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Clinical Trials/NCT01937624
NCT01937624CompletedNot Applicable

Pediatric Distal Radius US Study

The Hawkins Foundation1 site in 1 country51 target enrollmentStarted: March 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
51
Locations
1
Primary Endpoint
Presence of Fracture

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to 15 Years (Child)
Sex
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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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