The Effectiveness of Blood Metal Ions in Identifying Patients with Unilateral Birmingham Hip Resurfacing and Corail-Pinnacle Metal-on-Metal Hip Implants at Risk of Adverse Reactions to Metal Debris

Matharu, Gulraj S.; Berryman, Fiona; Brash, Lesley; Pynsent, Paul; Treacy, R. B. C.; Dunlop, David J.

doi:10.2106/jbjs.15.00340

Cited by 39 publications

(61 citation statements)

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“…Furthermore, in the occupational setting, an established relationship exists between high metal ion exposure and the development of certain cancers [ 12 ]. Although there is a theoretical increased risk of cancer in all patients receiving hip replacement, MoM hip replacements produce much higher concentrations of metal ions in the blood compared with conventional hip replacements, especially if the MoM hip replacement is not functioning optimally [ 21 , 22 ]. Hexavalent chromium (Cr 6+ ) is a known carcinogen [ 23 ].…”

Section: Introductionmentioning

confidence: 99%

The risk of developing cancer following metal-on-metal hip replacement compared with non metal-on-metal hip bearings: Findings from a prospective national registry “The National Joint Registry of England, Wales, Northern Ireland and the Isle of Man”

et al. 2018

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Background and purposeOver 1 million metal-on-metal hip replacements were implanted. Even well-functioning implants produce wear debris that can cause tissue damage, disseminate and cause DNA damage. We aimed to establish if there was an association between metal-on-metal hip replacement and the risk of subsequently developing cancer compared with alternative hip replacements.MethodsWe performed a population based prospective longitudinal cohort study using data from the National Joint Registry linked to Hospital Episode Statistics (n = 403,881 patients). We examined the incidence of a new diagnosis of cancer in patients who received a metal-on-metal bearing in comparison with those who received a non metal-on-metal bearing. Kaplan-Meier estimates of time to first cancer diagnosis were used with Cox proportional hazards regression models to assess the effect on the time to cancer diagnosis for all cancer types, haematological, malignant melanoma, urinary tract cancers or prostate cancer in men.ResultsThe maximum follow up available was 11.8 years with 25% of patients followed up for more than 6.8 years (mean follow up 4.6 years; median 4.3; IQR 2.1–6.8; range 0.01–11.8). Analyses by gender that adjusted for age at primary and presence or absence of linked Welsh (PEDW) records showed no increase in the risk of developing cancer according to the bearing surface implanted for all cancers, haematological cancers, malignant melanoma, urinary tract cancers or prostate cancer in men. For patients receiving a second hip replacement, there was also no difference.ConclusionWe have demonstrated that there is currently no evidence of an increase in the risk of cancer following primary hip replacement according to the type of bearing material used. Although the risk of revision in metal-on-metal bearing hip replacements is higher, it is reassuring that the risk of a new diagnosis of cancer is not currently increased. Despite the long term follow up available in this study, the latency period for some cancers is very long and therefore continued monitoring is required to ensure no new patterns emerge that may indicate need for universal screening.

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Section: Introductionmentioning

confidence: 99%

The risk of developing cancer following metal-on-metal hip replacement compared with non metal-on-metal hip bearings: Findings from a prospective national registry “The National Joint Registry of England, Wales, Northern Ireland and the Isle of Man”

et al. 2018

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“…Two recent studies identified implant-specific blood metal ion thresholds in patients who had undergone unilateral or bilateral Birmingham Hip Resurfacing (BHR; Smith & Nephew) or unilateral Corail-Pinnacle total hip replacement (DePuy) 14 , 15 . These designs are 2 of the most commonly implanted MoM hip devices worldwide 3 , 16 , 17 .…”

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“…Medicines and Healthcare products Regulatory Agency (MHRA) (7 μg/L for both cobalt and chromium) 5 and by experts in the U.S. (3 μg/L and 10 μg/L for both cobalt and chromium) 18 . Investigators who used the new implant-specific thresholds 14 , 15 missed fewer patients with ARMD than when they used the fixed thresholds proposed by regulatory authorities 5 , 18 . The implant-specific thresholds were derived in a large patient cohort (n = 783) and appear to be useful when managing patients with these particular MoM implant designs 14 , 15 .…”

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Blood Metal Ion Thresholds to Identify Patients with Metal-on-Metal Hip Implants at Risk of Adverse Reactions to Metal Debris

Matharu

Berryman

Judge

et al. 2017

The Journal of Bone and Joint Surgery

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Background:The authors of recent studies have reported newly devised implant-specific blood metal ion thresholds to predict adverse reactions to metal debris (ARMD) in patients who have undergone unilateral or bilateral metal-on-metal (MoM) hip arthroplasty. These thresholds were most effective for identifying patients at low risk of ARMD. We investigated whether these newly devised blood metal ion thresholds could effectively identify patients at risk of ARMD after MoM hip arthroplasty in an external cohort of patients.Methods:We performed a validation study involving 803 MoM hip arthroplasties (323 unilateral Birmingham Hip Resurfacing [BHR], 93 bilateral BHR, and 294 unilateral Corail-Pinnacle implants) performed in 710 patients at 3 European centers. All patients underwent whole-blood metal ion sampling, and were divided into 2 groups: those with ARMD (leading to revision or identified on imaging; n = 75) and those without ARMD (n = 635). Previously devised implant-specific blood metal ion thresholds (2.15 μg/L of cobalt for unilateral BHR; 5.5 μg/L for the maximum of either cobalt or chromium for bilateral BHR; and 3.57 μg/L of cobalt for unilateral Corail-Pinnacle implants) were applied to the validation cohort, and receiver operating characteristic curve analysis was used to establish the discriminatory characteristics of each threshold.Results:The area under the curve, sensitivity, specificity, and positive and negative predictive values for the ability of each implant-specific threshold to distinguish between patients with and without ARMD were, respectively, 89.4% (95% confidence interval [CI] = 82.8% to 96.0%), 78.9%, 86.7%, 44.1%, and 96.9% for unilateral BHR; 89.2% (CI = 81.3% to 97.1%), 70.6%, 86.8%, 54.5%, and 93.0% for bilateral BHR; and 76.9% (CI = 63.9% to 90.0%), 65.0%, 85.4%, 24.5%, and 97.1% for unilateral Corail-Pinnacle implants. Using the implant-specific thresholds, we missed 20 patients with ARMD (2.8% of the patients in this series). We missed more patients with ARMD when we used the fixed thresholds proposed by regulatory authorities: 35 (4.9%) when we used the U.K. threshold of 7 μg/L for both cobalt and chromium (p = 0.0003), 21 (3.0%) when we used the U.S. threshold of 3 μg/L for both cobalt and chromium (p = 1.0), and 46 (6.5%) when we used the U.S. threshold of 10 μg/L for both cobalt and chromium (p < 0.0001).Conclusions:This external multicenter validation study confirmed that patients with blood metal ion levels below new implant-specific thresholds have a low risk of ARMD after MoM hip arthroplasty. Using these implant-specific thresholds, we missed fewer patients with ARMD compared with when the thresholds currently proposed by regulatory authorities were used. We therefore recommend using implant-specific blood metal ion thresholds when managing patients who have undergone MoM hip arthroplasty.Level of Evidence:Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence.

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“…In addition, levels may be measured from serum, whole blood, or erythrocytes [13] and there is no conversion factor for these values as the intracellular and extracellular compartments act independently of each other [14]. Cobalt and chromium levels, or cobalt levels alone, may be used to identify patients at risk of adverse reactions to metal debris [15]. …”

Section: Discussionmentioning

confidence: 99%

Cobalt Cardiomyopathy Secondary to Hip Arthroplasty: An Increasingly Prevalent Problem

Tilney

Burg

Sammut

2017

Case Reports in Cardiology

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A forty-year-old man experienced worsening heart failure four years following bilateral complicated total hip replacement. His condition was extensively worked up but no underlying pathology was immediately evident. Given the cobalt-chromium alloy component present in the hip arthroplasties, the raised cobalt blood levels, and a fitting clinical picture coupled with radiological findings, the patient underwent right hip revision. Evidence of biotribocorrosion was present on direct visualisation intraoperatively. The patient subsequently experienced symptomatic improvement (NYHA class III to class I) and echocardiography showed recovery of ejection fraction. Cobalt exists as a bivalent and trivalent molecule in circulation and produces a cytotoxicity profile similar to nanoparticles, causing neurological, thyroid, and cardiological pathology. Blood levels are not entirely useful as there is no identifiable conversion factor for levels in whole blood, serum, and erythrocytes which seem to act independently of each other. Interestingly cobalt cardiomyopathy is frequently compounded by other possible causes of cardiomyopathy such as alcohol and a link has been postulated. Definitive treatment is revision of the arthroplasty as other treatments are unproven.

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The Effectiveness of Blood Metal Ions in Identifying Patients with Unilateral Birmingham Hip Resurfacing and Corail-Pinnacle Metal-on-Metal Hip Implants at Risk of Adverse Reactions to Metal Debris

Abstract: Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Cited by 39 publications

References 39 publications

The risk of developing cancer following metal-on-metal hip replacement compared with non metal-on-metal hip bearings: Findings from a prospective national registry “The National Joint Registry of England, Wales, Northern Ireland and the Isle of Man”

The risk of developing cancer following metal-on-metal hip replacement compared with non metal-on-metal hip bearings: Findings from a prospective national registry “The National Joint Registry of England, Wales, Northern Ireland and the Isle of Man”

Blood Metal Ion Thresholds to Identify Patients with Metal-on-Metal Hip Implants at Risk of Adverse Reactions to Metal Debris

Cobalt Cardiomyopathy Secondary to Hip Arthroplasty: An Increasingly Prevalent Problem

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