Total ankle replacement (TAR) is surgically complex; malalignment can arise due to surgical technique or failure to correct natural varus/valgus malalignment. Across joint replacement, malalignment has been associated with pain, component edge loading, increased wear and higher failure rates. Good component alignment is considered instrumental for long term TAR success. The conforming surface geometry of mobile bearing TARs leaves no freedom for coronal plane malalignment. The aim of this study was to investigate the biomechanical effect of coronal alignment on a mobile bearing TAR. Three TARs (Zenith, Corin Group) were tested under five coronal malalignment angles from 0–10° in a single station electromechanical knee simulator applying a typical ankle gait profile. As swing phase load is critical to TAR contact mechanics but will vary depending on the joint laxity. Swing loads of 100N, 300N and 500N were investigated. A positive control test with a swing load of 1000N was also studied, and was expected to eliminate the majority of lift off effects. Under each condition, the version was allowed to move freely while tests were performed, and the version profile under each alignment angle was recorded. Each test was carried out for 600 cycles in 25% bovine serum. Under the same loading conditions, but without lubrication, a Tekscan sensor recorded data from two cycles to assess the change in contact pressure and area at the five coronal angles.Introduction
Methods
Mal-positioning of the acetabular component in total hip replacement (THR) could lead to edge loading, accelerated component wear, impingement and dislocation [1,2]. In order to achieve a successful position for the acetabular component, the assessment of the acetabular orientation with reference to different coordinate systems is important [3]. The aims of the present study were to establish a pelvic coordinate system and a global body coordinate system, and to assess the acetabular orientations of natural hips with reference to the two coordinate systems. Three-dimensional (3D) computed tomographic (CT) images of 56 subjects (28 males and 28 females) lying supine were obtained from a public image archive (Cancer Image Archive, website: INTRODUCTION
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 input mechanical properties of knee replacement bearing materials, such as elastic modulus and Poisson's ratio, significantly contribute to the accuracy of computational models. They should therefore be determined from independent experimental studies, under similar test conditions to the clinical and experimental conditions, to provide reliability to the models. In most cases, the reported values in the literature for the elastic modulus and Poisson's ratio of the bearing materials have been measured under tensile test conditions, in contrast to the compressive operating conditions of the total knee replacements (TKR). This study experimentally determined the elastic modulus and Poisson's ratio of conventional and moderately cross-linked ultra-high molecular weight polyethylene (UHMWPE) under compressive test conditions. These material parameters will be inputs to future computational models of TKR. To determine the Poisson's ratio of the conventional and moderately cross-linked UHMWPE, contact areas of 12mm diameter cylindrical specimens of 10.2mm length were measured experimentally under a compressive displacement of 1mm, at a strain rate of 12mm/min that was held for 10minutes. A computational model was developed in Abaqus, 6.14–1, to simulate this experimental test assuming different values for the Poisson's ratio of the UHMWPE cylindrical specimens. The curve fitted relationship between the computationally predicted contact area and Poisson's ratio was used to calculate the Poisson's ratio of the UHMWPE specimens, using the experimentally measured contact areas. Using a similar approach, the equivalent elastic modulus of the UHMWPE was calculated using the computationally calculated curve fitted contact area-elastic modulus relationship, from the computational simulation of a ball-on-flat compression test, and the experimentally measured contact area from a ball-on-flat dynamic compression test. This experiment used 10mm thick UHMWPE flat specimens against a 63.5mm rigid ball, under a compressive dynamic sinusoidal loading of 250N average load, and 6000 cycles. The applied test conditions maintained the stress level within the reported range for the TKR.Introduction
Materials/Methods
Geometric variations of the hip joint can give rise to abnormal joint loading causing increased stress on the articular cartilage, which may ultimately lead to degenerative joint disease. In-vitro simulations of total hip replacements (THRs) have been widely reported in the literature, however, investigations exploring the tribology of two contacting cartilage surfaces, and cartilage against metal surfaces using complete hip joint models are less well reported. The aim of this study was to develop an in-vitro simulation system for investigating and comparing the tribology of complete natural hip joints and hemiarthroplasties with THR tribology. The simulation system was used to assess natural porcine hip joints and porcine hemiarthroplasty hip joints. Mean friction factor was used as the primary outcome measure to make between-group comparisons, and comparisons with previously published tribological studies. In-vitro simulations were conducted on harvested porcine tissue. A method was developed enabling natural acetabula to be orientated with varying angles of version and inclination, and natural femoral heads to be potted centrally with different orientations in all three planes. Acetabula were potted with 45° of inclination and in the complete joint studies, natural femoral heads were anatomically matched and aligned (n=5). Hemiarthroplasty studies (n=5) were conducted using cobalt chrome (CoCr) heads mounted on a spigot (Figure 1), size-matched to the natural head. Natural tissue was fixed using PMMA (polymethyl methacrylate) bone cement. A pendulum friction simulator (Simulator Solutions, UK), with a dynamic loading regime of 25–800N, ± 15° flexion-extension (FE) at 1 Hertz was used. The lubricant was a 25% (v/v) bovine serum. Axial loading and motion was applied through the femoral head and frictional torque was measured using a piezoelectric transducer, from which the friction factor was calculated.Introduction
Method
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
Surface wear of polyethylene is still considered a long-term risk factor for clinical success, particularly as life expectancy and activity levels increase. Computational models have been used extensively for preclinical wear prediction and optimization of total knee replacements (TKR). In most cases, the input wear parameters (wear factors and coefficients) to the computational models have been experimentally measured under average contact stresses to simulate standard activities. These wear studies are not therefore applicable for more adverse conditions that could lead to edge loading and high stress conditions, including higher levels of activities and severe loading conditions. The current study investigated the multidirectional pin-on-plate wear performance of moderately cross-linked ultra-high molecular weight polyethylene (UHMWPE) under high applied nominal contact stress, to be used as inputs to a computational model investigating adverse high stress conditions. Moderately cross-linked UHMWPE (GUR_1020,5Mrad gamma irradiation) pins were tested against cobalt–chrome alloy (CoCr) plates in a multidirectional pin-on-plate wear simulator. The CoCr metallic plates were polished to an average surface roughness of 0.01μm. The pin rotation and the plate reciprocation of ±30º and 28mm were in phase, having a common frequency of 1Hz, and resulted in a multidirectional motion at the pin-plate contact surface in a flat-on-flat configuration. Six different pin diameter and applied load combinations were tested, resulting in applied nominal contact stresses from 4 to 80[MPa](Fig.1). Each set was run for 1million cycles in 25% bovine serum as a lubricant. The volumetric wear was calculated from the weight loss measurements using a density 0.93mg/mm3 for the UHMWPE material. The wear factor and wear coefficient were calculated as (volumetric wear/(load x sliding distance)) and (volumetric wear/(contact area x sliding distance)) respectively[1]. Statistical analysis of the data was performed in ANOVA and significance was taken at p<0.05.Introduction
Materials/Methods
Contact between the femoral head and rim of the acetabular liner in total hip replacements has been linked to adverse tribological performance that may potentially shorten the lifespan of the prosthesis. Predicting the size and location of the contact area can be done computationally, however, experimental validation of these models is challenging due to the conforming nature of the bearing surfaces. This study aimed to develop a method of accurately determining the Metal-on-polyethylene and ceramic-on-polyethylene samples, with a nominal diameter of 36mm (DePuy Synthes, Leeds, UK), were tested with the cups orientated using a combination of inclination (equivalent to 45°, 55° and 65° in-vivo) and version (−20°, 0°, 20° and 40°) angles. The liners, which were first gold hard-coated (EMSCOPE SC 500, Quarum Technologies, UK), were inserted into a Pinnacle® titanium shell, and femoral heads were mounted on a vertical spigot (Figure 1). A single-station multi-axis electromechanical hip joint simulator (Prosim, Simulator Solutions, UK) was used to position the samples with 18.7° flexion, 6.2° adduction and 8.3° external rotation, congruous with just after heel strike (ISO 14242-1), and apply a 3kN static axial load through the centre of the femoral head. The contact area was generated by manually turning the head about the vertical axis of the centre of rotation of the applied load, removing the gold hard-coating from the contacting areas. The contact area was determined from photographs of the acetabular cup using SolidWorks (Dassault Systèmes, US) and ImageJ (National Institutes of Health, US) software packages. Three repeats under each combination of cup angles were completed, and the mean contact area and 95% confidence limits were determined for each bearing under all cup angle combinations.Introduction
Method
Previous studies have shown that third body damage to the femoral head in metal-on-polyethylene hip replacement bearings can lead to accelerated wear of the polyethylene liners. The resulting damage patterns observed on retrieved metal heads are typically scratches and scrapes. The damage created The aim of this study was to determine the wear rates of polyethylene liners articulating against retrievals and artificially damaged metal heads for the purpose of validating a computational wear prediction model; and to develop and validate an Twenty nine, 32mm diameter, metal-on-moderately cross-linked polyethylene bearings (MarathonTM) inserted into Ti-6Al-4V shells (Pinnacle®) were tested in this study. All products were manufactured by DePuy Synthes, Warsaw, Indiana, USA. Following a retrieval study seven different damage patterns were defined, and these were applied to the femoral heads using a four-degree-of-freedom CNC milling machine (Figure 1). The ProSim 10-station pneumatic hip joint simulator (Simulation Solutions, UK) was used for experimental wear simulation using standard gait cycles and testing each experimental group for 3 million cycles. The acetabular cups were inclined at 35° on the simulator (equivalent to 45° Introduction
Materials and Methods
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
Edge loading due to dynamic separation can occur due to variations in component positioning such as a steep cup inclination angle (rotational) or mismatch between the centres of rotation of the head and the cup (translational). The aim of this study was to determine the effect of variations in rotational and translational positioning of the cup on the magnitude of dynamic separation, wear and deformation of metal-on-polyethylene bearings. Eighteen 36mm diameter metal-on-polyethylene hip replacements were tested on an electromechanical hip simulator. Standard gait with concentric head and cup centres were applied for cups inclined at 45° (n=3) and 65° (n=3) for two million cycles. A further two tests with translational mismatch of 4mm applied between the head and cup bearing centres for cups inclined at 45° (n=6) and 65° (n=6) were run for three million cycles. Wear was determined using a microbalance and deformation by geometric analysis. Confidence intervals of 95% were calculated for mean values, and t-tests and ANOVA were used for statistical analysis (p<0.05). Under 4mm mismatch conditions, a steeper cup inclination angle of 65° resulted in larger dynamic separation (2.1±0.5mm) compared with cups inclined at 45° (0.9±0.2mm). This resulted in larger penetration at the rim under 65° (0.28±0.04mm) compared to 45° (0.10±0.09mm) cup inclination conditions (p<0.01). Wear rates under standard concentric conditions were 12.8±3.8 mm3/million cycles and 15.4±5.0 mm3/million cycles for cups inclined at 45° and 65° respectively. Higher wear rates were observed under 4mm of translational mismatch compared with standard concentric conditions at 45° (21.5±5.5 mm3/million cycles, p<0.01) and 65° (23.0±5.7 mm3/million cycles, p<0.01) cup inclination. Edge loading under dynamic separation conditions due to translational mismatch resulted in increased wear and deformation of the polyethylene liner. Minimising the occurrence and severity of edge loading through optimal component positioning may reduce the clinical failure rates of polyethylene.
Acellular porcine super flexor tendon (pSFT) offers a promising solution to replacement of damaged anterior cruciate ligament [1]. It is desirable to package and terminally sterilise the acellular grafts to eliminate any possible harmful pathogens. However, irradiation techniques can damage the collagen ultra-structure and consequently reduce the mechanical properties [2]. The aims of this study were to investigate the effects of irradiation sterilisation of varying dosages on the biomechanical properties of the acellular pSFT. Tendons were decellularised using a previously established protocol [1] and subjected to irradiation sterilisation using either 30 kGy gamma, 55 kGy gamma, 34 kGy E-beam, 15 kGy gamma, 15 kGy E-beam and (15+15) kGy E-beam (fractionated dose). Specimens then underwent stress relaxation and strength testing at 0 and 12 months post sterilisation to determine whether any effect on these properties was progressive. For stress relaxation testing, specimens were analysed using a Maxwell-Wiechert model. For strength testing, the ultimate tensile strength, Young's modulus and failure strain were assessed. Significant differences were found which demonstrated that all irradiation treatments had an effect on the time-independent and time-dependent viscoelastic properties of irradiated tendons compared to per-acetic acid only treated controls. Interestingly, no significant differences were found between the irradiated groups. Similar trends were found for the strength testing properties. No significant differences were found between groups at 0 and 12 months. Tendons retained sufficient biomechanical properties following sterilisation, however it was notable that there were no significant differences between the irradiated groups, as it was believed higher dosages would lead to a greater reduction in the mechanical properties. The changes observed were not altered further after 12 months storage, indicating the acellular pSFT graft has a stable shelf-life.
Edge loading due to dynamic separation can occur due to variations in component positioning such as a steep cup inclination angle (rotational) or mismatch between the centres of rotation of the head and the cup (translational). The aim of this study was to determine the effect of variations in rotational and translational positioning of the cup on the magnitude of dynamic separation, wear and deformation of metal-on-polyethylene bearings. Eighteen 36mm diameter metal-on-polyethylene hip replacements were tested on an electromechanical hip simulator. Standard gait with concentric head and cup centres were applied for cups inclined at 45° (n=3) and 65° (n=3) for two million cycles. A further two tests with translational mismatch of 4mm applied between the head and cup bearing centres for cups inclined at 45° (n=6) and 65° (n=6) were run for three million cycles. Wear was determined using a microbalance and deformation by geometric analysis. Confidence intervals of 95% were calculated for mean values, and t-tests and ANOVA were used for statistical analysis (p<0.05). Under 4mm mismatch conditions, a steeper cup inclination angle of 65° resulted in larger dynamic separation (2.1±0.5mm) compared with cups inclined at 45° (0.9±0.2mm). This resulted in larger penetration at the rim under 65° (0.28±0.04mm) compared to 45° (0.10±0.05mm) cup inclination conditions (p<0.01). Wear rates under standard concentric conditions were 12.8±3.8 mm3/million cycles and 15.4±5.0 mm3/million cycles for cups inclined at 45° and 65° respectively. Higher wear rates were observed under 4mm of translational mismatch compared with standard concentric conditions at 45° (21.5±5.5 mm3/million cycles, p<0.01) and 65° (23.0±5.7 mm3/million cycles, p<0.01) cup inclination. Edge loading under dynamic separation conditions due to translational mismatch resulted in increased wear and deformation of the polyethylene liner. Minimising the occurrence and severity of edge loading through optimal component positioning may reduce the clinical failure rates of polyethylene.
Wear particles produced by alumina ceramic-on-ceramic (CoC) bearings cause a minimal immunological response with low cytotoxicity and inflammatory potential1, 2. However, more comprehensive immunological studies are yet to be completed for the composite CoC (zirconia-toughened, platelet reinforced alumina) hip replacements due to difficulties in isolating the very low volume of clinically relevant wear debris generated by such materials Composite ceramic particles (commercial BIOLOX® delta powder) were obtained from CeramTec, Germany and clinically relevant CoCr wear particles were generated using a six station pin-on-plate wear simulator. L929 fibroblast cells were cultured with 50µm3 of CoCr wear debris or composite ceramic particles at low to high volumes ranging from 500µm3–0.5µm3 per cell and the cyctotoxic effects of the particles were assessed over a period of 6 days using the ATP-Lite™ cell viability assay. The composite ceramic particles were bimodal in size (0.1–2µm & 30–100nm) and showed mild cytotoxic effects when compared with equivalent particle volumes (50µm3) of clinically relevant CoCr nano-particles (10–120nm). The CoCr nano-particles had significant cytotoxic effects from day 1, whereas the composite ceramic particles only showed cytotoxic effects at particle concentrations of 50 and 500µm3 after 6 days. The increased cytotoxicity of the clinically relevant CoCr nano-particles may have been attributed to the release of Co and Cr ions. This study demonstrated the potential cytotoxic effects of model ceramic particles at very high volume concentrations, but it is unlikely that such high particle volumes will be experienced routinely
There is a demand for longer lasting arthroplasty implants driving the investigation of novel material combinations. PEEK has shown promise as an arthroplasty bearing material, with potentially relatively bio inert wear debris [1]. When coupled with an all-polyethylene tibial component this combination shows potential as a metal-free knee. In this study, the suitability of PEEK Optima® as an alternative to cobalt chrome for the femoral component of total knee replacements was assessed using experimental knee wear simulation under two kinematic conditions. Three cobalt chrome and three injection moulded PEEK Optima® (Invibio Biomaterial Solutions, UK) femoral components of similar geometry and surface roughness (mean surface roughness (Ra) ∼0.02µm) were coupled with all-polyethylene GUR1020 (conventional, unsterilised) tibial components in a 6 station ProSim knee simulator (Simulation Solutions, UK). 3 million cycles (MC) of wear simulation were carried out under intermediate kinematics (maximum anterior-posterior (AP) displacement 5mm) followed by 3MC under high kinematics (AP 10mm) [2] with 25% serum as the lubricant. The wear of the tibial component was assessed gravimetrically. At each measurement point, the surface roughness of the femoral components was determined using contacting profilometry and throughout testing, the bulk lubricant temperature was monitored close to the articulating surfaces. Statistical analysis was carried out using ANOVA, with significance at p<0.05.Introduction
Methods
To meet the demands of younger more active patients more robust pre-clinical wear testing methods are required, in order to simulate a wider range of activities. A new electromechanical simulator (Simulation Solutions, UK) with a greater range of motion, a driven abduction/adduction axis and improved input kinematic following has been developed to meet these requirements, as well as requirements of the relevant international standards. This study investigated the wear of a fixed bearing total knee replacement using this new electromechanical knee simulator, comparing with previous data from a pneumatic simulator. The wear of six Sigma CR fixed bearing TKRs (DePuy, UK) with curved moderately cross-linked polyethylene inserts (XLK) was determined in pneumatic and electromechanical Prosim knee simulators (Simulation Solutions, UK). Standard gait displacement controlled kinematics were used, with a maximum anterior-posterior displacement of either 10mm (high) or 5mm (intermediate) [1]. The output profiles from the simulators were obtained and compared to the demand input profiles. The lubricant used was 25% new-born calf serum and wear determined gravimetrically. Statistical analysis was performed using the one-way ANOVA with 95% confidence interval and significance was taken at p<0.05.Introduction
Materials/Methods
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. 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.Introduction
Materials and Methods
Total ankle replacements (TAR) are a much debated alternative to ankle fusion for treatment of end stage arthritis. Compared with hip and knee replacements these are implanted in small numbers with less than 500 per year recorded by the joint registry for England and Wales. The small numbers are a likely result of typically low mid-term survival rates, as well as extensive contra-indications for surgery. There have been multiple generations of TARs consisting of both constrained and unconstrained designs but due to device classification pre-clinical testing has been minimal. Five Zenith (Corin Group PLC), Titanium Nitride (TiN) coated, unconstrained TARs with conventional polyethylene inserts (Figure 1) were tested in an adapted knee simulator (Simulator Solutions, UK) for six million cycles (MC). The input parameters (Figure 2) were taken from available literature as there is no recognised ISO standard in place. A parametric study with three conditions was conducted to understand the impact of kinematic inputs on the polyethylene wear rate. These conditions aimed to understand the effect of both linear wear with isolated flexion, then multidirectional motion by implementing a rotational input with and without anterior/posterior (AP) displacement. Each condition was run for two MC. Stage One: Flexion and Load Stage Two: Flexion, Load, Rotation and Displacement Stage Three: Flexion, Load and Displacement A lubricant of 25% bovine serum, 0.03% Sodium Azide solution was used to replicate the protein content of the natural joint capsule. The wear was measured gravimetrically every million cycles and surface measurements taken with a contacting profilometer.Introduction
Method
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
Total ankle replacement (TAR) has been used as a surgical intervention for arthritis since the 1970s. However, unlike clinically successful hip and knee replacements, TARs are renowned for extensive contraindications to surgery and high failure rates with an average of 83% survival at 5 years. The majority cite aseptic loosening as the reason for failure. The aim of this study wais to analyse retrieved TARs visually and through interferometry to identify potential the failure mechanisms associated with these devices. Retrieved total ankle replacements (n=11) from consecutive revision surgeries carried out at Chapel Allerton Hospital, Leeds between August 2012 and January 2014, were collected for study at the University of Leeds, under an NRES approved procedure (09/H1307/60). The bearing surfaces of the samples were visually inspected for evidence of damage and wear. The bearing surfaces between the tibial component and the flat surface of the polyethylene insert were then examined using a scanning white light interferometer (NP Flex, Bruker, USA). It was not possible to characterise the talar bearing surface or the inferior polyethylene surface at this stage through interferometry due to the curvature of the surface. The components were aligned and five sections on each of the surfaces measured. These sections represented; anterior-medial, anterior-lateral, posterior-medial, posterior lateral and central regions of the bearing surfaces. 3D roughness values were recorded, and the mean 3D surface roughness compared between implants. Measurements were taken on the medial and lateral aspects of the bearing surfaces to investigate whether damage was location specific. A coefficient of determination was calculated to assess the relationship between implantation time and surface roughness.Introduction
Methods
