- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03190200
MRI Findings of Epiphyseal Growth Plate in Healthy Children
August 2, 2023 updated by: University of Minnesota
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.
Study Overview
Detailed 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
Study Type
Observational
Enrollment (Actual)
7
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
-
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Minnesota
-
Minneapolis, Minnesota, United States, 55454
- University of Minnesota
-
-
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
6 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
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
Description
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 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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
MRI
Subjects with healthy knees
|
No intervention - observational trial using MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OCD
Time Frame: 18 months
|
The Development of Osteochondritis Dissecans is the outcome of interest
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2018
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
July 1, 2023
Study Registration Dates
First Submitted
June 14, 2017
First Submitted That Met QC Criteria
June 15, 2017
First Posted (Actual)
June 16, 2017
Study Record Updates
Last Update Posted (Actual)
August 3, 2023
Last Update Submitted That Met QC Criteria
August 2, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORTHOSURG-2017-25849
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on OCD - Osteochondritis Dissecans
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Vericel CorporationRecruitingChondral Defect | Articular Cartilage Disorder of Knee | Articular Cartilage Defect | Osteochondritis Dissecans (OCD)United States
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Boston Children's HospitalThe Hospital for Sick Children; Children's Hospital of Philadelphia; University... and other collaboratorsCompletedJuvenile Osteochondritis DissecansUnited States, Canada
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