NCT06159153

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2025

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

November 28, 2023

Last Update Submit

February 13, 2026

Conditions

Meniscus LesionACL InjuriesMeniscus Disorder

Keywords

dynamic ultrasonographyarthroscopyMRIInterventional trial

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Dynamic Ultrasonography assessment

EXPERIMENTAL

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

Diagnostic Test: Dynamic Ultrasonography assessment

Interventions

Dynamic Ultrasonography assessmentDIAGNOSTIC_TEST

Ultrasound evaluation that will be compared with an MRI.

Dynamic Ultrasonography assessment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (6)

  • 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.

    PMID: 29730682BACKGROUND

  • 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.

    PMID: 24474166BACKGROUND

  • 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.

    PMID: 24240983BACKGROUND

  • 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.

    PMID: 29626617BACKGROUND

  • 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.

    PMID: 23412237BACKGROUND

  • 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.

    PMID: 21982460BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Luca Andriolo, MD

    Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 6, 2023

Study Start

November 9, 2023

Primary Completion

December 19, 2025

Study Completion

December 19, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)