Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Meniscus Disorder; Knee Osteoarthritis

Treatments: Diagnostic Test: Ultrasonographic evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT06113536

US-MEN

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 202 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 and 80 years;
2. Signs and symptoms of degenerative pathology of knee cartilage;
3. Patients with Radiographic (X-ray or MRI) signs of OA (K-L grade 0-4); 3.
4. Cooperative patients with pain that does not prevent orthostatism
5. Ability and consent of patients to actively participate in clinical follow-up;
6. Recently performed MRI (maximum 1 month).

Exclusion criteria

1. Patients unable to express consent;
2. Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
3. Patients undergoing knee surgery in the previous 12 months;
4. Patients with malignant neoplasms;
5. Patients with rheumatic diseases;
6. Patients with a history of total/subtotal meniscectomy;
7. Patients with symptomatology such that a dynamic examination in orthostatism is not possible; 7.
8. Patients abusing alcoholic beverages, drugs or medications;
9. Body Mass Index > 40;
10. Pregnant or lactating women;
11. Patients with axis deviation > 5°.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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202 participants in 1 patient group

Ultrasonographic evaluation

Experimental group

Description:

Ultrasonographic evaluation for assessment of possible meniscal extrusion

Treatment:

Diagnostic Test: Ultrasonographic evaluation