To compare the effectiveness of robotic-arm–assisted total knee replacement with conventional total knee replacement in patients with advanced knee osteoarthritis.
Approach:
Study Design: The RACER-Knee trial was a pragmatic, multicenter, participant- and assessor-masked study involving random assignment of patients to either robotic-arm–assisted replacement or conventional replacement.
Participants: Patients with knee osteoarthritis undergoing total knee replacement were recruited from 10 hospitals in England, Scotland, and Wales.
Outcome Measures: The primary outcome was the 12-month Forgotten Joint Score, with secondary outcomes including postoperative pain, opioid consumption, and knee function.
Key Findings:
Mean Forgotten Joint Scores were approximately 49 in the robotic group and 50 in the conventional group, with an adjusted difference of 1.5 points favoring conventional surgery, which did not meet the prespecified 12-point target difference.
Measures during hospitalization, including postoperative pain and opioid consumption, were similar between groups, while out-of-hospital measures showed no clear differences.
Robotic assistance resulted in greater precision in alignment but increased mean operating time by 10.5 minutes.
Economic analysis indicated higher costs for robotic-assisted replacement, with a 4% probability of cost-effectiveness at the willingness-to-pay threshold.
Interpretation:
Robotic-arm–assisted total knee replacement may not provide a clinically meaningful improvement over conventional methods in the context studied.
Limitations:
Secondary findings warrant caution due to lack of adjustment for multiple comparisons, which may affect their reliability.
Results from the Mako-based trial may not apply to other robotic technologies, necessitating separate evaluations.
Conclusion:
Follow-up beyond 12 months is ongoing, and the study was funded by the National Institute for Health and Care Research Health Technology Assessment Programme.
Postoperative rates of complex regional pain syndrome type 1 and pain and functional outcomes may improve among patients receiving prophylactic mecobalamin following foot and ankle surgery.
