Clinical and Radiological Evaluation of ACL Reconstruction Results

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injuries

• Registration Number: NCT05504018
• Lead Sponsor: Samsun University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Study Start: 2022-09-02
• Status Verified: 2024-04
• Primary Completion: 2024-04-04
• Study Completion: 2024-04-15
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Magnetic Resonance Imaging (MRI) of Graft	1 year	Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation

Secondary Outcome Measures

Name	Time	Method
Difference in Computed Tomography (CT) imaging of Tunnels	1 day, 6 months, 1 year	Femoral and Tibial Tunnel Morphological Changes
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)
Isokinetic Dynamometer	1 year	Measurement of knee extension and flexion torque using the isokinetic dynamometer
Marx Activity Rating Score	1 year	Clinical Outcomes

Trial Locations

Locations (1)

Ahmet E. Okutan; 🇹🇷 Samsun, Turkey