RecruitingNot ApplicableNCT06858930

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


Sponsor

Beijing Tsinghua Chang Gung Hospital

Enrollment

76 participants

Start Date

Jan 24, 2025

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called ACL footprint localization after preoperative navigation executed by rmanual execution and a procedure called ACL footprint localization after preoperative navigation executed by robotic arm for people with anterior cruciate ligament rupture. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREACL 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.

PROCEDUREACL 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.


Locations(1)

Beijing Tsinghua Chang Gung Hospital.

Beijing, Beijing Municipality, China

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NCT06858930


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