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Pediatric Distal Radius US Study

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ClinicalTrials.gov Identifier: NCT01937624
Recruitment Status : Completed
First Posted : September 9, 2013
Last Update Posted : May 5, 2015
Information provided by (Responsible Party):
The Hawkins Foundation

Brief Summary:
The purpose of the study is to evaluate the sensitivity and specificity of using a diagnostic musculoskeletal ultrasound in pediatric distal radius fractures in an outpatient setting. Ultrasound reliability and accuracy will be tested. The result of the diagnostic ultrasound will be compared to x-ray diagnosis under routine conditions in the investigator's injury and fracture treatment evening clinic. Data will be collected and recorded during the duration of the 12 week study. Through the literature review and experience with ultrasound, the investigators anticipate that diagnostic ultrasound will provide very high sensitivity and specificity in diagnosing distal radius fractures in children.

Condition or disease Intervention/treatment
Distal Radius Fractures Device: Diagnostic Ultrasound Radiation: X-ray imaging

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pediatric Distal Radius US Study
Study Start Date : March 2013
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Diagnostic ultrasound
The diagnostic musculoskeletal ultrasound will be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis.
Device: Diagnostic Ultrasound
Other Name: Sonosite Ultrasound
Active Comparator: Radiographic imaging
X-ray imaging of the wrist
Radiation: X-ray imaging

Primary Outcome Measures :
  1. Presence of fracture [ Time Frame: Duration of office visit ]
    Diagnostic ultrasound will be used to determine if the bones do or do not have a fracture. Fractures will be based on the presence or absence of cortical disruption or irregularity on the ultrasound.

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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pediatric patient with a wrist injury.

Exclusion Criteria:

  • Gross deformity of the injured body part, suspected open fractures and the need for emergent surgery

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): NCT01937624

United States, South Carolina
Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
The Hawkins Foundation
Principal Investigator: Kyle Cassas, MD Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System

Responsible Party: The Hawkins Foundation
ClinicalTrials.gov Identifier: NCT01937624     History of Changes
Other Study ID Numbers: Pro00021828
First Posted: September 9, 2013    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by The Hawkins Foundation:
Diagnostic ultrasound

Additional relevant MeSH terms:
Radius Fractures
Forearm Injuries
Arm Injuries
Wounds and Injuries
Fractures, Bone