Comparison of Standard ACL Reconstruction Versus TARS-Augmented Reconstruction
Comparison of Standard Anterior Cruciate Ligament Reconstruction and Tape Active Reconstruction System (TARS)-Augmented Reconstruction: A Prospective Randomized Controlled Study
Samsun University
80 participants
Feb 28, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria5
- 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
- Provision of written informed consent
Exclusion Criteria7
- 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
- Revision ACL reconstruction
- Requirement for additional surgical procedures during the same operation
- Inability to comply with follow-up protocol
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
ACL reconstruction using semitendinosus tendon autograft
Arthroscopic single-bundle ACL reconstruction using a quadrupled semitendinosus tendon autograft was performed with additional Tape Active Reconstruction System (TARS) augmentation. High-strength suture tape was applied to provide load sharing during early rehabilitation. The postoperative rehabilitation protocol was identical to the control group.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07418476