About this trial
This study is designed to compare standard anterior cruciate ligament (ACL) reconstruction using hamstring autograft with ACL reconstruction augmented using the Tape Active Reconstruction System (TARS). Eligible patients aged 18 to 44 years with a complete ACL rupture will be prospectively enrolled and randomized in a 1:1 ratio into two study groups. Participants will be evaluated preoperatively and postoperatively at regular follow-up visits, with the final assessment performed at 12 months after surgery. Outcome assessments will include patient-reported outcome measures, objective clinical examination of knee stability, instrumented laxity measurements, and radiological evaluation.
Eligibility criteria
Qualifiers
Age between 18 and 44 years
Diagnosis of complete ACL rupture confirmed by clinical examination and imaging
Planned primary single-bundle anatomic ACL reconstruction using hamstring autograft
Intact contralateral knee
Disqualifiers
Cartilage lesions grade 2 or higher according to the Outerbridge classification
Combined ligament injuries or inflammatory arthritis
Tibial slope greater than 12 degrees
Advanced knee laxity
Trial design
Treatments tested in this trial
- ACL Reconstruction
- TARS-Augmented ACL Reconstruction