Anterior Cruciate Ligament (ACL)
Conditions
Keywords
anterior cruciate ligament, suture tape augmentation, t2 mapping
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.
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.
Interventions
PROCEDUREACL Reconstruction
ACL reconstruction using semitendinosus tendon autograft
PROCEDURETARS-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.
Sponsors
Samsun University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participant- and assessor-blinded trial
Intervention model description
Prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Side to side difference in anterior tibial translation (mm) | Preoperative and 12 months postoperatively | Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC) Score | 12 months | 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) |
| Marx Activity Rating Scale | 12 months | 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. |
| Radiological assessment using MRI for graft maturation and integration | 12 months | 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed