Objectives

We investigated the reliability of the cobalt-chromium (CoCr) synovial joint fluid ratio (JFR) in identifying the presence of a severe aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) response and/or suboptimal taper performance (SOTP) following metal-on-metal (MoM) hip arthroplasty. We then examined the possibility that the CoCr JFR may influence the serum partitioning of Co and Cr.

Objectives

This study aimed to characterise and qualitatively grade the severity of the corrosion particles released into the hip joint following taper corrosion.

We retrospectively analysed concentrations of chromium and cobalt ions in samples of synovial fluid and whole blood taken from a group of 92 patients with failed current-generation metal-on-metal hip replacements. We applied acid oxidative digestion to our trace metal analysis protocol, which found significantly higher levels of metal ion concentrations in blood and synovial fluid than a non-digestive method. Patients were subcategorised by mode of failure as either ‘unexplained pain’ or ‘defined causes’. Using this classification, chromium and cobalt ion levels were present over a wider range in synovial fluid and not as strongly correlated with blood ion levels as previously reported. There was no significant difference between metal ion concentrations and manufacturer of the implant, nor femoral head size below or above 50 mm. There was a moderately positive correlation between metal ion levels and acetabular component inclination angle as measured on three-dimensional CT imaging.

Our results suggest that acid digestion of samples of synovial fluid samples is necessary to determine metal ion concentrations accurately so that meaningful comparisons can be made between studies.

Aims

Cardiac magnetic resonance (CMR) was used to assess whether cardiac function or tissue composition was affected in patients with well-functioning metal-on-metal hip resurfacing arthroplasties (MoMHRA) when compared with a group of controls, and to assess if metal ion levels correlated with any of the functional or structural parameters studied.

Aims

The present study investigated the five-year interval changes in pseudotumours and measured serum metal ions at long-term follow-up of a previous report of 28 mm diameter metal-on-metal (MoM) total hip arthroplasty (THA).

Objectives

Previous studies have suggested that metal-on-metal (MoM) Pinnacle (DePuy Synthes, Warsaw, Indiana) hip arthroplasties implanted after 2006 exhibit higher failure rates. This was attributed to the production of implants with reduced diametrical clearances between their bearing surfaces, which, it was speculated, were outside manufacturing tolerances. This study aimed to better understand the performance of Pinnacle Systems manufactured before and after this event.

Aims

This study presents the long-term survivorship, risk factors for prosthesis survival, and an assessment of the long-term effects of changes in surgical technique in a large series of patients treated by metal-on-metal (MoM) hip resurfacing arthroplasty (HRA).

The Articular Surface Replacement (ASR) hip resurfacing arthroplasty has a failure rate of 12.0% at five years, compared with 4.3% for the Birmingham Hip Resurfacing (BHR). We analysed 66 ASR and 64 BHR explanted metal-on-metal hip replacements with the aim of understanding their mechanisms of failure. We measured the linear wear rates of the acetabular and femoral components and analysed the clinical cause of failure, pre-revision blood metal ion levels and orientation of the acetabular component.

There was no significant difference in metal ion levels (chromium, p = 0.82; cobalt, p = 0.40) or head wear rate (p = 0.14) between the two groups. The ASR had a significantly increased rate of wear of the acetabular component (p = 0.03) and a significantly increased occurrence of edge loading (p < 0.005), which can be attributed to differences in design between the ASR and BHR. The effects of differences in design on the in vivo wear rates are discussed: these may provide an explanation as to why the ASR is more sensitive to suboptimal positioning than the BHR.

We carried out a cross-sectional study with analysis of the demographic, clinical and laboratory characteristics of patients with metal-on-metal hip resurfacing, ceramic-on-ceramic and metal-on-polyethylene hip replacements. Our aim was to evaluate the relationship between metal-on-metal replacements, the levels of cobalt and chromium ions in whole blood and the absolute numbers of circulating lymphocytes. We recruited 164 patients (101 men and 63 women) with hip replacements, 106 with metal-on-metal hips and 58 with non-metal-on-metal hips, aged < 65 years, with a pre-operative diagnosis of osteoarthritis and no pre-existing immunological disorders.

Laboratory-defined T-cell lymphopenia was present in13 patients (15%) (CD8⁺ lymphopenia) and 11 patients (13%) (CD3⁺ lymphopenia) with unilateral metal-on-metal hips. There were significant differences in the absolute CD8⁺ lymphocyte subset counts for the metal-on-metal groups compared with each control group (p-values ranging between 0.024 and 0.046). Statistical modelling with analysis of covariance using age, gender, type of hip replacement, smoking and circulating metal ion levels, showed that circulating levels of metal ions, especially cobalt, explained the variation in absolute lymphocyte counts for almost all lymphocyte subsets.

Objectives

The high revision rates of the DePuy Articular Surface Replacement (ASR) and the DePuy ASR XL (the total hip arthroplasty (THA) version) have led to questions over the viability of metal-on-metal (MoM) hip joints. Some designs of MoM hip joint do, however, have reasonable mid-term performance when implanted in appropriate patients. Investigations into the reasons for implant failure are important to offer help with the choice of implants and direction for future implant designs. One way to assess the performance of explanted hip prostheses is to measure the wear (in terms of material loss) on the joint surfaces.

This study reports on ceramic-on-metal (CoM) bearings in total hip replacement. Whole blood metal ion levels were measured. The median increase in chromium and cobalt at 12 months was 0.08 μg/1 and 0.22 μg/1, respectively, in CoM bearings. Comparable values for metal-on-metal (MoM) were 0.48 μg/1 and 0.32 μg/1. The chromium levels were significantly lower in CoM than in MoM bearings (p = 0.02). The cobalt levels were lower, but the difference was not significant. Examination of two explanted ceramic heads revealed areas of thin metal transfer. CoM bearings (one explanted head and acetabular component, one explanted head and new acetabular component, and three new heads and acetabular components) were tested in a hip joint simulator. The explanted head and acetabular component had higher bedding-in. However, after one million cycles all the wear rates were the same and an order of magnitude less than that reported for MoM bearings. There were four outliers in each clinical group, primarily related to component malposition.

The peri-prosthetic tissue response to wear debris is complex and influenced by various factors including the size, area and number of particles. We hypothesised that the ‘biologically active area’ of all metal wear particles may predict the type of peri-prosthetic tissue response.

Peri-prosthetic tissue was sampled from 21 patients undergoing revision of a small diameter metal-on-metal (MoM) total hip arthroplasty (THA) for aseptic loosening. An enzymatic protocol was used for tissue digestion and scanning electron microscope was used to characterise particles. Equivalent circle diameters and particle areas were calculated. Histomorphometric analyses were performed on all tissue specimens. Aspirates of synovial fluid were collected for analysis of the cytokine profile analysis, and compared with a control group of patients undergoing primary THA (n = 11) and revision of a failed ceramic-on-polyethylene arthroplasty (n = 6).

The overall distribution of the size and area of the particles in both lymphocyte and non-lymphocyte-dominated responses were similar; however, the subgroup with lymphocyte-dominated peri-prosthetic tissue responses had a significantly larger total number of particles.

14 cytokines (interleukin (IL)-1ß, IL-2, IL-4, IL-5, IL-6, IL-10, IL-13, IL-17, interferon (IFN)-γ, and IFN-gamma-inducible protein 10), chemokines (macrophage inflammatory protein (MIP)-1α and MIP-1ß), and growth factors (granulocyte macrophage colony stimulating factor (GM-CSF) and platelet derived growth factor) were detected at significantly higher levels in patients with metal wear debris compared with the control group.

Significantly higher levels for IL-1ß, IL-5, IL-10 and GM-CSF were found in the subgroup of tissues from failed MoM THAs with a lymphocyte-dominated peri-prosthetic response compared with those without this response.

These results suggest that the ‘biologically active area’ predicts the type of peri-prosthetic tissue response. The cytokines IL-1ß, IL-5, IL-10, and GM-CSF are associated with lymphocyte-dominated tissue responses from failed small-diameter MoM THA.

Cite this article: Bone Joint J 2015;97-B:917–23.

The early failure and revision of bimodular primary total hip arthroplasty prostheses requires the identification of the risk factors for material loss and wear at the taper junctions through taper wear analysis. Deviations in taper geometries between revised and pristine modular neck tapers were determined using high resolution tactile measurements. A new algorithm was developed and validated to allow the quantitative analysis of material loss, complementing the standard visual inspection currently used.

The algorithm was applied to a sample of 27 retrievals (in situ from 2.9 to 38.1 months) of the withdrawn Rejuvenate modular prosthesis. The mean wear volumes on the flat distal neck piece taper was 3.35 mm³ (0.55 to 7.57), mainly occurring in a characteristic pattern in areas with high mechanical loading. Wear volume tended to increase with time to revision (r² = 0.423, p = 0.001). Implant and patient specific data (offset, stem size, patient’s mass, age and body mass index) did not correlate with the amount of material loss observed (p >  0.078). Bilaterally revised implants showed higher amounts of combined total material loss and similar wear patterns on both sides. The consistent wear pattern found in this study has not been reported previously, suggesting that the device design and materials are associated with the failure of this prosthesis.

Cite this article: Bone Joint J 2015;97-B:1350–7.

We investigated the changes seen on serial metal artefact reduction magnetic resonance imaging scans (MARS-MRI) of metal-on-metal total hip arthroplasties (MoM THAs). In total 155 THAs, in 35 male and 100 female patients (mean age 70.4 years, 42 to 91), underwent at least two MRI scans at a mean interval of 14.6 months (2.6 to 57.1), at a mean of 48.2 months (3.5 to 93.3) after primary hip surgery. Scans were graded using a modification of the Oxford classification. Progression of disease was defined as an increase in grade or a minimum 10% increase in fluid lesion volume at second scan. A total of 16 hips (30%) initially classified as ‘normal’ developed an abnormality on the second scan. Of those with ‘isolated trochanteric fluid’ 9 (47%) underwent disease progression, as did 7 (58%) of ‘effusions’. A total of 54 (77%) of hips initially classified as showing adverse reactions to metal debris (ARMD) progressed, with higher rates of progression in higher grades. Disease progression was associated with high blood cobalt levels or an irregular pseudocapsule lining at the initial scan. There was no association with changes in functional scores. Adverse reactions to metal debris in MoM THAs may not be as benign as previous reports have suggested. Close radiological follow-up is recommended, particularly in high-risk groups.

Cite this article: Bone Joint J 2015;97-B:1328–37.

We evaluated the concentrations of chromium and cobalt ions in blood after metal-on-metal surface replacement arthroplasty using a wrought-forged, high carbon content chromium-cobalt alloy implant in 64 patients. At one year, mean whole blood ion levels were 1.61 μg/L (0.4 to 5.5) for chromium and 0.67 μg/L (0.23 to 2.09) for cobalt. The pre-operative ion levels, component size, female gender and the inclination of the acetabular component were inversely proportional to the values of chromium and/or cobalt ions at one year postoperatively. Other factors, such as age and level of activity, did not correlate with the levels of metal ions. We found that the levels of the ions in the serum were 1.39 and 1.37 times higher for chromium and cobalt respectively than those in the whole blood.

The levels of metal ions obtained may be specific to the hip resurfacing implant and reflect its manufacturing process.

The issues surrounding raised levels of metal ions in the blood following large head metal-on-metal total hip replacement (THR), such as cobalt and chromium, have been well documented. Despite the national popularity of uncemented metal-on-polyethylene (MoP) THR using a large-diameter femoral head, few papers have reported the levels of metal ions in the blood following this combination. Following an isolated failure of a 44 mm Trident–Accolade uncemented THR associated with severe wear between the femoral head and the trunnion in the presence of markedly elevated levels of cobalt ions in the blood, we investigated the relationship between modular femoral head diameter and the levels of cobalt and chromium ions in the blood following this THR.

A total of 69 patients received an uncemented Trident–Accolade MoP THR in 2009. Of these, 43 patients (23 men and 20 women, mean age 67.0 years) were recruited and had levels of cobalt and chromium ions in the blood measured between May and June 2012. The patients were then divided into three groups according to the diameter of the femoral head used: 12 patients in the 28 mm group (controls), 18 patients in the 36 mm group and 13 patients in the 40 mm group. A total of four patients had identical bilateral prostheses in situ at phlebotomy: one each in the 28 mm and 36 mm groups and two in the 40 mm group.

There was a significant increase in the mean levels of cobalt ions in the blood in those with a 36 mm diameter femoral head compared with those with a 28 mm diameter head (p = 0.013). The levels of cobalt ions in the blood were raised in those with a 40 mm diameter head but there was no statistically significant difference between this group and the control group (p = 0.152). The levels of chromium ions in the blood were normal in all patients.

The clinical significance of this finding is unclear, but we have stopped using femoral heads with a diameter of ≤ 36 mm, and await further larger studies to clarify whether, for instance, this issue particularly affects this combination of components.

Cite this article: Bone Joint J 2014;96-B:43–7.

We prospectively assessed the efficacy of a ceramic-on-metal (CoM) hip bearing with uncemented acetabular and femoral components in which cobalt­–chrome acetabular liners and alumina ceramic heads were used.

The cohort comprised 94 total hip replacements (THRs) in 83 patients (38 women and 45 men) with a mean age of 58 years (42 to 70). Minimum follow-up was two years. All patients had pre- and post-operative assessment using the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), Oxford hip score and Short-Form 12 scores. All showed a statistically significant improvement from three months post-operatively onwards (all p < 0.001).

After two years whole blood metal ion levels were measured and chromosomal analysis was performed. The levels of all metal ions were elevated except vanadium. Levels of chromium, cobalt, molybdenum and titanium were significantly higher in patients who underwent bilateral THR compared with those undergoing unilateral THR (p < 0.001). Chromosomal analysis demonstrated both structural and aneuploidy mutations. There were significantly more breaks and losses than in the normal population (p < 0.001). There was no significant difference in chromosomal aberration between those undergoing unilateral and bilateral procedures (all analyses p ≥ 0.62).

The use of a CoM THR is effective clinically in the short-term, with no concerns, but the significance of high metal ion levels and chromosomal aberrations in the long-term remains unclear.

Cite this article: Bone Joint J 2013;95-B:1040–44.

The aim of this study was to establish the natural course of unrevised asymptomatic pseudotumours after metal-on-metal (MoM) hip resurfacing during a six- to 12-month follow-up period. We used repeated metal artefact reduction sequence (MARS)-magnetic resonance imaging (MRI), serum metal ion analysis and clinical examination to study 14 unrevised hips (mean patient age 52.7 years, 46 to 68, 5 female, 7 male) with a pseudotumour and 23 hips (mean patient age 52.8 years, 38 to 69, 7 female, 16 male) without a pseudotumour. The mean post-operative time to the first MARS-MRI scan was 4.3 years (2.2 to 8.3), and mean time between the first and second MARS-MRI scan was eight months (6 to 12). At the second MRI scan, the grade of severity of the pseudotumour had not changed in 35 hips. One new pseudotumour (Anderson C2 score, moderate) was observed, and one pseudotumour was downgraded from C2 (moderate) to C1 (mild). In general, the characteristics of the pseudotumours hardly changed.

Repeated MARS-MRI scans within one year in patients with asymptomatic pseudotumours after MoM hip resurfacing showed little or no variation. In 23 patients without pseudotumour, one new asymptomatic pseudotumour was detected.

This is the first longitudinal study on the natural history of pseudotumours using MARS-MRI scans in hip resurfacing, and mirrors recent results for 28 mm diameter MoM total hip replacement.

Cite this article: Bone Joint J 2013;95-B:1626–31.

The purpose of this study was twofold: first, to determine whether the five-year results of hip resurfacing arthroplasty (HRA) in Canada justified the continued use of HRA; and second, to identify whether greater refinement of patient selection was warranted.

This was a retrospective cohort study that involved a review of 2773 HRAs performed between January 2001 and December 2008 at 11 Canadian centres. Cox’s proportional hazards models were used to analyse the predictors of failure of HRA. Kaplan–Meier survival analysis was performed to predict the cumulative survival rate at five years. The factors analysed included age, gender, body mass index, pre-operative hip pathology, surgeon’s experience, surgical approach, implant sizes and implant types. The most common modes of failure were also analysed.

The 2773 HRAs were undertaken in 2450 patients: 2127 in men and 646 in women. The mean age at operation was 50.5 years (sd 8.72; 18 to 82) and mean follow-up was 3.4 years (sd 2.1; 2.0 to 10.1). At the last follow-up a total of 101 HRAs (3.6%) required revision. Using revision for all causes of failure as the endpoint, Kaplan–Meier survival analysis showed a cumulative survival of 96.4% (95% confidence interval (CI) 96.1 to 96.9) at five years. With regard to gender, the five-year overall survival was 97.4% in men (95% CI 97.1 to 97.7) and 93.6% in women (95% CI 92.6 to 94.6). Female gender, smaller femoral components, specific implant types and a diagnosis of childhood hip problems were associated with higher rates of failure. The most common cause of failure was fracture of the femoral neck, followed by loosening of the femoral component.

The failure rates of HRA at five years justify the ongoing use of this technique in men. Female gender is an independent predictor of failure, and a higher failure rate at five years in women leads the authors to recommend this technique only in exceptional circumstances for women.

Cite this article: Bone Joint J 2013;95-B:1044–50.