Anterior Cruciate Ligament Tear
Conditions
Brief summary
This study intends to perform an all-inside and complete tibial tunnel ACL reconstruction technique in 80 patients, and compare the clinical and radiological outcomes of the two surgical procedures through follow-up.
Detailed description
This is a prospective randomized, controlled, single-center clinical trial study on ACL reconstruction surgery technique. In this study, 80 patients with ACL rupture were recruited according to the enrollment criteria. The recruited patients were randomly divided into groups. The ratio of the control group is 1:1. In this study, 40 patients with ACL rupture in the experimental group will be treated with all-inside reconstruction technique, and 40 patients with ACL rupture in the control group will be treated with complete tibial tunnel technique. All operations will be performed with 4-strand autologous semitendinosus tendon. All fixations will be performed using an adjustable cortical suspensory system. After reconstruction, all subjects will participate in the collection of clinical function scores including Marx Activity score, IKDC score, and clinical evaluation including physical examination, joint laxity, CT and MRI imaging analysis.
Interventions
PROCEDUREAnterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft
Sponsors
Samsun University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have provided informed written written consent; * Patients aged between 18 and 45; * Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL) * Patients undergoing ACL reconstruction with a 8 mm four-strand semitendinosus autograft
Exclusion criteria
* Patients who have not signed informed consent; * Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery * Revision procedures * Patients unable to lay still in an MRI or CT scanner * Patients with a torn ACL or previous ACL reconstruction in the contralateral knee. * Patients who had an excessive tibial slope \>12 degrees
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signal to Noise Quotient | 1 year | Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Computed Tomography (CT) imaging of Tunnels | 1 day, 6 months, 1 year | Femoral and Tibial Tunnel Morphological Changes |
| International Knee Documentation Committee (IKDC) | 1 year | 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 Score | 1 year | Clinical Outcomes |
| Side to side difference in anterior tibial translation | 6 weeks, 3 months, 6 months, 9 months, 1 year | Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer |
Countries
Turkey (Türkiye)
Outcome results
None listed