No difference in patient reported outcome and inflammatory response after coated and uncoated total knee arthroplasty - a randomized controlled study.

研究概要

Seventy‑six patients undergoing primary TKA were randomized to an uncoated cobalt‑chromium implant (n=38) or the same system with a seven‑layer Advanced Surface (zirconium‑nitride) coating (n=34). The primary outcome was systemic inflammatory response profiled by serum cytokines (IL‑1β, IL‑5, IL‑6, IL‑8, IL‑10, IFN‑γ, TNF‑α). Secondary outcomes included PROMs (Oxford Knee Score, Knee Society Scores, EQ‑5D), satisfaction, and ROM. Outcomes were assessed pre‑op, 3 months, 1 year, and 3 years (PROMs emphasized at 1 and 3 years; cytokines pre‑op, 1 and 3 years). Overall, the results revealed no between‑group differences in cytokine patterns at any time point and no sustained differences in PROMs; a transient advantage in KSS Function at 1 year for the coated group (p=0.016) was not present at 3 years. In short, coated and uncoated TKA performed similarly for inflammation and patient‑reported outcomes through three years.