Metal ions generated from joint replacements are a cause for concern. There is no consensus on the best surrogate measure of metal ion exposure. This study investigates whether serum and whole blood concentrations can be used interchangeably to report results of cobalt and chromium ion concentrations. Concentrations of serum and whole blood were analysed in 262 concurrent specimens using high resolution inductively-coupled plasma mass-spectrometry. The agreement was assessed with normalised scatterplots, mean difference and the Bland and Altman limits of agreement. The wide variability seen in the normalised scatterplots, in the Bland and Altman plots and the statistically significant mean differences between serum and whole blood concentrations suggest that they cannot be used interchangeably. A bias was demonstrated for both ions in the Bland-Altman plots. Regression analysis provided a possible conversion factor of 0.71 for cobalt and 0.48 for chromium. However, even when the correction factors were applied, the limits of agreement were greater than ±67% for cobalt and greater than ±85% for chromium, suggesting that serum and whole blood cannot be used interconvertibly. This suggests that serum metal concentrations are not useful as a surrogate measure of systemic metal ion exposure

Metal-on-metal bearings for total hip replacement (THR) are becoming increasingly popular. Improved wear characteristics mean that these articulations are being inserted into younger patients in the form of THR and resurfacing procedures. This has led to concerns regarding potential carcinogenicity because of the increased exposure to metal ions that the procedure brings. We have studied the serum cobalt and chromium concentrations in patients who had primary, well-fixed Ring metal-on-metal THRs for more than 30 years. The levels of cobalt and chromium were elevated by five and three times, respectively compared with those in our reference groups. Metal-on-metal articulations appear to be the source of metal ions throughout the life of the prosthesis. In three patients who had undergone revision of a previous metal-on-metal THR to a metal-on-polyethylene replacement the levels of metal ions were within the normal range. The elevations of cobalt and chromium ions seen in our study were comparable with those in patients with modern metal-on-metal THRs

We report serum metal ion level data in patients with unilateral and bilateral hip resurfacing over a ten-year period. In these patients there is an increase in both cobalt and chromium levels above the accepted reference ranges during the first 18 months after operation. Metal ion levels remain elevated, but decline slowly for up to five years. However, the levels then appear to start rising again in some patients up to the ten-year mark. There was no significant difference in cobalt or chromium levels between men and women. These findings appear to differ from much of the current literature. The clinical significance of a raised metal ion level remains under investigation

Blood metal ions have been widely used to investigate metal-on-metal hip replacements, but their ability to discriminate between well-functioning and failed hips is not known. The Medicines and Healthcare products Regulatory Agency (MHRA) has suggested a cut-off level of 7 parts per billion (ppb). We performed a pair-matched, case-control study to investigate the sensitivity and specificity of blood metal ion levels for diagnosing failure in 176 patients with a unilateral metal-on-metal hip replacement. We recruited 88 cases with a pre-revision, unexplained failed hip and an equal number of matching controls with a well-functioning hip. We investigated the 7 ppb cut-off level for the maximum of cobalt or chromium and determined optimal mathematical cut-off levels from receiver-operating characteristic curves. The 7 ppb cut-off level for the maximum of cobalt or chromium had a specificity of 89% and sensitivity 52% for detecting a pre-operative unexplained failed metal on metal hip replacement. The optimal cut-off level for the maximum of cobalt or chromium was 4.97 ppb and had sensitivity 63% and specificity 86%. Blood metal ions had good discriminant ability to separate failed from well-functioning hip replacements. The MHRA cut-off level of 7 ppb provides a specific test but has poor sensitivity.

A prospective study of serum and urinary ion levels was undertaken in a triathlete who had undergone a metal-on-metal resurfacing arthroplasty of the hip four years previously. The one month study period included the final two weeks of training, the day of the triathlon, and the two weeks immediately post-race. Serum cobalt and chromium levels did not vary significantly throughout this period, including levels recorded on the day after the 11-hour triathlon. Urinary excretion of chromium increased immediately after the race and had returned to pre-race levels six days later. The clinical implications are discussed

Aims. The aim of this study was to assess the functional gain achieved following hip resurfacing arthroplasty (HRA). Patients and Methods. A total of 28 patients (23 male, five female; mean age, 56 years (25 to 73)) awaiting Birmingham HRA volunteered for this prospective gait study, with an age-matched control group of 26 healthy adults (16 male, ten female; mean age, 56 years (33 to 84)). The Oxford Hip Score (OHS) and gait analysis using an instrumented treadmill were used preoperatively and more than two years postoperatively to measure the functional change attributable to the intervention. Results. The mean OHS improved significantly from 27 to 46 points (p < 0.001) at a mean of 29 months (12 to 60) after HRA. The mean metal ion levels at a mean 32 months (13 to 60) postoperatively were 1.71 (0.77 to 4.83) µg/l (ppb) and 1.77 (0.68 to 4.16) µg/l (ppb) for cobalt and chromium, respectively. When compared with healthy controls, preoperative patients overloaded the contralateral good hip, limping significantly. After HRA, patients walked at high speeds, with symmetrical gait, statistically indistinguishable from healthy controls over almost all characteristics. The control group could only be distinguished by an increased push-off force at higher speeds, which may reflect the operative approach. Conclusion. Patients undergoing HRA improved their preoperative gait pattern of a significant limp to a symmetrical gait at high speeds and on inclines, almost indistinguishable from normal controls. HRA with an approved device offers substantial functional gains, almost indistinguishable from healthy controls. Cite this article: Bone Joint J 2019;101-B:1423–1430

Aims. The treatment of patients with allergies to metal in total joint arthroplasty is an ongoing debate. Possibilities include the use of hypoallergenic prostheses, as well as the use of standard cobalt-chromium (CoCr) alloy. This non-designer study was performed to evaluate the clinical outcome and survival rates of unicondylar knee arthroplasty (UKA) using a standard CoCr alloy in patients reporting signs of a hypersensitivity to metal. Patients and Methods. A consecutive series of patients suitable for UKA were screened for symptoms of metal hypersensitivity by use of a questionnaire. A total of 82 patients out of 1737 patients suitable for medial UKA reporting cutaneous metal hypersensitivity to cobalt, chromium, or nickel were included into this study and prospectively evaluated to determine the functional outcome, possible signs of hypersensitivity, and short-term survivorship at a minimum follow-up of 1.5 years. Results. At a mean follow-up of three years (1.5 to 5.7), no local or systemic symptoms of hypersensitivity to metal were observed. One patient underwent revision surgery to a bicondylar prosthesis due to a tibial periprosthetic fracture resulting in a survival rate of 98.8% (95% confidence interval (CI) 91.7 to 99.8; number at risk, 28) at three years with the endpoint of revision for any reason and a survival rate of 97.6% (95% CI 90.6 to 99.3; number at risk, 29) for the endpoint of all reoperations. Clinical outcome was good to excellent with a mean Oxford Knee Score of 42.5 (. sd. 2.5; 37 to 48). Conclusion. This study is the first demonstrating clinical results and survival analysis of UKA using a CoCr alloy in patients with a history of metal hypersensitivity. Functional outcome and survivorship are on a high-level equivalent to those reported for UKA in patients without a history of metal hypersensitivity. No serious local or systemic symptoms of metal hypersensitivity could be detected, and no revision surgery was performed due to an adverse reaction to metal ions

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

We describe the findings at six years in an ongoing prospective clinicoradiological and metal ion study in a cohort of 26 consecutive male patients with unilateral Birmingham Hip Resurfacing arthroplasties with one of two femoral head sizes (50 mm and 54 mm). Their mean age was 52.9 years (29 to 67). We have previously shown an early increase in the 24-hour urinary excretion of metal ions, reaching a peak at six months (cobalt) and one year (chromium) after operation. Subsequently there is a decreasing trend in excretion of both cobalt and chromium. The levels of cobalt and chromium in whole blood also show a significant increase at one year, followed by a decreasing trend until the sixth year

The purpose of this study was to evaluate whether concerns about the release of metal ions in metal-on-metal total hip replacements (THR) should be extended to patients with metal-bearing total disc replacements (TDR). Cobalt and chromium levels in whole blood and serum were measured in ten patients with a single-level TDR after a mean follow-up of 34.5 months (13 to 61) using inductively-coupled plasma mass spectrometry. These metal ion levels were compared with pre-operative control levels in 81 patients and with metal ion levels 12 months after metal-on-metal THR (n = 21) and resurfacing hip replacement (n = 36). Flexion-extension radiographs were used to verify movement of the TDR. Cobalt levels in whole blood and serum were significantly lower in the TDR group than in either the THR (p = 0.007) or the resurfacing group (p < 0.001). Both chromium levels were also significantly lower after TDR versus hip resurfacing (p < 0.001), whereas compared with THR this difference was only significant for serum levels (p = 0.008). All metal ion levels in the THR and resurfacing groups were significantly higher than in the control group (p < 0.001). In the TDR group only cobalt in whole blood appeared to be significantly higher (p < 0.001). The median range of movement of the TDR was 15.5° (10° to 22°). These results suggest that there is minimal cause for concern about high metal ion concentrations after TDR, as the levels appear to be only moderately elevated. However, spinal surgeons using a metal-on-metal TDR should still be aware of concerns expressed in the hip replacement literature about toxicity from elevated metal ion levels, and inform their patients appropriately

Modern metal-on-metal bearings produce less wear debris and osteolysis, but have the potential adverse effect of release of ions. Improved ceramic-on-ceramic bearings have the lowest wear of all, but the corrosion process has not been analysed. Our aim was to measure the serum ion release (ng/ml) in 23 patients having stable hip prostheses with a ceramic-on-ceramic coupling (group A) and to compare it with the release in 42 patients with a metal-on-metal bearing (group B) in the medium term. Reference values were obtained from a population of 47 healthy subjects (group C). The concentrations of chromium, cobalt, aluminium and titanium were measured. There was a significant increase of cobalt, chromium and aluminium levels (p < 0.05) in group B compared with groups A and C. Group A did not differ significantly from the control group. Despite the apparent advantage of a metal-on-metal coupling, especially in younger patients with a long life expectancy, a major concern arises regarding the extent and duration of ion exposure. For this reason, the low corrosion level in a ceramic-on-ceramic coupling could be advantageous

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. Patients and Methods. In all, 30 participants with no significant cardiac history were enrolled: 20 patients with well-functioning MoMHRA at mean follow-up of 8.3 years post-procedure (ten unilateral, ten bilateral; 17 men, three women) and a case-matched control group of ten non-MoM total hip arthroplasty patients (six men, four women). The mean age of the whole cohort (study group and controls) at the time of surgery was 50.6 years (41.0 to 64.0). Serum levels of cobalt and chromium were measured, and all patients underwent CMR imaging, including cine, T2* measurements, T1 and T2 mapping, late gadolinium enhancement, and strain measurements. Results. None of the MoMHRA patients showed clinically significant cardiac functional abnormality. The MoMHRA patients had larger indexed right and left end diastolic volumes (left ventricular (LV): 74 ml/m. 2. vs 67 ml/m. 2. , p = 0.045; right ventricular: 80 ml/m. 2. vs 71 ml/m. 2. , p = 0.02). There was a small decrease in T2 time in the MoMHRA patients (median 49 ms vs 54 ms; p = 0.0003). Higher metal ion levels were associated with larger LV volumes and with shorter T2 time. Conclusion. Although cardiac function is not clinically adversely affected in patients with well-functioning MoMHRA, modern imaging is able to demonstrate subtle changes in structure and function of the heart. As these changes correlate with systemic ion measurements, they may be consequences of wear debris deposition. Longer, longitudinal studies are necessary to determine whether cardiac function will become affected. . Cite this article: Bone Joint J 2019;101-B:540–546

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). Patients and Methods. A total of 72 patients (mean age 46.6 years (37 to 55); 43 men, 29 women; 91 hips) who underwent cementless primary MoM THA with a 28 mm modular head were included. The mean follow-up duration was 20.3 years (18 to 24). All patients had CT scans at a mean 15.1 years (13 to 19) after the index operation and subsequent follow-up at a mean of 20.2 years (18 to 24). Pseudotumour volume, type of mass, and new-onset pseudotumours were evaluated using CT scanning. Clinical outcomes were assessed by Harris Hip Score (HHS) and the presence of groin pain. Serum metal ion (cobalt (Co) and chromium (Cr)) levels were measured at the latest follow-up. Results. At final follow-up, pseudotumours were observed in 26/91 hips (28.6%). There was an increase in volume of the pseudotumour in four hips (15.4%), no change in volume in 21 hips (80.8%), and a decrease in volume in one hip (3.8%). There were no new-onset pseudotumours. There was no significant difference in HHS between patients with and without pseudotumours. At final follow-up, mean serum Co ion levels and median Co:Cr ratios were significantly greater in patients with pseudotumours, but the serum Cr ion levels were not significantly different. Conclusion. At a mean 20 years of follow-up, pseudotumours were observed in 26/91 hips (28.6%) with no new-onset pseudotumours during subsequent follow-up. Most pseudotumours in small-head MoM THA were static in volume and asymptomatic with normal serum metal ion levels. Cite this article: Bone Joint J 2019;101-B:317–324

We examined the relationships between the serum levels of chromium and cobalt ions and the inclination angle of the acetabular component and the level of activity in 214 patients implanted with a metal-on-metal resurfacing hip replacement. Each patient had a single resurfacing and no other metal in their body. All serum measurements were performed at a minimum of one year after operation. The inclination of the acetabular component was considered to be steep if the abduction angle was greater than 55°. There were significantly higher levels of metal ions in patients with steeply-inclined components (p = 0.002 for chromium, p = 0.003 for cobalt), but no correlation was found between the level of activity and the concentration of metal ions. A highly significant (p < 0.001) correlation with the arc of cover was found. Arcs of cover of less than 10 mm were correlated with a greater risk of high concentrations of serum metal ions. The arc of coverage was also related to the design of the component and to size as well as to the abduction angle of the acetabular component. Steeply-inclined acetabular components, with abduction angles greater than 55°, combined with a small size of component are likely to give rise to higher serum levels of cobalt and chromium ions. This is probably due to a greater risk of edge-loading

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

Aims. We investigated whether blood metal ion levels could effectively identify patients with bilateral Birmingham Hip Resurfacing (BHR) implants who have adverse reactions to metal debris (ARMD). Patients and Methods. Metal ion levels in whole blood were measured in 185 patients with bilateral BHRs. Patients were divided into those with ARMD who either had undergone a revision for ARMD or had ARMD on imaging (n = 30), and those without ARMD (n = 155). Receiver operating characteristic analysis was used to determine the optimal thresholds of blood metal ion levels for identifying patients with ARMD. Results. The maximum level of cobalt or chromium ions in the blood was the parameter which produced the highest area under the curve (91.0%). The optimal threshold for distinguishing between patients with and without ARMD was 5.5 µg/l (83.3% sensitivity, 88.4% specificity, 58.1% positive and 96.5% negative predictive values). Similar results were obtained in a subgroup of 111 patients who all underwent cross-sectional imaging. Between 3.2% and 4.3% of patients with ARMD were missed if United Kingdom (7 µg/l) and United States (10 µg/l) authority thresholds were used respectively, compared with 2.7% if our implant specific threshold was used, though these differences did not reach statistical significance (p ≥ 0.248). Conclusion. Patients with bilateral BHRs who have blood metal ion levels below our implant specific threshold were at low-risk of having ARMD. Cite this article: Bone Joint J 2016;98-B:1455–62

Early failure associated with adverse reactions to metal debris is an emerging problem after hip resurfacing but the exact mechanism is unclear. We analysed our entire series of 660 metal-on-metal resurfacings (Articular Surface Replacement (ASR) and Birmingham Hip Resurfacing (BHR)) and large-bearing ASR total hip replacements, to establish associations with metal debris-related failures. Clinical and radiological outcomes, metal ion levels, explant studies and lymphocyte transformation tests were performed. A total of 17 patients (3.4%) were identified (all ASR bearings) with adverse reactions to metal debris, for which revision was required. This group had significantly smaller components, significantly higher acetabular component anteversion, and significantly higher whole concentrations of blood and joint chromium and cobalt ions than asymptomatic patients did (all p < 0.001). Post-revision lymphocyte transformation tests on this group showed no reactivity to chromium or cobalt ions. Explants from these revisions had greater surface wear than retrievals for uncomplicated fractures. The absence of adverse reactions to metal debris in patients with well-positioned implants usually implies high component wear. Surgeons must consider implant design, expected component size and acetabular component positioning in order to reduce early failures when performing large-bearing metal-on-metal hip resurfacing and replacement

Objectives. This study aimed to characterise and qualitatively grade the severity of the corrosion particles released into the hip joint following taper corrosion. Methods. The 26 cases examined were CoC/ABG Modular (n = 13) and ASR/SROM (n = 13). Blood serum metal ion levels were collected before and after revision surgery. The haematoxylin and eosin tissue sections were graded on the presence of fibrin exudates, necrosis, inflammatory cells and corrosion products. The corrosion products were identified based on visible observation and graded on abundance. Two independent observers blinded to the clinical patient findings scored all cases. Elemental analysis was performed on corrosion products within tissue sections. X-Ray diffraction was used to identify crystalline structures present in taper debris. Results. The CoC/ABG Modular patients had a mean age of 64.6 years (49.4 to 76.5) and ASR/SROM patients had a mean age of 58.2 years (33.3 to 85.6). The mean time in situ for CoC/ABG was 4.9 years (2 to 6.4) and ASR/SROM was 6.1 years (2.5 to 8.1). The blood serum metal ion concentrations reduced following revision surgery with the exception of Cr levels within CoC/ABG. The grading of tissue sections showed that the macrophage response and metal debris were significantly higher for the ASR/SROM patients (p < 0.001). The brown/red particles were significantly higher for ASR/SROM (p < 0.001). The taper debris contained traces of titanium oxide, chromium oxide and aluminium nitride. Conclusion. This study characterised and qualitatively graded the severity of the corrosion particles released into the hip joint from tapers that had corrosion damage. Cite this article: S. Munir, R. A. Oliver, B. Zicat, W. L. Walter, W. K. Walter, W. R. Walsh. The histological and elemental characterisation of corrosion particles from taper junctions. Bone Joint Res 2016;5:370–378. DOI: 10.1302/2046-3758.59.2000507

Aims. We wished to investigate the influence of metal debris exposure on the subsequent immune response and resulting soft-tissue injury following metal-on-metal (MoM) hip arthroplasty. Some reports have suggested that debris generated from the head-neck taper junction is more destructive than equivalent doses from metal bearing surfaces. . Patients and Methods. We investigated the influence of the source and volume of metal debris on chromium (Cr) and cobalt (Co) concentrations in corresponding blood and hip synovial fluid samples and the observed agglomerated particle sizes in excised tissues using multiple regression analysis of prospectively collected data. A total of 199 explanted MoM hips (177 patients; 132 hips female) were analysed to determine rates of volumetric wear at the bearing surfaces and taper junctions. . Results. The statistical modelling suggested that a greater source contribution of metal debris from the taper junction was associated with smaller aggregated particle sizes in the local tissues and a relative reduction of Cr ion concentrations in the corresponding synovial fluid and blood samples. Metal debris generated from taper junctions appears to be of a different morphology, composition and therefore, potentially, immunogenicity to that generated from bearing surfaces. Conclusion. The differences in debris arising from the taper and the articulating surfaces may provide some understanding of the increased incidence of soft-tissue reactions reported in patients implanted with MoM total hip arthroplasties compared with patients with hip resurfacings. Cite this article: Bone Joint J 2016;98-B:925–33

Aims

The purpose of this study was to directly compare the Modular Dual Mobility (MDM) Mobile Bearing Hip System (Stryker, USA) and large femoral heads (LFHs) in revision total hip arthroplasties (THAs) at mid-term follow-up, with specific emphasis on survival free of re-revision for dislocation, any re-revision, dislocation, and the risk of metal-related complications.