Diffusion MRI and Growth Plate Injuries: Pilot Study

Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01774539
• Other study ID #: H12-03016
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2013
• Last updated: June 10, 2016
• Start date: November 2014
• Est. completion date: February 2017

Study information

• Verified date: June 2016
• Source: University of British Columbia
• Contact: Sameer Desai
• Phone: 604-875-2359
• Email: sameer.desai[@]cw.bc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fracture

Intervention

Other:
• Diffusion MRI
Each subject will undergo one diffusion MRI scan to identify characteristics of their physes

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Pediatric Orthopaedic Society of North America

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue characterization of growth plate using diffusion MRI	Diffusion MRI scan of injured and contralateral (control) physis.	4-6 weeks following injury	No