Objectives

Metal-on-metal (MoM) hip resurfacing was introduced into clinical practice because it was perceived to be a better alternative to conventional total hip replacement for young and active patients. However, an increasing number of reports of complications have arisen focusing on design and orientation of the components, the generation of metallic wear particles and serum levels of metallic ions. The procedure introduced a combination of two elements: large-dimension components and hard abrasive particles of metal wear. The objective of our study was to investigate the theory that microseparation of the articular surfaces draws in a high volume of bursal fluid and its contents into the articulation, and at relocation under load would generate high pressures of fluid ejection, resulting in an abrasive water jet.

INTRODUCTION. Ceramic-on-ceramic hip resurfacing offers a bone conserving treatment for more active patients without the potential metal ion risks associated with resurfacing devices. The Biolox Delta ceramic material has over 15 years of clinical history with low wear and good biocompatibility but has been limited previously in total hip replacement to 48mm diameter bearings [1]. Further increasing the diameter for resurfacing bearings and removing the metal shell to allow for direct fixation of the ceramic cup may increase the wear of this material and increase the risk of fracture. METHODS. Eighteen implants (ReCerf™, MatOrtho, UK; Figure1) were wear tested; six were ⊘40mm (small) and twelve ⊘64mm (large). All small and six large implants were tested under ISO 14242 standard conditions for 5 million cycles (mc) at 30° inclination (45° clinically). The six remaining large implants were tested under microseparation conditions in which rim contact was initiated during heel strike of the gait cycle for 5mc. Cups were orientated at 45° inclination (60° clinically) to allow for separation of the head and cup with a reduced 50N swing phase load and a spring load applied to induce a 0.5mm medial-superior translation of the cup. Wear was determined gravimetrically at 0.5mc, 1mc and every mc after. RESULTS. Wear was low in both standard and microseparation tests, less than 1mm. 3. cumulatively over 5mc (Figure 2). Standard conditions showed a run-in wear phase over the first mc followed by negligible wear in both diameters. The run-in wear significantly increased from 0.2mm. 3. /mc in the 40mm diameter bearings to 0.5mm. 3. /mc with the larger diameter implants. Under microseparation conditions, there was low wear over the first mc, increasing to 0.28mm. 3. /mc between 1–3mc. The wear rate reduced to 0.11mm. 3. /mc from 3=5mc. Stripe wear was evidenced on the microseparated components. There were no incidences of fracture or squeaking. DISCUSSION. Biolox Delta is known for its low wear rates but published results have only reported testing up to ⊘36mm [2]. Increasing the diameter to 64mm showed increased wear compared to smaller diameters but this was only significant over the first mc suggesting similar performance long term. Microseparation testing of these large sized bearings doubled the cumulative wear produced over 5mc but wear measured was still much lower than other bearing combinations. Wear of metal-on-metal resurfacing implants under these high angle, microseparation conditions has been reported up to 10.5mm. 3. /mc [3], significantly higher than any wear rate reported in the current study. Despite the 3mm wall thickness, no fracture of the cup occurred but stripe wear was observed in the ceramic components. SIGNIFICANCE. Biolox Delta ceramic is appropriate for use in larger diameters without excessive wear or damage to the bearings. The improved biocompatibility of the material may allow for hip resurfacing to be offered to more patients than currently available. For any figures or tables, please contact the authors directly

Summary Statement. A new 28mm-diameter ceramic-on-ceramic (COC) acetabular bearing couple (Biomet Orthopedics) showed extremely low wear, even under adverse microseparation conditions∗. The wear results are similar or more favorable than those reported for clinical retrievals and wear testing of similar ceramic bearings. Introduction. A new acetabular shell and ceramic insert design (Biomet) incorporates features to help prevent malalignment during implantation, while still providing secure fixation within the acetabular shell. The incorporation of Biolox. ®. Delta (zirconia toughened alumina, CeramTec) material should provide improved wear resistance over pure alumina ceramics. The goal of this study is to evaluate the wear durability of this system for standard and microseparation testing. Materials & Methods. The 28 mm diameter ceramic heads and inserts (CeramTec) were seated on taper spigots and within acetabular shells (Biomet), respectively. Six sets of parts were tested for 5M cycles of standard hip wear testing (ISO 14242) and an additional six sets of parts for 2M cycles of microseparation testing. The microseparation testing protocol included a steep cup angle (60° in-vivo), side load, and reduced axial load to induce head-liner separation. The lateral displacement was increased from 0.5mm, to 1mm, and then to 2mm in order to replicate wear features observed in extreme situations of clinical retrievals. [1]. The parts were weighed (gravimetric wear rates) and photographed throughout the test. SEM, transformation, and wear debris analyses were completed. Results. The steady-state wear rate throughout standard testing was 0.0094 +/− 0.0029 mm. 3. /10. 6. cycles (+/-95% CI). The initial 0.5mm microseparation distance (0–1M cycles) showed no signs of wear. Most heads showed wear stripes after increasing to 1.0mm (1–1.5M cycles), and then all test parts showed stripes after increasing to 2mm. The increased visibility in wear stripes correlated with an increased level of measured wear. For the 2mm separation-distance testing interval, the wear rate was 0.178 +/− 0.052mm. 3. /10. 6. cycles. Discussion/Conclusion. The lack of wear stripes during 0.5mm of microseparation is an indication of the strength of the implants. A distance of 1–2mm is an extreme level of microseparation and the 60° in-vivo cup inclination created an even worse-case situation for wear; however, the implants showed excellent mechanical strength and low wear rates. SEM and transformation analyses showed minimal wear and evidence of stress-induced ceramic toughening. Microseparation testing at another lab . [2]. has shown a similarly low wear rate (0.5 mm. 3. /10. 6. cycles) for Biolox. ®. Delta ceramic, with Biolox. ®. Forte (alumina ceramic, without zirconia) showing a considerably higher wear rate (6.3mm. 3. /10. 6. cycles). The standard testing wear rate (0.0094+/-0.0029 mm. 3. /10. 6. cycles) was much lower than the average wear rate (0.69+/-0.63 mm. 3. /10. 6. cycles) of several COC implant retrievals by Walter . [1]. The 28mm steady-state wear rate of this test is better than or equal to the wear rate (0.0101 mm. 3. /10. 6. cycles) observed in other 28mm COC systems.∗∗. ∗Ceramic-on-Ceramic articulation is not cleared for use in the United States. ∗∗Laboratory results are not necessarily indicative of clinical performance

Aim: In alumina-on-alumina (Al/Al) THA, microsepa-ration is reported to accelerate wear and to be a risk factor of alumina cup fracture. While microseparation after THA is detected during walking, microseparation also occurs in relation to the hip position. Using Al/Al THA with cemented polyethylene-back alumina cup, the microseparation is clearly visible on plain roentgen-ograms. The aim of this study is to investigate the factors that affect hip position related microseparation. Materials and Methods: We performed 65 primary Al/Al THA. An average age at operation was 61.1 years and an average follow-up period was 29.5 months. Roentgenograms were taken in hip neutral position, abduction, adduction, external rotation and internal rotation. Results: Microseparation was observed in 15 hips (23.1%); 10 hips with hip external rotation and 5 hips with hip abduction. An average abduction angle of the cup was 33.5±9.8 degrees with microseparation and 36.6±7.3 degrees without microseparation. An average anteversion of the cup was 9.7±6.7 degrees and 7.8±5.8 degrees, respectively. The factors that brought about microseparation were postoperative muscle weakness in 3 hips, impingement in 9, cup malposition (abduction angle: 19, 23 degrees) in 2, and short off-set stem in one. Discussion and Conclusions: It should be noted that microseparation is not a rare phenomenon and it occurs in hip particular position even if it can not be detected on routine roentgenograms

Introduction:. Microseparation has resulted in more than ten-fold increase in ceramic-on-ceramic and metal-on-metal bearing wear, and even fracture in a zirconia head [1–4]. However, despite the greater microseparation reported clinically for metal-on-polyethylene wear, less is known about its potential detrimental effects for this bearing couple. This study was therefore designed to simulate the effects of micromotion using finite element analysis and to validate computational predictions with experimental wear testing. Methods:. Experimental wear rates for low and highly crosslinked polyethylene hip liners were obtained from a previously reported conventional hip wear simulator study [5]. A finite element model of the wear simulation for this design was constructed to replicate experimental conditions and to compute the wear coefficients that matched the experimental wear rates. We have previous described out this method of validation for knee wear simulation studies [6,7]. This wear coefficient was used to predict wear in a Dual-Mobility hip component (Fig 1). Dual mobility total hip arthroplasty components, Restoration ADM (Fig 1), with highly crosslinked acetabular liners were experimentally tested: the control group was subjected to wear testing using the ISO 14242-1 waveform on a hip wear simulator. The microseparation group was subjected to a nominal 0.8 mm lateral microseparation during the swing phase by engaging lateral force springs and reducing the swing phase vertical force. Results:. The wear coefficients that matched experimental wear rates for the low and highly crosslinked polyethylene liners were 4.57×10. −10. and 5.89×10. −11. mm. 3. N. −1. mm. −1. , respectively. Introducing microseparation in the conventional hip increased the wear rate by 15.59 mm. 3. /million cycles in the low crosslinked liner and by 1.12 mm. 3. /million cycles in the highly crosslinked liner (Fig 2). Discussion:. Microseparation did increase predicted wear rates for the low crosslinked polyethylene liner and supports the hypothesis that microseparation can adversely affect the wear of hip arthroplasty. However, the predicted and experimental increase for the dual mobility highly crosslinked liners due to microseparation was low (3.3 mm. 3. and 2.9 mm. 3. /million cycles, respectively) and below the threshold for clinical relevance. The small increase in wear rate in our study supports the high wear tolerance to wear of a dual-mobility sequentially crosslinked polyethylene liner

Introduction. Translational surgical mismatch in the centres of rotation of the femoral head and acetabular cup in hip joint replacements can lead to dynamic microseparation resulting in edge loading contact [1]. Increased wear in retrieved ceramic-on-ceramic bearings has been associated with edge loading [2]. Hip joint simulators were used to replicate increased wear rate, stripe wear and bimodal wear debris size distribution, as seen clinically [3,4]. Recently developed electromechanical simulators are able to comply with the latest international standards, which include three axes of rotation conditions [5]. Previous simulators had applied two axes of rotation under microseparation conditions [6]. Therefore, the aim of this study was to compare the wear of ceramic-on-ceramic bearings obtained under edge loading due to microseparation conditions during gait using the same electromechanical hip joint simulator with two axes of rotation and three axes of rotation conditions. Materials and Methods. A six-station electromechanical hip joint simulator (ProSim EM13, Simulation Solutions, UK) was set up with 36mm diameter ceramic-on-ceramic (BIOLOX® delta, PINNACLE®, DePuy Synthes, UK) hip replacements. The wear was determined for two million cycles under standard conditions with two axes of rotation conditions (n=6), two million cycles under microseparation conditions with two axes of rotation conditions (n=6) (Figure 1a), and two million cycles under microseparation conditions with three axes of rotation conditions (n=6) (Figure 1b). The loading profiles [5,7] comprised of 3kN twin peak loads and 300N swing phase load under standard conditions. The swing phase load was reduced to approximately 70N under microseparation conditions. Approximately 0.5mm of dynamic microseparation between the head and the cup was applied in the medial/lateral direction. The components were lubricated with 25% new-born calf serum supplemented with 0.03% sodium azide to minimise bacterial growth. The gravimetric wear rates were compared over two million cycles for each test (XP205, Mettler Toledo, UK). The mean wear rates of the head and cup were calculated with 95% confidence limits and statistical analysis was carried out (t-test) with significance levels taken at p<0.05. A coordinate-measurement machine (Legex 322, Mitutoyo, UK) was used to construct a three-dimensional map of the femoral head surface wear. Results. Under standard conditions, the mean wear rate of BIOLOX® delta ceramic-on-ceramic bearings was 0.03±0.01 mm3/million cycles. The mean wear rates under microseparation conditions for two axes and three axes of rotation conditions were 0.14±0.01 mm3/million cycles and 0.14±0.03 mm3/million cycles respectively. There was no statistically significant difference between the wear rates using two axes and three axes of rotation conditions under microseparation conditions (p=0.86). Stripe wear was observed and wear depth measured on the femoral heads under microseparation conditions using two axes (Figure 2a) and three axes (Figure 2b) of rotation. Conclusion. Higher wear rates were observed under microseparation compared with standard conditions, as reported in a previous study [6]. Similar wear rates were obtained under microseparation conditions with two axes and three axes of rotation conditions using the same simulator

Following total hip replacement surgery, fluroscopy studies have shown that a mean separation of 2 mm can occur between CoCr femoral heads and UHMWPE acetabular cups during the swing phase of gait [. 1. ]. In vivo and in vitro studies [. 2. , . 3. ] of alumina ceramic on ceramic hip replacements have demonstrated that swing phase microseparation followed by the impact of the femoral head on the acetabular insert rim can lead to accelerated wear. However, wear remains low. A similar trend was observed when metal on metal hip replacements were tested under microseparation conditions [. 4. ]. The purpose of the current study was to examine the wear of ceramic on polyethylene bearings under standard and microseparation conditions. A physiological hip simulator was used, loads and motions were applied to approximate in vivo conditions. The alumina ceramic heads and polyethylene cups were 28 mm in diameter and were tested for 5 million cycles in 25% new born calf serum at 1 Hertz. Microseparation was achieved by displacing the femoral head inferiorly during swing phase, where the head contacted the inferior cup rim and was laterally displaced. On heel strike the head contacted the superior cup rim prior to relocation. The volumetric wear of the polyethylene inserts was approximately four times less under microseparation conditions (5.6 ± 5.3 mm3 per million cycles), in comparison to standard conditions (25.6 ± 5.3 mm3 per million cycles). Deformation of the cup rim was observed, but some of this was attributed to creep. It is postulated that this reduction in wear was due to the separation of the components in swing phase improving the entrapment of lubricant, hence reducing wear via a squeeze film lubrication mechanism. In conclusion, surgical procedures that produce a small and controlled amount of joint laxity and microseparation may lead to a reduction in wear of the polyethylene acetabular cups

Purpose of the study: Implantation of the acetabular socket with high inclination generates increased contract stress, wear and revision rate for total hip arthroplasty (THA). Study of ceramic-on-ceramic THA explants has revealed a high wear rate in bands, suggesting a microseparation effect generating edge loading. There have not been any studies examining the influence of the cup inclination on the contact pressures in ceramic-on-ceramic THA exposed to microseparation between the head and the cup. Material and methods: A finite elements model of a ceramic-on-ceramic hip prosthesis was developed with ABAQUS in order to predict the surface contact and the distribution of the contract pressures, first during ideal centred function then under conditions of microseparation. A 32mm head and a radial clearance head (30μm) were used. The cup was positioned in zero anteversion and 45, 65, 70, and 90° anteversion. Progressive microseparation (0 to 500 μm) was imposed. A 2500N loading force was applied to the centre of the head. Results: For 45° inclination, edge loading appeared for mediolateral separation greater than 30 μm and became complete for 60 μm separation. When edge loading appeared, the contact surface was elliptic. The length of the lesser axis converged towards 0.96mm; the greater axis towards 8.15mm, respectively in the anteroposterior and mediolateral directions. For inclinations of 45°, the contact pressure was 66 Mpa for the centred force. As the mediolateral separation increased, the maximal contact pressure increased, converging towards an asymptotic value of 205 MPa. Increasing the inclination angle of the cup generated an increase in the maximal contact pressure. However, this increase in contact pressure generated by the increasing inclination angle was negligible if the microseparation increased. Discussion: Cup inclination and mediolateral laxity increase stress forces of ceramic-on-ceramic THA and should be avoided. However, the influence of the cup inclination becomes negligible beyond a separation value of 240 μm, the stress forces already having reached their asymptotic value

In vivo and in vitro studies of ceramic on ceramic (COC) bearings have demonstrated that swing phase microseparation followed by the impact of the femoral head on the superior acetabular insert rim leads to accelerated wear. However, resultant wear remained low. The wear of ceramic on polyethylene (COP) and metal on metal (MOM) couples under swing phase microseparation is unknown, this study aimed to compare the wear of these total hip replacements under standard and microseparation conditions. A physiological hip simulator was used, loads and motions were applied to approximate in vivo conditions. Microseparation was achieved by displacing the femoral head inferiorly during swing phase, the head contacted the inferior cup rim and was laterally displaced. On heel strike the head contacted the superior cup rim prior to relocation. Components (as shown in table 1) were tested for 5 million cycles, at a frequency of 1 hertz in 25% (v/v) new born calf serum. Under standard conditions, wear of COC and MOM bearings was significantly lower than wear of COP couples. Under microseparation conditions the COC and MOM wear increased by 4 and 25 times respectively. Microseparation conditions reduced wear of COP couples by a factor of 4. Creep deformation and damage to the UHMWPE cup rim was observed, however, wear remained low. It is postulated that this reduction in polyethylene wear is due to the separation of the components in swing phase improving the entrapment of lubricant, hence wear is reduced via a squeeze film lubrication mechanism

INTRODUCTION. Retrieval and clinical studies of metal-on-metal (MoM) bearings have associated increased wear. 1. and elevated patient ion levels. 2. with steep cup inclination angles and edge loading conditions. The University of Leeds have previously developed a hip simulator method that has been validated against retrievals and shown to replicate clinically relevant wear rates and wear mechanisms. 3,4. This method involves introducing lateral microseparation to represent adverse joint laxity and offset deficiency. This study aimed to investigate the effect of microseparation representing translational malpostion, and increased cup inclination angle, representing rotational malposition, in isolation and combined on the wear of different sizes (28 and 36mm) MoM bearing in total hip replacement (THRs). MATERIALS AND METHODS. The wear of size 28mm and 36mm MoM THRs bearings was determined under different in vitro conditions using the Leeds II hip simulator. For each size bearing, two clinical cup inclination angles were considered, 45° (n=3) and 65° (n=3). The first three million cycles were run under standard gait conditions and subsequently three million cycles were run under microseparation conditions. Standard gait cycles included a twin peak load (300N–3000N), extension/flexion (−15°/+30°) and internal/external rotation (±10°). Microseparation. 4. was achieved by applying a 0.4–0.5mm medial displacement to the cup relative to the head during the swing phase of the standard gait cycle resulting in edge loading at heel strike. The lubricant was 25% (v/v) new-born calf serum. The wear volume was determined through gravimetric analysis every million cycles. One way ANOVA was performed (significance: p<0.05), and 95% confidence limits were calculated. RESULTS. Under standard gait conditions, the 28mm MoM bearing showed head-rim contact and increased wear rate with increased cup inclination angle but the 36mm bearing did not show any increase in wear. Microseparation and edge loading increased the wear rate of MoM bearings for all cup inclination angle conditions and bearing sizes (Figure 1). DISCUSSION. With the larger size bearings, head-rim contact occurred at a steeper cup inclination angle (>65°) providing an advantage over smaller bearings. Under standard gait conditions, where head-rim contact did not occur, wear was low, due to mixed lubrication and wear reduction through a protein boundary film. However, edge loading of the cup, with elevated stress, caused excess damage and wear. This effect was more dominant with microseparation conditions to that of head-rim contact due to increased cup inclination angle alone. Under microseparation conditions, there were no significant differences in the wear rates of the 28mm and the 36mm size bearings. However, the wear rates obtained in this study for 28mm and 36mm bearings were significantly lower than those obtained for size 39mm surface replacement MoM bearings (8.99 mm. 3. /million cycles) tested under the same adverse conditions. 5. . CONCLUSION. This study shows the importance of acetabular cup design and correct surgical positioning of the femoral head and acetabular cup and restoration of offset and cup centre. ACKNOWLEDGEMENT. This study was supported by the Furlong Research Charitable Foundation (FRCF) and the National Institute of Health Research (NIHR) as part of a collaboration with the Leeds Musculoskeletal Biomedical Research Unit (LMBRU). The components were custom made specifically for this project by Corin Ltd

INTRODUCTION. Ceramic-on-ceramic hip replacements have generated great interest in recent years due to substantial improvements in manufacturing techniques and material properties. 1. Microseparation conditions that could occur due to several clinical factors such as head offset deficiency, medialised cup combined with laxity of soft tissue resulting in a translation malalignment, have been shown to cause edge loading, replicate clinically relevant wear mechanisms. 2,3. and increase the wear of ceramic-on-ceramic bearings. 3,4. The aim of this study was to investigate the influence of increasing the femoral head size on the wear of ceramic-on-ceramic bearings under several clinically relevant simulator conditions. MATERIALS AND METHODS. The wear of size 28mm and 36mm ceramic-on-ceramic bearings (BIOLOX® Delta, CeramTec, Germany) was determined under different in vitro conditions using the Leeds II hip simulator. For each size bearing, two clinical cup inclination angles were considered, 55° (n=3) and 65° (n=3) for the 28mm bearing and 45° (n=3) and 65° (n=3) for the 36mm bearing. The first two (28mm study) or three (36mm study) million cycles ran under standard gait conditions and a subsequent three million cycles ran under microseparation conditions. A standard gait cycle included a twin peak load (300N–3000N), extension/flexion (−15°/+30°) and internal/external rotation (±10°). Microseparation. 3. was achieved by applying a 0.4–0.5mm medial displacement to the cup relative to the head during the swing phase of the standard gait cycle resulting in edge loading at heel strike. The lubricant was 25% (v/v) new-born calf serum which was changed approximately every 333,000 cycles. The wear volume was ascertained through gravimetric analysis every million cycles. One way ANOVA was performed (significance: p<0.05), and 95% confidence limits were calculated. RESULTS AND DISCUSSION. The mean wear rate under standard gait conditions was 0.05mm. 3. / million cycles for the 28mm bearings and significantly lower (p=0.003) for the 36mm bearings (Figure 1) which could be due to improved lubrication regime. The wear of ceramic-on-ceramic bearings was not influenced by the increase in cup inclination angle for either bearing size (Figure 1). The introduction of microseparation into the gait cycle resulted in stripe wear on the femoral head with a corresponding wear area at the rim of the acetabular cup and significantly higher wear rates of the ceramic-on-ceramic bearings (Figure 2). The wear rate of BIOLOX® Delta bearings under microseparation conditions was still low (<0.25mm. 3. /million cycles) compared to the third generation alumina ceramic-on-ceramic bearings (1.84mm. 3. /million cycles). 4. under the same adverse conditions. Under microseparation conditions, the wear rate of size 36mm bearings was significantly higher (p=0.004) than that for size 28mm bearings. This was thought to be due to the larger contact area for the larger bearings and deprived lubrication under edge loading conditions. For both bearing sizes, the combination of both steep cup inclination angles and microseparation conditions did not increase the wear rates any further compared to microseparation conditions alone (Figure 3). This study shows the importance of surgical positioning of the femoral head and acetabular cup and the importance of testing new bearing materials and designs using these adverse simulator methods. ACKNOWLEDGEMENT. This study was supported by the Furlong Research Charitable Foundation (FRCF) and the National Institute of Health Research (NIHR) as part of a collaboration with the Leeds Musculoskeletal Biomedical Research Unit (LMBRU)

Background

High cup abduction angles generate increased contact stresses, higher wear rates and increased revision rates. However, there is no reported study about the influence of cup abduction on stresses under head lateralisation conditions for ceramic-on-Ceramic THA.

Introduction and Aims. In order to improve the longevity and design of an implant, a wide range of pre-clinical testing conditions should be considered including variations in surgical delivery, and patients' anatomy and biomechanics. The aim of this research study was to determine the effect of the acetabular cup inclination angle with different levels of joint centre mismatch on the magnitude of dynamic microseparation, occurrence and severity of edge loading and the resultant wear rates in a hip joint simulator. Methods. The six-station Leeds Mark II Anatomical Physiological Hip Joint Simulator and 36mm diameter ceramic-on-ceramic bearings (BIOLOX® delta) were used in this study. A standard gait cycle, with a twin-peak loading (2.5kN peak load and approximately 70N swing phase load), extension/flexion 15°/+30° and internal/external ±10° rotations, was applied. Translational mismatch in the medial-lateral axis between the centres of rotation of the head and the cup were considered. In this study, mismatches of 2, 3 and 4 (mm) were applied. Two acetabular cup inclination angles were investigated; equivalent to 45° and 65° in-vivo. These resulted in a total of six conditions [Figure 1] with n=6 for each condition. Three million cycles were completed under each condition. The lubricant used was 25% (v/v) new-born calf serum supplemented with 0.03% (w/v) sodium azide to retard bacterial growth. The wear of the ceramic bearings were determined using a microbalance (XP205, Mettler Toledo, UK) and a coordinate measuring machine (Legex 322, Mitutoyo, UK). The stripe wear was analysed using RedLux software. The dynamic microseparation displacement was measured using a linear variable differential transformer. Mean wear rates and 95% confidence limits were determined and statistical analysis (one way ANOVA) completed with significance taken at p<0.05. Results Increasing the medial-lateral joint centre mismatch from 2 to 3 to 4mm resulted in an increased dynamic microseparation [Figure 2]. A similar trend was observed for the wear. A higher level of medial-lateral mismatch increased the wear rate under both 45° and 65° cup inclination angle conditions [Figure 3]. The mean wear rates obtained under 65° were significantly higher compared to those obtained under the 45° cup inclination angle conditions for a given medial-lateral mismatch in the joint centre (p=0.02 for 2mm mismatch, p=0.02 for 3 mm mismatch, and p<0.01 for 4mm mismatch). Conclusions. The condition with the acetabular cups positioned at an inclination of 45° exhibited greater resistance to dynamic microseparation for any given medial-lateral mismatch in the centres of rotation. Higher wear rates correlated with higher levels of dynamic microseparation. These results highlight how different conditions can alter the severity of edge loading, and highlight the necessity of understanding how the surgical positioning can affect the occurrence of edge loading and wear. Future studies will look into the other factors which can influence the microseparation conditions such as joint laxity, swing phase load and version angles

Introduction. Increased wear rates [1, 2] and acetabular rim fracture [3] of hip replacement bearings reported clinically have been associated with edge loading, which could occur due to rotational and/or translational mal-positioning [4]. Surgical mal-positioning can lead to dynamic microseparation mechanisms resulting in edge loading conditions. In vitro microseparation conditions have replicated stripe wear and the bi-modal wear debris distribution observed clinically [5, 6]. The aim of this study was to investigate the effect of steep cup inclination, representing rotational mal-positioning, on the magnitude of dynamic microseparation, severity of edge loading, and the resulting wear rate of a ceramic-on-ceramic bearing, under surgical translational mal-positioning conditions. Materials and Methods. Ceramic-on-ceramic bearings where the ceramic liner was inserted into a titanium alloy cup (BIOLOX® delta and Pinnacle® respectively, DePuy Synthes, UK) were tested on the six-station Leeds II hip simulator. The first test was run with the cups inclined at an angle equivalent, clinically, to 45° (n=6) and the second test was run with the cups inclined at an angle equivalent, clinically, to 65° (n=6). A standard gait cycle was run. A fixed surgical translational mal-positioning of 4mm between the centres of rotations of the head and the cup in the medial/lateral axis was applied on all stations. Both tests ran for three million cycles each. The lubricant used was 25% new-born calf serum. Wear was assessed gravimetrically using a microbalance (XP205, Mettler Toledo, UK) and geometrically using a coordinate measuring machine (CMM, Legex 322, Mitutoyo, UK). Statistical analysis was done using one way ANOVA with significance taken at p<0.05. Results. The magnitude of dynamic microseparation was significantly (p<0.01) higher when the inclination angle of the cup was steeper (Figure 1) under the same level of translational mal-positioning of 4mm. This has resulted in significantly (p<0.01) higher wear rates of 1.01mm. 3. /million cycles for the steep cup inclination group of 65° compared to 0.32mm. 3. /million cycles for the 45° inclined cups group (Figure 2). Furthermore, the penetration on the femoral heads was significantly (p<0.01) higher for the steep cup inclination angle group with a mean (±95% confidence limit) penetration of 33±6µm under the 65° cup inclination angle condition and 15±3µm under the 45° cup inclination angle condition (Figure 3). Discussion and Conclusion. This study showed that cup inclination angle affects the magnitude of dynamic microseparation for a given surgical translational mal-position, thus leading to severe edge loading and increased wear rates with increased cup inclination angles. The occurrence and severity of the resulting edge loading causing increased wear in hip bearings will depend on the combinations of surgical variations, such as steep inclination angle, excessive version angle, medialised cups, head offset deficiencies, stem subsidence, and joint laxity. Future work will include studying the effect of these variables on the level of dynamic microseparation, severity of edge loading, the offset frictional torque and level of resulting wear

Introduction. Stripe wear, observed on retrieved ceramic hip replacements, has only been replicated in vitro under translational mal-positioning conditions where the centres of rotation of the head and the cup are mismatched. 1,2. ; an in vitro condition termed “microseparation”. The aim of this study was to compare the edge loading mechanisms observed under microseparation conditions due to translational mal-positioning conditions simulated on two different hip joint simulators. Materials and Methods. The components used in this study were zirconia-toughened-alumina ceramic-on-ceramic bearings (36 mm) inserted into titanium alloy acetabular cups (BIOLOX® delta and Pinnacle® respectively, DePuy Synthes Joint Reconstruction, Leeds, UK). Six couples were tested for two million cycles under 0.5 mm dynamic microseparation conditions on the Leeds II hip joint simulator as described by Nevelos et al. 2. and Stewart et al. 3. (Figure 1). Ten bearing couples were tested for two million cycles under microseparation conditions achieved in two different ways on the ProSim pneumatic hip joint simulator (SimSol, Stockport, UK). Two conditions were tested; condition (1)- the femoral head was left to completely separate (the vertical motion was controlled at 1 mm) causing it to contact the inferior rim of the acetabular cup before edge loading on the superior rim at heel strike (n = 5) and condition (2)- springs were placed below the plate holding the femoral head to control the tilt of the head laterally towards the rim of the acetabular cup as the negative pressure was applied (n = 5; Figure 1). Wear was assessed gravimetrically every million cycles using a microbalance (Mettler AT201, UK). Three-dimensional reconstructions of the wear area on the heads were obtained using a coordinate measuring machine (Legex 322, Mitutoyo, UK) and SR3D software (Tribosol, UK). Results. The wear rates of the 36 mm ceramic-on-ceramic bearings obtained under microseparation conditions on the ProSim, where the medial-lateral displacement was controlled (condition 2), and under microseparation conditions on the Leeds II simulator were 0.22 mm. 3. and 0.13 mm. 3. /million cycles respectively, however, the difference was not statistically significant (p = 0.092). The wear rates obtained under microseparation conditions on the Leeds II and the ProSim (condition 2) were both significantly higher (p = 0.006 and p = 0.009 respectively) than the wear rate obtained under microseparation conditions on the ProSim where full distraction of the head was provided (condition 1, 0.05 mm. 3. /million cycles). The wear stripe areas formed on the femoral head under the three simulator set-ups are shown in Figure 2. Discussion and Conclusion. Edge loading due to translational mal-positioning with 0.5 mm dynamic medial-lateral displacement on the Leeds II simulator has been validated against retrievals and shown to replicate stripe wear mechanisms, wear rates and bimodal wear debris distribution as that observed in vivo. 1,2,4,5. The edge loading due to translational mal-positioning simulated on different machines can result in different wear rates and wear mechanisms. One microseparation technique (condition 2) achieved on the ProSim simulator has demonstrated similar results to the validated Leeds II simulator

Ceramic-on-ceramic total hip replacements (THRs) have shown low wear volumes in standard gait hip simulator studies. 1. However clinical reports have indicated a variation in wear rates and formation of stripe wear on the ceramic femoral heads. 2. The aim of this study was to investigate the influence of different clinical conditions such as cup inclination angle and microseparation (head offset deficiency) on the wear of ceramic-on-ceramic THRs. The six station Leeds II hip joint simulator was used to investigate the wear of size 28mm ceramic-on-ceramic bearing couples. The alumina matrix composite ceramic material (AMC, Biolox Delta, CeramTec AG, Germany) was used in this study. The lubricant used was 25% bovine serum. The study was carried out for a total of five million cycles; the first two million cycles under standard gait conditions and a further three million cycles under microseparation conditions. During microseparation, a lateral movement of 0.5mm was applied to the cup relative to the head during the swing phase of the gait cycle. 3. Three of the cups were mounted to provide a clinical angle of 55°, which is referred to as the ‘standard’ condition; and the other three cups were mounted to provide a clinical angle of 65°, which is referred to as the ‘steep angle’ condition. These combinations provided four different testing conditions: standard, steep cup angle, microseparation, and combination of steep cup angle and microseparation conditions. Volumetric wear was determined gravimetrically and statistical analysis was performed using One Way ANOVA (significance at p< 0.05). Increasing the cup inclination angle from 55° to 65° had no significant effect on the wear rate in Biolox Delta ceramic-on-ceramic THRs under both standard (p> 0.42) and microseparation (p> 0.55) conditions. Under standard gait conditions, the mean wear rate for both cup inclination angles was very low at 0.05 mm3/million cycles. The introduction of microseparation to the standard gait cycle significantly increased the mean wear rates (p< 0.01) to 0.13 mm3/ million cycles for the ‘standard’ cup inclination angle of 55° and 0.11 mm3/million cycles for the ‘steep’ cup inclination angle of 65°. A stripe of wear on the head also formed, with corresponding superior rim wear on the cup. For comparison, the steady state wear rate of HIPed third generation alumina ceramic (Biolox Forte) under microseparation conditions was 1.3 mm3/million cycles [. 4. ]. In conclusion, increasing the cup inclination angle by 10° had no influence on the wear rate of Biolox Delta ceramic-on-ceramic bearings. The introduction of microseparation conditions significantly increased the wear rate and resulted in stripe-like wear on the femoral head, which has previously been observed on retrieved ceramic prosthesis. However, these wear rates were still low, and were ten times lower than those previously reported for Biolox Forte

In vitro the introduction of microseparation and edge loading to hip simulator gait cycle has replicated clinically relevant wear rates and wear mechanisms in ceramic-on-ceramic bearings. [1]. , and elevated the wear rates of MoM surface replacements (SR) to levels similar to those observed in retrievals. [2]. The aim was to assess the wear of two different sized MoM total hip replacement bearings under steep cup inclination angles and adverse microseparation and edge loading conditions. Two tests were performed on the Leeds II hip joint simulator using two different size bearings (28mm and 36mm). Cups were mounted to provide inclination angles of 45 degrees (n=3) and 65 degrees (n=3). The first three million cycles were under standard gait conditions. Microseparation and edge loading conditions as described by Nevelos et al. [1]. were introduced to the gait cycle for the subsequent three million cycles. The lubricant was 25% new born calf serum. The mean wear rates and 95% confidence limits were determined and statistical analysis was performed using One Way ANOVA. Under standard gait conditions, when the cup inclination angle increased from 45 degrees to 65 degrees, the wear of size 28mm bearing significantly (p=0.004) increased by 2.7-fold, however, the larger bearings did not show any increase in wear (p=0.9). The introduction of microseparation conditions resulted in a significant (p=0.0001) increase in wear rates for both bearing sizes under both cup inclination angle conditions. Under microseparation conditions, the increase in cup inclination angle had no influence on the wear rate for both bearing sizes (Figure 1). With larger bearings, head-rim contact occurs at a steeper cup inclination angle providing an advantage over smaller bearings. The introduction of edge loading and microseparation conditions resulted in a significant increase in wear rates for both bearing sizes. The wear rates obtained in this study under combined increased cup inclination angle and microseparation were half of those obtained when SR MoM bearings were tested under similar adverse conditions. [2]. This study shows the importance of prosthesis design and accurate surgical positioning of the head and acetabular cup in MoM THRs

Introduction. Ceramic composites have been developed to further improve the mechanical properties, reduce risk of fracture, and increase the survivorship of ceramic-on-ceramic bearings in total hip replacement. 1. . The aim of this study was to evaluate the wear of two novel ceramic composite materials under edge loading conditions due to translational mal-positioning when used in both like-on-like and mixed pairing configurations; and to compare their performance to earlier generation ceramic-on-ceramic bearings. Materials and Methods. The head-on-cup configurations of three ceramic materials (see Figure 1), were ATZ-on-ATZ, ZTA-on-ZTA, Al. 2. O. 3. -on-Al. 2. O. 3. , ATZ-on-ZTA, ZTA-on-ATZ, Al. 2. O. 3. -on-ATZ, ATZ-on-Al. 2. O. 3. and Al. 2. O. 3. -on-ZTA. All combinations were size 28mm and were supplied by Mathys Orthopädie GmbH (Morsdorf, Germany). They were tested for four million cycles on the Leeds II hip simulator under microseparation. 2,3,4. conditions representing translational mal-positioning. The gait cycle comprised extension/flexion (−15º/+30º), internal external rotation (+/−10º) and a twin peak load with a maximum of 3kN. Microseparation was achieved by applying a 0.5mm dynamic medial/lateral displacement using a spring load resulting in edge loading at heel strike. New-born calf serum (25%) was used as a lubricant. Wear was assessed gravimetrically every million cycles. Statistical analysis was performed using one-way ANOVA (significance taken at p<0.05). Results. The wear of ATZ-on-ZTA, ATZ-on-Al. 2. O. 3. and Al. 2. O. 3. -on-Al. 2. O. 3. was biphasic with a bedding in wear rate between zero and one million cycles under translational malpositioning conditions and a lower steady state wear rate between one and four million cycles. The bedding in and steady state wear rates of ATZ-on-ZTA (1.16mm. 3. /million cycles bedding in and 0.18mm. 3. /million steady state) and ATZ-on-Al. 2. O. 3. (0.66mm. 3. /million cycles bedding in and 0.20mm. 3. /million steady state) were lower than that of Al. 2. O. 3. -on-Al. 2. O. 3. (1.54mm. 3. /million cycles bedding in and 0.55mm. 3. /million steady state) bearing combination (see Figure 2). However, there was statistically no significant difference (p=0.35) between the wear rates. The wear rates of the other bearing combinations under these adverse microseparation conditions, ZTA-on-ZTA and ATZ-on-ATZ, Al. 2. O. 3. -on-ATZ, Al. 2. O. 3. -on-ZTA, and ZTA-on-ATZ were very low with no clear bedding in and steady state phases (see Figure 1). The wear rates of these combinations, over the four million cycles of test under adverse microseparation conditions, were all lower than 0.14mm. 3. /million cycles. Discussion and Conclusion. The mixed material combinations (ATZ-on-ZTA, ATZ-on-Al. 2. O. 3. , Al. 2. O. 3. -on-ATZ, Al. 2. O. 3. -on-ZTA and ZTA-on-ATZ) tested in this study have shown slightly higher wear rates when compared to ATZ in like-on-like configuration, but superior wear resistance when compared to Alumina BIONIT® (Mathys) and BIOLOX® forte (CeramTec) Al. 2. O. 3. -on-Al2O. 3. bearings tested under the same adverse microseparation conditions

Introduction: Following hip replacement surgery the tension of the soft tissues and the laxity of the joint may vary. Variations in surgical approach, technique and fixation method may influence the effective joint laxity and the level of force applied across the prostheses during the swing phase of gait. The aim of this study was to investigate the effect of different swing phase load conditions on the wear metal-on-metal hip prostheses using a hip simulator. Methods: Cobalt chrome metal-on-metal bearings, 28mm in diameter were tested for five million cycles in a Prosim hip simulator with flexion-extension and internal-external rotation kinematic inputs. A Paul-type twin peak loading curve was applied, which was modified to provide three different swing phase load conditions;. Low positive swing phase load (< 100N). Positive swing phase load (300N, as per standard ISO 14242–1). Negative swing phase load, leading to microseparation and joint laxity. All tests were carried out in 25% (v/v) new-born bovine serum, with gravimetric wear measurements completed every million cycles. Results: The wear rates for the different swing phase conditions are shown in Figure I. Elevating the swing phase load from 100N to 300N (ISO load) increased the overall wear rate by 10-fold. Introducing microseparation into the gait cycle increased wear by a further 3-fold. These results indicate the sensitivity of metal-on-metal bearing wear to swing phase load conditions and joint laxity. Discussion: Little attention to date has been paid to the importance of joint laxity and swing phase load on the wear rate of hip replacements. Elevation of wear rates with increased swing phase load was probably due to the depletion of fluid film lubrication. This was consistent with the findings under stop-start motion [Medley et al., 2002] and demonstrates the dependency of metal-on-metal hip replacements on fluid film lubrication conditions. Testing with a negative swing phase load elevated wear due to microseparation of the components, the head contacted the insert rim at heel strike which caused a stress concentration and damage to the insert rim. The results demonstrate that the wear performance of metal-on-metal hip replacements is highly dependent on swing phase load conditions. It is postulated that the fixation method and surgical technique can effect the swing phase load; over tensioning of the soft tissue may increase the swing phase load, whereas joint laxity will cause a negative swing phase load and possibly microseparation

Background. Many factors contribute to the occurrence of edge-loading conditions in hip replacement; soft tissue tension, surgical position, patient biomechanical variations and type of activities, hip design, etc. The aim of this study was to determine the effect of different levels of rotational and translational surgical positioning of hip replacement bearings on the occurrence and severity of edge-loading and the resultant wear rates. Method. The Leeds II Hip-Joint Simulator and 36mm diameter alumina matrix composite ceramic bearings (BIOLOX delta, DePuy Synthes, UK) were used in this study. Different levels of mismatch between the reconstructed rotational centres of the head and the cup were considered (2, 3 and 4mm) in the medial-lateral axis. Two cup inclination angles were investigated; an equivalent to 45 and 65 degrees in-vivo, thus six conditions (n=6 for each condition) were studied in total with three million cycles completed for each condition. The wear of the ceramic-on-ceramic bearings were determined using a microbalance (Mettler Toledo, XP205, UK) and the dynamic microseparation displacement was measured using a Liner Variable Differential Transformer. Results. When a translational joint centre mismatch was coupled with a higher cup inclination angle, the severity of edge-loading increased when compared with the effect of those variables applied individually. Increasing the medial-lateral joint centre mismatch from 2 to 3 to 4mm resulted in increased wear rates under both cup inclination angles, with the 65 degree cup inclination angle having significantly higher wear rate than the cup inclination angle of 45 degree (p=0.02, p=0.02, and p<0.01 respectively). Conclusion. The cups with a 45 degree inclination angle showed greater resistance to dynamic microseparation as a result of joint centre mismatch. This study demonstrated that optimal position should not only consider the rotational position of the acetabular cup but also the relative centres of rotation of the head and the cup. Disclosure. John Fisher is a paid consultant to DePuy Synthes. Jonathan Thompson and Graham H. Issac are employees at DePuy Synthes