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

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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Tear
• Intervention / Treatment: Procedure: Anterior Cruciate Ligament Reconstruction

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 Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Samsun, Turkey
    • Samsun University
  • Samsun, Turkey
    • Ahmet E. Okutan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Anterior Cruciate Ligament Reconstruction; Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft
Active Comparator: 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.	Procedure: Anterior Cruciate Ligament Reconstruction; Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signal to Noise Quotient	Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Difference in Computed Tomography (CT) imaging of Tunnels	Femoral and Tibial Tunnel Morphological Changes	1 day, 6 months, 1 year
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
Marx Activity Rating Score	Clinical Outcomes	1 year

Collaborators and Investigators

• Sponsor: Samsun University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): November 20, 2024

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: AEOALLACL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No