Diffusion MRI and Growth Plate Injuries: Pilot Study

NCT ID: NCT01774539

Last Updated: 2016-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Physeal Injury - Distal Radius

Patients who suffer a physeal fracture of the distal radius will be scanned and compared to their healthy contralateral limb.

Diffusion MRI

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diffusion MRI

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pediatric Orthopaedic Society of North America

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Firoz Miyanji, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sameer Desai

Role: CONTACT

604-875-2359

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sameer Desai

Role: primary

604-875-2359

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H12-03016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

129Xe MRI in Pediatric Population With BPD
NCT04035629 NOT_YET_RECRUITING PHASE1
MR-HIFU Treatment of Painful Osteoid Osteoma
NCT04658771 ACTIVE_NOT_RECRUITING PHASE2
Thoracic MRI Imaging in Children
NCT02714933 COMPLETED NA