Comparison of Combined Intra- and Extra-articular ACL Reconstruction with Anterolateral Ligament Using Hamstring Autograft Versus Isolated Intra-articular ACL Reconstruction with Quintuple or Sextuple Hamstring Autograft

What this Trial Is About

This research aims to compare two surgical methods for reconstructing the anterior cruciate ligament ACL using hamstring tendons in patients at increased risk of re-injury. It evaluates anatomical ACL reconstruction combined with extra-articular reconstruction of the anterolateral ligament ALL against isolated intra-articular ACL reconstruction using quintuple or sextuple hamstring autografts. The study focuses on reducing graft re-rupture and improving knee stability and function after surgery. Participants will be randomly assigned to one of two groups one receiving ACL reconstruction combined with ALL reconstruction using a gracilis tendon graft, and the other receiving isolated anatomical ACL reconstruction with a larger diameter hamstring graft. The surgical procedures are carefully described, and both groups will be treated with the same number of implants. Patients will be monitored at 3, 6, 9, 12, and 24 months after surgery. During the study, patients will undergo clinical evaluations and complete questionnaires assessing knee function, pain, stability, anxiety, and fear of movement. Data collection will be performed both in person and remotely using secure mobile platforms. The primary outcomes are clinical failure rate and graft rupture rate at a minimum of two years. Secondary outcomes include various functional capacity and stability scores, as well as psychological assessments. Adherence is supported through scheduled messaging, and safety will be monitored throughout the follow-up period.

Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction