Comparing two techniques for ACL reconstruction
A Randomized Controlled Trial to Evaluate the Graft Ligamentization and Integration in the Reconstruction of the Anterior Cruciate Ligament With or Without Detachment of Hamstring Tendon Tibial Insertion
This study is testing two different surgical methods for fixing a torn ACL to see which one helps active people recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 16 Years to 60 Years |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 2 sites (Bologna and 1 other locations) |
| Trial ID | NCT03746470 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare two surgical techniques for reconstructing the anterior cruciate ligament (ACL) using arthroscopy. Participants will be randomly assigned to either a technique that preserves the insertion of the semitendinosus and gracilis tendons or a technique that detaches these tendons from their insertion. The study will evaluate the outcomes of both methods to determine which is more effective for patients with complete ACL tears. The trial is designed for individuals aged 18 to 55 who lead an active lifestyle and have a confirmed ACL injury.
Who should consider this trial
Good fit: Ideal candidates are active individuals aged 18 to 55 with a traumatic ACL injury confirmed by MRI.
Not a fit: Patients with complex meniscal injuries, significant cartilage lesions, or other systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing ACL reconstruction.
How similar studies have performed: Previous studies have shown varying success with different ACL reconstruction techniques, making this approach both relevant and necessary for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 55 * MRI confirmed primary and total ACL injury of traumatic origin * Indication for ACL reconstruction in arthroscopy * Written informed consent * Active and non-sedentary lifestyle Exclusion Criteria: * Complex meniscal injuries * Cartilage lesions of sizes\> 2 cm2 * Other ligamentous lesions * Axis deviations greater than 10° * Rheumatic, neuromuscular or general systemic diseases * Prevention of injured knee traumas treated surgically * Difficulties in compliance in following the rehabilitation programs * Obesity (BMI ≥ 30) * Neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases, immunocompromised patients
Where this trial is running
Bologna and 1 other locations
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
- EOC - Unità Traumatologia e Ortopedia ORL — Lugano, Switzerland (Recruiting)
Study contacts
- Study coordinator: Marco Decogliano, MD
- Email: RicercaOrtopedia.ORL@eoc.ch
- Phone: +41918117029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.