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Treatment of Distal Radius Buckle Fractures

This study has been terminated.
(inadequate enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01762605
First Posted: January 8, 2013
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
  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: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences ( Wake Forest University ):

Primary Outcome Measures:
  • Pain [ Time Frame: 4-6 weeks ]

Enrollment: 11
Study Start Date: March 2010
Study Completion Date: November 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762605


Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Alison Gardner, MD Wake Forest University Health Science
  More Information

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01762605     History of Changes
Other Study ID Numbers: 1
First Submitted: January 3, 2013
First Posted: January 8, 2013
Last Update Posted: November 8, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries