Introduction

PEEK-OPTIMA™ has been considered as an alternative to cobalt chrome in the femoral component of total knee replacements. Whole joint wear simulation studies of both the tibiofemoral and patellofemoral joints carried out to date have shown an equivalent wear rate of UHMWPE tibial and patella components against PEEK and cobalt chrome (CoCr) femoral components. In this study, the influence of third body wear on UHMWPE-on-PEEK was investigated, tests on UHMWPE-on-CoCr were carried out in parallel to compare PEEK to a conventional femoral component material.

INTRODUCTION

There is great potential for the use of computational tools within the design and test cycle for joint replacement devices.

The increasing need for stratified treatments that are more relevant to specific patients, and implant testing under more realistic, less idealised, conditions, will progressively increase the pre-clinical experimental testing work load. If the outcomes of experimental tests can be predicted using low cost computational tools, then these tools can be embedded early in the design cycle, e.g. benchmarking various design concepts, optimising component geometrical features and virtually predicting factors affecting the implant performance. Rapid, predictive tools could also allow population-stratified scenario testing at an early design stage, resulting in devices which are better suited to a patient-specific approach to treatment.

The aim of the current study was to demonstrate the ability of a rapid computational analysis tool to predict the behaviour of a total hip replacement (THR) device, specifically the risk of edge loading due to separation under experimental conditions.

Component alignment and soft tissue constraints are key factors affecting function and implant survival after total knee replacement (TKR). Knee kinematics contribute to knee function whilst soft tissue constraints and component alignment impact polyethylene wear. This study experimentally investigated the effect of soft tissue constraints and component alignment on the kinematics and wear of a TKR.

A six station electromechanical ProSim knee simulator was used with the ISO 14243-1:2009 standard force control inputs; axial force, flexion-extension (FE), tibial rotation (TR) torque and anterior-posterior (AP) force. This allowed the kinematics to vary with the test conditions. The soft tissue constraints were simulated using virtual springs.

DePuy Sigma XLK fixed bearing TKRs were tested in 25% bovine serum (in 0.04% sodium azide) lubricant. The average output kinematics across 6 stations were found for each test and the peak values compared. The wear rates were calculated over 2 million cycles (MC), the serum was changed every 350,000 cycles and the tibial inserts weighed after every MC. A one way ANOVA and post hoc Tukey's test was used to compare the kinematics and wear with significance taken at p<0.05.

The kinematics and wear rates for three soft tissue conditions were established under ideal alignment (Table 1). The ISO standard springs for a cruciate substituting (CS) and a cruciate retaining (CR) prosthesis were used to represent a knee with a resected ACL and PCL and a knee with a resected ACL respectively. The third spring condition was based on clinical data to represent a “stiff” knee.

Three other alignment conditions were then assessed using “stiff” knee springs; 4° varus, 14° rotational mismatch and 10° posterior tibial slope. These alignments were chosen to represent the range found in clinical data.

Under ideal alignment the “stiff” knee springs had significantly lower peak AP and TR displacements (0.9mm, 2mm, 2mm and 3.6°, 7.1°, 7.8° for the “stiff”, CR and CS springs respectively) than the other springs (p<0.01). The “stiff” knee spring had a significantly lower wear rate than the CR spring; 1.58 ±1.20mm³/MC compared to 4.71±1.29 mm³/MC (p<0.01).

The varus and rotated components had significantly larger peak AP displacements of 2.56mm and 2.42mm respectively, than the ideal and tibial slope fixtures (1.97mm and 0.92mm respectively) (p<0.01). The rotated components had significantly higher internal rotation of 12.2° compared to 4.4°, 3.7° and 3.5° for the tibial slope, varus and ideal components respectively (p<0.01).

The ideal and varus components had significantly lower wear than the tibial slope and rotated components (1.58±1.20mm³/MC and 0.15±0.83mm³/MC compared to 8.24±7.72mm³/MC and 5.19±1.12mm³/MC respectively) (p<0.01). This may be due to increased AP and TR displacements with the rotated components and the increased anterior AP displacement with the tibial slope components, resulting in wear on the posterior edge of the tibial insert.

Soft tissue constraints and component alignment had a significant effect on the kinematics and wear. Experimental simulation should test a variety of soft tissue and alignment conditions to reflect the range observed clinically and determine causes for early failure.

For any figures or tables, please contact the authors directly.

Introduction

PEEK-OPTIMA™ has been considered as an alternative to cobalt chrome in the femoral component of total knee replacements. Wear simulation studies of both the tibiofemoral and patellofemoral joints carried out to date have shown an equivalent wear rate of UHMWPE tibial and patella components against PEEK and cobalt chrome (CoCr) femoral components implanted under optimal alignment conditions. In this study, fundamental pin-on-plate studies have been carried out to investigate the wear of UHMWPE-on-PEEK under a wider range of contact pressure and cross-shear conditions.

Introduction

The number of young and more active patients requiring total knee replacement (TKR) is increasing. Preclinical evaluation and understanding the long-term failure of TKR is therefore important. Preclinical wear simulation of TKR is usually performed according to the International Standards Organization (ISO) recommendations. Two international standards for preclinical wear simulation of TKRs have been developed so that the anterior-posterior (AP) translation and internal-external (IE) rotation can be driven in either force or displacement control. However, the effects of using different control regimes on the kinematics and wear of the same TKR have not been investigated. The current study investigated the kinematics, contact mechanics and wear performance of a TKR when running under ISO force and displacement control standards using an experimentally validated computational model.

Decellularised extracellular matrix scaffolds show great promise for the regeneration of damaged musculoskeletal tissues (cartilage, ligament, meniscus), however, adequate fixation into the joint remains a challenge. Here, we assess the osseo-integration of decellularised porcine bone in a sheep model. This proof-of-concept study supports the overall objective to create composite decellularised tissue scaffolds with bony attachment sites to enable superior fixation and regeneration.

Porcine trabecular bone plugs (6mm diameter, 10mm long) were decellularised using a novel bioprocess incorporating low-concentration sodium dodecyl sulphate with protease inhibitors. Decellularised bone scaffolds (n=6) and ovine allograft controls (n=6) were implanted into the condyle of skeletally mature sheep for 4 and 12 weeks. New bone growth was visualised by oxytetracycline fluorescence and standard resin semi-quantitative histopathology.

Scaffolds were found to be fully decellularised and maintained the native microarchitecture. Following 4-week implantation in sheep, both scaffold and allograft appeared well integrated. The trabecular spaces of the scaffold were filled with a fibro-mesenchymal infiltrate, but some areas showed a marked focal lymphocytic response, associated with reduced bone deposition. A lesser lymphocytic response was observed in the allograft control. After 12-weeks the lymphocytic reaction was minimised in the scaffold and absent in allografts. The scaffold showed a higher density of new mineralized bone deposition compared to allograft. New marrow had formed in both the scaffold and allografts.

Following the demonstration of osteointegration this bioprocess can now be transferred to develop decellularised composite musculoskeletal tissue scaffolds and decellularised bone scaffolds for clinical regeneration of musculoskeletal tissues.

Experimental simulation is the gold standard wear testing method for total knee replacements (TKR), with reliable replication of physiological kinematic conditions. When combined with a computational model, such a framework is able to offer deeper insight into the biomechanical and wear mechanisms. The current study developed and validated a comprehensive combined experimental and computational framework for pre-clinical biomechanics and wear simulation of TKR.

A six-station electro-mechanical knee simulator (SimSol, UK), capable of replicating highly demanding conditions with improved input kinematic following, was used to determine the wear of Sigma fixed bearing curved TKRs (DePuy, UK) under three different activities; standard-walking, deep-squat, and stairs-ascending. The computational model was used to predict the wear under these 3 conditions. The wear calculation was based on a modification of Archard's law which accounted for the effects of contact stress, contact area, sliding distance, and cross-shear on wear. The output wear predictions from the computational model were independently validated against the experimental wear rates.

The volumetric wear rates determined experimentally under standard-walking, deep-squat, and stairs-ascending conditions were 5.8±1.4, 3.5±0.8 and 7.1±2.0 [mm3/mc] respectively (mean ± 95% CI, n=6). The corresponding predicted wear rates were 4.5, 3.7, and 5.6 [mm3/mc]. The coefficient of determination for the wear prediction of the framework was 0.94.

The wear predictions from the computational model showed good agreement with the experimental wear rates. The model did not fully predict the changes found experimentally, indicating other factors in the experimental simulation not yet incorporated in the framework, such as plastic deformation, may play an additional role experimentally in high demand activities. This also emphasises the importance of the independent experimental validation of computational models.

The combined experimental and computational framework offered deeper insight into the contact mechanics and wear from three different standard and highly demanding daily activities. Future work will adopt the developed framework to predict the effects of patients and surgical factors on the mechanics and wear of TKR.

The concept of decellularised xenografts as a basis for anterior cruciate ligament (ACL) reconstruction was introduced to overcome limitations in alternative graft sources such as substantial remodelling delaying recovery and donor site morbidity. This study aimed to measure the biomechanical properties of decellularised porcine super flexor tendon (pSFT) processed to create ACL grafts of varying diameters, with a view to facilitating production of stratified ‘off the shelf’ products with specified functional properties for use in ACL reconstructive surgery.

Decellularisation was carried out using a previously established procedure, including antibiotic washes, low concentration detergent (0.1% sodium dodecyl sulphate) washes and nuclease treatments. Decellularised pSFTs were prepared to create double-bundle grafts of 7, 8 and 9mm diameter (n=6 in each group). Femoral and tibial fixations were simulated utilising Arthrex suspension devices (Tightrope®) and interference screws in bovine bone respectively.

Dynamic stiffness and creep were measured under cyclic loading between 50–250N for 1000 cycles at 1Hz. This was followed by ramp to failure at 200mm/min from which linear stiffness and load at failure were measured. Data were analysed using either 1- or 2-way ANOVA as appropriate with Tukey post-hoc analysis (p<0.05).

Significant differences were found between all groups for dynamic stiffness and between 7 & 9mm and 8 & 9mm groups for dynamic creep. Significant differences were also found between 7, 8 & 9mm groups for linear stiffness (167.8±4.9, 186.9±16.6 & 216.3±12.4N/mm respectively), but no significant differences were found between groups for load at failure (531.5±58.9, 604.1±183.3 & 627.9±72.4N respectively).

This study demonstrated that decellularised pSFTs possess comparable biomechanical properties to other ACL graft options (autografts and allografts). Furthermore, grafts can be stratified by their diameter to provide varying biomechanical profiles depending on the anatomy and individual needs of the recipient.

We have developed a decellularised porcine superflexor tendon (pSFT), which has shown promising regenerative capacity in an ovine model of anterior cruciate ligament (ACL) repair. This study investigated the strain rate dependent and dynamic mechanical properties of native and decellularised pSFTs.

Decellularisation was carried out using a previously established procedure, including antibiotic washes, low concentration detergent (0.1% sodium dodecyl sulphate) washes and nuclease treatments.

Three different strain rates were employed: 1, 10 & 100%s-1 (n=6 for all groups). Toe-region modulus (E0), linear-region modulus (E1), transition coordinates (εT, σT), tensile strength (UTS) and failure strain were calculated. For DMA, specimens were loaded between 1 & 5MPa with increasing frequency up to 2Hz. Dynamic (E*), storage (E') and loss (E'') moduli, and tan delta were calculated for native and decellularised groups (n=6). Data was analysed by 2-way ANOVA and Tukey post-hoc test (p<0.05).

For decellularised tendons, altering the strain rate did not affect any of the static tensile properties. For native pSFTs, the UTS, failure strain and E1 were not affected by changing the strain rate. Increasing the strain rate significantly increased E0 (1% vs 10% and 1% vs 100%) and σT (1% vs 100%) and decreased εT (1% vs 10% and 1% vs 100%) for native pSFT. E*, E' and E'' were all significantly reduced in decellularised specimens compared to native controls across all frequencies investigated. No significant differences were found for tan delta.

Evidence of strain rate dependency was witnessed in the native pSFTs by increase of the toe region modulus and displacements of the transition point coordinates. This response was not seen in the tissue following decellularisation. DMA demonstrated a reduction in dynamic, storage and loss moduli. Tan delta (E''/E') remained unchanged, indicating reductions in solid and fluid components are interlinked.

A pre-clinical experimental simulation model has been previously successfully developed, and was shown to have the potential for investigation of the biomechanical and tribological performance of early stage knee therapies. In order to investigate interventions that may necessitate sacrifice of the natural ligaments, it is necessary to replicate their function. This study investigated the most effective spring constraint conditions for the porcine knee model with the aim of replicating the natural ligament function.

The replication of natural ligament function was achieved through the use of physical springs in the anterior-posterior (AP) axis. Spring-9 (9 N/mm) and spring-20 (20 N/mm) were set at different free lengths in a natural knee simulator. The A/P displacement and shear force outputs from porcine knee samples (N=6) were measured and the most appropriate spring setting was determined by comparing the outputs at different spring settings with intact knee.

The A/P displacement of both spring-9 and spring-20 showed similar shapes to the all ligament control. Spring-9 with a free length of 4 mm and spring-20 with a free length of 5 mm showed minimal differences in A/P displacement output compared to the all ligament controls. There was no statistical difference between the two minimal differences either in A/P displacement or in shear force (paired t-test, p>0.05), which indicated that both conditions were appropriate spring constraint settings for the natural porcine knee model.

A porcine knee simulation model with refined spring constraint conditions was successfully developed in this study. Human knee model is currently under investigation using the methodology developed in porcine knee model, which will be more appropriate to investigate the effect of early stage knee therapies on the tribological function of the natural knee.

Variation in soft tissue constraints influence the kinematics and wear of total knee replacements (TKRs). The aim of this study was to experimentally investigate the effect of variation in the soft tissue constraints on the output kinematics of a fixed bearing TKR with different insert geometries. The kinematics have been shown to affect the wear rate of TKRs; increased output displacements may result in an increased wear rate. The soft tissue constraints were simulated experimentally using virtual springs.

A new generation six station electromechanical ProSim knee simulator was used with the ISO 14243–1:2009 standard force control inputs; axial force, flexion-extension (FE), tibial rotation (TR) torque and anterior-posterior (AP) force. This allowed the kinematics to vary due to the test conditions. The ISO standard spring tensions of 44N/mm and 0.36Nm/° and gaps of 2.5mm and 6° were used for the AP and TR springs respectively.

Different combinations of the input profiles were run in order to test the effect of their absence. The spring gaps were varied between 0mm–3mm and 0°–6° and the tensions between 0N/mm–250N/mm and 0Nm/°–1Nm/° for the AP and TR respectively. Three tibial insert designs were tested; high conformity curved (CVD), partially lipped (PLI) and flat.

DePuy PFC Sigma fixed bearing components were tested in 25% bovine serum (in 0.04% sodium azide) lubricant. For each test 100 cycles were recorded on each station and then averaged. The CVD insert was used for all tests, the PLI insert was also used to test the effect of spring tension.

The TR and AP output displacement profiles were affected by the FE position along with the TR torque and AP force respectively. The absence of these inputs changed the shape of the output profiles significantly. The spring gaps affected the peak AP and TR displacements (6.4mm to 3.7mm and 8° to 5.8° for maximum and zero spring gaps respectively). The spring tensions had a higher effect on the peak AP than TR position due to the design of the CVD insert restricting the TR movement (8.3mm to 3.7mm and 8.8° to 7.4° for no springs and maximum tension respectively). The spring gaps and tensions affected the amplitudes of the output profiles not their shape.

The lower conformity inserts had a higher peak TR position (23° for the flat and 8.1° for the CVD insert) which occurred earlier in the cycle. The flat insert resulted in more anterior displacement, potentially due to the high conformity on the anterior side of the CVD and PLI inserts. The spring tension test had an increased effect on the PLI than the CVD insert. The PLI insert resulted in a higher change in displacements due to the spring tensions (10.4mm to 3.5mm and 13.6° to 8.8°).

Soft tissue constraints and insert design had a significant effect on the kinematic outputs. Spring tensions and gaps for experimental testing should be chosen to reflect those of a specific patient group.

Introduction

PEEK-OPTIMA™ has been considered as an alternative bearing material to cobalt chrome in the femoral component of total knee replacements. To better understand the tribology of UHMWPE-on-PEEK-OPTIMA™ and to find the most appropriate environmental conditions under which to test this novel bearing material combination, a series of tests under different protein lubricant concentrations at rig (∼24°C) and elevated temperature (∼35°C) were carried out in simple geometry wear and friction rigs. Under all conditions, the wear of UHMWPE-on-PEEK-OPTIMA™ was compared to UHMWPE-on-cobalt chrome (CoCr).

Introduction

Experimental wear simulation of an all-polymer knee implant has shown an equivalent rate of wear of UHMWPE tibial components against PEEK-OPTIMA™ and cobalt chrome femoral components of a similar initial geometry and surface topography. However, when the patella is resurfaced with an UHMWPE patella button, it is important to also ascertain the wear of the patella. Wear debris from the patella contributes to the total volume of wear debris produced by the implant which should be minimised to reduce the potential for osteolysis and subsequent implant loosening. The aim of this study was to investigate the wear of the patellofemoral joint in an all-polymer knee implant. The wear of UHMWPE patellae articulating against PEEK-OPTIMA™ femoral components was compared to UHMWPE articulating against cobalt chrome femoral components.

Introduction and Aims

There are many surgical, implant design and patient factors that should be considered in preclinical testing of hip replacement which are not being considered in current standards. The aim of this study was to develop a preclinical testing method that consider surgical positioning, implant design and patient factors and predict the occurrence and severity of edge loading under the combination of such conditions. Then, assess the safety and reliability of the implant by predicting the wear, deformation and damage of the implant bearings under worst case conditions.

INTRODUCTION

Avascular necrosis (AVN) of the femoral head (FH) initiates from biological disruptions in the bone and may progress to mechanical failure of the hip. Mechanical and structural properties of AVN bone have not been widely reported, however such understanding is important when designing therapies for AVN. Brown et al.[1] assessed mechanical properties of different regions of AVN FH bone and reported 52% reduction in yield strength and 72% reduction in elastic modulus of necrotic regions when compared to non-necrotic bone. This study aimed to characterise structural and mechanical properties of FH bone with AVN and understand the relationship between lesion volume and associated mechanical properties.

Purpose and Background

Strengthening the lumbar extensor musculature is a common recommendation for CLBP. Although reported as effective, variability in response in CLBP populations is not well investigated. This study investigated variability in responsiveness to isolated lumbar extension (ILEX) resistance training in CLBP participants by retrospective analysis of 3 RCTS.

The ability to pre-clinically evaluate new cartilage substitution therapies in viable physiological biotribological models, such as the femoral-tibial joint would be advantageous. Methods for osteochondral (OC) plug culture have been developed and the aim of this study was to extend these methods to organ culture of whole femoral condylar and tibial osteochondral tissues.

Porcine femoral condyles and tibial plateau were aseptically dissected. The majority of cancellous bone was removed leaving intact cartilage and a layer of cortical bone. OC plugs were from porcine knee condyles. “Whole joint” tissues and OC plugs were cultured in defined medium and the viability of the cartilage at day 0, 8 or 14 days of culture assessed by XTT assay and LIVE/DEAD staining. Histological analysis (H&E; alcian blue staining) was used to determine cell number and visualise glycosominoglycans (GAGs). GAG levels were quantified in the cartilage using the dimethylene blue assay.

XTT conversion by OC plug cartilage reduced significantly between day 0 and day 8 with no further change between day 8 and 14. GAG levels did not change. “Whole joint” tissue behaved similarly with reduced XTT conversion between days 0 and 8 (femoral only) and days 0 and 14 (femoral and tibial). LIVE/DEAD staining showed the majority of cells remained alive in the mid and deep cartilage zones. There was a band of mainly dead cells in the surface zone, from day 0. There was no change in the GAG levels over the 14 day culture period.

In conclusion, large cuts of femoral and tibial osteochondral tissues were maintained in organ culture for extended periods. Surface zone chondrocytes rapidly lost membrane integrity ex-vivo whereas mid- and deep zone chondrocytes remained viable. It is hypothesised that physiological loading in a novel physically interactive bioreactor will improve the viability and will be the focus of future studies.

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.

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.

Introduction and Aims

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.

Introduction

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.

INTRODUCTION

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.

Introduction

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.

Introduction

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.

Introduction

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.

Introduction

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.

Introduction

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.

Introduction

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 in-vitro contact area between the femoral head and acetabular cup in metal-on-polyethylene and ceramic-on-polyethylene bearings under different component orientations.

Introduction

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 in vitro must represent the third body damage that occurs clinically. A computational model was developed to predict the acceleration of wear of polyethylene articulating against in vitro damaged femoral heads. This involved using a damage registry from retrieval femoral heads to develop standardized templates of femoral head scratches statistically representative of retrieval damage

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 in vitro standardised femoral head damage protocol for pre-clinical testing of hip replacements.

Introduction

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.

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 potential^{1, 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 in vitro. The aim of this study was to compare the cytotoxic effects of clinically relevant cobalt chromium (CoCr) nano-particles with commercial composite ceramic particles.

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 in vivo in such low wearing bearing materials. Future work will investigate the longer-term effects on genotoxicity and oxidative stress of low volumes of clinically-relevant generated BIOLOX® delta ceramic wear particles.

Introduction

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.

Introduction

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.

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.

Introduction

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.

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.

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 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.

Introduction

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.

Introduction

When third body particles originating from bone cement or bone void fillers become trapped between articulating surfaces of joint replacements, contact surfaces may be damaged leading to accelerated wear and premature failure of the implant. In this study, the damage to cobalt chrome counterfaces by third body particles from PMMA bone cement (GMV, DePuy) and various bone void fillers was investigated; then wear tests of UHMWPE were carried out against these surfaces.

Introduction

UHMWPE articulating against PEEK-OPTIMA® has the potential for use as a novel bearing couple in joint arthroplasty due to its potentially low wear rates and the bioinertness of its wear debris. The aim of this study was to investigate the role of protein in the lubricant on the wear of UHMWPE articulating against PEEK at both room and physiological temperature.

Introduction

Hip replacements are falling short of matching the life expectancy of coxarthritis patients, due to implanting THR in younger patients and due to increasingly active patients. The most frequently implanted hip prostheses use cross linked (XL) polyethylene (PE) on metal bearings in the USA and most of the Western world. Concerns remain in the long term around the potential of wear debris-induced aseptic loosening. Thus exploring lower-wearing alternative bearings remains a major research goal.

PEEK (poly-ether-ether-ketone) is a thermoplastic polymer with enhanced mechanical properties. This study compared the wear of PEEK to the wear of cross linked polyethylene, when sliding against cobalt chrome (CoCr) metallic counterfaces, and compared the wear of carbon-fibre reinforced (CFR)-PEEK to cross linked polyethylene when sliding against metallic and ceramic counterfaces under different contact stresses within the hip joint.

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.

Introduction

Wear debris induced osteolysis and loosening continue to cause clinical failure in total knee replacement (TKR). To improve longevity and reduce wear alternative materials have been examined. Carbon-fibre-reinforced poly–ether-ether-ketone (CFR-PEEK) has shown promising results in wear studies [1–2].

The aim of this study was to explore the use of CFR-PEEK and PEEK as alternative bearing materials for polyethylene in TKR through experimental knee joint wear simulation.

Summary Statement

Wear of total knee replacement (TKR) is a clinical concern. This study demonstrated low-conformity moderately cross-linked-polyethylene fixed bearing TKRs showed lower volumetric wear than conventional-polyethylene curved fixed bearing TKRs highlighting potential improvement in TKR performance through design and material selection.

Summary Statement

The frictional torque of ceramic-on-ceramic bearings tended to increase with increasing the bearings size (32, 48, 56mm). However, the frictional torque was significantly lower than that measured on metal-on-metal bearings under well positioned and well lubricated conditions.

Introduction:

Backside wear has been previously reported through in-vitro and in-vivo to have a significant contribution to the total wear in rotating bearing TKRs.

The present study investigated the contribution of backside wear to the total wear in the PFC Sigma rotating platform mobile bearing TKR. In addition, the wear results were compared to the computed wear rates of the PFC Sigma fixed bearing TKR, with two different bearing materials.

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.