NCT07418476 Comparison of Standard ACL Reconstruction Versus TARS-Augmented Reconstruction
| NCT ID | NCT07418476 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsun University |
| Condition | Anterior Cruciate Ligament (ACL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-02-28 |
| Primary Completion | 2026-07-30 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion Criteria * 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 Criteria * 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