Hamstring ACL reconstruction with or without TARS tape augmentation
Comparison of Standard Anterior Cruciate Ligament Reconstruction and Tape Active Reconstruction System (TARS)-Augmented Reconstruction: A Prospective Randomized Controlled Study
This trial will try whether adding the Tape Active Reconstruction System (TARS) to hamstring ACL reconstruction improves knee stability and graft maturation in adults aged 18–44 with a complete ACL tear.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Samsun University Academic / other |
| Locations | 1 site (Samsun, Samsun) |
| Trial ID | NCT07418476 on ClinicalTrials.gov |
What this trial studies
Adults with a complete ACL rupture are randomized 1:1 to standard single-bundle hamstring autograft reconstruction or the same reconstruction augmented with the Tape Active Reconstruction System (TARS). Participants are evaluated before surgery and followed at regular intervals with a final assessment at 12 months. Outcomes include patient-reported function, clinical knee stability tests (Lachman, pivot shift), instrumented laxity measurements with a KT-1000, and MRI including T2 mapping to assess graft maturation. The study prospectively collects clinical, functional, and imaging data to compare the two surgical approaches.
Who should consider this trial
Good fit: Adults aged 18 to 44 with a confirmed complete ACL rupture, an intact contralateral knee, and a plan for primary single-bundle hamstring autograft reconstruction are the intended participants.
Not a fit: Patients with cartilage lesions grade 2 or higher, combined ligament injuries, revision ACL reconstruction, tibial slope >12°, need for additional procedures, or inability to adhere to follow-up are excluded and unlikely to benefit from these results.
Why it matters
Potential benefit: If successful, TARS augmentation could reduce early graft laxity and failure and improve graft maturation, resulting in better functional stability for active patients.
How similar studies have performed: Small observational and biomechanical studies of suture-tape augmentation have suggested improved early stability, but high-quality randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Samsun, Samsun
- Samsun University — Samsun, Samsun, Turkey (Türkiye) (Recruiting)
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.