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NCT06858930

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

Recruiting now NA Last updated 5 March 2025
What this trial tests

NA trial testing ACL footprint localization after preoperative navigation executed by robotic arm in Anterior Cruciate Ligament Rupture in 76 participants. Currently enrolling.

Timeline
24 January 2025
Primary endpoint
24 January 2025
24 January 2029

Quick facts

Lead sponsorBeijing Tsinghua Chang Gung Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment76
Start date24 January 2025
Primary completion24 January 2025
Estimated completion24 January 2029
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Beijing Tsinghua Chang Gung Hospital

Who can join

Adults 18 to 80, any sex, with Anterior Cruciate Ligament Rupture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A novel approach to double-bundle posterior cruciate ligament reconstruction: leveraging individualized robotic navigation and multimodal imaging for superior precision and feasibility.
    Sun Y, Du H, Yu JK. · · 2026 · PMID 41586624 · DOI 10.1097/js9.0000000000004793

Verify or expand the search:

Other recruiting trials for Anterior Cruciate Ligament Rupture

Currently open trials in the same condition.

Other Beijing Tsinghua Chang Gung Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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