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Brace Versus Casting in Pediatric Radial Head Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03360318
Recruitment Status : Unknown
Verified November 2017 by pengzhang, Peking University People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
pengzhang, Peking University People's Hospital

Study Description
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Brief Summary:
Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month

Condition or disease Intervention/treatment Phase
Radial Fracture Device: elbow cast Device: Removable elbow brace Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brace Versus Casting in Pediatric Radial Head Fractures
Estimated Study Start Date : February 2, 2018
Estimated Primary Completion Date : February 5, 2019
Estimated Study Completion Date : February 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Mayo score [ Time Frame: 1 month ]
    Functional outcome as measured by the Mayo score at 4 weeks from the time of the initial injury


Secondary Outcome Measures :
  1. pain [ Time Frame: 1 month ]
    VAS score


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360318


Contacts
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Contact: peng zhang, MD 13010029908 hcooh@163.com

Locations
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China, Beijing
Peking University People's Hospital
Peking, Beijing, China, 100044
Contact: Peixun Zhang, Doctor    08613611237628    zhangpeixun@163.com   
Contact: Yichong Zhang, Doctor    08601088326550    zhangyichong@163.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: peng zhang, MD Peking University People's Hospital
More Information
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Responsible Party: pengzhang, Department of orthopaedics and trauma, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03360318    
Other Study ID Numbers: CSG-03qtd
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by pengzhang, Peking University People's Hospital:
pediatric
elbow fractures
management
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries