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. (ACL ALL)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Procedure: anterolateral ligament reconstruction

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacopo Conteduca, MD; Phone Number: 0039 3332280645; Email: conteduca85@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ALL Fixation at 0 Degrees of Knee Flexion; Participants undergoing combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction in which the ALL graft is fixed with the knee in full extension (0 degrees) during surgery.	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; Other Names: acl + all reconstruction
Active Comparator: ALL Fixation at 30 Degrees of Knee Flexion; Participants undergoing combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction in which the ALL graft is fixed with the knee flexed at 30 degrees during surgery.	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; Other Names: acl + all reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months
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.	24 months
kinesiophobia	Fear of movement and reinjury will be assessed using the Tampa Scale for Kinesiophobia (TSK-11) questionnaire. range 11-44	24 months
subjective knee function	Patient-reported knee function will be assessed using the International Knee Documentation Committee (IKDC) subjective knee evaluation form. range 0-100	24 months

Collaborators and Investigators

• Sponsor: ASL Lecce
• Investigators: Study Director: Jacopo Conteduca, MD, ASL Lecce

Publications and helpful links

General Publications

• Kelly SR, Cutter BM, Huish EG Jr. Biomechanical Effects of Combined Anterior Cruciate Ligament Reconstruction and Anterolateral Ligament Reconstruction: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2021 Jun 24;9(6):23259671211009879. doi: 10.1177/23259671211009879. eCollection 2021 Jun.
• Ariel de Lima D, de Lima LL, de Souza NGR, de Moraes Perez RA, Sobrado MF, Guimaraes TM, Helito CP. Clinical outcomes of combined anterior cruciate ligament and anterolateral ligament reconstruction: a systematic review and meta-analysis. Knee Surg Relat Res. 2021 Sep 23;33(1):33. doi: 10.1186/s43019-021-00115-1.

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: acl; anterolateral ligament; all; antepor cruciate ligament
• Additional Relevant MeSH Terms: Wounds and Injuries; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Leg Injuries; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Knee Injuries; Hemic and Lymphatic Diseases; Anterior Cruciate Ligament Injuries; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Enzymes; Enzymes and Coenzymes; Transferases; Acyltransferases; ATP Citrate (pro-S)-Lyase
• Other Study ID Numbers: Jacopo Conteduca

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to ethical and privacy considerations and the absence of a predefined data-sharing plan at the time of study design.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No