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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03190200
Other study ID # ORTHOSURG-2017-25849
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date July 1, 2023

Study information

Verified date August 2023
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to determine if by using MRI changes can be identified changes early on in the knees of young children that may be at risk for developing osteochondritis dissecans. If MRI can identify changes then better council can be offered about the risks of future activity and treatment options.


Description:

Each subject will be asked to undergo an MRI at enrollment, six,12, and 18 months. Subjects will be monitored for evidence of osteochondritis dissecans in order to determine if we can identify it and then create a treatment program to allow these children to avoid developing definitive disease


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date July 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria: 6-10-year-old children with a sibling with known OCD and 6-10-year-old children with a known OCD in the contralateral knee Exclusion Criteria: Unable to undergo an MRI

Study Design


Intervention

Device:
MRI
No intervention - observational trial using MRI

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary OCD The Development of Osteochondritis Dissecans is the outcome of interest 18 months