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OpenTrials
Completed

NCT Number: NCT01937624

Pediatric Distal Radius US Study

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.

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Key information

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System

Greenville, South Carolina, 29615, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic Ultrasound

Device

Other names: Sonosite Ultrasound

X-ray imaging

Radiation

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Hawkins Foundation

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2013
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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