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
TL;DR: The metal ion concentration in the patient's plasma has been shown to increase after TKA, its eventual adverse effects being widely debated and ways to reduce metal ion release from orthopaedic implants should be studied in detail.
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Abstract: 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.
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TL;DR: In 2005, a 60-year-old woman suffering from osteoarthritis received a total knee replacement (TKA) in another hospital using antibiotic-loaded cement and complained of partly eczematous reactions, which appeared about half a year after the primary surgery.
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