New Topographic Classification of Knee Bone Marrow Lesions (ncbe)

November 13, 2020 updated by: Pietro Randelli, MD, University of Milan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Milano, Milan, Italy, 20122
        • 2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

exam in 2018

Description

Inclusion Criteria:

  • age over 18 with mri with lesion consent given

Exclusion Criteria:

  • under mri previous surgery tumors no consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
a
Diagnostic test: mri
knee mri

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The lesions will be evaluated on knee MRI performed in the period between January 2017 to December 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2019

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 13, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ncbe

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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