Early Clinical Outcomes of a Nitrided Ti-6Al-4V Titanium Alloy Anatomic Total Knee Replacement System

Background/Objectives: To prevent potential complications for patients with metal hypersensitivity requiring total knee arthroplasty (TKA), implant coatings have been developed. Thermal nitriding of the titanium surface creates a TiN layer that increases hardness and wear resistance while preventing release of cobalt and chromium ions. The aim of this study was to evaluate the clinical safety and performance of an anatomic implant system comprised of thermally nitrided Ti-6Al-4V. Methods: This is an ongoing prospective, multicenter observational cohort study of primary and revision TKA patients. Patient-reported outcome measures including the Oxford Knee Score (OKS), Knee Society Score (KSS) Expectations subscale, EQ-5D-5L, physical exams, and radiographic assessments to document abnormalities were investigated in 94 patients who provided at least two years of follow-up data. The primary endpoint was improvement in the Oxford Knee Score (OKS), defined as the minimal clinically important difference (MCID, 7.0 points). Results: All outcome measures including patient-reported function (OKS) demonstrated significant improvements (19.4–22.6 points) exceeding the MCID with no between-group differences by bearing types utilized. Health-related quality of life as measured by EQ-5D-5L improved over the cohort and was maintained at 2-years post-operative. In total, three (1.4%) radiographic abnormalities were observed, all of which resolved at two-year follow-up. 12 (5.3%) serious complications were reported, none of which were related to the device. Two revisions have occurred, one due to infection and one due to a fall, in the ultracongruent bearing cohort (survivorship 98.1%, 95%CI 87.4–99.7). Implant survivorship was 100% in all other bearing cohorts. Conclusions: This anatomically designed, thermally nitrided titanium alloy implant demonstrated clinically significant improvements in function, PROMs, and quality of life in patients undergoing TKA regardless of bearing type. Excellent two-year implant survivorship between 98.1% and 100% across cohorts were observed, with no radiographic abnormalities at 2 years.