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

Meniscus Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159153
• Other study ID #: US- DYNAMIC
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2023
• Est. completion date: November 2025

Study information

• Verified date: January 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Luca Andriolo, MD
• Phone: 6366567
• Email: luca.andriolo[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 254
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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;

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Meniscus Disorder
• Meniscus Lesion

Intervention

Diagnostic Test:
• Dynamic Ultrasonography assessment
Ultrasound evaluation that will be compared with an MRI.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Alizadeh A, Babaei Jandaghi A, Keshavarz Zirak A, Karimi A, Mardani-Kivi M, Rajabzadeh A. Knee sonography as a diagnostic test for medial meniscal tears in young patients. Eur J Orthop Surg Traumatol. 2013 Dec;23(8):927-31. doi: 10.1007/s00590-012-1111-z. Epub 2012 Oct 27. — View Citation

Cook JL, Cook CR, Stannard JP, Vaughn G, Wilson N, Roller BL, Stoker AM, Jayabalan P, Hdeib M, Kuroki K. MRI versus ultrasonography to assess meniscal abnormalities in acute knees. J Knee Surg. 2014 Aug;27(4):319-24. doi: 10.1055/s-0034-1367731. Epub 2014 Jan 28. — View Citation

Dong F, Zhang L, Wang S, Dong D, Xu J, Wu H, Liu Y, Li M. The diagnostic accuracy of B-mode ultrasound in detecting meniscal tears: a systematic review and pooled meta-analysis. Med Ultrason. 2018 May 2;20(2):164-169. doi: 10.11152/mu-1252. — View Citation

Schroeder A, Musahl V, Urbanek C, Onishi K. Dynamic Sonographic Visualization of an Occult Posterior Lateral Meniscocapsular Separation: A Case Report. PM R. 2018 Nov;10(11):1288-1291. doi: 10.1016/j.pmrj.2018.03.017. Epub 2018 Apr 5. — View Citation

Sharifah MI, Lee CL, Suraya A, Johan A, Syed AF, Tan SP. Accuracy of MRI in the diagnosis of meniscal tears in patients with chronic ACL tears. Knee Surg Sports Traumatol Arthrosc. 2015 Mar;23(3):826-30. doi: 10.1007/s00167-013-2766-7. Epub 2013 Nov 17. — View Citation

Wareluk P, Szopinski KT. Value of modern sonography in the assessment of meniscal lesions. Eur J Radiol. 2012 Sep;81(9):2366-9. doi: 10.1016/j.ejrad.2011.09.013. Epub 2011 Oct 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic sensitivity of Dynamic Ultrasonography assessment	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
Primary	Diagnostic specificity of Dynamic Ultrasonography assessment	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