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

NCT ID: NCT05574946

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2024-11-20

Brief Summary

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.

Detailed Description

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.

Conditions

Anterior Cruciate Ligament Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

All-inside technique

Both of the femoral and tibial tunnel will be drilled in a retrograde manner using flip-cutter and femoral and tibial sockets will be created. Graft will be passed from the portal. Adjustable suspensory cortical fixation both on tibial and femoral side will be used.

Group Type: EXPERIMENTAL

Anterior Cruciate Ligament Reconstruction

Intervention Type: PROCEDURE

Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft

Complete tibial tunnel technique

Femoral tunnel will be drilled in an inside-outside manner using standard technique. Then the tibial tunnel will be drilled completely. Graft will be passed from the tibial tunnel. Adjustable suspensory cortical fixation both on the tibial and femoral side will be used.

Group Type: ACTIVE_COMPARATOR

Anterior Cruciate Ligament Reconstruction

Intervention Type: PROCEDURE

Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft

Interventions

Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsun University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Samsun University

Samsun, Samsun, Turkey (Türkiye)

Ahmet E. Okutan

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 34949188 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30364847 (View on PubMed)

Other Identifiers

AEOALLACL

Identifier Type: -

Identifier Source: org_study_id