BACKGROUND: This randomized-controlled trial was initiated to compare a new multilayer hypoallergenic coating system with the standard implant in total knee arthroplasty (TKA) in terms of serum metal ion levels, patient-reported outcomes (PROs), and implant survival.

METHODS: A total of 120 patients were randomized to receive a coated or standard TKA of the same knee system. Serum metal ion levels (ie, cobalt, chromium, molybdenum, and nickel) as well as knee function (Oxford Knee Score, OKS), quality of life (SF-36), and physical activity (UCLA activity scale) were assessed before surgery and until the 10 year follow-up. A total of 24 patients died and there was one revision in each group. This resulted in 85 patients who completed follow-up.

RESULTS: Both groups demonstrated equally good improvement in PROs after surgery and constant score values thereafter. The majority of patients had metal ion serum levels below detection limit. Only cobalt levels demonstrated a slight increase in the standard group at 5- and 10-year follow-up. However, all patients displayed values below 3 μg/L. The cumulative 10-year survival was 98% in both groups.

CONCLUSION: There were no problems with the new coating system. No relevant increase in metal ion serum levels were measured. A slight increase in cobalt serum levels in the standard TKA was noted, thus not reaching critical values. The new coating system demonstrated equally good PROs as the standard TKA. Excellent implant survival was observed in both groups.

LEVEL OF EVIDENCE: I.