NCT06858930

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Beijing Tsinghua Chang Gung Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anterior Cruciate Ligament Rupture

Interventions

Type	Name	Description
PROCEDURE	ACL footprint localization after preoperative navigation executed by robotic arm	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.
PROCEDURE	ACL footprint localization after preoperative navigation executed by rmanual execution	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.

Timeline

• Start date: 2025-01-24
• Primary completion: 2025-01-24
• Completion: 2029-01-24
• First posted: 2025-03-05
• Last updated: 2025-03-05

Locations

1 site across 1 country: China