Brace Versus Casting in Pediatric Radial Head Fractures

Radial Fracture Clinical Trial

Official title:

Brace Versus Casting in Pediatric Radial Head Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03360318
• Other study ID #: CSG-03qtd
• Status: Not yet recruiting
• Phase: N/A
• First received: November 28, 2017
• Last updated: November 28, 2017
• Start date: February 2, 2018
• Est. completion date: February 5, 2019

Study information

• Verified date: November 2017
• Source: Peking University People's Hospital
• Contact: peng zhang, MD
• Phone: 13010029908
• Email: hcooh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 5, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Radial Fracture
• Radius Fractures

Intervention

Device:
• elbow cast
elbow cast
• Removable elbow brace
Removable elbow brace

Locations

Country	Name	City	State
China	Peking University People's Hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mayo score	Functional outcome as measured by the Mayo score at 4 weeks from the time of the initial injury	1 month
Secondary	pain	VAS score	1 month