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Robot-Assisted Versus Conventional Arthroscopic ACL Reconstruction: A Prospective Comparative Study

NCT07086417 · Chunyan Jiang · Updated 25 July 2025

What is being tested
Robot-Assisted Arthroscopic ACL Reconstruction; Conventional Arthroscopic ACL Reconstruction
For
Anterior Cruciate Ligament
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 16 years and older. About 120 people. The full rules are on the registry page.
Where
Not stated
When
Starts or started 1 Aug 2025, ends Dec 2027. Registered 25 July 2025.
Results
None posted yet.

In the researchers' words

This study aims to evaluate the clinical efficacy and biomechanical accuracy of a newly developed robot-assisted system for anterior cruciate ligament (ACL) reconstruction. ACL injuries are among the most common sports-related injuries in active individuals and athletes, and reconstruction surgery is considered the gold standard for treatment. However, failure rates remain substantial-up to 10.3% in the general population and as high as 40% among high-demand patients, such as young athletes. One of the key technical factors contributing to graft failure is improper placement of the femoral and tibial bone tunnels during surgery, which affects graft isometry, kinematics, and long-term function. This prospective, randomized, controlled clinical trial will include 120 adult patients with confirmed ACL rupture. Subjects will be randomly assigned to two groups: an experimental group undergoing robot-assisted arthroscopic ACL reconstruction, and a control group receiving traditional arthroscopic ACL reconstruction. The investigational robot system is a custom-designed platform that integrates three primary modules: (1) preoperative planning, (2) intraoperative surgical assistance, and (3) biomechanical evaluation. The robot is designed to support precise tunnel positioning using CT/MRI fusion, dynamic motion tracking during surgery, and post-placement assessment of graft…
ClinicalTrials.gov, NCT07086417