Clinical and Radiological Evaluation of Anterior Cruciate Ligament Reconstruction Surgery With Follow-up at Least 1 Year
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anterior Cruciate Ligament Injuries
- Sponsor
- Samsun University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Magnetic Resonance Imaging (MRI) of Graft
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Ahmet Emin Okutan
Specialist in Orthopaedics
Samsun University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- Isokinetic Dynamometer(1 year)
- Marx Activity Rating Score(1 year)
- Difference in Computed Tomography (CT) imaging of Tunnels(1 day, 6 months, 1 year)
- International Knee Documentation Committee (IKDC)(1 year)