Clinical Trial

The Clinical Efficacy of Anterolateral Complex Augmentation in Patients With ACL Rupture Combined With Excessive Internal Tibial Rotation Subluxation: A Bidirectional Cohort Study

Enrolling by Invitation
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Summary
This project aims to establish a high-quality, large-scale, single-center bidirectional cohort study to evaluate the postoperative clinical efficacy of ACLR combined with ALC augmentation in a specific high-risk population-patients with ACL rupture exhibiting excessive internal tibial rotation subluxation (EIRTS) on preoperative MRI. The study population will consist of patients with primary ACL rupture, and high-risk individuals will be identified based on the presence of EIRTS on preoperative knee MRI. The exposure group will undergo ACLR combined with ALC augmentation, while the control group will receive standard ACLR. Observational indicators will include all baseline patient characteristics and postoperative clinical outcomes.
Trial Details
NCT Number NCT06961292
Lead Sponsor Peking University Third Hospital
Conditions Anterior Cruciate Ligament Rupture
Enrollment 335 participants
Start Date 2024-01-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-07