Fracture Treatment Clinical Trial
Official title:
Supportive Care Versus Casting for Distal Forearm Buckle Fractures in Children; A Randomized Controlled Trial
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 |
Verified date | August 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain | 4-6 weeks |