Diffusion MRI and Growth Plate Injuries: Pilot Study

June 10, 2016 updated by: University of British Columbia

Diffusion MRI as a Prognostic Tool in Growth Plate Injuries: A Pilot Study to Assess Feasibility

Children who suffer fractures to the growth plates (physes) of their bones are at risk for premature growth arrest which can lead to long term complications. There is currently no technique to predict who is at risk of growth arrest following a physeal injury. The investigators aim to determine if diffusion MRI (an imaging method to analyze tissue properties) can effectively pick up differences between a healthy growth plate and an injured one. This would allow orthopaedics surgeons to predict which injuries are at a higher risk of growth arrest, so earlier interventions can be done in the orthopaedic clinic.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine if diffusion MRI can be used for tissue characterization in childhood and adolescent growth plate injuries, and to get a better understanding of the physiologic disturbance of an injured physis

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

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

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Recruiting
        • British Columbia Children's Hospital
        • Contact:
        • Principal Investigator:
          • Firoz Miyanji, MD, FRCSC
        • Sub-Investigator:
          • Kishore Mulpuri, MBBS, MS, MHSc
        • Sub-Investigator:
          • Chris Reilly, MD, FRCSC
        • Sub-Investigator:
          • Ken Poskitt, MDCM

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

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study subjects will be selected from the Orthopaedic Trauma Clinic at BC Children's Hospital

Description

Inclusion Criteria:

  • Salter-Harris Type II, III, or IV fracture through the distal radius
  • Growth plates are open
  • Ages 8-12
  • Able to consent in English

Exclusion Criteria:

  • All fractures not sustained to distal radius
  • SH Type I or V fracture
  • Injury to contralateral limb
  • Previous injury to distal radius
  • Diseases known to alter bone healing or growth]
  • Contraindications to undergoing an MRI scan

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
Physeal Injury - Distal Radius
Patients who suffer a physeal fracture of the distal radius will be scanned and compared to their healthy contralateral limb.
Other: Diffusion MRI
Each subject will undergo one diffusion MRI scan to identify characteristics of their physes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue characterization of growth plate using diffusion MRI
Time Frame: 4-6 weeks following injury
Diffusion MRI scan of injured and contralateral (control) physis.
4-6 weeks following injury

Collaborators and Investigators

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

Sponsor

University of British Columbia

Collaborators

Pediatric Orthopaedic Society of North America

Investigators

  • Principal Investigator: Firoz Miyanji, MD, FRCSC, University of British Columbia

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

November 1, 2014

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

June 13, 2016

Last Update Submitted That Met QC Criteria

June 10, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H12-03016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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