Brace Versus Casting in Pediatric Radial Head Fractures

Peking University People's Hospital150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Radial Fracture

Interventions

elbow castDEVICE

elbow cast

Removable elbow braceDEVICE

Removable elbow brace

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Mayo score

Functional outcome as measured by the Mayo score at 4 weeks from the time of the initial injury

Time frame: 1 month

Secondary Outcomes

pain

VAS score

Time frame: 1 month

Central Contacts

peng zhang, MD

CONTACT

13010029908 hcooh@163.com

Data from ClinicalTrials.gov

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