Background: We investigated whether blood metal ions could effectively identify patients with metal-on-metal hip implants with two common designs (Birmingham Hip Resurfacing [BHR] and Corail-Pinnacle) who were at risk of adverse reactions to metal debris.
Methods: This single-center, prospective study involved 598 patients with unilateral hip implants (309 patients with the BHR implant and 289 patients with the Corail-Pinnacle implant) undergoing whole blood metal ion sampling at a mean time of 6.9 years. Patients were classified into two groups, one that had adverse reactions to metal debris (those who had to undergo revision for adverse reactions to metal debris or those with adverse reactions to metal debris on imaging; n = 46) and one that did not (n = 552). Three metal ion parameters (cobalt, chromium, and cobalt-chromium ratio) were compared between groups. Optimal metal ion thresholds for identifying patients with adverse reactions to metal debris were determined using receiver operating characteristic analysis.
Results: All ion parameters were significantly higher (p < 0.0001) in the patients who had adverse reactions to metal debris compared with those who did not. Cobalt maximized the area under the curve for patients with the BHR implant (90.5%) and those with the Corail-Pinnacle implant (79.6%). For patients with the BHR implant, the area under the curve for cobalt was significantly greater than that for the cobalt-chromium ratio (p = 0.0005), but it was not significantly greater than that for chromium (p = 0.8483). For the patients with the Corail-Pinnacle implant, the area under the curve for cobalt was significantly greater than that for chromium (p = 0.0004), but it was similar to that for the cobalt-chromium ratio (p = 0.8139). Optimal blood metal ion thresholds for identifying adverse reactions to metal debris varied between the two different implants. When using cobalt, the optimal threshold for identifying adverse reactions to metal debris was 2.15 μg/L for the BHR group and 3.57 μg/L for the Corail-Pinnacle group. These thresholds had good sensitivities (88.5% for the BHR group and 80.0% for the Corail-Pinnacle group) and specificities (84.5% for the BHR group and 76.2% for the Corail-Pinnacle group), high negative predictive values (98.8% for the BHR group and 98.1% for the Corail-Pinnacle group), and low positive predictive values (34.3% for the BHR group and 20.0% for the Corail-Pinnacle group). The authority thresholds proposed by the United States (3 μg/L and 10 μg/L) and the United Kingdom (7 μg/L) missed more patients with adverse reactions to metal debris at 2.0% to 4.7% (twelve to twenty-eight patients) compared with our implant-specific thresholds at 1.2% (seven patients missed).
Conclusions: Patients who underwent metal-on-metal hip arthroplasty performed with unilateral BHR or Corail-Pinnacle implants and who had blood metal ions below our implant-specific thresholds were at low risk of adverse reactions to metal debris. These thresholds could be used to rationalize follow-up resources in asymptomatic patients. Analysis of cobalt alone is acceptable. Implant-specific thresholds were more effective than currently recommended fixed authority thresholds for identifying patients at risk of adverse reactions to metal debris requiring further investigation.
Level of Evidence: Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.
Investigation performed at the Royal Orthopaedic Hospital, Birmingham, United Kingdom
A commentary by Lawrence D. Dorr, MD, is linked to the online version of this article at jbjs.org.
Disclosure: Four authors of this study (F.B., P.B.P., R.B.C.T., and D.J.D.) received, through their institutions, a grant from the manufacturer of the device that is the subject of this study. One author of this study (G.S.M.) received a grant from the Royal College of Surgeons of England and the Arthritis Research Trust, which provided this author’s salary in the form of a surgical research fellowship. On the Disclosure of Potential Conflicts of Interest forms, which are provided with the online version of the article, one or more of the authors checked “yes” to indicate that the author had a relevant financial relationship in the biomedical arena outside the submitted work and “yes” to indicate that the author had other relationships or activities that could be perceived to influence, or have the potential to influence, what was written in this work.
- Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated
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