equation 1. Severity of Edge Loading = ∫. t. t0. F(x) dx + ∫. t. t0. F(y) dy … Equation 1,. where F(x) is the axial load, F(y) is the medial-lateral load and t-t0 is the duration of edge loading. The wear of the ceramic bearings were determined using gravimetric analysis (XP205, Mettler Toledo, UK). Results. The wear rates of ceramic-on-ceramic bearings increased as the magnitude of dynamic separation (Figure 1), the maximum load at the rim during edge loading (Figure 2), and the severity of edge loading (Figure 3) increased. The magnitude of dynamic separation was found to have the highest correlation to the wear rate under the conditions tested in this study (R. 2. =0.94). Conclusions. A preclinical testing approach has been developed to understand the occurrence and severity of edge loading associated with variation of component positioning. A good correlation was found between the wear rates obtained for ceramic-on-ceramic bearings and the magnitude of parameters obtained under edge loading during a short-term biomechanical study. For figures/tables, please contact authors directly.

INTRODUCTION

Since the early 2000s, highly cross-linked (HXL) UHMWPE's have become a popular option with multiple experimental and clinical studies showing that gamma or electron radiation doses between 50–100kGY reduce wear and potentially extend the bearing life of UHMWPE. However, the increased wear resistance came at a compromise to mechanical properties due to the cross-linking process. Vitamin E has been added to some HXL UHMWPE materials to offer a solution to the compromise by increasing oxidation resistance and maintaining sufficient fatigue strength. However, limited data is available on the effect of the fabrication process, especially the method of irradiation, on the properties of the Vitamin E blended HXL UHMWPE. The purpose of this study was to evaluate the effects of adding the antioxidant vitamin E to highly crosslinked UHMWPE on wear rates.

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. 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. Hip implant research has been carried out for decades using hip simulators to reflect situations in vivo. With regards to metal on metal (MoM) implant testing, it has been reported that there is no significant difference between the wear generated by various cobalt chromium (CoCr) microstructures. On the contrary, higher wear, metal ion levels and subsequent failures have been reported in heat treated (high carbon, low carbide) devices compared to as cast (high carbon, high carbide) devices in vivo. During testing, the bearing surfaces may be masked from the effect of microstructure on wear under fast and continuous cycles, while in vivo, the extensive range of kinetics and kinematics, stop/start motion, varying walking frequencies could break down the fluid film, resulting in a less favourable lubrication regime. The aims of this study were to develop a more physiologically relevant hip simulator test protocol, and investigate the effect of microstructure on wear. Materials & Methods. Three pairs of 50mm as cast (AC) and four pairs of 50mm double heat treated (DHT) CoCr MoM devices were tested in a ProSim hip simulator. In order to determine the frequency for testing, Patients' activities have been monitored using a Step Activity Monitor (SAM) device. The data showed a relatively slower walking pace (frequency) than that used in the hip simulator studies. The new frequency, along with stop/start motion and various kinetics and kinematics profiles have been used in putting together a more physiologically relevant hip simulator test protocol. The lubricant used in this study was new born calf serum with 0.2 % (w/v) sodium azide concentration diluted with de-ionised water to achieve an average protein concentration of 20 g/l. Gravimetric measurements have been taken at 0.5, 1, 1.5 & 2 million cycle (Mc) stages and ion analysis has been carried out on the serum samples. Results & Discussions. A biphasic wear pattern similar to the parts in vivo was observed. Under the newly developed physiologically relevant test conditions, the DHT CoCr devices generated 40% higher wear than the AC CoCr devices (Figure 1). The metal ion analysis results also showed a similar biphasic wear trend, however, the difference between the AC and DHT devices was further increased by approximately 30 % at 2 Million cycle stage (Figure 2). It has been reported that the DHT devices generate smaller size particles and in much larger numbers compared to those generated by the AC devices. This would result in a larger net surface area of the wear particles exposed to corrosion and thus would contribute to a higher amount of metal ion levels with the DHT devices compared to AC devices. Conclusion. The in vitro results obtained with the new test protocol correlate well with the in vivo results. The higher wear, metal ion levels observed with double heat treated CoCr devices compared to as cast CoCr in vivo were also represented in vitro, highlighting the effect of microstructure on wear

Introduction. Hip simulators proved to be valuable, pre-clinical tests for assessing wear. Preferred implant positioning has been with cup mounted above head, i.e. ‘Anatomical’ (Figs. 1a-c) . 1,2. while the ‘Inverted’ test (cup below head) was typically preferred in debris studies (Figs. 1d-f). 3,4. In an Anatomical study, wear patterns on cups and heads averaged 442 and 1668 mm² area, respectively, representing 8% and 30% of available hemi-surface (Table 1), i.e. the head pattern was ×3.8 times larger than cup. This concept of wear patterns is illustrated well in the ‘pin-on-disk’ test (Fig. 1) in which the oscillating pin has the ‘contained’ wear area (CWP) and the large wear track on the disk is the ‘distributed’ pattern (DWP). Hip simulators also create CWP and DWP patterns, site dependant on whether Anatomical (Fig. 1a-c) or ‘Inverted’ (Fig. 1d-f) test. However there is scant foundation as to clinical merits of either test mode. Retrieval studies of MOM bearings have indicated that cups have the larger wear patterns, i.e. contrary to simulator tests running Anatomical cups (Table 1). 5. Therefore we compared Anatomical and Inverted cup modes using 38mm and 40mm MOM in two 5-million cycle simulator studies. Methods. 38mm and 40mm MOM bearings were run in Anatomical mode (study-1) and Inverted (study-2) mode, respectively, in a hip simulator. Lubricant was bovine serum diluted to provide protein concentration 17 mg/ml. Wear was measured gravimetrically and wear-rates calculated by linear regression. Wear patterns were assessed by stereomicroscopy and compared to algorithms using standard spherical equations. Results. MOM wear-rates ranged 0.3 to 6 mm³/Mc by 5-million cycles duration. Contained wear patterns (CWP) averaged 410 mm² for cups in study-1 (Anatomical) and 397 mm² for heads in study-2 (Fig. 3: Inverted). Distributed wear patterns (DWP) averaged 945mm² in study-1 (heads, Anatomical) and 846mm² in study-2 (cups, Inverted). Cup Hemi-ratios averaged 18% and 38% in studies 1 and 2 respectively (Table 2). Discussion. While vendor, implant and experimental differences were clearly present, study-1 (Anatomical) and study-2 (Inverted) produced almost identical CWP and DWP wear patterns, only reversed on heads versus cups. This unequivocal evidence demonstrated that there was no difference in wear mechanics for spherical CoCr bearings run in either test mode. In addition, wear patterns observed in MOM cup retrievals. 5. (1000–2700 mm²) were much larger than produced in Anatomical simulator tests (Fig. 2h: 400–500 mm²). Such large discrepancies in cup wear patterns between Anatomical simulator tests and retrieved MOM cups indicated that the Inverted cup mode (Fig. 2g) may be more clinically relevant

To prevent aseptic loosening resulting from osteolysis induced by polyethylene (PE) wear particles in THA, it is necessary to develop a high wear-resistance bearing material. We have investigated the bearing surface mimicking the articular cartilage; grafting a biocompatible polymer, poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC), onto the PE surface. High wear-resistance of PMPC-grafted surface has been revealed in the hip simulator wear test of 20 million cycles. Additionaly, in THA, oxidation degradation induced by residual free radicals resulting from gamma-ray irradiation for cross-linking or sterilization is also regarded as serious issue. Recently, gas plasma (GP) sterilization has been used as a less residual radical sterilization method. In this study, we ask a question: the GP sterilization would affect to PMPC surface and/or PE substrate? Hence, we investigated surface chemical, wear, mechanical, physical and oxidation properties of GP sterilized PMPC-grafted highly cross-linked PE (CLPE). GP-sterilized CLPE and PMPC-grafted CLPE (CLPE (GP) and PMPC-CLPE (GP), respectively; GUR 1020 resin, 75 kGy irradiation), and 25 kGy-gamma-sterilized PMPC-grafted CLPE (PMPC-CLPE (g); GUR 1020 resin, 50 kGy irradiation) were evaluated. Surface property of PMPC layer was evaluated by X-ray photoelectron spectroscopy (XPS), fourier-transform infrared (FT-IR) spectroscopy, fluorescence microscope and cross-sectional transmission electron microscope (TEM) observations. Wettability and lubrication of the PMPC-CLPE surface were evaluated by static water contact angle measurement and ball-on-plate friction test, respectively. Wear properties of the acetabular cups were examined by using hip simulator in the combination with Co-Cr-Mo femoral heads. To evaluate the GP sterilization effect to the CLPE substrate, tensile test, izod impact test, small punch test, gel content, residual radical concentration and oxidation degradation were conducted. Oxidation degradation was evaluated as oxidation index by using a FT-IR spectroscopy. By the XPS and FT-IR measurements, phosphorus peak and P-O peak attributed to grafted PMPC were observed, respectively. Uniform PMPC layer (100–200 nm thick) was observed on both surfaces of PMPC-CLPE (g) and PMPC-CLPE (GP) [Fig. 1]. Water contact angle of CLPE (GP) was almost 100 degree, while those for PMPC-CLPE (g) and PMPC-CLPE (GP) decreased dramatically to almost 10 degree. Dynamic coefficient of friction of PMPC-CLPE (g) and PMPC-CLPE (GP) was lower than that for CLPE (GP). In the hip simulator wear test, PMPC-CLPE (g) and PMPC-CLPE (GP) cups showed significantly lower amount of wear than that of CLPE (GP) [Fig. 2]. The number of the wear particles was extremely less in PMPC-CLPE (g) and PMPC-CLPE (GP), though the size was not different of all cases. Water thin film might be formed at the grafted PMPC layer, which acted as significantly efficient lubricant. There was no difference in the mechanical and physical properties among three groups. Oxidation index for PMPC-CLPE (GP) after acceleration of aging was lower than that of PMPC-CLPE (g). The GP sterilization might affect only to the PMPC-grafted surface, whereas gamma irradiation affects also to the PE substrate. From these results, the PMPC-CLPE (GP) is expected to be one of the great bearing materials having not only high-wear resistance but also high-oxidation resistance, which could give further longevity of implantation

Hip simulator studies on MOM bearings have historically involved ‘custom’ cetabular cups. I.e. having neither beaded layers nor biological coatings. The aim of this study was to investigate wear using such MOM bearings and evaluate the potential wear and evaluate the potential for error in the gravimetric assessment. Six x 38 mm HC Co-Cr bearings were supplied (Global and IO International Orthopaedics). The cups were received in ‘off-the-shelf’ condition with a cast Co-Cr beaded/HA-coated backing. To remove the HA-coating, the cups were pre-soaked in lemon juice for 4 days (articular surfaces shielded). Custom plastic fixtures were machined to fit the beaded contours of the cups. Test duration was 5Mc inorbital hip simulator (Shore-Western). MOM wear was estimated from serum ion contamination. Serum samples were digested and assessed using ICP/MS (Weck Labs Inc, CA). The majority of the HA-coating was removed from the cups after four days of soaking inlemon juice after 21 days of soaking all cup weights appeared atable (within 1 mg). Reflected-light microscopy (RLM) showed no descernible signs of HA and the total weight loss due to HA remval averaged∼400mg. During hip simulator there was no visual evidence of lost or broken beads, 3rd body abrasion etc (Sa<30nm). Both gravimetric and metal ion analysis showed consistent wear trends for all MOM cups. The MOM with the highest wear (predicted by ion analysis) demonstrated 1.2 mm (3)/Mc)OWR) at 5Mc. In comparsion, gravimetric analysis predicted an OWR of 1.3 mm (3)Mc for the same MOM, a difference of only 8%. Soaking beaded-HA cups in lemon juice and BCS proved effective in removing the coating. The beaded cups remained stable in weight during the wear study and caused little discrepancy in gravimetric analysis (8%). The method described did not lead to breaking of beads, elevated 3rd-body abrasion, cup damage or distorted wear scars