Clinical and Radiological Evaluation of ACL Reconstruction Results

April 15, 2024 updated by: Ahmet Emin Okutan, Samsun University

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

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.

Study Overview

Status

Completed

Conditions

Anterior Cruciate Ligament Injuries

Intervention / Treatment

Procedure: ACL reconstruction

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- - Samsun, Turkey
    - Ahmet E. Okutan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

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)

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic Resonance Imaging (MRI) of Graft Time Frame: 1 year	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
Difference in Computed Tomography (CT) imaging of Tunnels Time Frame: 1 day, 6 months, 1 year	Femoral and Tibial Tunnel Morphological Changes	1 day, 6 months, 1 year
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)	1 year
Marx Activity Rating Score Time Frame: 1 year	Clinical Outcomes	1 year
Isokinetic Dynamometer Time Frame: 1 year	Measurement of knee extension and flexion torque using the isokinetic dynamometer	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun University

Investigators

Principal Investigator: Ahmet Emin Okutan, MD, Samsun University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Putnis SE, Klasan A, Oshima T, Grasso S, Neri T, Coolican MRJ, Fritsch BA, Parker DA. Magnetic Resonance Imaging Assessment of Hamstring Graft Healing and Integration 1 and Minimum 2 Years after ACL Reconstruction. Am J Sports Med. 2022 Jul;50(8):2102-2110. doi: 10.1177/03635465221096672. Epub 2022 May 25.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2022

Primary Completion (Actual)

April 4, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria