NCT04642807 Management of Type 1 Supracondylar Humeral Fractures
| NCT ID | NCT04642807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Elbow Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2021-04-01 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study compares the clinical outcomes of treating pediatric Type 1 supracondylar fracture with a long arm soft cast and no clinical or radiographic follow-up versus the standard treatment in a long arm cast with clinical follow-up. This is the first multicenter randomized control trial looking at the clinical effectiveness, safety and parental satisfaction of managing inherently stable Type I supracondylar fractures without clinical or radiological follow-up. If found to be safe; children can be managed effectively without in-person follow-up, freeing clinic appointments to children on the waiting list and in these COVID times avoiding unnecessary contacts.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT04642807 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 8 Years, studying Elbow Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04642807 currently recruiting?
Yes, NCT04642807 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of British Columbia to inquire about joining.
Where is the NCT04642807 trial being conducted?
This trial is being conducted at South Brisbane, Australia, Vancouver, Canada.
Who is sponsoring the NCT04642807 clinical trial?
NCT04642807 is sponsored by University of British Columbia. The trial plans to enroll 52 participants.