RecruitingNot ApplicableNCT04642807

Management of Type 1 Supracondylar Humeral Fractures

Management of Type 1 Supracondylar Humeral Fractures: a Multicentre Randomized Control Trial


Sponsor

University of British Columbia

Enrollment

52 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 3 YearsMax Age: 8 Years

Inclusion Criteria1

  • \- Children 3 to 8 years of age with a diagnosed supracondylar humerus fracture Type 1 (undisplaced).

Exclusion Criteria5

  • 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.

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Interventions

PROCEDURELong arm soft cast

Participants in group 2 will have a long arm soft cast applied without clinical or radiological follow up.

PROCEDURELong arm full cast

Participants in group 1 will have a long arm full cast applied.


Locations(2)

Queensland Children's Hospital, 501 Stanley Street,

South Brisbane, Australia

BC Children's Hospital

Vancouver, British Columbia, Canada

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NCT04642807


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