NCT07451743Not yet recruiting
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.
Are Clinical Outcomes Unchanged by ALL Fixation at 0° or 30° of Knee Flexion in Combined ACL-ALL Reconstruction?
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 Jan 2026
- Start date
- 30 Mar 2026
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- ASL Lecce
- NCT number
- NCT07451743
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 30 Mar 2026 to the primary completion date, 1 Jan 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ACL reconstruction or revision surgery on the affected knee
- Concomitant knee osteoarthritis greater than Kellgren-Lawrence grade 1
- Concomitant ligament injuries requiring additional surgical procedures (except meniscal treatment)
Other illness
- History of neurological, vestibular, or visual disorders affecting balance or gait
- Inflammatory joint disease or systemic musculoskeletal disorders
Other
- Bilateral ACL injuries
- Incomplete baseline clinical data
- Inability to complete patient-reported outcome questionnaires or attend follow-up visits
Who the study is looking for
- 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
Age in the registry: 16 years to 45 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.