601 metal-on-metal total hip replacements with 36 mm heads a 5 minimum year follow up: Levels of ARMD remain low despite a comprehensive screening program

Atrey, Amit; Hart, Alister; Hussain, Nasir; Waite, Jonathan; Shepherd, A; Young, S. K.

doi:10.1016/j.jor.2016.10.023

Cited by 17 publications

(19 citation statements)

References 44 publications

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“…As observed in a study by Atrey et al [ 25 ], the Cr levels were never independently raised above Co, as in our patient. Furthermore, it has been suggested that Co (rather than Cr) is the more active ion that initiates an inflammatory reaction and it has a trend towards larger blood concentrations with longer follow-up [ 24 , 27 ].…”

Section: Discussionsupporting

confidence: 89%

“…In a retrospective study by Atrey et al on a consecutive series of 469 hips, 29 were revised (12 for ARMD) with a mean survivorship of the implant of 92.8% at a median time to follow-up of 84 months [ 25 ]. Umar et al reported the results of a cohort of patients aged ≤ 55 years; they performed 12 revisions in 109 hips (7 for ARMD) with an implant survival rate of 88.1% at a mean age of 10 years [ 26 ].…”

Section: Discussionmentioning

confidence: 99%

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Long-term results of the M2A-38-mm metal-on-metal articulation

Trévisan¹,

Piscitello²,

Klumpp³

et al. 2018

J Orthop Traumatol

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BackgroundLarge-diameter head metal-on-metal (MoM) bearings in total hip arthroplasty (THA) are associated with increased whole blood levels of chromium (Cr) and cobalt (Co), adverse reactions to metal debris (ARMD) and poor survival rates. The prevalence of high metals concentrations, ARMD and the risk of revision surgery may vary significantly among different prostheses and long-term studies are few. This single-center study reports the long-term results of the 38-mm MoM bearing system.Materials and methodsBetween 2003 and 2009, 80 patients received primary cementless THA using the large head metal-on-metal articulating surface M2A-38 cup (Biomet, Inc., Warsaw, IN, USA) at a single institution. Forty-five patients (53 hips) were retrospectively reviewed for a mean follow-up of 127 months.ResultsTwo cups were revised. The cumulative implant survival rate was 98% at 10 years and 74% at 13 years. In the whole sample, the median Co and Cr concentrations were 4.8 µg/L (IQR 1.2–4.9 µg/L) and 2.5 µg/L (IQR 0.6–3.0 µg/L), respectively. The incidence of Co or Cr levels > 7 μg/L was 15.5% and the incidence of ARMD was 3.8%. Co and Cr levels showed no correlation with cup inclination, Harris Hip Score, or total Hip Disability and Osteoarthritis Outcome score.ConclusionsOur results confirm that the problems of release of metal ions with the possible increase of metal circulating levels and of adverse reactions may also occur in the long term with this brand of MoM large head, and that a structured follow-up program is mandatory.Levels of evidenceLevel 4.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Long-term results of the M2A-38-mm metal-on-metal articulation

Trévisan¹,

Piscitello²,

Klumpp³

et al. 2018

J Orthop Traumatol

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“…However, whether a causal relationship exists remains unclear. Further studies will help to determine the true prevalence of this rare entity and to develop the current monitoring guidelines for potential adverse effects, both local and systemic, associated with MoM-HP [46].…”

Section: Discussionmentioning

confidence: 99%

Metal-on-Metal Hip Joint Prostheses: a Retrospective Case Series Investigating the Association of Systemic Toxicity with Serum Cobalt and Chromium Concentrations

Leikin

Dargan

et al. 2017

J. Med. Toxicol.

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Introduction There have been concerns about prosthesis failure and the potential for systemic toxicity due to release of cobalt and chromium from metal-on-metal hip joint prostheses (MoM-HP). There is conflicting evidence on whether there is a correlation between higher cobalt and chromium concentrations and systemic toxicity. Methods We undertook a retrospective review of consecutive patients with MoM-HP referred for outpatient review in toxicology clinics in London, UK, and in the USA recorded in the Toxicology Investigators Consortium (ToxIC) Registry from June 2011 to June 2015. Results Thirty-one cases were identified; the median (IQR) serum cobalt concentration was 10.0 (3.8-32.8) mcg/L, and the median (IQR) serum chromium concentration was 6.9 (3.7-18.7) mcg/L. Twenty-three (74.2%) had symptoms, most commonly lethargy, hearing loss, and tinnitus. The odds ratios of symptomatic/asymptomatic patients for metal ion concentrations above/below 7 mcg/L were 1.87 (95% CI 0.37-9.57, p = 0.45) and 0.60 (95% CI 0.10-3.50, p = 0.57) for cobalt and chromium, respectively. Two (6.5%) patients with systemic cobalt toxicity had median (IQR) serum cobalt concentrations significantly higher than those without systemic features (630.4 [397.6-863.2] mcg/L versus 9.8 [2.9-16.4] mcg/L; p = 0.017). However, overall, there were no differences between cobalt (p = 0.38) or chromium (p = 0.92) concentrations between symptomatic and asymptomatic patients and no clinical features or investigation results correlated with cobalt or chromium concentration. Conclusion Two (6.5%) of 31 individuals referred for assessment of MoM-HP were diagnosed with systemic cobalt toxicity. However, despite a high prevalence of reported symptoms, neither symptoms nor investigation results correlated with serum cobalt or chromium concentrations.

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“…Ethical approval was not required for our study as all centers prospectively followed patients with MoM implants according to published regulatory guidance 5 , 7 . The BHR and Corail-Pinnacle patient cohorts at each center have been previously described, with the follow-up protocols and blood metal ion analytical methods also detailed 22 - 26 . Specific details related to each center are provided below.…”

Section: Methodsmentioning

confidence: 99%

“…Between 2006 and 2011, 601 Corail-Pinnacle implants were performed 26 . Following arthroplasty, all patients, regardless of symptoms, underwent clinical assessment including pelvic radiographs and blood metal ion sampling.…”

Section: Methodsmentioning

confidence: 99%

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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601 metal-on-metal total hip replacements with 36 mm heads a 5 minimum year follow up: Levels of ARMD remain low despite a comprehensive screening program

Cited by 17 publications

References 44 publications

Long-term results of the M2A-38-mm metal-on-metal articulation

Long-term results of the M2A-38-mm metal-on-metal articulation

Metal-on-Metal Hip Joint Prostheses: a Retrospective Case Series Investigating the Association of Systemic Toxicity with Serum Cobalt and Chromium Concentrations

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

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