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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01762605
Other study ID # IRB00012567
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 2010
Est. completion date November 2012

Study information

Verified date August 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study determines if patients with buckle fractures of the distal radius and/or ulna treated with supportive care only demonstrate non-inferior outcomes in regard to pain control during healing, functional outcome at the wrist joint, and parental satisfaction, when compared with patients treated with the standard treatment regimen of 3-4 weeks in a short arm cast.


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 17 Years
Eligibility Inclusion Criteria: Children age 1-17 with buckle fractures of the distal radius and/or ulna. - Exclusion Criteria: - Patients are excluded if there is any other injury to the upper limb or serious bodily trauma that might complicate pain scores. Children with suspected or proven metabolic bone disease, or pathologic fractures are excluded due to resultant abnormal bone healing.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Supportive Care

Procedure:
Cast


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University

Outcome

Type Measure Description Time frame Safety issue
Primary Pain 4-6 weeks