MRI Findings of Epiphyseal Growth Plate in Healthy Children | NCT03190200

Studies
MRI Findings of Epiphyseal Growth Plate in Healthy Children

NCT03190200

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Aug 3, 2023Actual

Enrollment

7Actual

Phase

Not provided

Conditions

OCD - Osteochondritis Dissecans

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Jul 1, 2023Actual

First Submitted Date

Jun 14, 2017

First Submission Date that Met QC Criteria

Jun 15, 2017

First Posted Date

Jun 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2023

Last Update Posted Date

Aug 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRI		Subjects with healthy knees	Device: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Device	No intervention - observational trial using MRI	MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OCD	The Development of Osteochondritis Dissecans is the outcome of interest	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

10 Years

Standard Ages

Child

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55454	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010008	Osteochondritis Dissecans

Ancestor Terms

ID	Term
D010007	Osteochondritis
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided