- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06159153
Dynamic Ultrasonography VS MRI in the Evaluation of Meniscal Lesions in Patients With an Indication for Arthroscopy
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bologna, Italy, 40136
- Istituto Ortopedico Rizzoli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients with an indication for knee arthroscopy with:
- Age between 18 and 60 years;
- Unilateral involvement;
- Presence of symptomatology such that dynamic ultrasound examination is precluded;
- Ability and consent of patients to actively participate in the study;
Exclusion Criteria:
- Patients unable to express consent;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients with diabetes;
- Patients with metabolic disorders of the thyroid gland;
- Patients abusing alcoholic beverages, drugs or medications;
- Body Mass Index > 35;
- Pregnant or lactating women;
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Luca Andriolo, MD, Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- US- DYNAMIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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