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

February 13, 2026 updated by: Istituto Ortopedico Rizzoli

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dynamic Ultrasonography assessment
Patients admitted for ACL injury and indication for arthroscopy will have dynamic ultrasound evaluation that will be compared with an MRI.
Ultrasound evaluation that will be compared with an MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic sensitivity of Dynamic Ultrasonography assessment
Time Frame: 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.
baseline
Diagnostic specificity of Dynamic Ultrasonography assessment
Time Frame: 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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Luca Andriolo, MD, Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2023

Primary Completion (Actual)

December 19, 2025

Study Completion (Actual)

December 19, 2025

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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