Evaluating a Robotic Navigation System Versus Traditional Surgery for ACL Reconstruction in Adults Aged 18 to 80

What this Trial Is About

Researchers are evaluating a new robotic system designed to improve anterior cruciate ligament ACL reconstruction surgery. This advanced robot uses preoperative navigation to precisely place bone tunnels, aiming to enhance surgical accuracy and reduce complications. The study is a multi-center, randomized controlled trial led by Tsinghua University, focusing on the effectiveness of this domestic innovation in orthopedic surgery. The trial compares two surgical approaches for ACL reconstruction one using robotic surgery guided by the preoperative navigation system, and the other using traditional arthroscopic surgery performed by experienced surgeons after the same navigation planning. Both methods use a standardized double-bundle reconstruction technique. Participants are randomly assigned to either the robotic or manual surgery group. Participants will undergo surgery and then be followed up with various assessments over two years. Researchers will measure the accuracy of bone tunnel placement one week after surgery and track knee function and pain using scores like the Lysholm score, IKDC, Tegner scale, and visual analog scale at multiple points up to 24 months. The study includes detailed evaluations of knee movement and stability to monitor recovery and outcomes throughout the follow-up period.

Assessing the Efficacy of a Preoperative Navigation System in Anterior Cruciate Ligament Reconstruction