The fidelity of a 3D model created using image segmentation must be precisely quantified and evaluated for the model to be trusted for use in subsequent biomechanical studies such as finite element analysis. The bones within the ankle joint vary significantly in size and shape. The purpose of this study was to test the hypothesis that the accuracy and reliability of a segmented bone geometry is independent of the particular bone being measured. Computed tomography (CT) scan data (slice thickness 1 mm, pixel size 808±7 µm) from three anonymous patients was used for the development of the ankle geometries (consisting of the tibia, fibula, talus, calcaneus, and navicular bones) using Simpleware Scan IP software (Synopsys, Exeter, UK). Each CT scan was segmented 4 times by an inexperienced undergraduate, resulting in a total of 12 geometry assemblies. An experienced researcher segmented each scan once, and this was used as the ‘gold standard’ to quantify the accuracy. The solid bone geometries were imported into CAD software (Inventor 2023, Autodesk, CA, USA) for measurement of the surface area and volume of each bone, and the distances between bones (tibia to talus, talus to navicular, talus to calcaneus, and tibia to fibula) were carried out. The intra-class coefficient (ICC) was used to assess intra-observer reliability. Bland Altman plots were employed as a statistical measure for criteria validity (accuracy) [1].Abstract
Objectives
Methods
The aim of this work was to compare the different techniques and the different fluid permeability of the tissue following each technique through assessing the flow of radiopaque contrast agent using μCT image analysis and 3D modelling. Donated human tali specimens (n=12) were prepared through creating a 10mm diameter chondral defect in three different regions of each talus. Each region then underwent one of three surgical techniques: 1) Fine wire drilling, 2) Nanofracture or 3) Microfracture, equidistant sites in each defect to ensure even distribution. Each region then had an addition of 0.1 ml radiopaque contrast agent (Omnipaque™ 300), imaged using a clinical μCT scanner (SCANCO Medical AG, 73.6 μm resolution). Each μCT scan was segmented using Slicer 3D software (The Slicer Community, 2023 3D Slicer (5.2.2)). The segmentation package was used to segment the bone and contrast agent regions in each different surgical site of each sample. Each defect site was created into a cylinder and the ratio of segmented pixels of contrast agent against bone.Abstract
Objectives
Methods
The syndesmosis joint, located between the tibia and fibula, is critical to maintaining the stability and function of the ankle joint. Damage to the ligaments that support this joint can lead to ankle instability, chronic pain, and a range of other debilitating conditions. Understanding the kinematics of a healthy joint is critical to better quantify the effects of instability and pathology. However, measuring this movement is challenging due to the anatomical structure of the syndesmosis joint. Biplane Video Xray (BVX) combined with Magnetic Resonance Imaging (MRI) allows direct measurement of the bones but the accuracy of this technique is unknown. The primary objective is to quantify this accuracy for measuring tibia and fibula bone poses by comparing with a gold standard implanted bead method. Written informed consent was given by one participant who had five tantalum beads implanted into their distal tibia and three into their distal fibula from a previous study. Three-dimensional (3D) models of the tibia and fibula were segmented (Simpleware Scan IP, Synopsis) from an MRI scan (Magnetom 3T Prisma, Siemens). The beads were segmented from a previous CT and co-registered with the MRI bone models to calculate their positions. BVX (125 FPS, 1.25ms pulse width) was recorded whilst the participant performed level gait across a raised platform. The beads were tracked, and the bone position of the tibia and fibula were calculated at each frame (DSX Suite, C-Motion Inc.). The beads were digitally removed from the X-rays (MATLAB, MathWorks) allowing for blinded image-registration of the MRI models to the radiographs. The mean difference and standard deviation (STD) between bead-generated and image-registered bone poses were calculated for all degrees of freedom (DOF) for both bones.Abstract
Objectives
Methods
This abstract provides an update on the Open Ankle Models being developed at the University of Bath. The goal of this project is to create three fully open-source finite element (FE) ankle models, including bones, ligaments, and cartilages, appropriate musculoskeletal loading and boundary conditions, and heterogeneous material property distribution for a standardised representation of ankle biomechanics and pre-clinical ankle joint analysis. A computed tomography (CT) scan data (pixel size of 0.815 mm, and slice thickness of 1 mm) was used to develop the 3D geometry of the bones (tibia, talus, calcaneus, fibula, and navicular). Each bone was given the properties of a heterogeneous elastic material based on the CT greyscale. The density values for each bone element were calculated using a linear empirical relation, ρ= 0.0405 + (0.000918) HU and then power law equations were utilised to get the Young's Modulus value for each bone element [1]. At the bone junction, a thickness of cartilage ranging from 0.5–1 mm, and was modelled as a linear material (E=10 MPa, ν=0.4 [2]). All ligament insertions and positions were represented by four parallel spring elements, and the ligament stiffness and material attributes were applied in accordance with the published literature [2]. The ankle model was subjected to static loading (balance standing position). Four noded tetrahedral elements were used for the discretization of bones and cartilages. All degrees of freedom were restricted at the proximal ends of the tibia and fibula. The ground reaction forces were applied at the underneath of the calcaneus bone. The interaction between the cartilages and bones was modelled using an augmented contact algorithm with a sliding elastic contact between each cartilage. A tied elastic contact was used between the cartilages and the bone. FEbio 2.1.0 (University of Utah, USA) was used to construct the open-source ankle model.Abstract
Objectives
Methods
Ligament integrity is directly associated with ankle stability. Nearly 40% of ankle sprains result in chronic ankle instability, affecting biomechanics and potentially causing osteoarthritis. Ligament replacement could restore stability and avoid this degenerative pathway, but a greater understanding of ankle ligament behaviour is required. Additionally, autograft or allograft use is limited by donor-site morbidity and inflammatory responses respectively. Decellularised porcine grafts could address this, by removing cellular material to prevent acute immune responses, while preserving mechanical properties. This project will characterise commonly injured ankle ligaments and damage mechanisms, identify ligament reconstruction requirements, and investigate the potential of decellularised porcine grafts as a replacement material. Several porcine tendons were evaluated to identify suitable candidates for decellularisation. The viscoelastic properties of native tissues were assessed using dynamic mechanical analysis (DMA), followed by ramp to ‘sub-rupture’ at 1% strain/s, and further DMA. Multiple samples (n=5) were taken along the graft to assess variation along the tendon. When identifying suitable porcine tendons, a lack of literature on human ankle ligaments was identified. Inconsistencies in measurement methods and properties reported makes comparison between studies difficult. Preliminary testing on porcine tendons suggested there is little variation in viscoelastic properties along the length of tendon. Testing also suggested strain rates of 1%/s sub-rupture was not large enough to affect viscoelastic properties (no changes in storage or loss moduli or tanẟ). Further testing is underway to improve upon low initial sample numbers and confirm these results, with varying strain rates to identify suitable sub-rupture sprain conditions. This work highlights need for new data on human ankle ligaments to address knowledge gaps and identify suitable replacement materials. Future work will generate this data and decellularise porcine tendons of similar dimensions. Collagen damage will be investigated using histology and lightsheet microscopy, and viscoelastic changes through DMA.
Decellularised porcine superflexor tendon (pSFT) has been demonstrated to be a suitable scaffold for anterior cruciate ligament reconstruction[1]. While the role of collagen in tendons is well known, the mechanical role of glycosaminoglycans (GAGs) is less clear and may be altered by the decellularisation process. To determine the effects of decellularisation on pSFT GAG content and mechanical function and to investigate the consequences of GAG loss in tensile and compressive loading. pSFTs were decellularised following previous techniques [2]. For GAG removal, native pSFTs were treated with chondroitinase ABC (ChABC; 0.1U/mL, 72h). Cell and GAG removal was validated using histology and quantitative assays. Native, decellularised and ChABC treated groups (n=6) were biomechanically characterised. In tension, specimens underwent stress relaxation and strength testing using previous protocols [1]. Stress relaxation data was fitted to a modified Maxwell-Weichert model to determine time-dependent (E1 & E2) and time-independent moduli (E0). The toe and linear region moduli (Etoe, Elinear), in addition to tensile strength (UTS) and failure strain were determined from strength testing. In compression, specimens underwent confined loading conditions (ramp at 10 s-1 to 10% strain and hold). The aggregate modulus (HA) and zero-strain permeability (k0) were determined using previous techniques [3]. Data was analysed by one-way ANOVA with Tukey post-hoc test to determine significant differences between test groups (p<0.05). Quantitative assays showed no GAG reduction post-decellularisation, but a significant reduction after ChABC treatment. HA was only significantly reduced in the ChABC group. k0 was significantly higher for the ChABC group compared to decellularised. E0 was significantly reduced in the decellularised group compared to native and ChABC groups, while E1 and E2 were not different between groups. Etoe, Elinear, UTS and failure strain were not different between groups. Decellularisation does not affect GAG content or impair mechanical function in pSFT. GAG loss adversely affects pSFT compressive properties, revealing major mechanical contribution under compression, but no significant role under tension.
To be able to assess the biomechanical and functional effects of ankle injury and disease it is necessary to characterise healthy ankle kinematics. Due to the anatomical complexity of the ankle, it is difficult to accurately measure the Tibiotalar and Subtalar joint angles using traditional marker-based motion capture techniques. Biplane Video X-ray (BVX) is an imaging technique that allows direct measurement of individual bones using high-speed, dynamic X-rays. The objective is to develop an in-vivo protocol for the hindfoot looking at the tibiotalar and subtalar joint during different activities of living. A bespoke raised walkway was manufactured to position the foot and ankle inside the field of view of the BVX system. Three healthy volunteers performed three gait and step-down trials while capturing Biplane Video X-Ray (125Hz, 1.25ms, 80kVp and 160 mA) and underwent MR imaging (Magnetom 3T Prisma, Siemens) which were manually segmented into 3D bone models (Simpleware Scan IP, Synopsis). Bone position and orientation for the Talus, Calcaneus and Tibia were calculated by manual matching of 3D Bone models to X-Rays (DSX Suite, C-Motion, Inc.). Kinematics were calculated using MATLAB (MathWorks, Inc. USA). Pilot results showed that for the subtalar joint there was greater range of motion (ROM) for Inversion and Dorsiflexion angles during stance phase of gait and reduced ROM for Internal Rotation compared with step down. For the tibiotalar joint, Gait had greater inversion and internal rotation ROM and reduced dorsiflexion ROM when compared with step down. The developed protocol successfully calculated the in-vivo kinematics of the tibiotalar and subtalar joints for different dynamic activities of daily living. These pilot results show the different kinematic profiles between two different activities of daily living. Future work will investigate translation kinematics of the two joints to fully characterise healthy kinematics.
This study aims to assess the changes in mechanical behaviour over time in ‘haemarthritic’ articular cartilage compared to ‘healthy’ articular cartilage. Pin-on-plate and indentation tests were used to determine the coefficient of friction (COF) and deformation of ‘healthy’ and ‘haemarthritic articular cartilage. Osteochondral pins (8 mm) were extracted from porcine tali and immersed in exposure fluid for two hours prior to test. Pins were articulated against a larger bovine femoral plate for 3600 seconds under a load of 50 N. Osteochondral pins (8 mm) were loaded during indentation testing for 3600 seconds under a load of 0.25 N. To mimic the effect of a joint bleed in vitro; serum, whole blood and 50% v/v were used as exposure and lubricant fluids. COF and deformation were expressed as mean (n=3) and statistically analysed using a one-way ANOVA and post-hoc Tukey test (p>0.05). The serum condition yielded a COF of 0.0428 ± 0.02 with 0.08mm ± 0.04 deformation. The 50% v/v condition produced a higher COF of 0.0485 ± 0.02 and 0.21mm ± 0.04 deformation. The lowest COF and deformation were produced by the whole blood condition (0.0292 ± 0.02 and 0.06mm ± 0.006 respectively). Statistical analysis indicated no significant difference across the friction test conditions but a significant difference across all indentation test conditions (ANOVA, p>0.05). Combination of creep deformation and wear was observed on the articular surface up to 24 hours post-test in 50% v/v and whole blood conditions. The average haemophilia patient can experience multiple joint bleeds per year of which this study demonstrates the effect of just one joint bleed. This study has provided evidence of potential reversible and irreversible mechanical changes to articular cartilage surface during a joint bleed.
Decellularised porcine superflexor tendon (pSFT) provides an off-the-shelf, cost-efficient option for ACL reconstruction (ACLR). During decellularisation, phosphate buffered saline (PBS) is used for washing out cytotoxic solutes and reagents, maintaining tissue hydration. It has been shown to increase water content in tendon, swelling the tissue reducing mechanical properties. End stage PBS washes in the standard protocol were substituted with alternative solutions to study tissue swelling and its impact on the mechanical behaviour and matrix composition of pSFTs. 25%, 100% Ringers and physiological saline test groups were used (n=6 for all groups). pSFTs were subject to tensile and confined compression testing. Relative hydroxyproline (HYP), glycosaminoglycan (GAG) and denatured collagen content (DNC) were quantified. Modified decellularised tendon groups were compared to tendons decellularised using the standard protocol and native tendons. Specimen dimensions reduced (p=0.004) post-decellularisation only in 25% Ringers group. In all other modified groups, less swelling was apparent but not statistically different from standard group. Only 25% Ringers group had higher linear modulus (p=0.0035) and UTS (p=0.013) compared to standard group. All decellularised groups properties were reduced compared to native pSFTs. Stress relaxation properties showed a significant reduction in decellularised groups compared to native. Compression testing showed no significant differences in peak stress for modified decellularised groups compared to native. A reduction (p=0.036) was observed in standard group. Quantification of GAGs and DNC showed no significant differences between groups. HYP content was higher (p<0.0001) for saline group. A significant reduction in tissue swelling could be related to improved mechanical properties of decellularised pSFTs. Alternative solutions in end stage washes had no significant effect on quantities of matrix components, but altered structure/function could explain the differences in tensile and compressive behaviour, and should be further studied. In all decellularised groups, pSFTs retained suitable mechanical properties for ACLR.Abstract
The aim of this study was to develop an open-source finite element model of the ankle for identification of the best clinical treatment to restore stability to the ankle after injury. The ankle geometry was defined from the Visible Human Project Female CT dataset available from the National Library of Medicine, and segmented using Dragonfly software (Object Research Systems, 2020). The finite element model was created with FEBio (University of Utah, 2021) using the dynamic nonlinear implicit solver. Linear isotropic material properties were assigned to the bones (E=7300MPa, ν=0.3, ρ=1730kg/m3) and cartilage (E=10MPa, ν=0.4, ρ=1100kg/m3). Spring elements were used to represent the ligaments and material properties were taken from Mondal et al. [1]. Lagrangian contact was defined between the cartilaginous surfaces with μ=0.003. A standing load case was modelled, assuming even distribution of load between the feet. A reaction force of 344.3N was applied to the base of the foot, a muscle force of 252.2N, and the proximal ends of the tibia and fibula were fully constrained.Abstract
Objectives
Methods
Flattening of the talar dome is observed clinically in haemarthropathy as structural and functional changes advance but has not been quantified yet. In order to confirm clinical observation, and assess the degree of change, morphological measurements were derived from MR images. Four measurements were taken, using ImageJ (1.52v), from sagittal MRI projections at three locations – medial, lateral and central: Trochlear Tali Arc Length (TaAL), Talar Height (TaH), Trochlear Tali Length (TaL), and Trochlear Tali Radius (TaR). These measurements were used to generate three ratios of interest: TaR:TaAL, TaAL:TaL, and TaL:TaH. With the hypothesis of a flattening of the talar dome with haemarthropathy, it was expected that TaR:TaAL and TaL:TaH should be greater for haemophilic ankles, and TaAL:TaL should be smaller. A total of 126 MR images (ethics: MEEC 18–022) were included to assess the difference in those ratios between non-diseased ankles (33 images from 11 volunteers) and haemophilic ankles (93 images from 8 patients’ ankles). Non-diseased control measurements were compared to literature to assess the capacity of doing measurements on MRI instead of radiographs or CT.Abstract
OBJECTIVE
METHODS
Over 1% of the global population suffers with ankle osteoarthritis (OA), yet there is limited knowledge on the changes to subchondral bone with OA. In other joints, it has been shown that bone becomes osteosclerotic, with fewer, thicker trabeculae that become hypomineralised, causing an increased apparent bone volume fraction (BV/TV). Microstructural alterations reduce overall joint strength, which may impact the success of late-stage surgical interventions, such as total ankle arthroplasty (TAA). Previous ankle studies have evaluated changes to cartilage, bone plate and bone morphology with OA, hence this study aimed to characterise changes to trabecular architecture. Three ankle joints were isolated from non-diseased cadaveric feet (three males: 43, 50 and 57 years, MEEC 18-027). Cylindrical subchondral bone specimens (N=6, 6.5 mm Ø) were extracted from the tibial plafond. Osteoarthritic bone samples (N=6, distal tibia) were sourced from local patients (three males: 65, 58 and 68 years, NREC 07/Q1205/27) undergoing TAA surgery. Specimens were imaged using µCT at a 16 µm isotropic resolution (µCT-100 ScanCo Medical). Virtual cores of bone (6.5 mm Ø) were extracted from the image data of the osteoarthritic specimens and trimmed to a height of 4 mm. BoneJ was used to evaluate key morphological indices: BV/TV; anisotropy (DA); trabecular thickness (Tb.Th); trabecular density (Conn.D) and ellipsoid factor (EF) which characterises rod/plate geometry. Differences between the two groups of specimens were evaluated using a t-test with Bonferroni correction.Abstract
Objectives
Methods
Implant loosening remains a common cause of total ankle replacement (TAR) revision, and has been associated with wear-mediated osteolysis. Limited pre-clinical studies for TARs have been reported and the variety of experiment settings make it difficult to compare wear rates. Factors such as simulator control mechanism; whether pneumatic or electromechanical, may influence the integrity of the simulator outputs with respect to input profiles. This study compares the wear of a TAR, tested in electromechanical and pneumatic experimental simulators under identical input conditions. Twelve medium BOX® (MatOrtho Ltd) TARs (n=6 for each simulator) were tested in an electromechanical and pneumatic knee simulator (Simulation Solutions, UK) for 3 million cycles (Mc). Standard ‘Leeds’ displacement-controlled inputs were used. Kinematic performance was investigated by comparing the output profiles against the maximum demanded input values. The lubricant used was 25% new-born calf serum and wear was determined gravimetrically.Abstract
Objectives
Methods
Ankle arthritis is estimated to affect approximately 72 million people worldwide. Treatment options include fusion and total ankle replacement (TAR). Clinical performance of TAR is not as successful as other joint replacement and failure is poorly understood. Finite element analysis offers a method to assess the strain in bone implanted with a TAR. Higher strain has been associated with microfracture and alters the bone-implant interface. The aim of this study was to explore the influence of implant fixation on strain within the tibia when implanted with a TAR through subject-specific models. Five cadaveric ankles were scanned using a Scanco Xtreme CT. The Tibia and Talus were segmented from each scan and virtually implanted with a Zenith TAR (Corin, UK) according to published surgical technique. Patient specific models were created and run at five different positions of the gait cycle corresponding to peak load and flexion values identified from literature. Bone material properties were derived from CT greyscale values and all parts were meshed with linear tetrahedral elements. The implant-bone interface was adjusted to fully-fixed or frictionless contact, representing different levels of fixation post-surgery. Strain distributions around the tibial bone fixation were measured.Abstract
Introduction
Methods
Skeletal kinematics are traditionally measured by motion analysis methods such as optical motion capture (OMC). While easy to carry out and clinically relevant for certain applications, it is not suitable for analysing the ankle joint due to its anatomical complexity. A greater understanding of the function of healthy ankle joints could lead to an improvement in the success of ankle-replacement surgeries. Biplane video X-ray (BVX) is a technique that allows direct measurement of individual bones using highspeed, dynamic X-Rays. To develop a protocol to quantify in-vivo foot and ankle kinematics using a bespoke High-speed Dynamic Biplane X-ray system combined with OMC. Two healthy volunteers performed five level walks and step-down trials while simultaneous capturing BVX and synchronised OMC. participants undertook MR imaging (Magnetom 3T Prisma, Siemens) which was manually segmented into 3D bone models (Simpleware Scan IP, Synopsis). Bone position and orientation for the Talus, Tibia and Calcaneus were calculated by manual matching of 3D Bone models to X-Rays (DSX Suite, C-Motion, Inc.). OMC markers were tracked (QTM, Qualisys) and processed using Visual 3D (C-motion, Inc.).Abstract
Objective
Methods
Total ankle arthroplasty (TAA) is an alternative to ankle arthrodesis, replacing the degenerated joint with a mechanical motion-preserving alternative. Implant loosening remains a primary cause of TAA revision, and has been associated with wear-mediated osteolysis. Differing implant designs have a major influence on the wear performance of joint replacements. Providing a range of implant sizes allows surgeons a greater intra-operative choice for varying patient anatomy and potential to minimise wear. Minimal pre-clinical testing exists in the literature that investigates the effect of implant size on the wear behaviour. The aim of this study therefore was to investigate the effect of two different implant sizes on the wear performance of a TAA. Six ‘medium’ and six ‘extra small’ BOX® (MatOrtho Ltd, UK) TAA implants, of the same conceptual design and polyethylene insert thickness, were tested in a modified 6 station pneumatic knee simulator. 5 million cycles (Mc) of wear simulation were completed for each implant size, under kinematics aiming to replicate an ankle gait cycle (Figure 1) [1]. The simulator used had six degrees of freedom, of which four were controlled. The maximum axial load was 3150N, equivalent to 4.5 times body weight of a 70kg individual. The flexion profile ranged from −15° plantarflexion to 15° dorsiflexion. Rotation about the tibial component ranged from −2.3° of internal rotation to 8° external rotation, and anterior/posterior (AP) displacement ranged from 3.1 mm anterior to −0.9 mm posterior displacement. The lubricant used was 25% bovine serum supplemented with 0.04% sodium azide to prevent bacterial degradation. The wear of the TAA polyethylene inserts were determined gravimetrically after each Mc, with unloaded soak controls used to compensate for the uptake of moisture by the polyethylene.Background
Materials & Methods
Osteoarthritis is a debilitating disease affecting over 1.7 million people in the UK annually. Total ankle replacements are an increasingly sought option for repairing a late stage arthritic ankle, but result in the removal of significant portions of bone regardless of tissue quality. Hence, the mapping of bone quality would allow the use of targeted treatments at earlier stages of the disease. This study aims to develop characterisation methodologies using porcine tissue to investigate the mechanical properties of subchondral bone in the ankle. N=11 talar bone plugs (6mm diameter) were extracted from porcine ankles and embedded into Delrin endcaps using a thin layer of PMMA cement. These were scanned under micro-CT (16 microns) and subjected to quasi-static uniaxial compression to determine apparent stiffness for each specimen. Specimen-specific continuum FE models were developed, with material properties derived from the greyscale value of the underlying image. A python-based least squares regression (Opti4Abq, N=6) was used to minimise the difference between experimental and model stiffness values, to determine the coefficient linking greyscale and mechanical properties. Apparent stiffness, elastic modulus and compressive strength were compared to BV/TV, which was derived using BoneJ (a bone image plugin for the NIH ImageJ). The results show positive correlations between BV/TV and compressive strength, stiffness and Young's modulus. Average BV/TV across all samples was 0.45. Average experimental and computational stiffness were 986N/mm and 891 N/mm respectively. A 21.8% RMS error was found using the validation set (N=5), which was of similar order to the calibration set. Some specimens saw issues with misalignment of the specimen faces and the loading platens, likely causing overestimation of mechanical properties. This study has developed methods that can be translated for use with human ankle bone and will lead to the development of an accurate means of mapping arthritic bone in the ankle.
Total ankle replacement (TAR) is a substitute to ankle fusion, replacing the degenerated joint with a mechanical motion-conserving alternative. Compared with hip and knee replacements, TARs remain to be implanted in much smaller numbers, due to the surgical complexity and low mid-to-long term survival rates. TAR manufacturers have recently explored the use of varying implant sizes to improve TAR performance. This would allow surgeons a wider scope for implanting devices for varying patient demographics. Minimal pre-clinical testing has been demonstrated to date, while existing wear simulation standards lack definition. Clinical failure of TARs and limited research into wear testing defined a need for further investigation into the wear performance of TARs to understand the effects of the kinematics on varying implant sizes. Six medium and six extra small BOX® (MatOrtho) TARs will be tested in a modified knee simulator for 5 million cycles (Mc). The combinations of simulator inputs that mimic natural gait conditions were extracted from ankle kinematic profiles defined in previous literature. The peak axial load will be 3.15 kN, which is equivalent to 4.5 times body weight of a 70kg individual. The flexion profile ranges from 15° plantarflexion to 15° dorsiflexion. Rotation about the tibial component will range from −2.3° of internal rotation to 8° external rotation, while the anterior/posterior displacement will be 7mm anterior to −2mm posterior throughout the gait cycle. The components will be rotated through the simulation stations every Mc to account for inter-station variability. Gravimetric measurements of polyethylene wear will be taken at every Mc stage. A contact profilometer will also be used to measure average surface roughness of each articulating surface pre-and-post simulation. The development of such methods will be crucial in the ongoing improvement of TARs, and in enhancing clinical functionality, through understanding the envelope of TAR performance.
Total ankle replacement (TAR) is less successful than other joint replacements with a 77% survivorship at 10 years. Predominant indications for revision include: Insert dislocation, soft tissue impingement and pain/stiffness. Insert edge-loading may be both a product and cause of these indications and was reported to affect 22% of patients with the, now withdrawn from market, Ankle Evolutive System (AES) TAR (Transysteme, Nimes, France). Compressive forces up to seven times body weight over a relatively small contact area (∼6.0 to 9.2 cm2), in combination with multi-directional motion potentially causes significant polyethylene wear and deformation in mobile-bearing TAR designs. Direct methods of measuring component volume (e.g. pycnometer) use Archimedes' principle but cannot identify spatial changes in volume or form indicative of wear/deformation. Quantitative methods for surface analysis bridge this limitation and may advance methods for analysing the edge loading phenomena in TAR. Determine the frequency of edge loading in a cohort of explanted total ankle replacements and compare the quantitative surface characteristics using a novel explant analysis method.Introduction
Aim
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
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
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
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
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. Two novel materials were studied as an alternative to polyethylene as the tibial bearing surface in a TKR configuration using a Cobalt chrome femoral bearing in current clinical use. Six right Sigma CR fixed bearing TKRs (DePuy Synthes, UK) were paired with either PEEK or CFR-PEEK custom-made flat inserts (Invibio, UK) in a Prosim knee simulator (Simulator Solutions, UK). The tibial inserts were 14mm thick, to give an equivalent thickness to existing insert designs. A flat geometry was selected as this has previously been shown to yield low wear in polyethylene bearings [3]. The tests were conducted under High Kinematics, with anterior-posterior and internal-external displacement control [4]. Tests were conducted for three million cycles, lubricated with 25% bovine serum, with wear assessed gravimetrically at 1 and 3Mc. Images of the wear scars were recorded at completion of the study. Visual inspection of the tibial inserts was used to identify regions of wear damage for SEM analysis (EVO MA15-Smart SEM, Zeiss, Germany)Introduction
Methods
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. Wear of total knee replacement (TKR) continues to be a significant factor in the clinical performance of the implants. Historically, failure due to delamination and fatigue directed implant design towards more conforming implants to reduce contact stress. However, the new generations of more oxidatively-stable polyethylene have improved the long-term mechanical properties of the material, and therefore allowed more flexibility in the bearing design. The purpose of this study was to investigate the effect of insert conformity and material on the wear performance of a fixed bearing total knee replacement through experimental simulation.Summary Statement
Introduction
Backside wear has been previously reported through 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. The commercially available PFC Sigma rotating platform mobile bearing and PFC Sigma fixed bearing total knee replacements, size 3 (DePuy, UK) were tested, with either conventional or moderately cross-linked (5 MRad) GUR1020 UHMWPE bearing materials. The computational wear model for the knee implants was based on the contact area and an independent experimentally determined non-dimensional wear coefficient [1,2,3]. The experimental wear test for the mobile bearing was force controlled using the ISO anterior-posterior force (ISO14243-1-2009). However, due to time limitation of the explicit simulation required to run the force controlled model, the simulation was run using the AP displacements taken from the experimental knee simulator which was run under the ISO AP force. The Sigma fixed bearing TKR was run under high level of anterior-posterior displacements (maximum of 10 mm).Introduction:
Materials and Methods:
Wear debris induced osteolysis and loosening continue to be causes of clinical failure in total knee replacement (TKR). Laboratory simulation aims to predict the wear of TKR bearings under specific loading and motion conditions. However, the conditions applied may have significant influence on the study outcomes (1) The aim of this study was to examine the influence of femoral setup and kinematic inputs on the wear of a conventional polyethylene fixed bearing TKR through experimental and computational models. Six right Sigma CR fixed bearing TKRs (DePuy Synthes, Leeds, UK) with curved polyethylene inserts (GVF, GUR1020 UHMWPE) were tested in Prosim knee simulator (Simulator Solutions, UK). The femoral bearing was set up with the centre of rotation (CoR) on either on the distal radius of the implant (Distal CoR), as indicated by the device design, or according to the ISO specification (ISO CoR; ISO14243-3). The tests were conducted under ‘High Kinematics’ (2). It was necessary to reverse the direction of the anterior-posterior displacement for the tests conducted with the ISO centre of rotation to maintain the contact region within the insert surface (Reverse High Kinematics). Tests were conducted for three million cycles, lubricated with 25% bovine serum, with wear assessed gravimetrically. The computational wear model for the TKR was based on the contact area and an independent experimentally determined non-dimensional wear coefficient, previously validated against the experimental data (3).Introduction
Methods
Wear of polyethylene continues to be a significant factor in the longevity of total knee replacement (TKR). Moderately cross-linked polyethylene has been employed to reduce the wear of knee prostheses, and more recently anti-oxidants have been introduced to improve the long-term stability of the polyethylene material. This is the initial study of the wear of a new anti-oxidant polyethylene and a new TKR design, which has modified femoral condylar geometry. The wear of a new TKR the Attune knee was investigated using a physiological six station Prosim knee wear simulator (Simulator Solutions, UK). Six mid-size Attune fixed bearing cruciate retaining TKRs (DePuy Inc, Warsaw, USA) were tested for a period of 6 million cycles. The inserts were manufactured from AOX™, a compression moulded GUR1020 polyethylene incorporating Covernox™ solid anti-oxidant. The AOX polymer was irradiated to 8M Rad, to give a moderately cross-linked material. High and intermediate kinematics, under anterior-posterior displacement control were used for this study (McEwen Introduction
Materials and Methods
During broach preparation and implant insertion of the proximal femur the surgeon may be able to use audible pitch changes to judge broaching adequacy and implant position. The aim of this study was to analyse the sound produced and explain the sound spectra using acoustic physics. A highly sensitive microphone was used to digitally record the sound made during femoral preparation and definitive implant insertion in 9 patients undergoing total hip arthroplasty. The sound data was analysed using a fast Fournier transformation spectrum analyser. The highest 4 peak spectral amplitudes of the first broach, the last strike of the final broach and the definitive implant were recorded. The sound spectra produced by striking the implant introducer in isolation were analysed in a similar manner.Introduction
Methods
Concerns regarding UHMWPE wear particle induced osteolysis in total hip replacement (THR, [1]) have led to alternative materials to be sought. Carbon-fibre reinforced poly-ether-ether-ketone (CFR-PEEK) has shown reduced wear in hip and knee configurations compared with conventional polyethylene [2-4]. The aim of this study was to investigate the wear performance of a ceramic-on-CFR PEEK THR through a simulator study. Five 36mm diameter Biolox Delta heads were paired with extruded CFR-PEEK cups and tested in a hip wear simulator (Simulator Solutions, UK) for 10 million cycles (Mc). Tests were performed in a Prosim hip simulator, which applied a twin peak loading cycle, with a peak load of 3kN. Flexion-extension of −15 to +30 degrees was applied to the head and internal-external rotation of +/− 10 degrees was applied to the cup, components were mounted anatomically. The lubricant was 25% (v/v) calf serum supplemented with 0.03% (w/v) sodium azide. Wear was assessed gravimetrically at several intervals adjusted for moisture uptake using loaded and unloaded soak controls.Introduction
Methodology
Ceramic-on-metal (ceramic head and metal liner, COM) hip replacements have shown reduced wear in comparison to metal-on-metal (MOM) bearings. This has been attributed to reduced corrosive and adhesive wear, and differential hardness. The study assessed the performance of ceramic and metal bearings in different configurations under adverse conditions, ceramic heads on metal liners (COM) were compared to metal heads on ceramic inserts (MOC), with head on cup rim loading under micro-separation hip joint simulation. Components used were made of zirconia-platelet toughened alumina (Biolox Delta) and CoCrMo alloy. Hip simulator testing applied a twin-peak loading cycle and walking motions with the prosthesis in the anatomical position. Testing was conducted in calf-serum for 2-million cycles. A standard simulator cycle was adapted, the head sub-luxed in the swing-phase forcing the head onto the cup rim at heel strike. The overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/Mc). The contact of the head against the rim of the cup caused deep stripe wear on the metallic heads of the MOC bearings. This region on the head is exposed to high stress conditions and susceptible to damage in edge contact, the effect of this is increased when the cup is a harder material than the head. The wear of a metal-on-metal (MOM) couple under similar conditions was almost two-fold greater than the MOC couple (1.58mm3/Mc, Williams et al., 2006) providing further evidence of the reduced wear with COM in comparison to MOM. The COM concept allows thin metal shells to be used with larger ceramic heads and protects against ceramic liner chipping. COM bearings are undergoing clinical trials, early data suggests reduced metal ion release in patients compared to metal-on-metal.
Ceramic-on-metal (COM) bearings have shown reduced wear and friction compared with metal-on-metal (MOM) bearings in-vitro. Lower wear has been attributed to a reduction in corrosive wear, smoother surfaces, improved lubrication and differential hardness reducing adhesive wear. Clinical studies have also shown reduced metal ion levels in-vivo compared with MOM bearings. The aim of this study was to examine two explanted COM bearings (one head and cup, one head only), and to assess the effect of in-vivo changes on the wear performance of the COM bearings by comparing the wear of the explanted bearings with three new COM implants in a hip wear simulator. Two 28mm diameter COM bearings were provided for analysis. These were visually examined and surface profilometry was performed using a 2-D contacting profilometer (Form Talysurf, Taylor Hobson, UK). Scanning electron microscopy was used to image the regions of transfer on the ceramic heads, and EDX to assess the transfer composition (Philips XL30 ESEM). Hip simulator testing was conducted for 2 million cycles (Mc) comparing the explanted bearings with three new 28mm COM bearings. Tests were performed in a Prosim simulator (SimSol, UK), which applied a twin peak loading cycle, with a peak load of 3kN. Flexion-extension of − 15 to 30 degrees was applied to the head and internal-external rotation of +/− 10 degrees was applied to the cup, components were mounted in the anatomical position. The lubricant was 25% (v/v) calf serum supplemented with 0.03% (w/v) sodium azide and was changed approximately every 0.33Mc. Wear was measured gravimetrically at 0.5, 1 and 2 Mc. Regions of material transfer, identified on both ceramic explant heads, were shown to be CoCr material by EDX analysis, suggesting metallic transfer from the metal cup. Profilometry traces across metallic transfer showed comparable surface roughness measurements compared to unworn material. The overall mean wear rate for the new COM bearings at 2Mc was 0.047 ± 0.06mm3/Mc. The mean wear rate for the explanted head articulated with a new cup was slightly lower at 0.034mm3/Mc. The mean wear rate for the explanted head and cup was highest at 0.15mm3/Mc. It was noted that the explanted head/cup had higher bedding in wear compared with the other bearings, but still significantly less than a new MOM bearing (mean bedding-in wear rate 2.03 ± 2.59 mm3/Mc). The steady-state wear was comparable with the new bearings. As the orientation of these implants in-vivo was unknown, it is proposed that the elevated wear during bedding-in of the explanted head/cup bearing may be due to the alignment of the components. The wear rates of the explanted ceramic head against a new cup were comparable with the new bearings, suggesting that the presence of metallic transfer on the ceramic head does not adversely affect the wear behaviour of COM bearings.
The combination of a ceramic head articulating against a metal acetabular liner (CoM) has shown reduced metal ion levels compared with a metal-on-metal bearing (MoM) in hip simulator studies. A randomized prospective clinical trial was undertaken using CoM and MoM bearings in an otherwise identical total hip procedure. The initial clinical results were encouraging. This report comprises a further review of metal ion data. Patients received identical components with the exception of the bearing surface material but all were 28mm diameter. All components were supplied by DePuy International Ltd. Patients were assessed pre-operatively, 3m, 12m and >
24m (median 32m). Whole blood samples were collected at regular follow-ups, frozen and analysed in batches using high resolution Inductively Coupled Plasma – Mass Spectrometry (ICP-MS). All recruited patients are included irrespective of outcome. However some patients failed to attend specific follow-ups and some contaminated samples had to be discarded. Statistical significance was analyzed using a non-parametric comparison (Mann-Whitney test). After 3m and 12m implantation there were between 21 and 24 patients available for analysis in both the CoM and MoM cohort and after >
24m point 10 and 9 respectively. There were four outliers (either Cr or Co >
10ug/l) in both the CoM and MoM groups. In common with previous studies (with the exception of two marginal outliers), these were related to component position. They were implanted with either a cup abduction angle of >
55°, an anteversion angle of >
30° or both. Other studies with the same design of component have reported no significant outliers. The median Cr and the Co levels are lower with the CoM bearing compared with the MoM at all measurements points following implantation. The median background (pre-operative) levels for the combined CoM and MoM group were Cr: 0.22ug/l and Co: 0.49ug/l. These were significantly different (p=0.006). In the CoM group, the median 12m Cr and Co values were 0.43ug/l and 0.72ug/l respectively. The comparable values for MoM are 0.68ug/l and 0.83ug/l. Increases in metal ion levels from pre-operative levels are used as the primary ion level outcome in this study because the background level will comprise of the order of 30–50% of the overall value. The increase in Cr for CoM and MoM from pre-op levels to 12m significantly different for Cr (p=0.015). It has a lower significance for combined metal ion levels (p=0.029). This difference in not significant for Co (p=0.195). In agreement with predictions from hip simulator studies, CoM bearings in this study produced lower levels of metal ions than comparable MoM bearings at all time points. However the difference is less than that predicted in the laboratory and is much more pronounced with Cr than with Co.
Ceramic-on-metal (ceramic head and metal liner, COM) hip replacements have shown reduced wear in comparison to metal-on-metal (MOM) bearings (Firkins et al., 1999). This has been attributed to a reduction in corrosive wear, differential hardness and a reduction in adhesive wear. In a clinical report on the use of a metal-on-ceramic hip replacement (Valenti et al., 2007) which consisted of a stainless steel head and alumina ceramic insert at revision 6-months post-op massive metallosis and macroscopic wear was observed. The aim of this study was to assess the performance of ceramic and metal bearings in different configurations under adverse conditions, ceramic heads on metal liners (COM) were compared to metal heads on ceramic inserts (MOC), with head on cup rim loading under micro-separation hip joint simulation. Components used were made of zirconia-platelet toughened alumina (Biolox Delta) and high carbon (0.2wt%) CoCrMo alloy (DePuy International Ltd, UK). Hip simulator testing applied a twin-peak loading cycle and walking motions with the prosthesis in the anatomical position. The lubricant (25% calf-serum) was changed every 0.33Mc, wear was measured gravimetrically. Testing was conducted for 2-million cycles, a standard simulator cycle was adapted so the head subluxed in the swing phase forcing the head onto the cup rim at heel strike (Williams et al., 2006). The total overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/Mc). The contact of the head against the rim of the cup at heel strike caused deep stripe wear on the metallic heads of the MOC bearings. This region on the head is exposed to high stress conditions and susceptible to damage in edge contact, the effect of this is increased when the cup is a harder material than the head. The wear of a metal-on-metal (MOM) couple under similar conditions was almost two-fold greater than the MOC couple (1.58mm3/Mc, Williams et al., 2006) providing further evidence of the reduced wear with COM in comparison to MOM. The explant described Valenti et al. included a stainless steel head, this is a softer material compared to CoCr, and wears at a higher level. It can be postulated that the wear under adverse conditions would be further increased. The COM concept can provide increased design flexibility; thin metal shells can be used with larger ceramic heads. Additionally the design protects against ceramic liner chipping. COM bearings are currently undergoing clinical trials, early data suggests reduced metal ion release in patients with COM bearings compared to metal-on-metal (Williams et al., 2007).
Ceramic head and metal liner hip replacements (COM) have shown reduced wear in comparison to metal-on-metal (MOM) bearings. The aim of this study was to further assess the performance by a wear simulator study under standard and adverse conditions, including the wear of a metal head against a ceramic liner. Components were Biolox Delta and CoCrMo alloy. Hip simulator testing applied a simplified walking cycle to anatomically mounted prostheses. The lubricant was 25% calf-serum and wear was measured gravimetrically. In hip simulator testing with edge loading a standard cycle was adapted so the head sub-luxed in the swing phase forcing the head onto the edge of the cup at heel strike, this was applied to ceramic on metal and metal on ceramic material combinations. Under standard conditions the total overall mean wear rate of the MOM THR (1.01±0.38mm3/Mc) was significantly higher in comparison to the COM and COC (<
0.015mm3/Mc). The overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/Mc). The contact of the head against the rim of the cup caused deep stripe wear on the metallic heads of the MOC bearings. This region on the head is exposed to high stress conditions and susceptible to damage in edge contact, the effect of this is increased when the cup is a harder material than the head. The wear of a metal-on-metal (MOM) couple under similar conditions was almost two-fold greater than the MOC couple (1.58mm3/Mc, Williams et al., 2006) providing further evidence of the reduced wear with COM in comparison to MOM. Reduced wear from COM bearings will address some concerns associated with MOM THRs regarding reports of elevated ion levels clinically. These studies have provided valuable data demonstrating reduced wear with COM bearings. COM bearings are undergoing clinical trials, early data suggests reduced metal ion release in patients compared to metal-on-metal
This study reports on ceramic-on-metal (CoM) bearings in total hip replacement. Whole blood metal ion levels were measured. The median increase in chromium and cobalt at 12 months was 0.08 μg/1 and 0.22 μg/1, respectively, in CoM bearings. Comparable values for metal-on-metal (MoM) were 0.48 μg/1 and 0.32 μg/1. The chromium levels were significantly lower in CoM than in MoM bearings (p = 0.02). The cobalt levels were lower, but the difference was not significant. Examination of two explanted ceramic heads revealed areas of thin metal transfer. CoM bearings (one explanted head and acetabular component, one explanted head and new acetabular component, and three new heads and acetabular components) were tested in a hip joint simulator. The explanted head and acetabular component had higher bedding-in. However, after one million cycles all the wear rates were the same and an order of magnitude less than that reported for MoM bearings. There were four outliers in each clinical group, primarily related to component malposition.
Ceramic on metal bearings for hip replacement have shown reduced friction, wear, and metal ion levels in comparison to metal on metal bearings. Lower wear has been attributed to a reduction in corrosive wear, smoother surfaces and improved lubrication and differential hardness and reduction in adhesive wear. The aim of this study was to further assess the performance of novel differential hardness COM THRs in two different bearing configurations. The effect of bearing configuration was examined by comparing COM (ceramic head on metal liner) with metal-on-ceramic (metal head on ceramic liner) (MOC) bearings in micro-separation hip simulator testing. Components used were zirconia-platelet toughened alumina (Biolox Delta) heads and high carbon (0.2wt%) CoCrMo alloy cups, tested in COM and MOC configurations, (, (DePuy International Ltd, UK). Micro-separation hip simulator testing was conducted for 2 million cycles (Mc) using a Prosim hip simulator (SimSol, UK), which applied a twin peak loading cycle and walking motions with the prosthesis positioned in the anatomical position. The lubricant (25% calf serum) was changed approximately every 0.33Mc and wear was measured gravimetrically. A negative force was applied to the head during the swing phase, to produce a joint laxity and head – rim contact, the head relocated in the stance phase. The total overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/ Mc). The contact of the head against the rim of the cup at heel strike caused deep stripe wear on the metallic heads of the MOC bearings. Stripes of metallic transfer were visible on all the ceramic heads (COM bearings). The COM bearings had much lower wear rates than the MOC bearings under harsh micro-separation conditions. This suggests that the head in a differential hardness bearing should be the harder material. The COM concept also provides increased design flexibility; thin metal shells can be used with larger ceramic heads. Additionally the design protects against ceramic liner chipping. COM bearings are currently undergoing clinical trials.
Large diameter metal-on-metal (MOM) bearings are becoming increasingly popular for young, active patients. Clearance is a particularly important consideration for designing MOM implants, considering historical experience of equatorial contact and high frictional torque. Lubrication theory predicts increasing the clearance will result in diminished lubrication, resulting in increased friction and wear. Clinical cases of transient squeaking in patients with resurfacing bearings have been noted in recent years, with some reporting an incidence of up to 10% between 6 months and 2 years post-implantation. This study aimed to investigate the impact of increasing clearance on the lubrication, friction and squeaking of a large diameter metal-on-metal resurfacing bearing through frictional studies. Clinical-grade MOM implants of 55mm diameter and 100μm diametric clearance, and custom-made, 55mm bearings with diametric clearances of approximately 50μm and 200μm (DePuy International Ltd) were tested in a friction simulator. Components were inverted with a flexion-extension of ±25o applied to the head and lubricated with 25% and 100% newborn bovine serum. A peak load of 2kN, with swing-phase loads of 25N, 100N and 300N were applied. Sound data was recorded during each friction test using a MP3 recorder and pre-amplifier. A microphone was set up at a distance of 50mm from the implant, and data recorded over a minimum of 10 seconds where sound was generated. Sound data was assessed through narrow band analysis on Frequency Master software (Cirrus Research, UK). Lubrication was assessed by directly measuring the separation between the head and cup during the test cycle by ultrasonic methods (Tribosonics, UK). An ultrasound sensor was bonded to the back of the cup and reflection measurements were taken during the friction tests with a sampling rate of 100Hz. Using equations which related reflection coefficient to lubricant properties and thickness, values for the film thickness were calculated. The surface replacement with the largest clearance yielded the highest friction factor for each test condition. The difference between the large clearance bearing and the smaller clearance samples was statistically significant in 25% bovine serum, the more clinically relevant lubricant (ANOVA, p<
0.05). The 50μm clearance group yielded similar results to the 100μm clearance bearing, although a slight increase in friction was observed. Squeaking occurred during every test in the large clearance group. There was a reduced incidence of squeaking in the smaller clearances, with the lowest incidence observed in the 100μm clearance group. The smallest separation of the head and cup was observed within the large clearance bearings. The best lubrication condition measured ultrasonically was observed within the 100μm clearance bearing. There appeared to be good correlation between friction, lubrication and the incidence of squeaking. This study suggests a large diametric clearance results in reduced lubrication, increased friction and an increased incidence of squeaking. However, there is a minimum diametric clearance that can be tolerated, as clearance must accommodate the manufacturing tolerance.
