Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis

Study Overview
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Brief Summary
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This is a diagnostic, open-label, single-center interventional study. The aim of the study is to evaluate the relationship between medial and lateral meniscus extrusion determined by dynamic ultrasound study and bone edema assessed by MRI study in patients with knee OA. As a secondary objective, the correlation of the above parameters with the patient's symptomatology assessed by subject clinical questionnaires will be evaluated.

Detailed Description
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Patients with a diagnosis of knee OA will be included in a study involving evaluation of the correlation between meniscal extrusion assessed by dynamic ultrasonography and bone edema assessed on MRI. A total of 202 patients will be included, who, after providing their signed informed consent to participate in the study, will undergo dynamic ultrasonography. After giving signed consent to participate in the study, the patient will undergo the following examinations:: ultrasound evaluation for assessment of possible meniscal extrusion; At the same time as the ultrasound examination, subjective questionnaires will be administered to patients.Recent radiological examinations of the patients or from the patient's medical record will be collected during or before the diagnostic investigation.

Official Title
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Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis and Comparison With Magnetic Resonance Imaging Study.

Conditions
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Knee Osteoarthritis, Meniscus Disorder

Intervention / Treatment
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* Diagnostic Test: Ultrasonographic evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 80 years; Signs and symptoms of degenerative pathology of knee cartilage; Patients with Radiographic (X-ray or MRI) signs of OA (K-L grade 0-4); 3. Cooperative patients with pain that does not prevent orthostatism Ability and consent of patients to actively participate in clinical follow-up; Recently performed MRI (maximum 1 month). Exclusion Criteria: Patients unable to express consent; Patients undergoing intra-articular infiltration of other substance in the previous 6 months; Patients undergoing knee surgery in the previous 12 months; Patients with malignant neoplasms; Patients with rheumatic diseases; Patients with a history of total/subtotal meniscectomy; Patients with symptomatology such that a dynamic examination in orthostatism is not possible; 7. Patients abusing alcoholic beverages, drugs or medications; Body Mass Index > 40; Pregnant or lactating women; Patients with axis deviation > 5°.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a diagnostic, open-label, single-center interventional study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasonographic evaluation<br>Ultrasonographic evaluation for assessment of possible meniscal extrusion | Diagnostic Test: Ultrasonographic evaluation<br>* Ultrasonographic evaluation for assessment of possible meniscal extrusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meniscal extrusion | Meniscal extrusion in clinostatism and orthostatism, assessed in millimeters (mm) or percent meniscal extrusion relative to tibial margin, and difference between the two measurements | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC-Subjective Score (Subjective International Knee Documentation Committee) | This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function | baseline | 
| KOOS Score ( Knee Injury and Osteoarthritis Outcome score) | The full questionnaire consists of five subscales and they cover: pain (9 items), symptoms (7 items of which two relate to stiffness), functions and activities of daily living (17 items) physical function, sports activities and leisure (5 items) and quality of life in relation to the knee (4 items). All items in the relevant subscales have the same response mode, use a 5-point Likert scale, and each question is assigned a score from 0 to 4, where 0 indicates no difficulty and 4 a severe difficulty). Score range 0-100 for each subscale | baseline | 
| VAS-dolore (Visual Analogue Scale) | Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to no pain and the strongest pain imaginable. | baseline | 
| Tegner Activity Level Scale | The Tegner Activity Level Scale: allows the estimation of a subject's motor activity level with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as soccer at the national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders. | baseline | 
| EQ-VAS | Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to no pain and the strongest pain imaginable. | baseline | 
| Objective parameters - Circumferences | Bilateral trans- and supra- patellar circumferences measurement for comparative analysis.The measurement will be taken by the orthopedist by meter and will be reported in centimeters | baseline | 
| Objective parameters- Range of Motion | Evaluation of the Range of Motion for comparative analysis. Range of motion (ROM) is a term used to describe how far you can move a joint or muscle in various directions. It is used to measure how much you can move a joint on your own (active ROM) or with the assistance of someone else (passive ROM).Range of motion is measured using a goniometer. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dynamic ultrasonography, Nuclear magnetic resonance imaging, Meniscal extrusion, Osteoarthritis