Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
NCT07418476

Comparison of Standard ACL Reconstruction Versus TARS-Augmented Reconstruction

Led by Samsun University · Updated on 2026-03-03

80

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comparison of Standard ACL Reconstruction Versus TARS-Augmented Reconstruction

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 44 years
  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Samsun University

Samsun, Samsun, Turkey (Türkiye)

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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