Long arm soft cast: Participants in group 2 will have a long arm soft cast applied without clinical or radiological follow up.
Long arm full cast: Participants in group 1 will have a long arm full cast applied.
Study 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
Sex
ALL
Min age
3 Years
Max age
8 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Faces Pain Scale - Revised (FPS-R) — 3 weeks post fracture The Faces Pain Scale - Revised (FPS-R) will be used to measure pain score. The scale uses a 0 to 10 metric that is in close linear relationship with a visual analogue pain scale. 0 is no pain and 10 is very much pain.
Trial sites (2)
Facility
City
Region
Status
Queensland Children's Hospital, 501 Stanley Street,
South Brisbane
Australia
Recruiting
BC Children's Hospital
Vancouver
British Columbia
Recruiting
More University of British Columbia trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.