Brace Versus Casting in Pediatric Radial Head Fractures

November 28, 2017 updated by: pengzhang, Peking University People's Hospital
Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: peng zhang, MD
  • Phone Number: 13010029908
  • Email: hcooh@163.com

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100044
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Elbow cast
Device: Elbow cast
Device: elbow cast
elbow cast
Experimental: Removable elbow brace
Device: Removable elbow brace
Device: Removable elbow brace
Removable elbow brace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mayo score
Time Frame: 1 month
Functional outcome as measured by the Mayo score at 4 weeks from the time of the initial injury
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain
Time Frame: 1 month
VAS score
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Peng Zhang, MD, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 2, 2018

Primary Completion (Anticipated)

February 5, 2019

Study Completion (Anticipated)

February 5, 2019

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

December 4, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSG-03qtd

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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