Purpose Metal ion release by orthopaedic implants may cause local and systemic effects and induce hypersensitivity reactions. Coated implants have been developed to prevent or reduce these effects. This study was initiated to investigate the safety of a novel coating for total knee arthroplasty (TKA) implants. Methods A total of 120 patients undergoing primary TKA with no history of hypersensitivity and no other metal implant were randomised to receive either a coated or uncoated implant. Chromium (Cr), cobalt (Co), molybdenum (Mb) and nickel (Ni) hypersensitivity patch testing and plasma ion concentrations were evaluated pre-operatively and one year post-operatively. Results At the one year follow-up both groups demonstrated significant improvement in knee function and quality of life. One new weakly positive reaction to Co in the TKA group with coated implant and two doubtful skin reactions to Ni (one in each group) were noted. Even with sensitisation to implant materials no skin reactions were observed. Plasma metal ion concentrations did not increase and were not elevated at the one year follow-up in either group. Conclusions Sensitisation after TKA was rare and had no influence on clinical results. TKA with coated implant and standard TKA demonstrated no plasma metal ion elevation.
BMC Musculoskeletal Disorders Open Access Study protocolStudy rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses AbstractBackground: 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.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.