NCT03360318

Brace Versus Casting in Pediatric Radial Head Fractures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month

Detailed description

Radial Head Fractures are common injury in children. In this study, healthy children with Mason type I or II radial head fractures are planned to be included. Outcome Measures: The primary outcome measure will be an assessment of functional daily activities as measured by the MAYO score at four weeks post injury. Secondary outcomes will include an assessment of pain scores using VAS. Sample Size and Analysis: Assuming a standard deviation of 10%, alpha = 0.05, beta = 0.2 and 10% dropout rate yields a sample size of 150 patients. Secondary analyses will include Fisher's Exact test to compare proportions of children with full range of motion of the injured ankle at four weeks and with full baseline activity level at four months, and the area under the curve of a pain-time profile curve will be compared using a Student's t-test.

Conditions

• Radial Fracture

Interventions

Type	Name	Description
DEVICE	elbow cast	elbow cast
DEVICE	Removable elbow brace	Removable elbow brace

Timeline

• Start date: 2018-02-02
• Primary completion: 2019-02-05
• Completion: 2019-02-05
• First posted: 2017-12-04
• Last updated: 2017-12-04

Locations

1 site across 1 country: China