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Comparison of Standard ACL Reconstruction Versus TARS-Augmented Reconstruction

ConditionAnterior Cruciate Ligament (ACL)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ACL Reconstruction

    Procedure/Surgery

    ACL reconstruction using semitendinosus tendon autograft

  • TARS-Augmented ACL Reconstruction

    Procedure/Surgery

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Standard ACL ReconstructionActive comparator 1 intervention
Group B: TARS-Augmented ACL ReconstructionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Side to side difference in anterior tibial translation (mm)

Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer.

Time frame
Preoperative and 12 months postoperatively

Secondary outcomes

1

International Knee Documentation Committee (IKDC) Score

Patient reported outcome measures of symptoms, sports activity \& knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)

Time frame
12 months
2

Marx Activity Rating Scale

Patient-reported outcome measure of participation in high-demand sports activities, assessing the frequency of running, cutting, decelerating, and pivoting movements. Scores range from 0 to 16, with 0 indicating no participation in these activities and 16 indicating very frequent participation in pivoting and impact activities.

Time frame
12 months
3

Radiological assessment using MRI for graft maturation and integration

Graft maturation was assessed using MRI with T2 mapping sequences, and T2 values were measured at intra-articular graft regions using standardized regions of interest. Graft integration was assessed according to the Ge et al. grading system (Grade 1-3) based on the quality of graft-bone interface integration

Time frame
12 months

Other outcomes

Sponsors and contacts

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Samsun University

Lead sponsor

Source ClinicalTrials.gov
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