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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
71
Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft
Samsun University
Samsun, Samsun, Turkey (Türkiye)
Ahmet E. Okutan
Samsun, Turkey (Türkiye)
Signal to Noise Quotient
Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation
Time frame: 1 year
Difference in Computed Tomography (CT) imaging of Tunnels
Femoral and Tibial Tunnel Morphological Changes
Time frame: 1 day, 6 months, 1 year
International Knee Documentation Committee (IKDC)
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: 1 year
Marx Activity Rating Score
Clinical Outcomes
Time frame: 1 year
Side to side difference in anterior tibial translation
Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer
Time frame: 6 weeks, 3 months, 6 months, 9 months, 1 year
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