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.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-45
SponsorASL Lecce

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a unilateral anterior cruciate ligament (ACL) rupture confirmed by clinical examination and magnetic resonance imaging (MRI)

Persistent knee instability despite conservative treatment

Ability to understand the study procedures and provide written informed consent

Willingness to comply with the postoperative rehabilitation protocol and follow-up schedule

Disqualifiers

Previous ACL reconstruction or revision surgery on the affected knee

Bilateral ACL injuries

Concomitant knee osteoarthritis greater than Kellgren-Lawrence grade 1

Concomitant ligament injuries requiring additional surgical procedures (except meniscal treatment)

Trial design

Design model

Parallel

Treatments tested in this trial

  • anterolateral ligament reconstruction

    Procedure/Surgery

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ALL Fixation at 0 Degrees of Knee FlexionActive comparator 1 intervention
Group B: ALL Fixation at 30 Degrees of Knee FlexionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

graft rerupture rate

Graft rerupture is defined as a failure of the reconstructed anterior cruciate ligament (ACL), diagnosed by clinical evidence of knee instability and confirmed by imaging findings consistent with graft discontinuity or revision surgery.

Time frame
24 months

Secondary outcomes

1

anterior knee laxity

Anterior knee laxity will be assessed as the side-to-side difference (in millimeters) between the operated and contralateral knee using a Rolimeter arthrometer.

Time frame
24 months
2

pivot shift test

Rotational knee stability will be evaluated using the pivot shift test, graded according to standard clinical classification (grade 0 to 3) by an experienced examiner.

Time frame
24 months
3

kinesiophobia

Fear of movement and reinjury will be assessed using the Tampa Scale for Kinesiophobia (TSK-11) questionnaire. range 11-44

Time frame
24 months
4

subjective knee function

Patient-reported knee function will be assessed using the International Knee Documentation Committee (IKDC) subjective knee evaluation form. range 0-100

Time frame
24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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