Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses

BACKGROUND: Any metal placed in a biological environment undergoes corrosion. Thus, with their large metallic surfaces, TKA implants are particularly prone to corrosion with subsequent release of metal ions into the human body which may cause local and systemic toxic effects and hypersensitivity reactions, and increase cancer risk. To address this problem, a new 7-layer zirconium coating developed especially for cobalt-chrome orthopaedic implants was tested biomechanically and found to lower metal ion release. The purpose of the proposed clinical trial is to compare the metal ion concentration in patients' plasma before and after implantation of a coated or uncoated TKA implant. METHODS/DESIGN: In this randomised controlled trial, 120 patients undergoing primary TKA will be recruited at the Department of Orthopaedic Surgery of the University Hospital in Dresden, Germany, and randomised to either the coated or uncoated prosthesis. Outcome assessments will be conducted preoperatively and at 3 months, 12 months and 5 years postoperatively. The primary clinical endpoint will be the chromium ion concentration in the patient's plasma after 1 and 5 years. Secondary outcomes include cobalt, molybdenum and nickel ion concentrations after 1 and 5 years, allergy testing for hypersensitivity against one of these metals, the Knee Society Score to assess clinical and physical function of the knee joint, the self-assessment Oxford Score and the Short Form 36 quality of live questionnaire. DISCUSSION: The metal ion concentration in the patient's plasma has been shown to increase after TKA, its eventual adverse effects being widely debated. In the light of this discussion, ways to reduce metal ion release from orthopaedic implants should be studied in detail. The results of this investigation may lead to a new method to achieve this goal. TRIALS REGISTER: Clinicaltrials registry NCT00862511