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Brace Versus Casting in Pediatric Radial Head Fractures

NCT ID: NCT03360318

Last Updated: 2017-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-02

Study Completion Date

2019-02-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Radial Fracture

Keywords

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pediatric elbow fractures management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Elbow cast

Device: Elbow cast

Group Type ACTIVE_COMPARATOR

elbow cast

Intervention Type DEVICE

elbow cast

Removable elbow brace

Device: Removable elbow brace

Group Type EXPERIMENTAL

Removable elbow brace

Intervention Type DEVICE

Removable elbow brace

Interventions

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elbow cast

elbow cast

Intervention Type DEVICE

Removable elbow brace

Removable elbow brace

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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pengzhang

Department of orthopaedics and trauma

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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peng zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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peng zhang, MD

Role: CONTACT

Phone: 13010029908

Email: [email protected]

Facility Contacts

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Peixun Zhang, Doctor

Role: primary

Yichong Zhang, Doctor

Role: backup

Other Identifiers

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CSG-03qtd

Identifier Type: -

Identifier Source: org_study_id