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

Sponsor
Samsun University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05574946
Collaborator
(none)
60
Enrollment
2
Locations
2
Arms
23.1
Anticipated Duration (Months)
30
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Anterior Cruciate Ligament Reconstruction
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique Using Adjustable Suspensory Fixation
Actual Study Start Date :
Oct 28, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Signal to Noise Quotient [1 year]

    Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation

Secondary Outcome Measures

  1. Difference in Computed Tomography (CT) imaging of Tunnels [1 day, 6 months, 1 year]

    Femoral and Tibial Tunnel Morphological Changes

  2. 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)

  3. Marx Activity Rating Score [1 year]

    Clinical Outcomes

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ahmet E. Okutan Samsun Turkey
2 Samsun University Samsun Turkey

Sponsors and Collaborators

  • Samsun University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmet Emin Okutan, Specialist in Orthopaedics, Samsun University
ClinicalTrials.gov Identifier:
NCT05574946
Other Study ID Numbers:
  • AEOALLACL
First Posted:
Oct 12, 2022
Last Update Posted:
Oct 31, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Oct 31, 2022