Splinting Versus Casting for Type I Supracondylar Fractures

Bone Fractures Clinical Trial

Official title:

Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912365
• Other study ID #: H13-01520
• Status: Completed
• Phase: N/A
• First received: July 26, 2013
• Last updated: January 8, 2018
• Start date: August 2013
• Est. completion date: June 2017

Study information

• Verified date: January 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Elbow fractures are very common in young children. Type I supracondylar fractures are stable fractures to the elbow that are treated conservatively across the world and typically heal very well without complications. There are several treatment options, including an above elbow cast or long arm splint. This study aims to determine if one treatment is no worse than the other in order to standardize the treatment of these fractures at our institution. The investigators hope to save families from extra hospital visits and reduce the amount of x-rays required for treatment of these fractures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

• Ages 3-12

• Type 1 supracondylar fracture

Exclusion Criteria:

• A type 2 or 3 supracondylar fracture

• Neurovascular compromise associated with the fracture

• Previous diagnosis with a metabolic or structural bone disease

• Other fractures to ipsilateral upper extremity

• History of injury to affected elbow

Related Conditions & MeSH terms

• Bone Fractures
• Fractures, Bone

Intervention

Procedure:
• Above Elbow Cast

• Long Arm Splint

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baumann's Angle	Baumann's angle of the injured elbow will be measured 6 months following the injury	6 Months
Secondary	Humero-Capitellar Angle	Humero-Capitellar Angle will be measured 6 Months following the injury	6 Months
Secondary	Functional Outcome Questionnaire	All participants will complete the Activity Scale for Kids-P 6 months following the injury	6 Months