Radial Fracture
Conditions
Keywords
pediatric, elbow fractures, management
Brief 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.
Interventions
DEVICEelbow cast
elbow cast
DEVICERemovable elbow brace
Removable elbow brace
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
5 to 18 years of age with one of the following fracture Undisplaced Maoson types I and II fractures of the radial head
Exclusion criteria
The diagnosis of elbow sprain or contusion; they occur primarily in adolescents with closed epiphyseal plates. All open fractures which require surgical debridement. All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease. Congenital anomalies of the elbow. Patients with coagulopathies. Multisystem trauma and multiple fractures of the same or opposite limb. Patients cognitively and developmentally delayed with inability to express pain and/or difficult assessment of baseline activity level. Injuries greater than 72 hours old. Past history of surgery or closed reduction of the same elbow within the last 6 months or ankle trauma of the same ankle within 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mayo score | 1 month | Functional outcome as measured by the Mayo score at 4 weeks from the time of the initial injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain | 1 month | VAS score |
Countries
China
Contacts
Primary Contactpeng zhang, MD
Outcome results
None listed