NCT03976141

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 14, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2019

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

16 days

First QC Date

May 17, 2019

Last Update Submit

November 13, 2020

Conditions

Knee Bone Marrow Lesions

Outcome Measures

Primary Outcomes (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.

    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

Study Arms (1)

a

Diagnostic Test: mri

Interventions

mriDIAGNOSTIC_TEST

knee mri

a

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

exam in 2018

You may qualify if:

  • age over 18 with mri with lesion consent given

You may not qualify if:

  • under mri previous surgery tumors no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Milan, Milan, 20122, Italy

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2019

First Posted

June 5, 2019

Study Start

May 14, 2019

Primary Completion

May 30, 2019

Study Completion

April 30, 2020

Last Updated

November 16, 2020

Record last verified: 2020-11

Locations

IT(1)