Dynamic Ultrasonography VS MRI in the Evaluation of Meniscal Lesions in Patients With an Indication for Arthroscopy

Not Applicable

Recruiting

• Conditions: ACL Injuries; Meniscus Disorder; Meniscus Lesion

• Registration Number: NCT06159153
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

This is a diagnostic, open-label, single-center interventional study.

This study aims to evaluate the diagnostic accuracy of dynamic ultrasonography for meniscal injuries in patients with an indication for arthroscopy, and to compare it with the study in MRI.

Detailed Description

Patients admitted for ACL injury and indication for arthroscopy will be included in a study involving the evaluation of the diagnostic accuracy of dynamic ultrasound compared with MRI.

A total of 254 patients will be included, who after providing their signed informed consent to participate in the study, will undergo dynamic ultrasound. After giving signed consent to participate in the study, the patient will undergo the ultrasound evaluation for assessment of possible meniscal injury; Radiological examinations in the patient's possession or from the patient's medical record will be collected during or before the diagnostic investigation.

Study Timeline

• Study Start: 2023-11-09
• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

Patients with an indication for knee arthroscopy with:

1. Age between 18 and 60 years;
2. Unilateral involvement;
3. Presence of symptomatology such that dynamic ultrasound examination is precluded;
4. Ability and consent of patients to actively participate in the study;

Exclusion Criteria

1. Patients unable to express consent;
2. Patients with malignant neoplasms;
3. Patients with rheumatic diseases;
4. Patients with diabetes;
5. Patients with metabolic disorders of the thyroid gland;
6. Patients abusing alcoholic beverages, drugs or medications;
7. Body Mass Index > 35;
8. Pregnant or lactating women;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Diagnostic sensitivity of Dynamic Ultrasonography assessment	baseline	Baseline ultrasonography evaluation for assessment of possible meniscal injury. The ultrasound examination will be compared with an MRI using the arthroscopy result as the gold standard.
Diagnostic specificity of Dynamic Ultrasonography assessment	baseline	Baseline ultrasonography evaluation for assessment of possible meniscal injury. The ultrasound examination will be compared with an MRI using the arthroscopy result as the gold standard.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy