Knee Bone Marrow LesionsncbeNCT03976141
New Topographic Classification of Knee Bone Marrow Lesions
An observational study of Knee Bone Marrow Lesions, run by University of Milan at 1 site in Italy.
Trial summary
the investigator are studying a new topographic classification of bone marrow lesion in the knee and validating it. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Bone Marrow Lesions
- What is being tested?
- mri
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 14 May 2019to 30 Apr 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: exam in 2018
Who may be able to join
- age over 18 with mri with lesion consent given
Who cannot join
- under mri previous surgery tumors no consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, Milan, 20122
About this study
Official title: Validation of a New Topographic Classification of Bone Marrow Lesions of the Knee
the investigator are studying a new topographic classification of bone marrow lesion in the knee and validating it.
- Conditions
- Knee Bone Marrow Lesions
- Being tested
- mri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mriDiagnostic test
knee mri
| Study group | Role | What they receive |
|---|---|---|
| a | Not described Receives: Diagnostic Test: mri |
What is being measured
The primary outcome is the main question the study is designed to answer.
The researchers will calculate the prevalence of BMLs in knee MRI and calculate the intra-observer and inter-observer reliability of the new classification proposed.
This study proposes a topographic classification for knee BMLs consisting in 5 different types of lesions. the classification proposed will be validated by 3 independent researchers.
Measured: The lesions will be evaluated on knee MRI performed in the period between January 2017 to December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start14 May 2019
- Primary completion30 May 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Bone Marrow LesionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Randelli, MD, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976141
- Sponsor's protocol ID
- ncbe
- Acronym
- ncbe
- Status last verified
- Nov 2020
- First submitted
- 17 May 2019
- Last updated
- 16 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Topographic Classification of Bone Marrow Lesions of the Knee
- ClinicalTrials.gov ID
- NCT03976141
- Acronym / sponsor ID
- ncbe / ncbe
- Conditions
- Knee Bone Marrow Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 5 Jun 2019 (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.
the investigator are studying a new topographic classification of bone marrow lesion in the knee and validating it.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a | – | Diagnostic Test: mri |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- exam in 2018
Key inclusion criteria (1 listed)
- age over 18 with mri with lesion consent given
Key exclusion criteria (1 listed)
- under mri previous surgery tumors no consent
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 |
|---|---|---|
| mriknee mri | Diagnostic test | a |
Primary outcome
The researchers will calculate the prevalence of BMLs in knee MRI and calculate the intra-observer and inter-observer reliability of the new classification proposed.
Time frame: The lesions will be evaluated on knee MRI performed in the period between January 2017 to December 2018
This study proposes a topographic classification for knee BMLs consisting in 5 different types of lesions. the classification proposed will be validated by 3 independent researchers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Bone Marrow Lesions, run by University of Milan 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Nov 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The researchers will calculate the prevalence of BMLs in knee MRI and calculate the intra-observer and inter-observer reliability of the new classification proposed. (time frame: The lesions will be evaluated on knee MRI performed in the period between January 2017 to December 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2020.