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NCT01937624 Clinical Trial

Pediatric Distal Radius US Study

Distal Radius Fractures Clinical Trial

Official title:
Pediatric Distal Radius US Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01937624
Other study ID # Pro00021828
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2013
Est. completion date November 2014

Study information
Verified date March 2019
Source The Hawkins Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender All
Age group 2 Years to 15 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Diagnostic Ultrasound

Radiation:
• X-ray imaging

Locations
Country Name City State
United States Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System Greenville South Carolina

Sponsors (1)
Lead Sponsor Collaborator
The Hawkins Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of Fracture 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. Duration of office visit
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