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NCT Number: NCT05574946

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsun University, Samsun, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anterior cruciate ligament reconstruction

Procedure

Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft

Primary outcomes

  1. Signal to Noise Quotient

    Time frame: 1 year

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

Secondary outcomes

  1. Difference in Computed Tomography (CT) imaging of Tunnels

    Time frame: 1 day, 6 months, 1 year

    Femoral and Tibial Tunnel Morphological Changes

  2. International Knee Documentation Committee (IKDC)

    Time frame: 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

    Time frame: 1 year

    Clinical Outcomes

  4. Side to side difference in anterior tibial translation

    Time frame: 6 weeks, 3 months, 6 months, 9 months, 1 year

    Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2022
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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