Treatment of Distal Radius Buckle Fractures
This study has been terminated.
(inadequate enrollment)
Sponsor:
Wake Forest University
Information provided by (Responsible Party):
Alison Gardner, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01762605
First received: January 3, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fracture Treatment |
Other: Supportive Care Procedure: Cast |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Wake Forest University:
Primary Outcome Measures:
- Pain [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 11 |
| Study Start Date: | March 2010 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Supportive Care
No casting or splinting, supportive care only by parents
|
Other: Supportive Care |
|
Active Comparator: Cast
Casting for 4 weeks
|
Procedure: Cast |
Eligibility| Ages Eligible for Study: | 1 Year to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Alison Gardner, Assistant Professor Emergency Medicine, Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01762605 History of Changes |
| Other Study ID Numbers: | 1 |
| Study First Received: | January 3, 2013 |
| Last Updated: | January 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on June 18, 2013