Clinical and Radiological Evaluation of ACL Reconstruction Results

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Procedure: ACL reconstruction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ACL reconstruction|Anterior cruciate ligament reconstruction surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic Resonance Imaging (MRI) of Graft | 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 | Femoral and Tibial Tunnel Morphological Changes | 1 day, 6 months, 1 year | 
| International Knee Documentation Committee (IKDC) | 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 | Clinical Outcomes | 1 year | 
| Isokinetic Dynamometer | Measurement of knee extension and flexion torque using the isokinetic dynamometer | 1 year |