NCT07451743

Are Clinical Outcomes Unchanged by ALL Fixation at 0° or 30° of Knee Flexion in Combined ACL-ALL Reconstruction? Despite Numerous Technical Descriptions of Anterolateral Procedures, There is Limited Knowledge Regarding the Effect of Knee Flexion Angle During Graft Fixation.

Are Clinical Outcomes Unchanged by ALL Fixation at 0° or 30° of Knee Flexion in Combined ACL-ALL Reconstruction?

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: ASL Lecce · Other Government
• Sex: All
• Age: 16 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates whether the knee flexion angle used during fixation of the anterolateral ligament (ALL) affects clinical outcomes in patients undergoing combined anterior cruciate ligament (ACL) and ALL reconstruction. Combined ACL and ALL reconstruction is increasingly used to improve rotational knee stability and reduce the risk of graft failure after ACL injury. However, the optimal knee position for fixing the ALL graft during surgery remains unclear. In this study, patients were treated with ALL fixation performed either in full knee extension (0 degrees) or at 30 degrees of knee flexion. Clinical outcomes, knee stability, patient-reported function, and graft failure rates were compared between the two groups at a minimum follow-up of two years. Outcomes were assessed using validated questionnaires, clinical examinations, and objective measurements of knee stability. The study aims to determine whether the knee flexion angle at the time of ALL fixation influences postoperative function, stability, or complication rates, and to provide clinical evidence to guide surgical technique in combined ACL and ALL reconstruction.

Conditions

• Anterior Cruciate Ligament Rupture

Interventions

Type	Name	Description
PROCEDURE	anterolateral ligament reconstruction	The intervention consists of a standardized combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction performed using anatomical single-bundle ACL reconstruction and anatomical ALL reconstruction. The surgical technique, graft selection, tunnel placement, fixation devices, and postoperative rehabilitation protocol are identical in both study arms. The only variable distinguishing the interventions is the knee flexion angle at the time of femoral fixation of the ALL graft. In one group, the ALL graft is tensioned and fixed with the knee in full extension (0 degrees). In the other group, the ALL graft is tensioned and fixed with the knee positioned at 30 degrees of flexion. No intraoperative measurements of graft tension are performed, and fixation is carried out according to a predefined standardized protocol. All procedures are performed by experienced surgeons using the same surgical landmarks for graft placement, with the intent of isolating the effect

Timeline

• Start date: 2026-03-30
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2026-03-05
• Last updated: 2026-03-05