Diffusion MRI and Growth Plate Injuries: Pilot Study

NCT01774539 | Unknown

• 1 other identifier: H12-03016
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fracture

Keywords

Fracture; Physeal injury; Diffusion MRI

Outcome Measures

Primary Outcomes (1)

• Tissue characterization of growth plate using diffusion MRI

  Diffusion MRI scan of injured and contralateral (control) physis.

  4-6 weeks following injury

Study Arms (1)

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

Interventions

Diffusion MRI OTHER

Each subject will undergo one diffusion MRI scan to identify characteristics of their physes

Physeal Injury - Distal Radius

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Pediatric Orthopaedic Society of North America: collaborator

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Firoz Miyanji, MD, FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sameer Desai

CONTACT

604-875-2359; sameer.desai@cw.bc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 24, 2013
• Study Start: November 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: June 13, 2016

Record last verified: 2016-06

Locations

CA (1)