Meniscus LesionNCT06159153
Dynamic Ultrasonography VS MRI in the Evaluation of Meniscal Lesions in Patients With an Indication for Arthroscopy
A study testing Dynamic Ultrasonography assessment in people with Meniscus Lesion and Meniscus Disorder, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Meniscus Lesion, Meniscus Disorder, ACL Injuries
- What is being tested?
- Dynamic Ultrasonography assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 9 Nov 2023to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Meniscus Lesion, Meniscus Disorder, ACL Injuries
- Being tested
- Dynamic Ultrasonography assessment
- Keywords
- dynamic ultrasonography, arthroscopy, MRI, Interventional trial
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Ultrasonography assessmentDiagnostic test
Ultrasound evaluation that will be compared with an MRI.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Dynamic Ultrasonography assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start9 Nov 2023
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Why it stopped: Organizational difficulties due to the interventions under study now being carried out outside the experimental center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Meniscus LesionStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Andriolo, MD, Principal investigator, Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159153
- Sponsor's protocol ID
- US- DYNAMIC
- Status last verified
- Feb 2026
- First submitted
- 28 Nov 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29730682Cook 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.
PubMed 24474166Sharifah 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.
PubMed 24240983Schroeder 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.
PubMed 29626617Alizadeh 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.
PubMed 23412237Wareluk 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.
PubMed 21982460
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Ultrasonography VS MRI in the Evaluation of Meniscal Lesions in Patients With an Indication for Arthroscopy
- ClinicalTrials.gov ID
- NCT06159153
- Acronym / sponsor ID
- US- DYNAMIC
- Conditions
- Meniscus Lesion, Meniscus Disorder, ACL Injuries
- Keywords
- dynamic ultrasonography, arthroscopy, MRI, Interventional trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Organizational difficulties due to the interventions under study now being carried out outside the experimental center
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Dynamic Ultrasonography assessment | Experimental | Diagnostic Test: Dynamic Ultrasonography assessmentPatients admitted for ACL injury and indication for arthroscopy will have dynamic ultrasound evaluation that will be compared with an MRI. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (8 listed)
- Patients unable to express consent;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients with diabetes;
- Patients with metabolic disorders of the thyroid gland;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Ultrasonography assessmentUltrasound evaluation that will be compared with an MRI. | Diagnostic test | Dynamic Ultrasonography assessment |
Primary outcome
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.
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.
Results and safety
The study was stopped early (reason given: Organizational difficulties due to the interventions under study now being carried out outside the experimental center). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 29730682Dong 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.
- Background: PubMed 24474166Cook 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.
- Background: PubMed 24240983Sharifah 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.
- Background: PubMed 29626617Schroeder 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.
- Background: PubMed 23412237Alizadeh 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.
- Background: PubMed 21982460Wareluk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Andriolo, MD principal investigator
Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Ultrasonography assessment in people with Meniscus Lesion and Meniscus Disorder, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Organizational difficulties due to the interventions under study now being carried out outside the experimental center). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity of Dynamic Ultrasonography assessment (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06159153, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.