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.
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. Three pairs of 50 mm DHOxZr prototype hip joint devices, each consisting of a DHOxZr modular head and a DHOxZr liner were wear tested in a ProSim hip joint simulator under standard testing conditions used by the Implant Development Centre (IDC), Smith & Nephew, Leamington Spa for 5 million cycles (Mc). The flexion/extension was 30° and 15°. 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 test frequency was 1 Hz. Gravimetric analysis was carried out at 0, 0.5, 1, 2, 3, 4 & 5 million cycles. The lubricant was new born calf serum with 2 g/l sodium azide concentration diluted with de-ionised water to achieve average protein concentration of 20 g/l. Lubricant was changed every 0.25Mc during the first million cycles of the test and at every 0.33 Mc from 1 to 5Mc.INTRODUCTION
METHODS
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. Between 2008 to 2010, ten 50 mm Birmingham Hip Resurfacing (BHR) devices were tested by the IDC tribology laboratory using two ProSim hip wear simulators in three different tests (T1, T2 and T3). All tests were performed following the same IDC testing protocols at 1 Hz frequency for 5 million cycles (Mc) or until after a steady state was reached. Paul type stance phase loadings with a maximum load of 3 kN and a swing phase load of 0.3 kN was used. The flexion and extension angles were 30 and 15 degree. The internal/external rotation angel was ±10 degree. Wear was measured gravimetrically using an analytical balance (Mettler, Toledo xp504) with an accuracy of 0.1 mg.INTRODUCTION
METHODS
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. Seventy Birmingham Hip Resurfacing (Smith & Nephew, UK) cups with known time in vivo were analysed. Linear wear of retrieved cups were assessed using a Talyrond 290 roundness machine. Deviations from the characteristic manufactured profile, was identified as a region of wear. Polar measurements across the wear region were taken to determine wear. The linear wear rate (LWR) of a component was defined as the linear wear (μm) divided by the duration of the implant life in vivo (years). Cups which showed the wear crossing over the edge of the cup were classified as edge loaded (EL). For all non-edge loaded (NEL) cups, the wear area was within the bearing surface. Cup orientation angles were conducted for 31 cups. This was determined by superimposing BHR models of appropriate size, generated by CAD ProEngineer Wildfire 4, onto anterior-posterior x-rays. Anatomical landmarks and specific features of the BHR were used as points of reference to determine cup version and inclination angles.INTRODUCTION
MATERIALS & METHODS
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 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. For the first time a novel design has been used to isolate the taper junction on modular devices on the hip simulators in order to compare the wear at the taper junction and articulating surface. The taper junction has been isolated in a small gaiter, while the head and cup were contained in a large gaiter. CoCrMo sleeves having an offset of +8 mm have been used on 50 mm modular heads along with Ti6Al4V stems. The acetabular components were standard BHR cups. Three devices (Smith & Nephew, UK) have been tested with newborn calf serum as a lubricant (in the large gaiter) and also as the medium containing the taper junction (in the small gaiter). The serum samples from the articulating surface and taper junction were analysed using HR-ICPMS. The locking interfaces at the taper junction have been left intact throughout the duration of the test. Both the head and the cup have been tested under anatomical conditions using the standard implant development centre's (IDC) profile for 2 million cycles (Mc). The lubricant was newborn 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°/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, with an 8 hour stop after every 16 hours of testing.Introduction
Method
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. Two groups of 44 mm MoM devices were tested, n=3 in each group. The devices were subjected to 1 and 2 mm of subluxation. The flexion/extension was 30° and 15° respectively, internal/external rotation was ±10°, and cup inclination was 35°. The force was Paul type stance phase loading with a maximum load of 3 kN, with ISO swing phase load of 0.3 kN, run at 1 Hz. The test was carried out on a ProSim deep flexion & subluxation hip wear simulator (SimSol, UK). Rather than separating the head and the cup (microseparation), or reducing the swing phase load, this simulator is equipped with a novel mechanism to achieve translation of the head, while subjecting the devices to subluxation. During the swing phase, a controlled lateral force necessary for the translation of the head is applied by a cam mechanism, head retraction will then take place on heel strike. The lubricant used was new born calf serum with 0.2 wt. % sodium azide concentration diluted with de-ionised water to achieve average protein concentration of 20 g/l. Lubricant was changed every 250k cycles. Gravimetric wear measurements have been taken at 0.25 & 0.5 Mc stages. Tests conducted with 1mm (Group 1) and 2mm (Group 2) subluxation significantly increased volumetric wear compared to standard hip simulator tests [1]. At 0.5 million cycles, group 1 and 2 produced an average volume loss of 4.38±0.98 mm3 (95% CL) and 7.07±1.64 mm3 (95% CL) respectively.Materials & Methods
Results
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. Seven (Subluxation n=4; standard test n=3) of 36mm Biolox Forte (R3, Smith & Nephew) ceramic devices were tested for 0.5m cycles (mc). Two of the subluxed joints were further tested to 1 Mc. The devices were subjected to subluxation under standard testing conditions. The flex/ext was 30° and 15° respectively, with internal/external rotation of ±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 at 1 Hz. The test was conducted on a ProSim hip joint wear simulator (SimSol, UK). The simulator is equipped with a novel mechanism to achieve translation of the head, to achieve subluxation. During the ISO swing phase load of 0.3kN, a controlled lateral force required for the translation of the head is applied by a cam mechanism, head retraction then occurs during heel strike. The lubricant used was new born calf serum diluted with de-ionised water to achieve average protein concentration of 20 g/l, with 0.2 wt % concentration NaN3, and changed every 250k cycles. Measurements have been taken at 0.5 & 1 mc stages.INTRODUCTION
MATERIALS & METHODS
All hip replacements depend upon good orientation and positioning to ensure that implants function well To investigate the correlation between edge loading and wear on retrieved implants through linear wear analysis and radiographic examination of implants Introduction
Aim
Hip implant research has been carried out for decades using hip simulators to reflect situations Three pairs of 50mm as cast (AC) and four pairs of 50mm double heat treated (DHT) CoCr MoM devices were tested in a ProSim hip simulator. In order to determine the frequency for testing, Patients' activities have been monitored using a Step Activity Monitor (SAM) device. The data showed a relatively slower walking pace (frequency) than that used in the hip simulator studies. The new frequency, along with stop/start motion and various kinetics and kinematics profiles have been used in putting together a more physiologically relevant hip simulator test protocol. The lubricant used in this study was new born calf serum with 0.2 % (w/v) sodium azide concentration diluted with de-ionised water to achieve an average protein concentration of 20 g/l. Gravimetric measurements have been taken at 0.5, 1, 1.5 & 2 million cycle (Mc) stages and ion analysis has been carried out on the serum samples.Introduction
Materials & Methods
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 if there is any correlation between activity and metal ions generated. 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.
8 MoMHRA implants revised due to pseudotumour; 22 MoMHRA implants revised due to other reasons of failure (femoral neck fracture and infection). 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.
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 significantly higher median linear wear rate of the acetabular component: 7.36um/year (range1.61–24.9um/year) vs. 1.28um/year (range 0.18–3.33um/year), p=0.001. 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 14.87um (range 1.93–161.68um) vs. 2.51um (range 0.23–6.04um) for the acetabular component, p=0.008. 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).
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.
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.
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.
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. Wear: The R3 devices generated typical characteristics of wear to the BHR devices, with a higher wear rate during the initial running in period (0 – 0.5 Mc) followed by a low steady state wear rate after 0.5 Mc. The average wear rate at 0.5 Mc was 1.86 mm3/Mc for the R3 and 1.80 mm3/Mc for the BHR devices. The wear rate during the steady state for the R3 and the BHR devices was reduced to 0.09 mm3/Mc and 0.12 mm3/Mc respectively. The difference in average wear rates between the BHR and R3 devices during the running in and steady states were not statistically significant (p >
0.05).
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.
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.