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.

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

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.

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.

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).

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

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.