Anterior Cruciate Ligament Rupture
Conditions
Keywords
acl, all, antepor cruciate ligament, anterolateral ligament
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.
Interventions
PROCEDUREanterolateral 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
Sponsors
ASL Lecce
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| graft rerupture rate | 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
| Measure | Time frame | Description |
|---|---|---|
| anterior knee laxity | 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. |
| pivot shift test | 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. |
| kinesiophobia | 24 months | Fear of movement and reinjury will be assessed using the Tampa Scale for Kinesiophobia (TSK-11) questionnaire. range 11-44 |
| subjective knee function | 24 months | Patient-reported knee function will be assessed using the International Knee Documentation Committee (IKDC) subjective knee evaluation form. range 0-100 |
Contacts
CONTACTJacopo Conteduca, MD
STUDY_DIRECTORJacopo Conteduca, MD
ASL Lecce
Outcome results
None listed