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
1 other identifier
interventional
100
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2026
CompletedFirst Posted
Study publicly available on registry
March 5, 2026
CompletedStudy Start
First participant enrolled
March 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
March 5, 2026
March 1, 2026
2.8 years
January 28, 2026
March 2, 2026
Conditions
Keywords
Outcome Measures
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.
24 months
Secondary Outcomes (4)
anterior knee laxity
24 months
pivot shift test
24 months
kinesiophobia
24 months
subjective knee function
24 months
Study Arms (2)
ALL Fixation at 0 Degrees of Knee Flexion
ACTIVE COMPARATORParticipants 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.
ALL Fixation at 30 Degrees of Knee Flexion
ACTIVE COMPARATORParticipants 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ASL Leccelead
Related Publications (2)
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.
PMID: 34250171BACKGROUNDAriel 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.
PMID: 34556187BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jacopo Conteduca, MD
ASL Lecce
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 28, 2026
First Posted
March 5, 2026
Study Start
March 30, 2026
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
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.