Variations in component positioning of total hip replacements can lead to edge loading of the liner, and potentially affect device longevity. These effects are evaluated using ISO 14242:4 edge loading test results in a dynamic system. Mediolateral translation of one of the components during testing is caused by a compressed spring, and therefore the kinematics will depend on the spring stiffness and damping coefficient, and the mass of the translating component and fixture. This study aims to describe the sensitivity of the liner plastic strain to these variables, to better understand how tests using different simulator designs might produce different amounts of liner rim deformation. A dynamic explicit deformable finite element model with 36mm Pinnacle metal-on-polyethylene bearing geometry (DePuy Synthes, Leeds, UK) was used with material properties for conventional UHMWPE. Setup was 65° clinical inclination, 4mm mismatch, 70N swing phase load, and 100N/mm spring. Fixture mass was varied from 0.5-5kg, spring damping coefficient was varied from 0-2Ns/mm. They were changed independently, and in combination. Maximum separation values were relatively insensitive to changes in the mass, damping coefficient, or both. The sensitivity of peak plastic strain, to this range of inputs, was similar to changing the swing phase load from 70N to approximately 150N – 200N. Increasing the fixture mass and/or damping coefficient increased the peak plastic strain, with values from 0.15-0.19. Liner plastic deformation was sensitive to the spring damping and fixture mass, which may explain some of the differences in fatigue and deformation results in UHMWPE liners tested on different machines or with modified fixtures. These values should be described when reporting the results of ISO14242:4 testing. Acknowledgements Funded by EPSRC grant EP/N02480X/1; CAD supplied by DePuy Synthes.
It is not always clear why some patients experience recurrent dislocation following total hip arthroplasty (THA). In order to plan appropriate revision surgery for such patients, however, it is important to understand the specific biomechanical basis for the dislocation. We have developed a novel method to analyse the biomechanical profile of the THA, specifically to identify edge loading and prosthetic impingement, taking into account spinopelvic mobility. In this study we compare the results of this analysis in THA patients with and without recurrent dislocation. Post-operative CT scans and lateral standing and seated radiographs of 40 THA patients were performed, 20 of whom had experienced postoperative dislocation. The changes in pelvic and femoral positions on the lateral radiographs were measured between the standing and seated positions, and a 3D digital model was then generated to simulate the movement of the hip when rising from a chair for each patient. The path of the joint reaction force (JRF) across the acetabular bearing surface and the motion of the femoral neck relative to the acetabular margin were then calculated for this “sit-to-stand” movement, in order to identify where there was risk of edge loading or prosthetic impingement.Background
Methods
In vivo fluoroscopic studies have proven that femoral head sliding and separation from within the acetabular cup during gait frequently occur for subjects implanted with a total hip arthroplasty. It is hypothesized that these atypical kinematic patterns are due to component malalignments that yield uncharacteristically higher forces on the hip joint that are not present in the native hip. This in vivo joint instability can lead to edge loading, increased stresses, and premature wear on the acetabular component. The objective of this study was to use forward solution mathematical modeling to theoretically analyze the causes and effects of hip joint instability and edge loading during both swing and stance phase of gait.Background
Objective
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
Total ankle replacement (TAR) is less successful than other joint replacements with a 77% survivorship at 10 years. Predominant indications for revision include: Insert dislocation, soft tissue impingement and pain/stiffness. Insert edge-loading may be both a product and cause of these indications and was reported to affect 22% of patients with the, now withdrawn from market, Ankle Evolutive System (AES) TAR (Transysteme, Nimes, France). Compressive forces up to seven times body weight over a relatively small contact area (∼6.0 to 9.2 cm2), in combination with multi-directional motion potentially causes significant polyethylene wear and deformation in mobile-bearing TAR designs. Direct methods of measuring component volume (e.g. pycnometer) use Archimedes' principle but cannot identify spatial changes in volume or form indicative of wear/deformation. Quantitative methods for surface analysis bridge this limitation and may advance methods for analysing the edge loading phenomena in TAR. Determine the frequency of edge loading in a cohort of explanted total ankle replacements and compare the quantitative surface characteristics using a novel explant analysis method.Introduction
Aim
There are many variables that can affect the occurrence and severity of edge loading in hip replacement. A translational mismatch between the centres of rotation of the head and cup may lead to dynamic separation, causing edge loading and increased wear. Combining a steep inclination angle with such translational mismatch in the medial-lateral axis caused a larger magnitude of separation and increased severity of edge loading. Previous studies have shown variation in the hip Swing Phase Load (SPL) during gait between different patients. The aim of this study was to apply a translational mismatch and determine the effect of varying the SPL on the occurrence and severity of edge loading under different cup inclination angles in a hip joint simulator. The Leeds II hip joint simulator with a standard gait cycle and 36mm diameter ceramic-on-ceramic bearings (BIOLOX® delta) were used in this study. The study was in two stages; [1] a biomechanical study where the magnitude of dynamic separation, the duration of edge loading and the magnitude of force under edge loading (severity) were assessed under variations in component positioning and SPLs. [2] A wear study to assess edge loading with selected input conditions. For the biomechanical study, a combination of four mismatches, three cup inclination angles, and eight SPLs (Table 1) were investigated. For the wear study, three SPL conditions were selected with one cup angle and one mismatch (Table 1). Three million cycles were completed under each condition. Mean wear rates and 95% confidence limits were determined and statistical analysis (one way ANOVA) completed (significance taken at p<0.05). Table 1: Study matrixIntroduction and Aims
Methods
Variations in component position can lead to dynamic separation and edge loading conditions. In vitro methods have been developed to simulate edge loading conditions and replicate stripe wear, increased wear rate, and bimodal wear debris size distribution, as observed clinically [1, 2]. The aim of this study was to determine the effects of translational and rotational positioning on the occurrence of dynamic separation and severity of edge loading, and then investigate the wear rates under the most severe separation and edge loading conditions on an electromechanical hip joint simulator. A 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. Three axes of rotation conditions (ISO 14242-1 [3]) was applied to the femoral head. This study was in two parts. I) A biomechanical test was carried out at 45° (n=3) and 65° (n=3) cup inclination angles with 1, 2, 3 and 4 (mm) medial-lateral translational mismatch between the centres of the head and cup. The amount of dynamic separation displacement between the head and cup was measured using a position sensor. The severity of edge loading was determined from the area under the axial force and medial-lateral force outputs during the time of separation [4]. II) A wear test was carried out at 45° (n=6) and 65° (n=6) cup inclination angles for three million cycles with translational mismatch of 4mm between the head and cup. The lubricant used was diluted new-born calf serum (25% v/v). Volumetric wear measurements were undertaken at one million cycle intervals and mean wear rates were calculated with 95% confidence limits. Statistical analysis was carried out using ANOVA and a t-test with significance levels taken at p<0.05.Introduction
Materials and Methods
The performance of total hip replacement (THR) devices can be affected by the quality of the tissues surrounding the joint or the mismatch of the component centres during hip replacement surgery. Experimental studies have shown that these factors can cause the separation of the two components during walking cycle (dynamic separation) and the contact of the femoral head with the rim of the acetabular liner (edge loading), which can lead to increased wear and shortened implant lifespan1. There is a need for flexible pre-clinical testing tools which allow THR devices to be assessed under these adverse conditions. In this work, a novel dynamic finite element model was developed that is able to generate dynamic separation as it occurs during the gait cycle. In addition, the ability to interrogate contact mechanics and material strain under separation conditions provides a unique means of assessing the severity of edge loading. This study demonstrates these model capabilities for a range of simulated surgical translational mismatch values, for ceramic-on-polyethylene implants. The components of the THR were aligned and constrained as illustrated in Figure 1. CAD models of commercially available implant geometries were used (DePuy Synthes, Leeds, UK) modified for model simplicity by removing anti-rotation features. The polyethylene cup liner was given elastic-plastic behaviour. An axial load following the Paul cycle pattern (5 repetitive cycles) with maximum of 3KN and swing phase load of 0.3KN, was applied through the cup holder. The effect of translational mismatch was implemented by using a spring element connected to the cup unit on the lateral side. The spring was compressed by a fixed amount to replicate a degree of medial-lateral mismatch of the components. The instantaneous resultant force vector dictated the dynamic sliding behaviour of the cup against the head. In this study, translational medial-lateral mismatch values of 1, 2, 3 and 4mm were used and the medial-lateral dynamic separation, contact pressure maps and plastic strain were recorded.Introduction
Methodology
Edge loading of hip replacements may result in plastic deformation, creep and wear at the rim of the cup and potentially fatigue failure. Variations in component positioning can lead to dynamic separation and edge loading [1]. The aim of this study was firstly to investigate the effects of translational and rotational positioning on the dynamic separation and severity of edge loading, and secondly to determine the wear rates of metal-on-polyethylene bearings under the more severe separation and edge loading conditions. A hip joint simulator (ProSim EM13, Simulation Solutions, UK) was set up with 36mm diameter metal-on-polyethylene hip replacements (Marathon™, DePuy Synthes Joint Reconstruction, Leeds, UK). This study was in two parts. I) A biomechanical test was carried out at 45° (n=3) and 65° (n=3) cup inclination angles with 1, 2, 3 and 4 (mm) medial-lateral translational mismatch between the head and cup centres. The severity of edge loading was calculated from the area under the axial force and medial-lateral force outputs during the time of separation when the load was acting on the edge of the cup [2]. II) For two conditions (two million cycles), the head and cup were concentric for cups inclined equivalent clinically to 45° (n=3) and 65° (n=3). For two further conditions (three million cycles), 4mm medial-lateral translational mismatch between centres was applied for cups inclined equivalent clinically to 45° (n=6) and 65° (n=6). Volumetric wear measurements were undertaken at one million cycle intervals. The lubricant was diluted new-born calf serum (25% v/v). Plastic deformation and wear were determined using a coordinate measurement machine. Mean values were calculated with 95% confidence limits. Statistical analysis was carried out using ANOVA and a t-test with significance levels taken at p<0.05.Introduction
Materials and Methods
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. 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).Introduction and Aims
Methods
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 replacement1. 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. The head-on-cup configurations of three ceramic materials (see Figure 1), were ATZ-on-ATZ, ZTA-on-ZTA, Al2O3-on-Al2O3, ATZ-on-ZTA, ZTA-on-ATZ, Al2O3-on-ATZ, ATZ-on-Al2O3and Al2O3-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 microseparation2,3,4 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).Introduction
Materials and Methods
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. 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.Introduction
Materials and Methods
Stripe wear, observed on retrieved ceramic hip replacements, has only been replicated 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. 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 al2 and Stewart et al3 (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).Introduction
Materials and Methods
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. 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.Introduction
Methods
Edge loading commonly occurs in all bearings in hip arthroplasty. Edge loading wear can occur in these bearings when the biomechanical loading axis reaches the edge and the femoral head loads the edge of the cup producing wear damage on both the head and cup edge. When the biomechanical loading axis passes through the polished articulating surface of the acetabular component and does not reach the edge, the center of the head and the center of the cup are concentric. The resulting wear known as concentric wear is low in metal-on-metal (MOM) bearings, and is negligible in ceramic-on-ceramic (COC) bearings. Edge loading is well defined in COC hip bearings. However, edge loading is difficult to identify in MOM bearings, since the metal bearing surfaces do not show wear patterns macroscopically. The aims of this study are to compare edge loading wear rates in COC and MOM bearings, and to relate edge loading to clinical complications. Twenty-nine failed large diameter metal-on-metal hip bearings (17 total hips, 12 resurfacings) were compared to 54 failed alumina-on-alumina bearings collected from 1998 to 2011. Most COC bearings were revised for aseptic loosening or periprosthetic bone fracture, while most MOM bearings were revised for pain, soft tissue reactions or impingement. The median time to revision was 3.2 years for the metal hip bearings and 3.5 years for alumina hip bearings. The surface topography of the femoral heads was measured using a RedLux AHP (Artificial Hip Profiler, RedLux Ltd, Southampton, UK).Introduction
Materials and Methods
Two types of ceramic materials currently used in total hip replacements are third generation hot isostatic pressed (HIPed) alumina ceramic (commercially known as BIOLOX® Ceramic bearings revised at one center from 1998 to 2010 were collected (61 bearings). Eleven Introduction
Material and Methods
Edge loading commonly occurs in all bearings in hip arthroplasty. The aim of this study compares metal bearings with edge loading to alumina bearings with edge loading and to metal bearings without edge loading. Seventeen failed large diameter metal-on-metal hip bearings (8 total hips, 9 resurfacings) were compared to 55 failed alumina-on-alumina bearings collected from 1998 to 2010. The surface topography of the femoral heads was measured using a chromatically encoded confocal measurement machine (Artificial Hip Profiler, RedLux Ltd.). The median time to revision for the metal hip bearings and the alumina hip bearings was 2.7 years. Forty-six out of 55 (84%) alumina bearings and 9 out 17 (53%) metal bearings had edge loading wear (p<0.01). The average volumetric wear rate for metal femoral heads was 7.87 mm3/yr (median 0.25 mm3/yr) and for alumina heads was 0.78 mm3/yr (median 0.18 mm3/yr) (p=0.02). The average volumetric wear rate for metal heads with edge loading was 16.51 mm3/yr (median 1.77 mm3/yr) and for metal heads without edge loading was 0.19 mm3/yr (median 0 mm3/yr) (p=0.1). There was a significant difference in gender, with a higher ratio of females in the alumina group than the metal group (p=0.02). Large diameter metal femoral heads with edge loading have a higher wear rate than smaller alumina heads with edge loading. Metal-on-metal bearings have low wear when edge loading does not occur.
Ceramic-on-ceramic hip replacements have generated great interest in recent years due to substantial improvements in manufacturing techniques and material properties1. 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 mechanisms2,3 and increase the wear of ceramic-on-ceramic bearings3,4. 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. The wear of size 28mm and 36mm ceramic-on-ceramic bearings (BIOLOX® INTRODUCTION
MATERIALS AND METHODS
Retrieval and clinical studies of metal-on-metal (MoM) bearings have associated increased wear1 and elevated patient ion levels2 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 mechanisms3,4. 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). The wear of size 28mm and 36mm MoM THRs bearings was determined under different INTRODUCTION
MATERIALS AND METHODS
All hip replacements depend upon good orientation and positioning to ensure that implants function well To investigate the correlation between edge loading and wear on retrieved implants through linear wear analysis and radiographic examination of implants Introduction
Aim
