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

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Tear
• Interventions: Procedure: Anterior Cruciate Ligament Reconstruction

• Registration Number: NCT05574946
• Lead Sponsor: Samsun University

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.

Study Timeline

• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-12
• Study Start: 2022-10-28
• Primary Completion: 2024-07-01
• Study Completion: 2024-11-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complete tibial tunnel technique	Anterior Cruciate Ligament Reconstruction	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.
All-inside technique	Anterior Cruciate Ligament Reconstruction	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.

Primary Outcome Measures

Name	Time	Method
Signal to Noise Quotient	1 year	Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation

Secondary Outcome Measures

Name	Time	Method
Marx Activity Rating Score	1 year	Clinical Outcomes
Side to side difference in anterior tibial translation	6 weeks, 3 months, 6 months, 9 months, 1 year	Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer
Difference in Computed Tomography (CT) imaging of Tunnels	1 day, 6 months, 1 year	Femoral and Tibial Tunnel Morphological Changes
International Knee Documentation Committee (IKDC)	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)

Trial Locations

Locations (2)

Ahmet E. Okutan; 🇹🇷 Samsun, Turkey

Samsun University; 🇹🇷 Samsun, Turkey