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New Topographic Classification of Knee Bone Marrow Lesions (ncbe)

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ClinicalTrials.gov Identifier: NCT03976141
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pietro Randelli, MD, University of Milan

Brief Summary:
the investigator are studying a new topographic classification of bone marrow lesion in the knee and validating it.

Condition or disease Intervention/treatment
Knee Bone Marrow Lesions Diagnostic Test: mri

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Validation of a New Topographic Classification of Bone Marrow Lesions of the Knee
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Group/Cohort Intervention/treatment
a Diagnostic Test: mri
knee mri




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
exam in 2018
Criteria

Inclusion Criteria:

  • age over 18 with mri with lesion consent given

Exclusion Criteria:

  • under mri previous surgery tumors no consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976141


Locations
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Italy
2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO Recruiting
Milano, Milan, Italy, 20122
Contact: Pietro Randelli, MD    00390258296413    pietro.randelli@unimi.it   
Contact: Alessandra Menon, PhD       ale.menon@me.com   
Sponsors and Collaborators
University of Milan

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Responsible Party: Pietro Randelli, MD, Professor, University of Milan
ClinicalTrials.gov Identifier: NCT03976141     History of Changes
Other Study ID Numbers: ncbe
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No