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

Anterior Cruciate Ligament Tear Clinical Trial

Official title:

Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique Using Adjustable Suspensory Fixation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574946
• Other study ID #: AEOALLACL
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear

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