There is a critical need for safe innovation in total joint replacements to address the demands of an ageing yet increasingly active population. The development of robust implant designs requires consideration of uncertainties including patient related factors such as bone morphology but also activity related loads and the variability in the surgical procedure itself. Here we present an integrated framework considering these sources of variability and its application to assess the performance of the femoral component of a total hip replacement (THR).

The framework offers four key features. To consider variability in bone properties, an automated workflow for establishing statistical shape and intensity models (SSIM) was developed. Here, the inherent relationship between shape and bone density is captured and new meshes of the target bone structures are generated with specific morphology and density distributions. The second key feature is a virtual implantation capability including implant positioning, and bone resection. Implant positioning is performed using automatically identified bone features and flexibly defined rules reflecting surgical variability. Bone resection is performed according to manufacturer guidelines. Virtual implantation then occurs through Boolean operations to remove bone elements contained within the implant's volume. The third feature is the automatic application of loads at muscle attachment points or on the joint contact surfaces defined on the SSIM. The magnitude and orientation of the forces are derived from models of similar morphology for a range of activities from a database of musculoskeletal (MS) loads. The connection to this MS loading model allows the intricate link between morphology and muscle forces to be captured. Importantly, this model of the internal forces provides access to the spectrum of loading conditions across a patient population rather than just typical or average values. The final feature is an environment that allows finite element simulations to be run to assess the mechanics of the bone-implant construct and extract results for e.g. bone strains, interface mechanics and implant stresses. Results are automatically processed and mapped in an anatomically consistent manner and can be further exploited to establish surrogate models for efficient subsequent design optimization. To demonstrate the capability of the framework, it has been applied to the femoral component of a THR.

An SSIM was created from 102 segmented femurs capturing the heterogeneous bone density distributions. Cementless femoral stems were positioned such that for the optimal implantation the proximal shaft axis of the femurs coincided with the distal stem axis and the position of the native femoral head centre was restored. Here, the resection did not affect the greater trochanter and the implantations were clinically acceptable for 10000 virtual implantations performed to simulate variability in patient morphology and surgical variation. The MS database was established from musculoskeletal analyses run for a cohort of 17 THR subjects obtaining over 100,000 individual samples of 3D muscle and joint forces. An initial analysis of the mechanical performance in 7 bone-implant constructs showed levels of bone strains and implant stresses in general agreement with the literature.

This study reports the mid-term results of a large bearing uncemented metal on metal total hip replacement (MOMHTHR) matched series using the Synergy stem and Birmingham modular head in 36 hips (mean follow up 61 months). All patients underwent clinical, metal ion and MRI assessment. Wear analysis was performed on retrieved heads using Redlux non-contact optical profilometry.

Seven patients (19%) have undergone revision surgery. All revisions had two or more of either symptoms, high metal ions or an MRI suggestive of an adverse reaction to metal debris (ARMD). There was no evidence of component malposition or impingement. Frank staining of tissues together with high volume dark brown fluid collections were found in all cases. All stems and cups were well fixed. In 4 cases pubic and ischial lysis (adjacent to the inferior fins) was observed. All 7 cases had radiological, intraoperative and histological evidence of ARMD (Figure 1). The failure cohort had significantly higher whole blood cobalt ion levels and OHS (p = 0.001), but no significant difference in cup size (p = 0.77), gender predominance, stem offset or cup position (p = 0.12). Sleeves had been used in all revision cases

Wear analysis (n = 4) demonstrated increased wear at the trunnion/sleeve interface in a distribution compatible with micromotion (Figure 2). There was normal wear at the articulating surface.

This series further demonstrates unacceptable failure rates in LHMOMTHR in a series where a compatible stem for the BHR modular head was used. Use of a CoCr sleeve within a CoCr head taper appears to contribute to abnormal wear and therefore potential ARMD and subsequent failure.

Introduction:

Novel biomaterials may offer alternatives to metal arthroplasty bearings. To employ these materials in thin, bone conserving implants would require direct fixation to bone, using Titanium/HA coatings. Standard tests are used to evaluate the adhesion strength of coatings to metal substrates [1], versus FDA pass criteria [2]. In tensile adhesion testing, a disc is coated and uniform, uniaxial tension is exerted upon the coating-substrate interface; the strength is calculated from the failure load and surface area. Rapid failure occurs when the peak interface stress exceeds the adhesion strength, as local failure will propagate into an increasing tensile stress field.

Ceramics and reinforced polymers (e.g. carbon-fibre-reinforced PEEK), have considerably different stiffness (E) and Poisson's Ratio (ν) from the coating and implant metals. We hypothesised that this substrate-coating stiffness mismatch would produce stress concentrations at the interface edge, well in excess of the uniform stress experienced with coatings on similar stiffness metals.

The poor outcome of large head metal on metal total hip replacements (LHMOMTHR) in the absence of abnormal articulating surface wear has focussed attention on the trunnion / taper interface. The RedLux ultra-precision 3D form profiler provides a novel indirect optical method to detect small changes in form and surface finish of the head taper as well as quantitative assessment of wear volume. This study aimed to assess and compare qualitatively tapers from small and large diameter MOMTHR's. Tapers from 3 retrieval groups were analysed. Group 1: 28mm CoCr heads from MOMTHRs (n=5); Group 2: Large diameter CoCr heads from LHMOMTHRs (n=5); Gp 3 (control): 28mm heads from metal on polyethylene (MOP) THRs; n=3). Clinical data on the retrievals was collated. RedLux profiling of tapers produced a taper angle and 3D surface maps. The taper angles were compared to those obtained using CMM measurements. There was no difference between groups in mean 12/14 taper angles or bearing surface volumetric and linear wear. Only LHMOMs showed transfer of pattern from stem trunnion to head taper, with clear demarcation of contact and damaged areas.3D surface mapping demonstrated wear patterns compatible with motion or deformations between taper and trunnion in the LHMOM group. These appearances were not seen in tapers from small diameter MOM and MOP THRs. Differences in appearance of the taper surface between poorly functioning LHMOMTHRs and well functioning MOP or MOM small diameter devices highlight an area of concern and potential contributor to the mode of early failure.

The poor outcome of large head metal on metal total hip replacements (LHMOMTHR) in the absence of abnormal wear at the articulating surfaces has focussed attention on the trunnion / taper interface. The RedLux ultra-precision 3D form profiler provides a novel indirect optical method to detect small changes in the form and surface finish of the head taper as well as a quantitative assessment of wear volume. This study aimed to assess and compare qualitatively the tapers from well functioning small diameter, with poorly functioning LHMOMTHR's using the above technique.

Representative pre-clinical analysis is essential to ensure that novel prosthesis concepts offer an improvement over the state-of-the-art. Proposed designs must, fundamentally, be assessed against cyclic loads representing common daily activities [Bergmann 2001] to ensure that they will withstand conceivable in-vivo loading conditions. Fatigue assessment involves:

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cyclic mechanical testing, representing worst-case peak loads encountered in-vivo, typically for 10 million cycles, or

Cyclic stresses from gait loading are super-imposed upon residual assembly stresses. In thick walled devices, the residual component is small in comparison to the cyclic component, but in thin section, bone preserving devices, residual assembly stresses may be a multiple of the cyclic stresses, so a different approach to fatigue assessment is required.

Modular devices provide intraoperative flexibility with minimal inventories. Components are assembled in surgery with taper interfaces, but resulting residual stresses are variable due to differing assembly forces and potential misalignment or interface contamination. Incorrect assembly can lead to incomplete seating and dissociation [Langdown 2007], or fracture due to excessive press-fit stress or point loading [Hamilton 2010]. Pre-assembly in clean conditions, with reproducible force and alignment, gives close control of assembly stresses. Clinical results indicate that this is only a concern with thick sectioned devices in a small percentage of cases [Hamilton 2010], but it may be critical for thin walled devices.

A pre-clinical analysis method is proposed for this new scenario, with a case study example: a thin modular cup featuring a ceramic bearing insert and a Ti-6Al-4V shell (Fig. 1). The design was assessed using FE predictions, and manufacturing variability from tolerances, surface finish effects and residual stresses was assessed, in addition to loading variability, to ensure physical testing is performed at worst case:

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assembly loads were applied, predicting assembly residual stress, verified by strain gauging, and a range of service loads were superimposed.

The predicted worst-case stress conditions were analysed against three ‘constant life’ limits [Gerber, 1874, Goodman 1899, Soderberg 1930], a common aerospace approach, giving predicted safety factors. Finally, equivalent fatigue tests were conducted on ten prototype implants.

Taking a worst-case size (thinnest-walled 48 mm inner/58 mm outer), under assembly loading the peak tensile stress in the titanium shell was 274 MPa (Fig. 2). With 5kN superimposed jogging loading, at an extreme 75° inclination, 29 MPa additional tensile stress was predicted. This gave mean fatigue stress of 288.5 MPa and stress amplitude of 14.5 MPa (R=0.9). Against the most conservative infinite life limit (Soderberg), the predicted safety factor was 2.40 for machined material, and 2.03 for forged material, or if a stress-concentrating surface scratch occurs during manufacturing or implantation (Fig. 3). All cups survived 10,000,000 fatigue cycles.

This study employed computational modelling and physical testing to verify the strength of a joint prosthesis concept, under worst case static and fatigue loading conditions. The analysis technique represents an improvement in the state of the art where testing standards refer to conventional prostheses; similar methods could be applied to a wide range of novel prosthesis designs.

Introduction

Edge loading commonly occurs in all bearings in hip arthroplasty. Edge loading wear can occur in these bearings when the biomechanical loading axis reaches the edge and the femoral head loads the edge of the cup producing wear damage on both the head and cup edge. When the biomechanical loading axis passes through the polished articulating surface of the acetabular component and does not reach the edge, the center of the head and the center of the cup are concentric. The resulting wear known as concentric wear is low in metal-on-metal (MOM) bearings, and is negligible in ceramic-on-ceramic (COC) bearings. Edge loading is well defined in COC hip bearings. However, edge loading is difficult to identify in MOM bearings, since the metal bearing surfaces do not show wear patterns macroscopically. The aims of this study are to compare edge loading wear rates in COC and MOM bearings, and to relate edge loading to clinical complications.

Introduction

Two types of ceramic materials currently used in total hip replacements are third generation hot isostatic pressed (HIPed) alumina ceramic (commercially known as BIOLOX®forte, CeramTec) and fourth generation alumina matrix composite ceramic consisting of 75% alumina, 24% zirconia, and 1% mixed oxides (BIOLOX®delta, CeramTec). Delta ceramic hip components are being used worldwide, but very few studies have analyzed retrieved delta bearings. The aim of this study is to compare edge loading ‘stripe’ wear on retrieved femoral heads from delta-on-delta, delta-on-forte and forte-on-forte ceramic bearings revised within 2 years in vivo.

The poor outcome of large head metal on metal total hip replacements (LHMOMTHR) in the absence of abnormal wear at the articulating surfaces has focussed attention on the trunnion/taper interface. The RedLux ultra-precision 3D form profiler provides a novel indirect optical method to detect small changes in form and surface finish of the head taper as well as a quantitative assessment of wear volume. This study aimed to assess and compare qualitatively the tapers from small diameter with LHMOMTHR's. 3 groups of retrieval tapers were analysed (Group 1: 28mm CoCr heads from MOMTHRs (n=5); Group 2: Large diameter CoCr heads from LHMOMTHRs (n=5); Group 3: 28mm heads from metal on polyethylene (MOP) THRs; n=3). Clinical data on the retrievals was collated. Both bearing surfaces and head tapers were measured for wear using the Redlux profiling non contact measurement system. Measurements included taper angle and 3D surface maps. Taper angles obtained with the Redlux method were compared to those obtained using CMM measurement on 3 parts. The Redlux profiling, including imprints, was also repeated 3 times to gauge potential errors. There was no difference in mean 12/14 taper angles between groups. There was no difference in volumetric and linear wear at the bearing surface between groups. Only the LHMOMs showed transfer of pattern from the stem to the internal head taper, with clear demarcation of the contact and damaged area between head taper and stem trunnion. 3D surface mapping demonstrated wear patterns compatible with motion or deformations between taper and trunnion in the LHMOM group alone. Discussion: Differences in appearance of the taper surface between LHMOMTHRs and MOP or MOM small diameter devices highlight an area of concern and potential contributor to the mode of early failure. Further work is required to fully qualify the Redlux method capabilities.

Edge loading commonly occurs in all bearings in hip arthroplasty. The aim of this study compares metal bearings with edge loading to alumina bearings with edge loading and to metal bearings without edge loading.

Seventeen failed large diameter metal-on-metal hip bearings (8 total hips, 9 resurfacings) were compared to 55 failed alumina-on-alumina bearings collected from 1998 to 2010. The surface topography of the femoral heads was measured using a chromatically encoded confocal measurement machine (Artificial Hip Profiler, RedLux Ltd.).

The median time to revision for the metal hip bearings and the alumina hip bearings was 2.7 years. Forty-six out of 55 (84%) alumina bearings and 9 out 17 (53%) metal bearings had edge loading wear (p<0.01). The average volumetric wear rate for metal femoral heads was 7.87 mm3/yr (median 0.25 mm3/yr) and for alumina heads was 0.78 mm3/yr (median 0.18 mm3/yr) (p=0.02).

The average volumetric wear rate for metal heads with edge loading was 16.51 mm3/yr (median 1.77 mm3/yr) and for metal heads without edge loading was 0.19 mm3/yr (median 0 mm3/yr) (p=0.1). There was a significant difference in gender, with a higher ratio of females in the alumina group than the metal group (p=0.02).

Large diameter metal femoral heads with edge loading have a higher wear rate than smaller alumina heads with edge loading. Metal-on-metal bearings have low wear when edge loading does not occur.

Two types of ceramic materials currently used in total hip replacements are third generation hot isostatic pressed (HIPed) alumina ceramic (commercially known as BIOLOX®forte, CeramTec) and an alumina matrix composite material consisting of 75% alumina, 24% zirconia, and 1% mixed oxides (BIOLOX®delta, CeramTec). The aim of this study is to compare BIOLOX delta femoral heads to BIOLOX forte femoral heads revised within 2 years in vivo.

Ceramic bearings revised at one center from 1998 to 2010 were collected (61 bearings). BIOLOX delta heads (n=11) revised between 1–33 months were compared to BIOLOX forte femoral heads with less than 24 months in vivo (n=20). The surface topography of the femoral heads was measured using a chromatically encoded confocal measurement machine (Artificial Hip Profiler, RedLux Ltd.).

The median time to revision for BIOLOX delta femoral heads was 12 months, compared to 13 months for BIOLOX forte femoral heads. Sixteen out of 20 BIOLOX forte femoral heads and 6 out of 11 BIOLOX delta femoral heads had edge loading wear. The average volumetric wear rate for BIOLOX forte was 0.96 mm3/yr (median 0.13 mm3/yr), and 0.06 mm3/yr (median 0.01 mm3/yr) for BIOLOX delta (p=0.03). There was no significant difference (p>0.05) in age, gender, time to revision or femoral head diameter between the two groups.

Early results suggest less volumetric wear with BIOLOX delta femoral heads in comparison to BIOLOX forte femoral heads.

Introduction: Metal on metal hip resurfacing arthroplasty-induced pseudotumours are a serious complication, which occur in 1.8% of patients who undergo this procedure in our institution. The aim of this study was to measure the 3D in vivo wear on the surface of resurfacing components revised for pseudotumour, compared to a control group.

Method: Thirty-six hip resurfacing implants were divided into two groups; 18 patients with a clinical and histopathological diagnosis of pseudotumour and 18 controls (revised for femoral neck fracture and infection). Three dimensional contactless metrology (Redlux^™ Ltd) was used to scan the surface of the femoral and acetabular components, to a resolution of 20 nanometers. The location, depth and area of the wear scar were determined for each component. A separate blinded analysis to determine the presence of absence of impingement was performed by one of the authors.

Results: The volumetric wear rate for femoral component of the pseudotumour group was 3.29 mm3/yr (SD5.7) and 0.79 mm3/yr (SD1.2) for the control group (p=0.005). In the pseudotumour group, the volumetric wear rate of the acetabular component was 2.5 mm3/yr (SD6.9) compared to 0.36 mm3/yr (SD0.80) for the control group (p=0.008). Edge-wear was detected in 89% of acetabular components in the pseudotumour group and 21% of those in the control group (p=0.01). Anterior or posterior edge-wear, consistent with impingement was present on the femoral components of 73% of patients in the pseudotumour group and 22% in the control group (p=0.01).

Discussion: This work demonstrates that implants revised for pseudotumour have significantly higher volumetric wear rates than controls. They also have a significantly higher incidence of edge-wear than controls. We suggest that a significant proportion of pseudotumours are associated with high concentrations of metal wear debris; however a minority may result from a hypersensitivity reaction to metal ions.

Introduction: Metal on metal hip resurfacing arthroplasty-induced pseudotumours are a serious complication, which occur in 4% of patients who undergo this procedure. The aim of this study was to measure the 3D in vivo wear on the surface of resurfacing components revised for pseudotumour, compared to a control group.

Method: Thirty-nine hip resurfacing implants were examined; these were sourced from our institutions prosthesis retrieval bank. They were divided into two groups; 22 patients with a clinical and histopathological diagnosis of pseudotumour and 17 controls. Patient demographics and time to revision were known. Three dimensional contactless metrology (Redlux™ Ltd) was used to scan the surface of the femoral and acetabular components, to a resolution of 20 nanometers. The location, depth and area of the wear scar was determined for each component. Volumetric wear was determined, along with the presence of absence of edge-loading. A separate blinded analysis to determine the presence of absence of impingement was performed by one of the authors. ANOVA was used to test for differences in wear and Fishers Exact test was used to compare the incidence of edge-loading between the groups.

Results: The volumetric wear rate for femoral component of the pseudotumour group was 4.7mm3/yr (SD3.5) and 1.7 mm3/yr (SD1.5) for the control group (p=0.03). In the pseudotumour group, the volumetric wear rate of the acetabular component was 3.5 mm3/yr (SD3.6) compared to 0.02 mm3/yr (SD0.07) for the control group (p=0.01). Edge-loading was detected in 74% of acetabular components in the pseudotumour group and 22% of those in the control group (p=0.01). Anterior or posterior edge-loading, consistent with impingement was present on the femoral components of 73% of patients in the pseudotumour group and 22% in the control group (p=0.01).

Discussion: This work demonstrates that implants revised for pseudotumour have significantly higher volumetric wear rates than controls. They also have a significantly higher incidence of edge-loading and impingement than controls. Edge-loading significantly increases wear. We suggest that pseudotumours are caused by high concentrations of metal wear debris, which have been shown to have a toxic effect on osteocytes and macrophages. This is the one of the first studies to demonstrate a clear link between pseudotumours and increased bearing surface wear. It is also the first to demonstrate that edge-loading, due to impingement, occurs in a significant number of patients who develop this condition. Improved implantation techniques and resurfacing designs may help avoid this serious complication of hip resurfacing.

During conventional hip arthroplasties, the diseased femur is rigidified using a metallic stem. The insertion of the stem induces a change in the stress distribution in the surrounding femur, and the bone remodels; this stress distribution is a direct result of the stem stiffness characteristics. Healthy healing of the femur requires that the bone be loaded as naturally as possible. If the bone is not loaded appropriately, it can resorb which may result in stem loosening and revision. Although current rigid metallic femoral stems are very successful, a poor stress distribution may become a critical problem for younger patients as the stem/femoral bone construct will be subjected to higher loads for longer times, and since remodelling is faster, loosening can occur earlier. Reduced stiffness stems have therefore been investigated, but early failures have been reported due to increased movements, poor initial stability and the low proximal stiffness of the stem. A novel biocompatible carbon fibre reinforced plastic (CFRP) stem has been developed in light of these past experiences1. Using a series of analytical models and experimental validation tests1, the fibre type and architecture have been tailored along and across the stem to achieve healthy bone remodelling and proximal strength of the construct. In addition, a biocompatible hydroxyapatite coating was specifically designed to enhance interface strength and stability2. The present study describes the mechanical behaviour of this novel stem with particular emphasis on the stem/bone interface. 4 static and 29 fatigue tests were performed according to ISO7206; these tests were complemented by acoustic emission monitoring to identify failure mechanisms3. A stress versus number of cycles to failure (SN) curve was obtained to describe the fatigue behaviour (i) under constant amplitude cycling at various load levels and (ii) incorporating rest periods and overloads. In addition, a mechanical test was designed to characterise the motions between the bone and the stem during sinusoidal fatigue loading (5000 cycles, 0.2–2kN, 1Hz). Two linear variable differential transformers measured the vertical and horizontal displacements at the stem/ bone interface in the proximal region. 3 tests were performed on CFRP stems and 3 on a metallic stem. The CFRP stem exceeded the standard requirements. The SN curve showed good repeatability across the loading spectrum. The inclusion of overloads/static loads during fatigue had a beneficial effect on the stem endurance. This is attributed to the development of microcracks, which dissipate the load, and to creep of the resin. The amplitude of recoverable motion observed at the interface during each load cycle was similar for both types of stem (20mm and 4mm in the horizontal and vertical directions respectively) and remained below the recommended limit4. Composite materials offer high design flexibility. This has been exploited in the development of a compliant, mechanically tailored biocompatible hip stem for femoral reconstruction, and could provide an answer to hip replacement for younger, more active patients.