Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique

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Description

This study intends to perform an all-inside and complete tibial tunnel ACL reconstruction technique in 60 patients, and compare the clinical and radiological outcomes of the two surgical procedures through follow-up.

Study Overview

Start Date
October 28, 2022
Completion Date
October 1, 2024
Enrollment
60
Date Posted
October 12, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Ahmet E. Okutan
Samsun, Turkey

Samsun University
Samsun, Turkey

Eligibility

Minimum Age (years)
18
Maximum Age (years)
45
Eligibility Criteria
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

Study Contact Info

Study Contact Name
Ahmet Emin Okutan, MD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
This is a prospective randomized, controlled, single-center clinical trial study on ACL reconstruction surgery technique. In this study, 60 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, 30 patients with ACL rupture in the experimental group will be treated with all-inside reconstruction technique, and 30 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.
NCTid (if applicable)
NCT05574946