Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pediatric Distal Radius US Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by The Hawkins Foundation
Information provided by (Responsible Party):
The Hawkins Foundation Identifier:
First received: August 28, 2013
Last updated: September 4, 2013
Last verified: September 2013

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 Intervention
Distal Radius Fractures
Device: Diagnostic Ultrasound
Radiation: X-ray imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pediatric Distal Radius US Study

Resource links provided by NLM:

Further study details as provided by The Hawkins Foundation:

Primary Outcome Measures:
  • Presence of fracture [ Time Frame: Duration of office visit ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 103
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   2 Years to 15 Years
Genders Eligible for Study:   Both
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
  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 identifier: NCT01937624

Contact: Carlisle Shealy, BS 864-454-7458

United States, South Carolina
Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System Recruiting
Greenville, South Carolina, United States, 29615
Contact: Carlisle Shealy, BS    864-454-7458   
Principal Investigator: Kyle Cassas, MD         
Sponsors and Collaborators
The Hawkins Foundation
Principal Investigator: Kyle Cassas, MD Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
  More Information

No publications provided

Responsible Party: The Hawkins Foundation Identifier: NCT01937624     History of Changes
Other Study ID Numbers: Pro00021828
Study First Received: August 28, 2013
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Hawkins Foundation:
Diagnostic ultrasound processed this record on February 27, 2015