NCT07418476

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Feb 2026Jul 2027

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

February 28, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 11, 2026

Last Update Submit

February 28, 2026

Conditions

Anterior Cruciate Ligament (ACL)

Keywords

anterior cruciate ligamentsuture tape augmentationt2 mapping

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • International Knee Documentation Committee (IKDC) Score

    12 months

  • Marx Activity Rating Scale

    12 months

  • Radiological assessment using MRI for graft maturation and integration

    12 months

Study Arms (2)

Standard ACL Reconstruction

ACTIVE COMPARATOR

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

TARS-Augmented ACL Reconstruction

EXPERIMENTAL

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

Interventions

ACL ReconstructionPROCEDURE

ACL reconstruction using semitendinosus tendon autograft

Standard ACL Reconstruction
TARS-Augmented ACL ReconstructionPROCEDURE

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.

TARS-Augmented ACL Reconstruction

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, Samsun, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 38617885BACKGROUND

  • 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.

    PMID: 35425845BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participant- and assessor-blinded trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

February 28, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2027

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)