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NCT Number: 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.

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.

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Key information

Conditions

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Knee Injuries Leg Injuries Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Wounds and Injuries

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • History of neurological, vestibular, or visual disorders affecting balance or gait
  • Inflammatory joint disease or systemic musculoskeletal disorders
  • Incomplete baseline clinical data
  • Inability to complete patient-reported outcome questionnaires or attend follow-up visits

Treatment and study plan

anterolateral ligament reconstruction

Procedure

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

Other names: acl + all reconstruction

Primary outcomes

  1. graft rerupture rate

    Time frame: 24 months

    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.

Secondary outcomes

  1. anterior knee laxity

    Time frame: 24 months

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

  2. pivot shift test

    Time frame: 24 months

    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.

  3. kinesiophobia

    Time frame: 24 months

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

  4. subjective knee function

    Time frame: 24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jacopo Conteduca, MD

CONTACT

[email protected]

0039 3332280645

Sponsors and collaborators

Lead sponsor

ASL Lecce

Other Gov

Registry information

Official study title

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

Acronym: ACL ALL

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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