Management of Type 1 Supracondylar Humeral Fractures
Recruiting now · Not applicable
Conditions studied: Elbow Fracture, Trauma
In brief
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.
Key facts
- Study ID
- NCT04642807
- Run by
- University of British Columbia
- People needed
- 52
- Starts
- 2021-04-01
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2024-12-11
Who can join
Age: 3 and older, up to 8. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Children 3 to 8 years of age with a diagnosed supracondylar humerus fracture Type 1 (undisplaced).
You may not qualify if…
- 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 is running
- Queensland Children's Hospital, 501 Stanley Street, — South Brisbane, Australia (enrolling)
- BC Children's Hospital — Vancouver, British Columbia, Canada (enrolling)
Full record on ClinicalTrials.gov
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