Ten-Year Outcomes of Hypoallergenic Coated and Standard Implants in Total Knee Arthroplasty: A Randomized Controlled Trial.

研究概要

118 patients undergoing primary total knee arthroplasty (TKA) were randomized to receive either a hypoallergenic titanium-niobium-nitride (TiNbN)-coated implant or a standard uncoated cobalt-chromium-molybdenum (CoCrMo) implant. The primary outcomes of interest were implant survival, patient-reported outcomes, and serum metal concentrations. Secondary outcomes included the Oxford Knee Score (OKS), Short Form-36 (SF-36), University of California, Los Angeles (UCLA) Activity Score, and patient satisfaction measured using a visual analogue scale (VAS). Clinical outcomes were assessed up to 10 years, while serum metal concentrations were measured up to 5 years. Overall, the results revealed comparable 10-year implant survival, knee function, health-related quality of life, and patient satisfaction between groups. Although the coated implants demonstrated lower serum chromium concentrations at 1 year, this difference was no longer significant at 5 years. These findings suggested that TiNbN-coated implants provided similar long-term clinical outcomes and implant durability compared with standard TKA implants.