Brace Versus Casting in Pediatric Radial Head Fractures

Not Applicable

• Conditions: Radial Fracture
• Interventions: Device: Removable elbow brace; Device: elbow cast

• Registration Number: NCT03360318
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-11-28
• Last Update Submitted: 2017-11-28
• Study First Posted: 2017-12-04
• Last Update Posted: 2017-12-04
• Study Start: 2018-02-02
• Primary Completion: 2019-02-05
• Study Completion: 2019-02-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Removable elbow brace	Removable elbow brace	Device: Removable elbow brace
Elbow cast	elbow cast	Device: Elbow cast

Primary Outcome Measures

Name	Time	Method
Mayo score	1 month	Functional outcome as measured by the Mayo score at 4 weeks from the time of the initial injury

Secondary Outcome Measures

Name	Time	Method
pain	1 month	VAS score

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Peking, Beijing, China