Pediatric Distal Radius US Study

Completed

• Conditions: Distal Radius Fractures
• Interventions: Device: Diagnostic Ultrasound; Radiation: X-ray imaging

• Registration Number: NCT01937624
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-09
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2016-03-07
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-04
• Last Update Submitted: 2019-03-04
• Results First Posted: 2019-06-06
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Pediatric patient with a wrist injury.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic ultrasound and radiographic imaging	X-ray imaging	- The diagnostic musculoskeletal ultrasound and x-rays will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis.
Diagnostic ultrasound and radiographic imaging	Diagnostic Ultrasound	- The diagnostic musculoskeletal ultrasound and x-rays will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis.

Primary Outcome Measures

Name	Time	Method
Presence of Fracture	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.

Trial Locations

Locations (1)

Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System; 🇺🇸 Greenville, South Carolina, United States