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Brace Versus Casting in Pediatric Radial Head Fractures

P

Peking University

Status

Unknown

Conditions

Radial Fracture

Treatments

Device: elbow cast
Device: Removable elbow brace

Study type

Interventional

Funder types

Other

Identifiers

NCT03360318
CSG-03qtd

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

150 participants in 2 patient groups

Elbow cast
Active Comparator group
Description:
Device: Elbow cast
Treatment:
Device: elbow cast
Removable elbow brace
Experimental group
Description:
Device: Removable elbow brace
Treatment:
Device: Removable elbow brace

Trial contacts and locations

1

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Central trial contact

peng zhang, MD

Data sourced from clinicaltrials.gov

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