Better radiological outcomes but equal clinical function of a novel knee arthroplasty robot system: a prospective randomized controlled trial.

研究概要

One hundred thirty-nine patients with knee osteoarthritis were randomized to receive robot-assisted Total Knee Arthoplasty (TKA ) (n=73) or conventional instrumented TKA (n=66). The primary outcome was the proportion with ≤3° deviation between planned and postoperative mechanical axis (HKA) at 12 weeks. Secondary outcomes included component alignment angles (FFC, FTC, LFC, LTC), operative time, blood loss, range of motion (ROM), KSS, WOMAC, and adverse events. Outcomes were assessed at baseline and 12 weeks. Overall, the results revealed a higher radiographic inlier rate with robotics and smaller errors for several component angles, at the cost of longer operative time; early ROM and patient-reported outcomes were similar, and no events were deemed related to the robot. These findings suggest the system improves radiological precision without short-term functional advantage.