NCT07418476

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Samsun University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Anterior cruciate ligament reconstruction is one of the most commonly performed procedures in sports orthopaedic surgery. Although standard hamstring autograft reconstruction provides good clinical outcomes, residual anterior knee laxity and graft failure remain concerns, particularly in young and active patients. Augmentation using the Tape Active Reconstruction System (TARS) has been introduced as an adjunct technique intended to share load with the graft during the early healing phase and potentially improve postoperative stability. The aim of this study is to evaluate whether ACL reconstruction augmented using TARS results in superior clinical, functional, and radiological outcomes compared with standard ACL reconstruction alone. The study will prospectively collect demographic, clinical, functional, and imaging data and analyze the relationship between surgical technique and postoperative outcomes. Patients will be evaluated preoperatively and at 12 months postoperatively. Assessments will include objective knee stability testing using the KT-1000 arthrometer, clinical examination (Lachman and pivot shift tests), functional outcome scores, and radiological evaluation. Magnetic resonance imaging (MRI), including T2 mapping sequences, will be performed at 1 year to evaluate graft maturation, and integration.

Conditions

• Anterior Cruciate Ligament (ACL)

Interventions

Type	Name	Description
PROCEDURE	ACL Reconstruction	ACL reconstruction using semitendinosus tendon autograft
PROCEDURE	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.

Timeline

• Start date: 2026-02-28
• Primary completion: 2026-07-30
• Completion: 2027-07-30
• First posted: 2026-02-18
• Last updated: 2026-03-03

Locations

1 site across 1 country: Turkey (Türkiye)