Robotic-arm-assisted versus conventional total knee replacement (RACER-Knee): a pragmatic, multicentre, participant-masked and assessor-masked, superiority, randomised controlled trial

研究概要

339 patients with advanced knee osteoarthritis undergoing total knee replacement (TKR) were randomized to receive Mako robotic-arm-assisted TKR (rTKR) or conventional TKR (cTKR). The primary outcome of interest was the Forgotten Joint Score (FJS) at 12 months. Secondary outcomes included early postoperative pain, opioid use, Oxford Knee Score (OKS), EuroQol 5-Dimension 5-Level (EQ-5D-5L), complications, radiographic alignment, and health-care costs. Outcomes were assessed during hospitalization and at 3, 6, and 12 months after randomization. Overall, the results of the study revealed no clinically meaningful difference in 12-month FJS between rTKR and cTKR, while secondary patient-reported outcomes and safety were also similar. Although rTKR improved the precision of implant alignment, it increased operating time and costs. rTKR as delivered in routine practice did not provide additional clinical benefit over cTKR during the first postoperative year.