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

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament (ACL)
• Intervention / Treatment: Procedure: ACL Reconstruction; Procedure: TARS-Augmented ACL Reconstruction

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Samsun
    • Samsun, Samsun, Turkey (Türkiye)
      • Recruiting
      • Samsun University
      • Contact: Burak T. Unek, MD.; Phone Number: +90 553 206 84 88; Email: tayfununek@icloud.com
      • Principal Investigator: Ahmet E. Okutan, Assoc.Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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
• Provision of written informed consent

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard ACL Reconstruction; 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; ACL reconstruction using semitendinosus tendon autograft
Experimental: TARS-Augmented 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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	12 months

Collaborators and Investigators

• Sponsor: Samsun University

Publications and helpful links

General Publications

• Smith PA, Daniel AV, Stensby JD, Cook CS, Wijdicks CA. Quadriceps Tendon Autograft ACL Reconstruction With Suture Tape Augmentation: Safe Results Based on Minimum 2-Year Follow-up MRI. Orthop J Sports Med. 2024 Apr 11;12(4):23259671241239275. doi: 10.1177/23259671241239275. eCollection 2024 Apr.
• Kitchen BT, Mitchell BC, Cognetti DJ, Siow MY, Howard R, Carroll AN, Bastrom TP, Edmonds EW. Outcomes After Hamstring ACL Reconstruction With Suture Tape Reinforcement in Adolescent Athletes. Orthop J Sports Med. 2022 Apr 8;10(4):23259671221085577. doi: 10.1177/23259671221085577. eCollection 2022 Apr.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: anterior cruciate ligament; suture tape augmentation; t2 mapping
• Other Study ID Numbers: OMUKAEK 2025/436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No