An interventional study of ACL Reconstruction and TARS-Augmented ACL Reconstruction in Anterior Cruciate Ligament (ACL), sponsored by Samsun University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Samsun University · Not applicable, Interventional, and Treatment
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.
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.
Samsun University is the lead sponsor of 81 studies on the registry; 21 are open to participants now.
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Exclusion Criteria
Patients will undergo single-bundle anatomic ACL reconstruction using a quadrupled hamstring (semitendinosus) autograft. Femoral and tibial fixation will be performed using adjustable cortical suspension devices according to standard surgical techniques.
Procedure: ACL Reconstruction
Patients will undergo the same standard ACL reconstruction procedure with augmentation using the Tape Active Reconstruction System (TARS). Within the TARS technique, high-strength suture tape is applied to provide load sharing and graft protection during the early rehabilitation period.
Procedure: TARS-Augmented ACL Reconstruction
ACL reconstruction using semitendinosus tendon autograft
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.
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
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
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
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
Plan to share: No
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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