Back to resultsTreatment of Distal Radius Buckle Fractures
Primary Purpose
Fracture Treatment
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supportive Care
Cast
Sponsored by
About this trial
This is an interventional treatment trial for Fracture Treatment
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Supportive Care
Cast
Arm Description
No casting or splinting, supportive care only by parents
Casting for 4 weeks
Outcomes
Primary Outcome Measures
Pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01762605
Brief Title
Treatment of Distal Radius Buckle Fractures
Official Title
Supportive Care Versus Casting for Distal Forearm Buckle Fractures in Children; A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
inadequate enrollment
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive Care
Arm Type
Experimental
Arm Description
No casting or splinting, supportive care only by parents
Arm Title
Cast
Arm Type
Active Comparator
Arm Description
Casting for 4 weeks
Intervention Type
Other
Intervention Name(s)
Supportive Care
Intervention Type
Procedure
Intervention Name(s)
Cast
Primary Outcome Measure Information:
Title
Pain
Time Frame
4-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Frino, MD
Organizational Affiliation
Atrium Health Wake Forest Baptist
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Treatment of Distal Radius Buckle Fractures
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