FractureNCT01774539
Diffusion MRI and Growth Plate Injuries: Pilot Study
An observational study of Fracture, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Fracture
- What is being tested?
- Diffusion MRI
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Study subjects will be selected from the Orthopaedic Trauma Clinic at BC Children's Hospital
Who may be able to join
- Salter-Harris Type II, III, or IV fracture through the distal radius
- Growth plates are open
- Ages 8-12
- Able to consent in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Sameer Desai, 604-875-2359, sameer.desai@cw.bc.ca
Firoz Miyanji, MD, FRCSC
About this study
Official title: 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.
Read the 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
- Conditions
- Fracture
- Being tested
- Diffusion MRI
- Keywords
- Fracture, Physeal injury, Diffusion MRI
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion MRIOther
Each subject will undergo one diffusion MRI scan to identify characteristics of their physes
| Study group | Role | What they receive |
|---|---|---|
| Physeal Injury - Distal Radius | Patients who suffer a physeal fracture of the distal radius will be scanned and compared to their healthy contralateral limb. Receives: Other: Diffusion MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue characterization of growth plate using diffusion MRI
Diffusion MRI scan of injured and contralateral (control) physis.
Measured: 4-6 weeks following injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startNov 2014
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Orthopaedic Society of North America
- Responsible party
- Sponsor
- Investigators
- Firoz Miyanji, MD, FRCSC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774539
- Sponsor's protocol ID
- H12-03016
- Status last verified
- Jun 2016
- First submitted
- 22 Jan 2013
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion MRI as a Prognostic Tool in Growth Plate Injuries: A Pilot Study to Assess Feasibility
- ClinicalTrials.gov ID
- NCT01774539
- Acronym / sponsor ID
- H12-03016
- Conditions
- Fracture
- Keywords
- Fracture, Physeal injury, Diffusion MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Pediatric Orthopaedic Society of North America
- Study start
- Nov 2014
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physeal Injury - Distal Radius | – | Other: Diffusion MRIPatients who suffer a physeal fracture of the distal radius will be scanned and compared to their healthy contralateral limb. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study subjects will be selected from the Orthopaedic Trauma Clinic at BC Children's Hospital
Key inclusion criteria (4 listed)
- Salter-Harris Type II, III, or IV fracture through the distal radius
- Growth plates are open
- Ages 8-12
- Able to consent in English
Key exclusion criteria (6 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion MRIEach subject will undergo one diffusion MRI scan to identify characteristics of their physes | Other | Physeal Injury - Distal Radius |
Primary outcome
Tissue characterization of growth plate using diffusion MRI
Time frame: 4-6 weeks following injury
Diffusion MRI scan of injured and contralateral (control) physis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Firoz Miyanji, MD, FRCSC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sameer Desai (604-875-2359, sameer.desai@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue characterization of growth plate using diffusion MRI (time frame: 4-6 weeks following injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2016.