Cobalt chrome alloy is commonly used in joint replacement surgery. However, it is recognised that some patients develop lymphocyte mediated delayed type hypersensitivity (DTH) responses to this material, which may result in extensive bone and soft tissue destruction.
A total of 606 DNA samples, from 397 males and 209 female patients, were typed. This included 176 from patients with failed prostheses, and 430 from asymptomatic patients at a mean of >10 years follow up. C-index and ROC(t) scores suggested a high degree of discrimination, whilst the IBS indicated good calibration and further backed up the indication of high discriminatory ability. At ten years, the weighted mean survival probability error was < 4%. At present, there are no tests in widespread clinical use which use a patient's genetic profile to guide implant selection or inform post-operative management. The algorithm described herein may address this issue and we suggest that the application may not be restricted to the field of MoM hip arthroplasty.
Despite the positive outcomes in shoulder joint replacements in the last two decades, polyethylene wear debris in metal-on-polyethylene artificial shoulder joints is well-known as a limitation in the long-term survival of shoulder arthroplasties systems. Consequently, there is an interest in the use of novel materials as an alternative to hard bearing surfaces such as pyrolytic carbon layer (PyroCarbon). In the present study, the unique Newcastle Shoulder Wear Simulator was used (Smith A physiological combined cycled “Repeat-motion-load” (RML) (Ramirez-Martinez Introduction
Materials and Methods
Total hip replacement with metal-on-polymer (MoP) hip prostheses is a successful treatment for late-stage osteoarthritis. However, the wear debris generated from the polymer acetabular liners remains a problem as it can be associated with osteolysis and aseptic loosening of the implant. This has led to the investigation of more wear resistant polymers in orthopaedics. Cross-linked polyethylene (XLPE) is now the gold-standard acetabular liner material. However, we asked if carbon fibre reinforced polyether ether ketone (CFR-PEEK) might be a lower wear material. In addition, we sought to understand the influence of contact stress on the wear of both XLPE and CFR-PEEK as this has not previously been reported. A 50-station circularly translating pin-on-disc (SuperCTPOD) machine was used to wear test both XLPE and CFR-PEEK pins against cobalt chromium (CoCr) discs to investigate the influence of contact stress on their wear rates. Fifty XLPE and 50 CFR-PEEK pins were articulated against CoCr discs. The pins, 9 mm in outer diameter and 12 mm in height, were drilled with different diameter holes to generate different sized annuli and thus, different contact areas. The pins were tested at 1.10, 1.38, 1.61, 2.00 and 5.30 MPa, which are typical contact stresses observed in the natural hip joint. An additional pin for every test group was used as a control to track the lubricant uptake. The discs were polished to 0.015 μm Sa prior to testing. The test stations contained 16 ml of diluted newborn calf serum (protein concentration: 22 g/L). Wear was measured gravimetrically with a balance (resolution: 10 μm) every 500,000 cycles. A standardised cleaning and weighing protocol was followed.Introduction
Materials and Methods
We aimed to identify genes associated with the development of ALVAL at relatively low levels of wear. At our unit all patients undergoing revision of a MoM hip prosthesis have periprosthetic tissue samples graded for ALVAL. Explants undergo volumetric wear testing of the bearing and taper surfaces. We identified patients with moderate/severe ALVAL who had been exposed to lower than the median wear rate of all recorded patients who had developed ALVAL (<3mm3/year). This was termed the “ALVAL” group. We then identified all patients whose tissues had shown no signs of ALVAL. The patients in the two groups were sent buccal DNA collection kits. DNA was examined using next generation sequencing. Alleleic frequencies in the two groups were compared using Fisher's test and compared to a background UK population group (n=8514). We then conducted binary logistic regression with patient age, sex, primary source of debris (taper/bearing) and HLA genotype as the predictors. With the hypothesis that a cobalt/albumin metalloprotein acts as the epitope, we used validated binding prediction software to determine the relative affinities of the binding grooves created by different DQA1/DQB1 genetic combinations for albumin derived peptides. Given the protection that male sex and younger age appears to confer against ALVAL, we hypothesized that testosterone peptides may compete for these binding sites.Introduction
Methods
We explanted NeuFlex metacarpophalangeal (MP) joint prostheses to identify common features, such as position of fracture, and thus better understand the reasons for implant failure. Explanted NeuFlex MP joint prostheses were retrieved as part of an-ongoing implant retrieval programme. Following revision MP joint surgery the implants were cleaned and sent for assessment. Ethical advice was sought but not required. The explants were photographed. The position of fracture, if any, was noted. Patient demographics were recorded.Objective
Methods
Shoulder joint prostheses have become the most commonly replaced after knee and hip artificial implants. Reverse shoulder arthroplasty (RSA) is the treatment option for patients with severe osteoarthritis, rotator cuff arthropathy or a massive rotator cuff tear with pseudoparalysis. Though successful, the long-term survival of such implants are limited by wear of the materials in contact [1, 2]. The aim of this study was to investigate RSA wear Four new JRI Orthopaedics Reverse Shoulder 42 mm diameter VAIOS with cobalt-chromium (CoCr) glenospheres and ultra-high molecular weight polyethylene (UHMWPE) humeral components were tested. A five million cycles wear test was undertaken using the unique Newcastle Shoulder Wear Simulator with dilute bovine serum as a lubricant. “Mug to mouth” was performed as the ADL to the test prostheses in intervals of 100 cycles, following by 5 seconds of high load (450N) with no motion simulating an ADL such as “lifting an object”. This combined load cycle was then repeated. A fifth reverse shoulder prosthesis was subject to dynamic loading only in a soak control station. Wear was assessed gravimetrically and roughness (Sa) of the articulating surfaces was measured with a non-contacting profilometer.INTRODUCTION
MATERIALS AND METHODS
Metal-on-polyethylene (MoP) is the most commonly used bearing couple in total hip replacements (THRs). Retrieval studies (Cooper A 6-station anatomical hip joint simulator was used to investigate material loss at the articulating and taper-trunnion surfaces of 32mm diameter metal-on-cross-linked polyethylene (MoXLPE) joints for 5 million cycles (Mc) with a sixth joint serving as a dynamically loaded soak control. Commercially available cobalt-chromium-molybdenum (CoCrMo) femoral heads articulating against XLPE acetabular liners (7.5Mrad) were used with a diluted new-born-calf-serum lubricant. Each CoCrMo femoral head was mounted on a 12/14 titanium alloy trunnion. The test was stopped every 0.5Mc, components were cleaned and gravimetric measurements performed following ISO 14242-2 and the lubricant was changed. Weight loss (mg) obtained from gravimetric measurements was converted into volume loss (mm3) and wear rates were calculated from the slopes of the linear regression lines in the volumetric loss versus number of cycles plot for heads, liners and trunnions. Additionally, volumetric measurements of the head tapers were obtained using a coordinate measuring machine (CMM) post-test. The surface roughness (Sa) of all heads and liners was measured pre and post-test. At the end of the test, the femoral heads were cut and the roughness of the worn and unworn area was measured. Statistical analysis was performed using a paired-t-test (for roughness measurements) and an independent sample t-test (for wear rates).Introduction
Methods
The bearing surfaces of ceramic-on-ceramic (CoC) total hip replacements (THR) show a substantially lower wear rate than metal-on-polyethylene (MoP) THR Three 36mm CoC hips were tested in a hip simulator for 5 million cycles (Mc). BIOLOX®delta ceramic femoral heads were mounted on 12/14 titanium (Ti6Al4V) trunnions. Wear of femoral heads, acetabular liners and trunnions was determined gravimetrically using the analytical balance. Roughness measurements (Sa) were taken on the articulating surfaces (pre and post-test) and on the trunnion surfaces (worn and unworn). Furthermore, Energy Dispersive X-ray Spectroscopy (EDX) was used to identify and quantify the wear debris present in the lubricant using scanning electron microscope (SEM).Introduction
Methods
Some reports have suggested that debris generated from the head neck taper junction is more destructive than equivalent doses from metal bearing surfaces. Part 1. We examined the relationship between the source (taper/bearing) and volume of metal debris on Cr and Co concentrations in corresponding blood and hip synovial fluid samples and the observed agglomerated particle sizes in excised tissues using regression analysis of prospectively collected data at a single revision unit. Part 2. We investigated variables most strongly associated with macroscopic soft tissue injury as documented at revision surgery using ordinal logistic regression. Independent variables included source and volume of CoCr exposure, Cr and Co joint fluid concentrations, joint fluid grade, ALVAL (Aseptic Lymphocytic Vasculitis Associated Lesion) grade, presence of vascular hyalinisation, agglomerated particle size, implant type, patient sex and age.Background
Methods
Historical studies have reported incidences of taper corrosion in retrieved MoP hips of 20–50%. These studies relied on visual assessments, rather than using modern analytical techniques. The Northern Retrieval Registry was initiated to routinely analyse all retrieved hips. The volumetric wear rates of retrieved Exeter head tapers were measured using a coordinate measuring machine using validated methods and compared to the available results obtained from an ongoing study of failed MoM prostheses. Power analysis suggested that we would need at least fifty Exeter head tapers to provide significant results. Non-parametric tests were used to assess differences. We have previously identified head diameter/offset/taper angle and taper surface roughness as variables associated with taper wear. The effect of bearing material combination remains unquantified. These design variables were entered into a multiple regression model following log normalisation of taper wear.Introduction
Patients/Materials and Methods
Metal-on-metal retrieval studies indicated that MOM wear-rates could rise as high as 60–70mm3/year in short-term failures (Morlock, 2008). In contrast, some MOM and ceramic-on-ceramic (COC) devices of 1970's era performed admirably over 2–3 decades (Schmalzreid, 1996; Shishido, 2003). While technology has aided analysis of short-term MOM and COC failures (Morlock 2008; Lord 2011), information on successful THA remains scant. Lack of long-term data creates difficulties in setting benchmarks for simulator studies and establishing guidelines for use in standards. In this study we compared clinical and wear histories for a 30-year MOM and a 32-year COC to establish such long-term, wear-rates. The McKeeTM retrieval was cemented and made 100% of CoCr alloy (Fig. 1a). This patient had a right femoral fracture at 47 years of age, treated by internal-fixation, which failed. Her revision with a Judet implant also failed, leaving her right hip as a Girdlestone. At the age of 68, she had a McKee THA implanted in left hip, and used it until almost 98 years of age (Campbell, 2003). The COC case was a press-fit AutophorTM THA, head and cup made of alumina ceramic, with the only metal being the CoCr stem (Fig. 1c). This was implanted in a female patient 17-years of age active in sports (water-skiing). This modular THA was revised 32-years later due to hip pain from cup migration. Wear on these implants was identified by stereomicroscopy and stained red for photography (Fig. 1). Cup-to-neck impingement was denoted by circumferential neck notching, roughness was assessed by interferometry, and wear determined by CMM (Lord, 2011). McKee head wear covered 1092mm2 area (Figs. 1a, 2: hemi-area ratio 58%). There was no stripe wear and head roughness was 36nm (Ra). Cup wear covered an area of 1790mm2 (hemi-area 63%). Circumferential damage was noted on the supero-posterior femoral neck with scuff marks also on posterior collar (Fig. 2c). Head and cup wear amounted to 37.7 and 25.2mm3, respectively. Total MOM wear was 62.9mm3, indicating a wear-rate of 2.1mm3/year. Ceramic head wear consisted of two circular patterns (Fig. 1c), the major one of area 1790mm2 (hemi-area 79%). No wear stripes were identified. Non-worn and extensively worn surfaces had roughness (Ra) 17nm and 123nm, respectively. The cup showed 360o circumferential arc of rim wear with a small, non-wear zone inferiorly (Fig. 1c). Gray metallic transfer was evident, EDS revealing Co and Cr (Fig. 3a). Head and cup wear volumes were 77.2 and 54mm3, respectively. Total COC wear amounted to 131.2mm3 indicating a wear-rate of 4.1mm3/year. These two THA functioned successfully over 3 decades. The McKee retrieval had minor signs of impingement but no adverse “stripe wear”. This MOM performed satisfactorily due to good positioning and patient's advanced age (68 to 98Yrs of age). The COC patient was 17 years of age at index surgery and active. The ceramic cup showed 360o of edge wear, CoCr transfer and a COC wear-rate double that of the MOM retrieval. Thus the high ceramic wear-resistance protected this youthful patient.
In this study, we aimed to investigate the effect of the topography of the female taper surface on taper wear. We measured volumetric material loss at the female taper surface of the first consecutive 36mm MoM hips received at our centre. The MoM hips were from a single manufacturer and possessed matching: head size (36mm); taper geometry (5.65 degree 12 14 tapers); and metallurgy (cobalt chrome female taper mated with a titanium stem). Volume loss was measured with a coordinate measuring machine using validated methods. Surface roughness was measured using a Surftest SJ400. There were 111 head tapers available for analysis. The majority had been revised secondary to ARMD, and a minority for loosening. The mean duration of implantation was 56 months. Volumetric wear values were log normalised in order to construct a multiple regression model to investigate the interaction of head offset, the head taper angle and the Rp value of the female taper surface. Rp is a roughness parameter, which is a measure of the peaks above the plateau of a surface.Introduction
Patients/Materials & Methods
There is much current debate concerning wear and corrosion at the taper junctions of large head total hip replacements, particularly metal-on-metal hips. Is such damage a modern concern or has it always occurred in total hip replacement but not previously noted. To investigate this five explanted V40 Exeter femoral stems (Stryker Howmedica) were obtained following revision surgery at a single centre. In all cases, the 24–26 mm femoral heads were still attached. In conventional ‘small head’ modular hip prostheses such as the Exeter, negligible wear and corrosion is seen at the taper junction of explanted devices.Introduction
Hypothesis
Recent NICE guidance recommends use of a well proven cemented femoral stem for hip hemiarthroplasty in management of fractured neck of femur. The Exeter Trauma Stem (ETS) has been designed based on the well proven Exeter hip stem. It has a double taper polished stem design, proclaimed to share geometry and surface finish with the Exeter hip. This study investigated the surface finish of the two stems in order to investigate the hypothesis that they were different. Two ETS and two Exeter stems were examined using a profilometer with a sensitivity of one nanometer. Macroscopic visual inspection showed that the two Exeter stems had significantly smoother surface finish than the ETS stems. The roughness average (RA) values on the ETS stems were approximately an order of magnitude higher than those of the Exeter stems, mean of 0.235μm compared with 0.025μm (p<0.0001). This difference in surface finish has implications for the biomechanical functioning of the stem. Previous change of the Exeter stem to a matt surface-finish in 1976 resulted in a significant increase in stem failure rates and an understanding of the importance of the polished surface-finish in order to function within a taper-slip philosophy. By changing the surface finish in the ETS stem, longevity of the implant may similarly be affected. Clinical results have yet to be published demonstrating this. We recommend the manufacturer reconsiders the surface finish of the ETS stem to ensure it functions as well as the Exeter primary stem with which it shares a design philosophy.
Wear of polymeric glenoid components has been identified as a cause of loosening and failure of shoulder implants1,2 in vivo. A small number of shoulder joint simulators have been built for in vitro wear testing, however none have been capable of testing with physiological motion patterns in three axes and with physiological loading. The Newcastle Shoulder Wear Simulator was designed with three axes of motion, which are programmable so that different activities of daily living might be replicated. The simulator uses three pneumatic cylinders with integral position encoders to move five shoulder prostheses simultaneously in the flexion-extension, abduction-adduction, and internal-external rotation axes. Axial loading is applied with pneumatic cylinders supplied from a pneumatic proportional valve via a manifold, which also supplies a sixth static control station. In order to establish if that the machine can actually perform as intended, commissioning trials were conducted replicating lifting a 0.5 Kg weight to head height as a daily living activity. During the commissioning trials JRI Orthopaedics Reverse VAIOS shoulder prostheses were tested in 50% bovine serum at ambient temperature. The results show that the shoulder joint wear simulator can satisfactorily reproduce a daily living activity deliberately selected for having a large range of motion and loading. Other daily activities, such as drinking from a mug, are less demanding in the ranges of motion and loading and represent no difficulty in being reproduced on the simulator. Now successfully commissioned, this new multi-station shoulder wear simulator can wear test current and new designs of shoulder prosthesis in vitro
Ten explanted pyrolytic carbon components of a number of finger prostheses were obtained at revision surgery for wear analysis. Implants were removed for either dislocation or failure of fixation. Hypothesis Failure of the components was due to wear from the articulating surfaces, as occurs in many hip and knee prostheses. The articulating surfaces were examined using a ZYGO NewView 5000 non-contact profilometer with a resolution of 1nm, to determine the roughness average (RA) of the surface. A total of 86 RA measurements were taken. Detailed images of the surface displayed as a 3D map of were acquired. The RA values for each component were averaged and compared against the British standard for orthopaedic implants, which states that the articulating surfaces of devices made of metal or ceramic should have RA values lower than 0.050 µm.Introduction
Methods
Previous studies have suggested that the modular junction of metal on metal (MoM) total hip replacements (THR) is an important source of metallic debris. We carried out a prospective study using custom techniques to analyse one of the largest collections of failed contemporary MoM devices in the world. All explants from patients who had suffered adverse reactions to metal debris (ARMD) were included in this study. These explants included: 82 36mm THRs, and 147 resurfacing head THRs and 140 resurfacing arthroplasties from several manufactures. Volumetric wear analysis of the bearing surfaces and taper junctions was carried out using a coordinate measuring machine. The relationships between total metallic loss and metal ion concentrations and the macroscopic and histological tissue appearance of THR patients were compared to those in resurfacing patients. Mann Whitney test for non-parametric data was used to assess significant differences between groups.Background
Methods
We have previously described the relationship between wear rates of MOM components and soft tissue necrosis. In this study we investigated the link between wear rates, metal ion concentrations and osteolysis. All unilateral patients who underwent revision of hip resurfacings at our centre were included. Retrieved components were analysed using a coordinate measuring machine to determine total volumetric material loss and rates of wear. Given the accuracy of the wear calculations (which we have previously published), wear rates were considered “abnormal” if ≥3mm3/yr. ROC curves were constructed to determine a Co concentration which would be clinically useful to detect abnormal wear. During revision, the presence/absence of osteolysis was documented.Background
Methods
Total hip prostheses which use a ceramic head within a metal liner are a relatively recent innovation. As such, survivorship rates from independent centres alongside explant analysis are rare. The early clinical experience with this novel ceramic-on-metal (CoM) bearing couple is reported alongside explant analysis of failed devices. All CoM hips implanted between 2008 and 2009 at a single hospital by a single surgeon were reviewed. Radiographs were analysed using EBRA software to determine acetabular cup inclination and anteversion angles. Blood metal ion concentrations were measured using inductively coupled plasma mass spectroscopy (ICPMS). Explants were measured for bearing surface and taper wear using a high precision co-ordinate measuring machine (Mitutoyo Legex 322, manufacturer's claimed accuracy 0.8µm). The roughness of the articulating surfaces of heads and liners was measured with a non-contact profilometer (ZYGO NewView 5000, 1nm resolution).Introduction
Methods and materials
The failure and subsequent withdrawal of the ASR device in both its resurfacing and THR form has been well documented. The National Joint Registry report of 2010 quoted figures of 12–13% failure at five years. Adverse reaction to metal debris (ARMD) is a poorly understood condition and patients developing severe metal reactions may go unrecognised for sometime. In 2004 a single surgeons prospective study of the ASR bearing surface was undertaken. We present the ARMD failure rates of the ASR resurfacing and ASR THR systems. The diagnosis of ARMD was made by the senior author and was based on clinical history, examination, ultrasound findings, metal ion analysis of blood and joint fluid, operative findings and histopathological analysis of tissues retrieved at revision. Mean follow up was 52 months (24–81) and 70 patients were beyond 6 years of the procedure at the time of writing. Kaplan Meier survival analysis was carried out firstly with joints designated “failure” if the patient had undergone revision surgery or if the patient had been listed. A second survival analysis was carried out with a failure defined as a serum cobalt > 7µg/L. Full explant analysis was carried out for retrieved prostheses.Background
Patients and Methods
