Assessing the Efficacy of a Preoperative Navigation System in Anterior Cruciate Ligament Reconstruction
Beijing Tsinghua Chang Gung Hospital
76 participants
Jan 24, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
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Interventions
Anterior cruciate ligament (ACL) reconstruction is performed using the preoperative navigation of Naton Robotics, followed by random assignment to either robotic surgery or traditional manual surgery. The difference between the two lies in whether the localization of the ACL footprint is performed by a human or by the robotic arm. The surgical technique is standardized as double-bundle reconstruction.
Anterior cruciate ligament (ACL) reconstruction is performed using the preoperative navigation of Naton Robotics, followed by random assignment to either robotic surgery or traditional manual surgery. The difference between the two lies in whether the localization of the ACL footprint is performed by a human or by the robotic arm. The surgical technique is standardized as double-bundle reconstruction.
Locations(1)
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NCT06858930