Metal Ion Levels Not Sufficient as a Screening Measure for Adverse Reactions in Metal-on-Metal Hip Arthroplasties (original) (raw)
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Acta orthopaedica Belgica, 2018
We investigated whether blood metal ions could effectively identify bilateral metal-on-metal total hip arthroplasty (THA) patients at risk of adverse reactions to metal debris (ARMD). Whole blood metal ions were sampled in 50 patients with bilateral 36mm Corail-Pinnacle THAs. Patients were divided into ARMD (n=10) and non-ARMD groups (n=40), with optimal ion thresholds for identifying ARMD determined using receiver operating characteristic analysis. Maximum cobalt or chromium produced the highest area under the curve (71.8%). The optimal ion threshold for distinguishing between patients with and without ARMD was 4.0μg/l (90.0%=sensitivity, 65.0%=specificity, 39.1%=positive predictive value, 96.3%=negative predictive value). Fixed regulatory authority thresholds missed more patients with ARMD (10%-12% missed) compared to our threshold (2% missed). Bilateral THA patients with blood metal ions below our threshold were at low-risk of ARMD. Compared to currently recommended fixed authori...
Metal ion trend in patients with metal-on-metal total hip arthroplasty: a 10-year prospective study
HIP International, 2018
Introduction: There have been reported adverse reactions in patients with large head metal-on-metal hip arthroplasty, therefore metal particle debris are a cause for concern. The aim of this study was to evaluate the release trend of metal ions and the correlated variables. Methods: 54 patients were prospectively enrolled into the study from 2004 to 2006. All patients had 36-mm metal head, Pinnacle acetabular component, Summit stem and Ultamet CoCr alloy liner (Depuy Inc.), and underwent clinical and radiological management. The haematic concentration of Cr-Co at 0, 6, 12, 24, 60 and 120 months after the implantation was analysed in a sub-cohort of 34 patients. Results: 10-year revision rate for each case was 8.9%. The average concentration of Co at 120 months was 3.12 μg/L (median 2.20) with 53% values >2 μg/L and 1 >7 μg/L. After 6 months the median levels of Cr and Co were higher than time 0 ( p < 0.0001); no significant differences were found between 6 and 24 months; wh...
Levels of metal ions after small- and large-diameter metal-on-metal hip arthroplasty
The Journal of bone and joint surgery. British volume, 2003
Metal-on-metal (MOM) bearings for hip arthroplasty are increasing in popularity. Concern remains, however, regarding the potential toxicological effects of the metal ions which these bearings release. The serum levels of cobalt and chromium in 22 patients who had undergone MOM resurfacing arthroplasty were compared with a matched group of 22 patients who had undergone 28 mm MOM total hip arthroplasty (THA). At a median of 16 months (7 to 56) after resurfacing arthroplasty, we found the median serum levels of cobalt and chromium to be 38 nmol/l (14 to 44) and 53 nmol/l (23 to 165) respectively. These were significantly greater than the levels after 28 mm MOM THA which were 22 nmol/l (15 to 87, p = 0.021) and 19 nmol/l (2 to 58, p < 0.001) respectively. Since the upper limit for normal patients without implants is typically 5 nmol/l, both groups had significantly raised levels of metal ions. MOM bearings of large diameter, however, result in a greater systemic exposure of cobalt an...
The Journal of Arthroplasty, 2014
Keywords: MARS MRI metal-on-metal arthroplasty inclincation metal ions ARMD Following the global recall of all ASR metal on metal hip products, our aim was to correlate MRI findings with acetabular inclination angles and metal ion levels in patients with these implants. Both cobalt and chromium levels were significantly higher in the presence of a periprosthetic fluid collection. There was no association between the presence of a periprosthetic mass, bone marrow oedema, trochanteric bursitis or greater levels of abductor muscle destruction for cobalt or chromium. There was no association between the level of periprosthetic tissue reaction and the acetabular inclination angle with any of the pathologies identified on MRI. The relationship between MRI pathology, metal ion levels and acetabular inclination angles in patients with ASR implants remains unclear adding to the complexity of managing patients.
The Journal of bone and joint surgery. British volume, 2011
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-dimens...
Clinical physiology and functional imaging, 2017
Metal-on-metal (MoM) bearings in total hip arthroplasties and hip resurfacing arthroplasties have recently shown a new type of complication: adverse reactions to metal debris (ARMD). ARMD is characterized by local severe inflammation and tissue necrosis leading to implant failures. The gluteal muscle region is important for the patient outcome after revision surgery. This prospective positron emission tomography/computed tomography (PET/CT) study was undertaken to evaluate the characteristics of 2-deoxy-2-[18 F]fluoro-d-glucose ([18 F]FDG) and [68 Ga]Gallium citrate ([68 Ga]Citrate) PET/CT in ARMD patients. [18 F]FDG and [68 Ga]Citrate PET/CT were performed in 18 hip arthroplasty patients: 12 ARMD patients (with 16 MoM hips) and six arthroplasty controls without ARMD. Tracer uptake was evaluated visually, and maximum standardized uptake (SUVmax ) was measured in the gluteal muscle region. ARMD severity was graded by metal artefact reduction sequence-magnetic resonance imaging (MARS-...
Journal of Arthroplasty, 2011
It is unknown if the presence of bilateral well-functioning large-head metal-on-metal (MOM) total hip arthroplasties (THAs) leads to higher serum metal ion concentrations than unilateral MOM THA. Elevated levels (chromium, 17 μg/L; cobalt, 19 μg/L) have been associated with poorly functioning MOM THA with metallosis. Fourteen patients having undergone bilateral and 25 patients having undergone unilateral large-head primary MOM THA were compared. Harris Hip Scores, University of California Los Angeles activity scores, radiographs, serum creatinine, and serum cobalt and chromium levels were obtained. Only cobalt ion levels were significantly higher in the bilateral group than in the unilateral group (1.8 μg/L vs 1.0 μg/L, P = .029). Comparatively, this magnitude is clinically rather low because ion levels did not approach those associated with metallosis in either group. We conclude that although patients with well-functioning bilateral MOM THA may have slightly higher cobalt levels, neither cobalt nor chromium levels approach those seen in poorly functioning MOM THA with metallosis. Keywords: metal-on-metal, serum metal ions, total hip arthroplasty, cobalt, chromium.
Concordance between laboratories in metal ion testing in patients with metal-on-metal hip implants
Canadian Journal of Surgery, 2019
Background: Testing of whole blood or serum metal ion levels has become an important part of assessing and monitoring the performance of metal-on-metal bearings, both in hip resurfacing arthroplasty and in total hip replacement. The aim of this study was to determine the concordance between 2 laboratories testing cobalt and chromium ion levels in patients with metal-on-metal bearings. Methods: Serum and whole blood samples from patients who had undergone metalon-metal resurfacing or large-diameter total hip arthroplasty were tested for cobalt and chromium ions in laboratory A (a recognized laboratory) and laboratory B (tasked with testing clinical specimens). Laboratory A performed cobalt and chromium testing on whole blood, and laboratory B performed cobalt testing on whole blood and chromium testing on serum. Results: Samples from 104 patients were tested. Laboratory B reported lower whole blood cobalt levels than laboratory A. Furthermore, laboratory A reported that all patients had elevated whole blood cobalt ion levels compared to the normal reference values for the laboratory, whereas laboratory B reported that 46 patients (44.2%) had whole blood cobalt ion levels within the normal reference range for the laboratory. Conclusion: This comparative study highlights the importance of using a single laboratory for metal ion testing, as values generated from different laboratories may not be directly comparable. With recent literature suggesting that whole blood cobalt levels as low as 1 ppb may be a predictor of adverse reactions to metal debris, accurate clinical measurement needs to be increasingly exact.
The Journal of Arthroplasty, 2009
In this prospective randomized study, we investigate metal ion concentrations and clinical outcome 2 years after metal-on-metal (28 patients) or metal-on-polyethylene (26 patients) hip arthroplasty with 28-mm modular heads. Metal ion concentrations in patient serum were analyzed by high-resolution plasma mass spectrometry. The clinical outcome was almost identical in both groups with respect to the Harris hip score and the Medical Outcome Study Short Form-36; and on plain radiography, no signs of loosening occurred in any group. In the metal-on-metal group, concentrations of all investigated ions increased significantly when compared with preoperative values: cobalt, 15.3-fold (95% confidence interval [CI],2); chromium, 5.2-fold (CI, 3.5-7.0); nickel, 2.1-fold (CI, 1.2-3.0); and manganese, 1.6-fold (CI, 1.3-2.0). In the metal-on-polyethylene group, a smaller but significant increase in the concentrations of cobalt and nickel occurred, whereas concentrations of the other ions did not change significantly. Keywords: hip arthroplasty, metal ions, metal bearing, metal-on-metal, cobalt, chromium, nickel, manganese.