anterior cruciate ligament reconstruction
ProcedureAnterior Cruciate Ligament Reconstruction with four strand semitendinosus graft
NCT Number: NCT05574946
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.
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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Samsun University, Samsun, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft
Time frame: 1 year
Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation
Time frame: 1 day, 6 months, 1 year
Femoral and Tibial Tunnel Morphological Changes
Time frame: 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)
Time frame: 1 year
Clinical Outcomes
Time frame: 6 weeks, 3 months, 6 months, 9 months, 1 year
Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer
Samsun University
Other
Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique Using Adjustable Suspensory Fixation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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