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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.

NCT07451743 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ASL Lecce

    lead OTHER_GOV

Principal Investigators

  • Jacopo Conteduca, MD · ASL Lecce

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2029-01-01
Completion
2029-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07451743 on ClinicalTrials.gov