ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Distal Radius Buckle Fractures

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.
ClinicalTrials.gov Identifier: NCT01762605
Recruitment Status : Terminated (inadequate enrollment)
First Posted : January 8, 2013
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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.

Condition or disease Intervention/treatment Phase
Fracture Treatment Other: Supportive Care Procedure: Cast Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Supportive Care
No casting or splinting, supportive care only by parents
Other: Supportive Care
Active Comparator: Cast
Casting for 4 weeks
Procedure: Cast



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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.

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

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries