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

S

Samsun University

Status

Completed

Conditions

Anterior Cruciate Ligament Tear

Treatments

Procedure: Anterior Cruciate Ligament Reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT05574946
AEOALLACL

Details and patient eligibility

About

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.

Full 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.

Enrollment

71 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

71 participants in 2 patient groups

All-inside technique
Experimental group
Description:
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.
Treatment:
Procedure: Anterior Cruciate Ligament Reconstruction
Complete tibial tunnel technique
Active Comparator group
Description:
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.
Treatment:
Procedure: Anterior Cruciate Ligament Reconstruction

Trial contacts and locations

2

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Central trial contact

Ahmet Emin Okutan, MD

Data sourced from clinicaltrials.gov

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