Comparison of Standard ACL Reconstruction Versus TARS-Augmented Reconstruction

Condition(s) studied

Investigational drug(s) / intervention(s)

ACL Reconstruction: ACL reconstruction using semitendinosus tendon autograft

TARS-Augmented ACL Reconstruction: 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.

Study 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

Primary outcome measure(s)

• Side to side difference in anterior tibial translation (mm) — Preoperative and 12 months postoperatively
  Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer.

Trial sites (1)

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