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Completed

NCT Number: NCT05504018

Clinical and Radiological Evaluation of ACL Reconstruction Results

The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1 years after the intervention through a clinical visit. Such assessments will include the patient reported outcomes, the objective examination of the knee during a medical examination to quantify its stability and the radiological examination.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmet E. Okutan

Samsun, Turkey (Türkiye)

About this study

The literature presents a number of studies on the reconstruction of the anterior cruciate ligament, as well as numerous registers, but the identification of factors and parameters determining the outcomes remains largely debated. The study aims to analyze the potentially individual and operative parameters and identify the factors responsible for the clinical and radiological outcomes. In addition to collecting patient data in terms of features and clinical-radiological status, objective data will be documented and correlated.

The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). These patients will be followed and evaluated preoperatively, at 6 months and at 1 years after surgery during a clinical visit. Such assessments will include the patient reported outcomes, the objective examination of the knee during a medical examination to quantify its stability and the radiological examination.

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)

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.

Treatment and study plan

ACL reconstruction

Procedure

Anterior cruciate ligament reconstruction surgery

Primary outcomes

  1. Magnetic Resonance Imaging (MRI) of Graft

    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. Isokinetic Dynamometer

    Time frame: 1 year

    Measurement of knee extension and flexion torque using the isokinetic dynamometer

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

Clinical and Radiological Evaluation of Anterior Cruciate Ligament Reconstruction Surgery With Follow-up at Least 1 Year

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2022
Registry last updated
Apr 16, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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