Computer aided Total Hip Arthroplasty (THA) surgery is known to improve implantation precision, but clinical trials have failed to demonstrate an improvement in survivorship or patient reported outcome measures (PROMs). Our aim was to compare the risk of revision, PROMs and satisfaction rates between computer guided and THA implanted without computer guidance.

We used the National Joint Registry dataset and linked PROMs data. Our sample included THAs implanted for osteoarthritis using cementless acetabular components from a single manufacturer (cementless and hybrid). An additional analysis was performed limiting the sample size to THAs using cementless stems (fully cementless). The primary endpoint was revision (of any component) for any reason. Kaplan Meier survivorship analysis and an adjusted Cox Proportional Hazards model were used.

41683 non computer guided, and 871 (2%) computer guided cases were included in our cementless and hybrid analysis. 943 revisions were recorded in the non-guided and 7 in the computer guided group (adjusted Log-rank test, p= 0.028). Cumulative revision rate at 10 years was 3.88% (95%CI: 3.59 – 4.18) and 1.06% (95%CI: 0.45 – 2.76) respectively. Cox Proportional Hazards adjusted HR: 0.45 (95%CI: 0.21 – 0.96, p=0.038). In the fully cementless group, cumulative revision rate at 10 years was 3.99% (95%CI: 3.62 – 4.38) and 1.20% (95%CI: 0.52 – 3.12) respectively. Cox Proportional Hazards adjusted HR: 0.47 (95%CI: 0.22 – 1.01, p=0.053). There was no statistically significant difference in the 6-month Oxford Hip Score, EQ-5D, EQ-VAS and success rates. Patient Satisfaction (single-item satisfaction outcome measure) was improved in the computer guided group but this finding was limited by a reduced number of responses.

In this single manufacturer acetabular component analysis, the use of computer guided surgery was associated with a significant reduction in the early risk of revision. Causality cannot be inferred in view of the observational nature of the study, and further database and prospective studies are recommended to validate these findings.

INTRODUCTION

One of the recent advances in the hard-on-hard hip arthroplasty is the development of a new material of diffusion hardened oxidised zirconium (DHOxZr). The DHOxZr material consists of a ceramic layer on the top surface which is supported by a thick oxygen diffusion hardened (DH) zone underneath. With the desired properties of metal substrate, ceramic surface and a gradient structure of the oxygen diffusion zone, the DHOxZr-on-DHOxZr bearing combination is expected to produce low wear and minimal metal ions. This can possibly address the concerns associated with metal hypersensitivity associated with metal on metal bearings and fracture risk associated with ceramics. The aim of this study was to evaluate the wear of DHOxZr-on-DHOxZr as a possible hard on hard bearing combination in hips.

INTRODUCTION

Hip wear simulator test results could be affected by many non-bearing related factors such as fixation surface conditions, equipment calibration and component set-up. In an effort to improve the accuracy, reliability and repeatability of hip simulator test, a quality management system has been established at the IDC hip tribology laboratory, which has been accredited by UKAS (United Kingdom Accreditation Service) in accordance with the recognised international standard ISO17025. This study demonstrates that under well-controlled laboratory and testing conditions, satisfactory repeatability can be achieved during hip simulator studies.

INTRODUCTION

Whilst there is a great deal of research on hip implants, few studies have looked at implant orientation and the subsequent effect upon the wear performance of a hip resurfacing. This study aimed to measure implantation angles through radiographic analysis and linear wear for retrieved acetabular cups in order to investigate possible causal links between wear and implant orientation.

Introduction

Ion analysis has been used as one of the key indicators to assess the performance of MoM devices in patients. Modular devices, in particular having larger overall surface area (the stem and sleeve), and locking interfaces (head – bore, sleeve- taper and sleeve-bore, stem-taper surfaces) than other MoM devices are expected to release greater number of ions. Concerns have been expressed that the ion release at the taper junction might be a potential cause leading to the failure of the implant [Garbuz et al, 2010].

The aim of this study was to look into the wear and the associated ion release from the taper junction and the articulating surface of modular devices.

INTRODUCTION

Analysis of retrieved ceramic components have shown areas of localized ‘stripe wear’, which have been attributed to joint laxity and/or impingement resulting in subluxation of the head, causing wear on the edge of the cup. Studies have been conducted into the effects of mild subluxation, however few in vitro tests have looked at severe subluxation. The aim of this study was to develop a more clinically relevant subluxation protocol.

Metal-on-Metal devices generate significantly lower volumetric wear than conventional total hip replacements. However, clinically some patients may suffer some form of laxity in their joints leading to subluxation of the joint, which in turn may cause edge loading of an implant thereby increasing the chances of failure due to higher than expected wear.

In this study, the effect of subluxation on MoM implant wear was investigated on a hip joint simulator.

Introduction

All hip replacements depend upon good orientation and positioning to ensure that implants function well in vivo. Mal-orientated devices can lead to poor patient gait, poor range of motion, impingement, edge loading and high wear, which in turn may result in the premature failure of the implants.

Introduction

Hip implant research has been carried out for decades using hip simulators to reflect situations in vivo. With regards to metal on metal (MoM) implant testing, it has been reported that there is no significant difference between the wear generated by various cobalt chromium (CoCr) microstructures. On the contrary, higher wear, metal ion levels and subsequent failures have been reported in heat treated (high carbon, low carbide) devices compared to as cast (high carbon, high carbide) devices in vivo. During testing, the bearing surfaces may be masked from the effect of microstructure on wear under fast and continuous cycles, while in vivo, the extensive range of kinetics and kinematics, stop/start motion, varying walking frequencies could break down the fluid film, resulting in a less favourable lubrication regime. The aims of this study were to develop a more physiologically relevant hip simulator test protocol, and investigate the effect of microstructure on wear.

Evidence with respect to conventional hip arthroplasties suggests that device wear is related to patient activity rather than duration of usage. Activity level questionnaires appear to suggest that subjects with resurfacing arthroplasties continue to remain active after the procedure. However there is a paucity of objective evidence relating to the step rates of these patients in their daily lives and its effect on metal ions generated. The aim of this investigation is to assess

the activity levels of hip resurfacing patients as follow up progresses and

Twenty-five consecutive male patients (average age 56 years) who underwent a unilateral 50 mm diameter hip resurfacing carried out by a single surgeon (DJWM) were recruited after informed consent. Patient step activity (Step Activity Monitor, SAM, Cymatech. Seattle WA, USA) was recorded at 1, 2, and 4-year follow-up stages and at the same time patient whole blood samples were collected and analysed using High Resolution Inductively Coupled Mass Spectroscopy (HR-ICPMS).

All patients in this study had well functioning hips at the four year follow up stage. All femoral components implanted were within the desired range of neutral to 10°. The mean acetabular component inclination angle was 42° (33° – 55°). Patient overall step activity remains unchanged up to the 4-year follow-up period.

At one year follow up, the whole blood cobalt and chromium concentrations show no correlation to mean number of steps taken per day by each patient (r2=0.02).

The correlation between whole blood cobalt and chromium concentration versus a function of body weight and peak index is not significant (r2=0.11).

This study provides objective evidence of the activity rates of patients at different stages of follow-up after a MoM surface replacement arthroplasty. It should be emphasised that the walking speeds of these patients on average was significantly slower than 1 Hz, which is generally used in laboratory hip simulator studies.

Introduction: Pseudotumours (soft-tissue masses relating to the hip joint) following metal-on-metal hip resurfacing arthroplasty (MoMHRA) have been associated with elevated serum and hip aspirate metal ion levels, suggesting that pseudotumours occur when there is increased wear. This study aimed to quantify in vivo wear of implants revised for pseudotumours and a control group of implants revised for other reasons of failure.

Methods: A total of 30 contemporary MoMHRA implants in two groups were investigated in this Institutional Review Board approved study:

8 MoMHRA implants revised due to pseudotumour;

The linear wear of retrieved implants was measured using a Taylor-Hobson Roundness machine. The average linear wear rate was defined as the maximum linear wear depth divided by the duration of the implant in vivo.

Results: In comparison with the non-pseudotumour implant group, the pseudotumour implant group was associated with:

significantly higher median linear wear rate of the femoral component: 8.1um/year (range 2.75–25.4um/year) vs. 1.79um/year (range 0.82–4.15um/year), p=0.002; and

Similarly, differences were also measured in absolute wear values. The median absolute linear wear was significantly higher in the pseudotumour implant group:

21.05um (range 2.74–164.80um) vs. 4.44um (range 1.50–8.80um) for the femoral component, p=0.005; and

Wear on the acetabular cup components in the pseudotumour group always involved the edge, indicating edge-loading of the bearing. In contrast, edge-loading was observed in only one acetabular component in the non-pseudotumour group of implants. The deepest wear was observed well within the bearing surface for the rest of the non-pseudotumour group. The difference in the incidence of edge-loading between the two groups was statistically significant (Fisher’s exact test, p=0.03).

Discussion: Significantly greater linear wear rates of the MoMHRA implants revised due to pseudotumour support the in vivo elevated metal ion concentrations in patients with pseudotumours. This study provides the first direct evidence to confirm that pseudotumour is associated with increased wear at the MoM articulation. Furthermore, edge-loading with the loss of fluid film lubrication may be the dominant wear generation mechanism in patients with pseudotumour.

Introduction: Although clinical results for the Metal-on-Metal (MoM) devices have been excellent, recently some concerns have been raised regarding the occurrence of periprosthetic soft tissue lesions (PSTL) in some patients with MoM devices. Clinical studies and retrieval analyses have shown that devices revised due to groin pain and PSTL generally have significantly higher wear that has been attributed to edge loading of the implants.

Aim: The retrieval study was to investigate the cause of edge-loading of MoM devices in vivo.

Materials and Methods: In this study 13 retrieved Birmingham Hip Resurfacing (BHR) devices were examined. All devices were supplied with radiographs showing the in vivo position of the implant. Linear wear was assessed using a Taylor-Hobson Talyrond 290 roundness machine. Multiple roundness profiles were obtained to locate the area of maximum wear on each component. Edge loaded devices were identified when the maximum linear wear occurred at the edge of the cup. Non-edge loaded pairs showed wear area within the articulating surface of the cup.

The in vivo abduction angle and version angle of the cup were determined by superimposing the BHR models onto the radiographs (ProEngineer Wildfire 4 with ISDX II extension software) using anatomical references and specific features of the BHR.

Results: Linear wear: Among the 13 devices investigated, 11 were edge loaded with the maximum linear wear occurred at the edge of the cup. The remaining 2 pairs were non-edge loaded. The average joint linear wear rate of the edge loaded devices was 49.9 μm per year, and that for the two non-edge loaded devices was 2.4 μm per year. Edge loaded pairs had far greater linear wear than non-edge loaded components.

Cup orientation: The abduction angles of the two non-edge loaded cups were 31° and 39°, and their version angles were 12 and 16° respectively. These angles were within recommended orientation for the BHR. In contrast, the adduction angles and/or version angles of all edge loaded devices were outside the recommended orientation. Their abduction angle varied from 40° to 66° and version angle from 5° to 46°.

The edge loaded devices with higher inclination angles and/or higher version angels generally had higher linear wear. There is strong correlation between the cup orientation and the linear wear of the implant.

Conclusion: Mal-orientated devices in this study showed clear signs of edge loading which in turn resulted in significant increase in wear compared to the well orientated/non-edge loaded devices.

Introduction: In vitro studies have shown that low clearance bearings have the potential to generate low wear. However, cementless acetabular cups are designed to be press fitted into the acetabulum, which could generate compressive stresses and non-uniform cup deformation during implantation. Deformation of the low clearance acetabular cups could also potentially lead to clamping or seizure of the joints and high frictional torque leading to implant failure. To obtain the benefit of low clearance and low wear, without compromising the tribological performance of the cup, a deflection compensation (DefCom) cup was designed. DefCom offers the benefits of low wear associated with low clearance components whilst reducing the risk of component seizure and high frictional torque due to component deformation.

Aim: The study was conducted in order to evaluate the tribological performance of a DefCom acetabular cup.

Materials and Methods: 50 mm diameter metal-on-metal DefCom hip resurfacing cups were used in this study. The components had an average clearance of 105±3 μm at the articulating sphere. Three of the cups were deformed plastically, along the ilial-ischeal column of the acetabulum. The degree of deformation was measured using the coordinate measuring machine, measuring the change in diameter of the cup in the direction of deformation. The cups were deformed on average by 65μm. The devices were tested in a ProSim hip wear Simulator for 5 million cycles. The lubricant was new born calf serum with 0.2% sodium azide diluted with de-ionised water to achieve protein concentration of 20 mg/ml. The flexion/extension was 30° and 15° with an internal/external rotation of ±10°. The force was Paul-type stance phase loading with a maximum load of 3 kN and a swing phase load of 0.3 kN, conducted at 1 Hz.

Results: The DefCom and deformed DefCom components showed a similar bi-phasic wear pattern to that of the BHR devices. Showing a period of ‘running in’ wear up to 1 Mc and then a reduced wear rate during the steady state phase from 1 Mc onwards. The DefCom devices produced a wear rate of 0.24 mm3/Mc, whilst the deformed DefCom joints produced a wear rate of 0.48 mm3/Mc for the running-in phase. Steady state wear was achieved for all joints after 1 Mc. The average steady state wear (1.0–5.0 Mc) rate for the DefCom joints was 0.12 mm3/Mc, with 0.14 mm3/Mc for the deformed joints joint. The wear rate for the non-deformed DefCom device is lower than that generated by the BHR, which were 0.72 mm3/Mc and 0.18 mm3/Mc for the running-in and steady state wear, respectively.

Conclusion: The study has shown that the DefCom acetabular cup has the potential to reduce the initial running-in wear by reducing the clearance at the contact area between the head and cup, whilst compensating for deformation that may occur during cup implantation.

Introduction: Based on the clinical success of large head metal-on-metal (MoM) bearings technologies in the resurfacing arena, a multi-bearing acetabular system, known as R3 system, was developed by Smith & Nephew. The novel R3 system utilizes porous coated Ti-6-4 shells in which liners of crosslinked UHMWPE, ceramic, or as-cast CoCr liners can be placed. The as-cast CoCr metallurgy and microstructure is identical to the clinically successful Birmingham Hip Replacement (BHR) resurfacing system. The design and manufacturing aspects such as diametrical clearance, surface roughness, and spherical form are all identical for the two systems.

Aim: to evaluate the tribological performance of R3 devices as compared to that of standard BHR devices.

Materials and Methods: Five pairs of 46 mm MoM R3 devices (Smith & Nephew) and three pairs of 48 mm BHR devices (Smith & Nephew) were tested in a ProSim hip wear Simulator. The lubricant was new born calf serum with 0.2% sodium azide diluted with de-ionized water to achieve protein concentration of 20 g/l. The flexion/extension was 30° and 15° and the internal/external rotation was +/− 10°. The force was Paul-type stance phase loading with a maximum load of 3 kN and a standard ISO swing phase load of 0.3 kN. The frequency was 1 Hz.

One R3 joint and one BHR device were friction tested in a ProSim hip friction simulator at 0, 3 and 5 million cycles of wear testing. The test was conducted in new born calf serum with added carboxy methyl cellulose (CMC) to generate viscosities of 1 to 100 cP. The loading cycle was set at maximum loads of 2 kN and minimum load of 0.1 kN. The flexion/extension was 30° and 15°, and the frequency was 1 Hz.

Results and Discussions:

Friction: The coefficient of friction (COF) of the R3 joint varied from 0.08 to 0.14 depending on the viscosity of the serum and cycles of wear simulation test. Under physiologically relevant lubricant conditions (1, 3 and 10 cP), the COF for the R3 device tested was comparable to that of the standard BHR device.

Conclusion: The test results presented in this study show that the tribological performances of the R3 and the BHR devices are comparable.

Introduction: The accepted method of assessing wear following a hip simulator test has been to use a precision balance. As the MoM devices produce significantly less weight loss than hard-on-soft bearings, the measurements of MoM devices are now almost at the detection limit of many balances. There is a need for a method that can be used in conjunction with gravimetric analysis that will provide an accurate assessment of ion concentration levels that will support the gravimetric measurements.

Aim: To develop a method to assess wear using metal ion analysis in order to support gravimetric measurements of metal on metal devices.

Materials and methods: Hip simulator test: Three pairs of 50 mm diameter as cast CoCr MoM devices were tested in a ProSim hip wear simulator (SimSol Stockport/UK) under physiologically relevant conditions. The lubricant was new born calf serum with 0.2 % sodium azide concentration diluted with de-ionised water for protein concentration of 20 g/l. Stop-start motion was implemented every 100 cycles. Lubricant changed every 125 k cycles. The frequency was 0.5 Hz. Wear was assessed gravimetrically at every 0.5 million cycles (Mc) interval.

Ion analysis: Serum was collected from test station and allowed to settle for 12 hours. An aliquot of 20 ml from lubricant was collected. Each sample was centrifuged at 2500 g-force for 10 minutes. A 10 ml aliquot was collected from each sample and was further centrifuged at 2500 g-force for 10 minutes. 1.5 ml aliquot was collected and stored at −20 °C. A high resolution inductively-coupled plasma mass spectrometry instrument (ELEMENT, ThermoFinnigan MAT, Bremen/Germany) was then used for the analysis of metal ions.

Results and Discussion: The average cumulative metal ion levels at 0.5, 1 and 1.5 Mc showed similar trends in wear to that of the average cumulative weight loss assessed gravimetrically. There were similar biphasic wear trends in both metal ion levels and gravimetric weight losses. Other studies have also shown similar correlation between volume loss and ion concentration levels. The percentage distribution of Co, Cr and Mo in the metal ion samples are in close agreement with nominal chemical composition of the material tested.

Conclusion: This study showed that metal ion measurements can help to confirm gravimetrically measured material loss.

Introduction: To develop a more physiologically relevant hip simulator test protocol and study the effect of microstructure on the wear performance of as-cast (AC) and double heat treated (DHT) devices under the new protocol.

Methods: Three pairs of AC and four pairs of DHT 50 mm CoCr metal-on-metal (MoM) devices were tested. The lubricant used was bovine serum. Stop-start motion was implemented between the two sets of kinetics and kinematics that alternated every 100 cycles throughout the test. Condition one: The flexion/extension was 30° and 15° respectively. The internal/external rotation was ±10°. The force was Paul type stance phase loading with a maximum load of 3 kN and a standard ISO swing phase load of 0.3 kN. Condition two: The flexion/extension was ±22°. The internal/external rotation was ±8°. The force was a maximum stance phase load of 2.2 kN and a swing phase load of 0.24 kN at 0.5 Hz frequency. Wear was assessed gravimetrically.

Result: The masking effect of 1 Hz speed and uninter-rupted motion, in providing exaggerated lubrication regime, was exposed under more physiologically relevant test conditions. The AC devices have significantly reduced wear when compared to the DHT devices. It can also be seen that from 0.5 to 2 Mc the divergence in wear has increased.

Conclusion: A more physiologically relevant hip simulator test protocol was successfully developed and implemented, in showing the effect of microstructure on wear as seen in vivo, where high wear of DHT devices has been observed. 295

Introduction: The purpose of this study was to determine the effects of edge loading on in vivo wear of hip resurfacings from retrievals.

Methods: The wear of retrieved BHR heads and cups was assessed using a Taylor-Hobson Talyrond 290 roundness machine. The maximum deviation of the profile from an ideal circle was taken as the maximum linear wear. Edge loaded devices (Figure 1a) were classified as cups which showed the maximum area of wear crossing over the edge of the cup. For all non-edge loaded pairs (Figure 1b), the wear area on the cup was within the sphere of the cup. In this study 50 pairs (diameter size 38 mm to 54 mm) were analysed.

Results: 28 pairs were classified as edge loaded, and 22 were not. Edge loaded pairs display greater linear wear than non-edge loaded components (Table 1). Edge loaded components showed no correlation between time in vivo and linear wear.

Discussion: Edge loaded pairs have a far greater range of linear wear which may be due to the variation of the angles of the components in vivo. Edge loading may be caused by an open cup, impingement and/or high combined anteversion angle of both the head and cup. The success of a hip resurfacing depends strongly upon articulation occurring within the sphere of the cup, which is reliant upon good component orientation.

Hip simulators have been used for ten years to determine the tribological performance of large-head metal-on-metal devices using traditional test conditions. However, the hip simulator protocols were originally developed to test metal-on-polyethylene devices. We have used patient activity data to develop a more physiologically relevant test protocol for metal-on-metal devices. This includes stop/start motion, a more appropriate walking frequency, and alternating kinetic and kinematic profiles.

There has been considerable discussion about the effect of heat treatments on the wear of metal-on-metal cobalt chromium molybdenum (CoCrMo) devices. Clinical studies have shown a higher rate of wear, levels of metal ions and rates of failure for the heat-treated metal compared to the as-cast metal CoCrMo devices. However, hip simulator studies in vitro under traditional testing conditions have thus far not been able to demonstrate a difference between the wear performance of these implants.

Using a physiologically relevant test protocol, we have shown that heat treatment of metal-on-metal CoCrMo devices adversely affects their wear performance and generates significantly higher wear rates and levels of metal ions than in as-cast metal implants.

The presence of pseudotumours, which are soft-tissue masses relating to the hip, after metal-on-metal hip resurfacing arthroplasty has been associated with elevated levels of metal ions in serum, suggesting that pseudotumours occur when there is increased wear. We aimed to quantify the wear in vivo of implants revised for pseudotumours (eight) and of a control group of implants (22) revised for other reasons of failure.

We found that the implant group with pseudotumours had a significantly higher rate of median linear wear of the femoral component at 8.1 μm/year (2.75 to 25.4) than the 1.79 μm/year (0.82 to 4.15; p = 0.002) of the non-pseudotumour group. For the acetabular component a significantly higher rate of median linear wear of 7.36 μm/year (1.61 to 24.9) was observed in the pseudotumour group compared with 1.28 μm/year (0.81 to 3.33, p = 0.001) in the other group. Wear of the acetabular component in the pseudotumour group always involved the edge of the implant, indicating that edge-loading had occurred.

Our findings are the first direct evidence that pseudotumour is associated with increased wear at the metal-on-metal articulation. Furthermore, edge-loading with the loss of fluid-film lubrication may be an important mechanism of generation of wear in patients with a pseudotumour.

Second-generation metal-on-metal bearings were introduced as a response to the considerable incidence of wear-induced failures associated with conventional replacements, especially in young patients. We present the results at ten years of a consecutive series of patients treated using a metal-on-metal hip resurfacing. A distinct feature of the bearings used in our series was that they had been subjected to double-heat treatments during the post-casting phase of their manufacture. In the past these bearings had not been subjected to thermal treatments, making this a unique metal-on-metal bearing which had not been used before in clinical practice.

We report the outcome of 184 consecutive hips (160 patients) treated using a hybrid-fixed metal-on-metal hip resurfacing during 1996. Patients were invited for a clinicoradiological follow-up at a minimum of ten years. The Oxford hip score and anteroposterior and lateral radiographs were obtained. The mean age at operation was 54 years (21 to 75). A series of 107 consecutive hips (99 patients) who received the same prosthesis, but subjected to a single thermal treatment after being cast, between March 1994 and December 1995, were used as a control group for comparison.

In the 1994 to 1995 group seven patients (seven hips) died from unrelated causes and there were four revisions (4%) for osteolysis and aseptic loosening. In the 1996 group nine patients died at a mean of 6.9 years after operation because of unrelated causes. There were 30 revisions (16%) at a mean of 7.3 years (1.2 to 10.9), one for infection at 1.2 years and 29 for osteolysis and aseptic loosening. Furthermore, in the latter group there were radiological signs of failure in 27 (24%) of the 111 surviving hips.

The magnitude of the problem of osteolysis and aseptic loosening in the 1996 cohort did not become obvious until five years after the operation. Our results indicate that double-heat treatments of metal-on-metal bearings can lead to an increased incidence of wear-induced osteolysis.