A Randomized Study Comparing Robotic-Assisted and Conventional Total Knee Replacement in Adults

What this Trial Is About

Researchers are evaluating the clinical and economic effects of Robotic-Assisted Total Knee Replacement RTKR compared to conventional Total Knee Replacement TKR in adults with knee osteoarthritis who need knee replacement surgery. This study is a multicenter, randomized, controlled trial designed to compare the two surgical methods and assess their impact on patient outcomes and healthcare costs. The main focus is on the Forgotten Joint Score FJS, which measures how often patients are aware of their knee joint in daily life, reflecting the success of the surgery in restoring natural knee function. Participants are randomly assigned to receive either robotic-assisted total knee replacement or the standard total knee replacement procedure. The study includes two groups one undergoing RTKR and the other undergoing conventional TKR. Treatments are performed according to local guidelines, and the trial is preference-tolerant, allowing for patient and surgeon preferences within the randomization design. During the study, participants will be followed for up to two years after surgery. Assessments include patient-reported outcome measures such as the Forgotten Joint Score at 6 weeks, 12 months, and 24 months, as well as knee instability scales, quality of life questionnaires, x-rays to evaluate implant positioning, and monitoring for adverse events. The primary outcome measure is the Forgotten Joint Score at 24 months post-surgery. Safety and other outcomes will be tracked throughout the follow-up period to evaluate both clinical benefits and economic impacts.

RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques