Radial Fracture Clinical Trial
Official title:
Brace Versus Casting in Pediatric Radial Head Fractures
Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03749174 -
Radius Fracture Anesthesia and Rehabilitation (RADAR)
|
N/A |