Comparing treatments for pediatric Type 1 elbow fractures
Official title: Management of Type 1 Supracondylar Humeral Fractures: a Multicentre Randomized Control Trial
Run by University of British Columbia · NCT04642807 · Data updated 2026-11-12
This study tests if treating kids with Type 1 elbow fractures using a soft cast without follow-up visits is just as safe and effective as the standard cast with follow-up, especially during the COVID-19 pandemic.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 8 Years |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | University of British Columbia Academic / other |
| Locations | 2 sites (South Brisbane and 1 other locations) |
| Status | Recruiting |
| Started | April 1, 2021 |
| Main results expected | June 2025 |
| Study ends | June 2025 |
| Registry record updated | December 11, 2024 |
| Trial ID | NCT04642807 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 to 8 years with a diagnosed Type 1 supracondylar humeral fracture.
✕Probably not a fit
Patients with Type II or III fractures, neurovascular compromise, or pre-existing bone diseases will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the clinical outcomes and parental satisfaction of treating pediatric Type 1 supracondylar humeral fractures using a long arm soft cast without follow-up versus the standard long arm cast with follow-up. It aims to determine if these fractures can be managed safely without in-person consultations, especially during the COVID-19 pandemic. The study involves clear instructions for parents and assesses whether this approach leads to similar pain management and satisfaction levels. This is the first multicenter randomized control trial of its kind.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary clinic visits and exposure to COVID-19 for children with stable fractures.
How similar studies have gone: This approach is novel and has not been extensively tested in previous studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Children 3 to 8 years of age with a diagnosed supracondylar humerus fracture Type 1 (undisplaced). Exclusion Criteria: * Children diagnosed with a Type II or III supracondylar fracture or any other elbow injury * Children who present with neurovascular compromise associated with their fracture * Children who have been previously diagnosed with a metabolic or structural bone disease that predisposes them to fractures Diagnostic criteria for a Type I supracondylar fracture will include either: A) A clear fracture line through the supracondylar region with no displacement or angulation of the distal humerus (including a normal anterior humeral line that intersects the capitellum) OR B) The absence of a clear fracture line but history of an extension injury to the arm AND tenderness at the elbow AND local swelling AND presence of a posterior fat pad on plain radiographs.
Where it's running
-
Queensland Children's Hospital, 501 Stanley Street,
South Brisbane, Australia Recruiting -
BC Children's Hospital
Vancouver, British Columbia, Canada Recruiting
Study contacts
- Study coordinator: Harpreet Chhina, MSc
- Email: hchhina@cw.bc.ca
- Phone: 604-875-2000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.