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Brace Versus Casting in Pediatric Radial Head Fractures

Primary Purpose

Radial Fracture

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

elbow cast

Removable elbow brace

About this trial

This is an interventional treatment trial for Radial Fracture focused on measuring pediatric, elbow fractures, management

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Elbow cast

Removable elbow brace

Arm Description

Device: Elbow cast

Device: Removable elbow brace

Outcomes

Primary Outcome Measures

Mayo score

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

Secondary Outcome Measures

pain

VAS score

Full Information

NCT ID

NCT03360318

First Posted

November 28, 2017

Last Updated

November 28, 2017

Sponsor

Peking University People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03360318

Brief Title

Brace Versus Casting in Pediatric Radial Head Fractures

Official Title

Brace Versus Casting in Pediatric Radial Head Fractures

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2, 2018 (Anticipated)

Primary Completion Date

February 5, 2019 (Anticipated)

Study Completion Date

February 5, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radial Fracture

Keywords

pediatric, elbow fractures, management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Elbow cast

Arm Type

Active Comparator

Arm Description

Device: Elbow cast

Arm Title

Removable elbow brace

Arm Type

Experimental

Arm Description

Device: Removable elbow brace

Intervention Type

Device

Intervention Name(s)

elbow cast

Intervention Description

elbow cast

Intervention Type

Device

Intervention Name(s)

Removable elbow brace

Intervention Description

Removable elbow brace

Primary Outcome Measure Information:

Title

Mayo score

Description

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

Time Frame

1 month

Secondary Outcome Measure Information:

Title

pain

Description

VAS score

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

peng zhang, MD

Phone

13010029908

hcooh@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

peng zhang, MD

Organizational Affiliation

Peking University People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University People's Hospital

City

Peking

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peixun Zhang, Doctor

Phone

08613611237628

zhangpeixun@163.com

First Name & Middle Initial & Last Name & Degree

Yichong Zhang, Doctor

Phone

08601088326550

zhangyichong@163.com

12. IPD Sharing Statement

Learn more about this trial

Brace Versus Casting in Pediatric Radial Head Fractures

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