An observational study to determine the sensitizing potential of orthopedic implants

Abstract

Introduction: Patients who receive orthopedic implants have been shown to develop sensitivity to its components and there are concerns that this sensitivity might lead to contact dermatitis or implant-related problems like loosening and/or failure. The objective of the study was to determine the sensitizing potential of orthopedic implants. Methods: Fifty-four patients undergoing knee, hip, or shoulder replacement surgeries between July 2014 and July 2015 were recruited. Patch tests were performed before the implant surgery with 10 allergens likely to be implicated in metal hypersensitivity. Postimplant patch test was performed 6 months after surgery. A majority of the patch tests were applied on the arms. Results: Four positive reactions were recorded in the preimplant patch tests – three positive reactions to nickel and one to chromium. Thirty patients made themselves available for the follow-up patch test. The incidence of new contact sensitivity to components of implants was 13.8% (4/29) at 6 months. One patient who had undergone knee replacement developed eczematous lesions around the knee joint after surgery. This patient tested negative to patch test at both the times. Limitations: Short follow-up duration and performing patch tests on the arms, a site known to elicit less positive patch test response compared to the back in sensitized individuals, are limitations of the study. Conclusion: There is an increase in the sensitivity to implanted components after 6 months of joint replacement surgery. The incidence of new sensitivity to a component of the implant was 13.8% (4/29). In this context, nickel is a good sensitizer and could sensitize 50% of patients who received a nickel-containing implant.