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

NCT ID: NCT06159153

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-09

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Meniscus Lesion Meniscus Disorder ACL Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dynamic Ultrasonography assessment

Patients admitted for ACL injury and indication for arthroscopy will have dynamic ultrasound evaluation that will be compared with an MRI.

Group Type EXPERIMENTAL

Dynamic Ultrasonography assessment

Intervention Type DIAGNOSTIC_TEST

Ultrasound evaluation that will be compared with an MRI.

Interventions

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Dynamic Ultrasonography assessment

Ultrasound evaluation that will be compared with an MRI.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luca Andriolo, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

Locations

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Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luca Andriolo, MD

Role: CONTACT

6366567 ext. 051

Roberta Licciardi, MSc

Role: CONTACT

6366567 ext. 051

Facility Contacts

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Luca Andriolo, MD

Role: primary

6366567 ext. 051

Roberta Licciardi, MSc

Role: backup

6366567 ext. 051

References

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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.

Reference Type BACKGROUND
PMID: 29730682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24474166 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24240983 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29626617 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23412237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21982460 (View on PubMed)

Other Identifiers

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US- DYNAMIC

Identifier Type: -

Identifier Source: org_study_id

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