Clinical Trial

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

Recruiting
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Summary
The ACL surgery robot features a preoperative navigation system that enhances the precision of bone tunnel placement. As the first dual-bundle reconstruction surgical robot developed in China, it integrates advanced technology to ensure accurate anatomical alignment. This multi-center study aims to evaluate the robot's effectiveness in improving surgical outcomes and reducing complications, demonstrating the potential of domestic innovations in orthopedic surgery. With its high accuracy in locating bone tunnel footprints, this robot represents a significant advancement in ACL reconstruction techniques. The trial is designed as a randomized controlled trial (RCT) led by a prospective randomized cohort. The study is initiated by Tsinghua University's long-term professor, Yu Jiakuo, and the product has received China's Class III clinical registration certificate.
Trial Details
NCT Number NCT06858930
Lead Sponsor Beijing Tsinghua Chang Gung Hospital
Collaborators: Nanyang Orthopedic Hospital, Weifang Yidu Central Hospital
Conditions Anterior Cruciate Ligament Rupture
Enrollment 76 participants
Start Date 2025-01-24
Primary Completion 2025-01-24 (estimated)
Study Completion 2029-01-24 (estimated)
Updated on ClinicalTrials.gov 2025-03-05