Comparing treatments for pediatric Type 1 elbow fractures
Management of Type 1 Supracondylar Humeral Fractures: a Multicentre Randomized Control Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 2 sites (South Brisbane and 1 other locations) |
| Trial ID | NCT04642807 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 8 years with a diagnosed Type 1 supracondylar humeral fracture.
Not a fit: Patients with Type II or III fractures, neurovascular compromise, or pre-existing bone diseases will not benefit from this study.
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 performed: This approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
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 this trial is running
South Brisbane and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.