Diffusion MRI and Growth Plate Injuries: Pilot Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of British Columbia
Sponsor:
Collaborator:
Pediatric Orthopaedic Society of North America
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01774539
First received: January 22, 2013
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Fracture
Other: Diffusion MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diffusion MRI as a Prognostic Tool in Growth Plate Injuries: A Pilot Study to Assess Feasibility

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Tissue characterization of growth plate using diffusion MRI [ Time Frame: 4-6 weeks following injury ] [ Designated as safety issue: No ]
    Diffusion MRI scan of injured and contralateral (control) physis.


Estimated Enrollment: 10
Study Start Date: September 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774539

Contacts
Contact: Sameer Desai 604-875-2359 sameer.desai@cw.bc.ca

Locations
Canada, British Columbia
British Columbia Children's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Sameer Desai    604-875-2359    sameer.desai@cw.bc.ca   
Principal Investigator: Firoz Miyanji, MD, FRCSC         
Sub-Investigator: Kishore Mulpuri, MBBS, MS, MHSc         
Sub-Investigator: Chris Reilly, MD, FRCSC         
Sub-Investigator: Ken Poskitt, MDCM         
Sponsors and Collaborators
University of British Columbia
Pediatric Orthopaedic Society of North America
Investigators
Principal Investigator: Firoz Miyanji, MD, FRCSC University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01774539     History of Changes
Other Study ID Numbers: H12-03016
Study First Received: January 22, 2013
Last Updated: June 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Fracture
Physeal injury
Diffusion MRI

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 20, 2014