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Treatment of Distal Radius Buckle Fractures

This study has been terminated.
(inadequate enrollment)
Sponsor:
Information provided by (Responsible Party):
Alison Gardner, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01762605
First received: January 3, 2013
Last updated: March 13, 2017
Last verified: March 2017
  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: No masking
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alison Gardner, Wake Forest University Health Sciences:

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762605

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

Responsible Party: Alison Gardner, Assistant Professor Emergency Medicine, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01762605     History of Changes
Other Study ID Numbers: 1
Study First Received: January 3, 2013
Last Updated: March 13, 2017

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 25, 2017