Comparison of Standard ACL Reconstruction Versus TARS-Augmented Reconstruction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorSamsun University

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

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators