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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05574946
Other study ID # AEOALLACL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 28, 2022
Est. completion date October 1, 2024

Study information

Verified date February 2024
Source Samsun University
Contact Ahmet Emin Okutan, MD
Phone +905375757657
Email ahmeteokutan@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft

Locations

Country Name City State
Turkey Ahmet E. Okutan Samsun
Turkey Samsun University Samsun

Sponsors (1)

Lead Sponsor Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Bhimani R, Shahriarirad R, Ranjbar K, Erfani A, Ashkani-Esfahani S. Transportal versus all-inside techniques of anterior cruciate ligament reconstruction: a systematic review. J Orthop Surg Res. 2021 Dec 23;16(1):734. doi: 10.1186/s13018-021-02872-x. — View Citation

Colombet P, Saffarini M, Bouguennec N. Clinical and Functional Outcomes of Anterior Cruciate Ligament Reconstruction at a Minimum of 2 Years Using Adjustable Suspensory Fixation in Both the Femur and Tibia: A Prospective Study. Orthop J Sports Med. 2018 Oct 22;6(10):2325967118804128. doi: 10.1177/2325967118804128. eCollection 2018 Oct. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Signal to Noise Quotient Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation 1 year
Secondary Difference in Computed Tomography (CT) imaging of Tunnels Femoral and Tibial Tunnel Morphological Changes 1 day, 6 months, 1 year
Secondary 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) 1 year
Secondary Marx Activity Rating Score Clinical Outcomes 1 year
Secondary Side to side difference in anterior tibial translation Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer 6 weeks, 3 months, 6 months, 9 months, 1 year
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