Pediatric Distal Radius US Study

NCT ID: NCT01937624

Last Updated: 2019-06-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Distal Radius Fractures

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Diagnostic ultrasound and radiographic 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

Intervention Type DEVICE

X-ray imaging

Intervention Type RADIATION

Interventions

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Diagnostic Ultrasound

Intervention Type DEVICE

X-ray imaging

Intervention Type RADIATION

Other Intervention Names

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Sonosite Ultrasound

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hawkins Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyle Cassas, MD

Role: PRINCIPAL_INVESTIGATOR

Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System

Locations

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Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System

Greenville, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00021828

Identifier Type: -

Identifier Source: org_study_id

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