NCT00652548

Brief Summary

This studies investigates the hypothesis that bedside ultrasound is as accurate as plain x-rays for diagnosing clavicle fractures in children in a pediatric emergency department. Children with shoulder injuries are enrolled and receive both an ultrasound imaging (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or better)accuracy, with less cost, time, and radiation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

March 28, 2008

Last Update Submit

March 29, 2017

Conditions

Fractures

Keywords

ClavicleFractureUltrasoundRadiation

Outcome Measures

Primary Outcomes (1)

  • Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs

    Single visit to emergency department

Secondary Outcomes (3)

  • Unblinded real-time bedside US by the ED physician vs. radiographs

    Single ED visit

  • Interoperator reliability between the blinded reviewer and bedside ED physician

    Single ED visit

  • FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs

    Single ED visit

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children age 1-18 years presenting to a tertiary center pediatric emergency department complaining of recent traumatic shoulder injury.

You may qualify if:

  • Age 1-18 years
  • Pain from recent shoulder/clavicle injury
  • Intact neurovascular exam
  • Radiographs performed as part of normal ED evaluation

You may not qualify if:

  • Hemodynamic instability
  • Multisystem trauma
  • Altered mental status
  • Open wounds to injured shoulder
  • Developmental delay
  • Prior radiographs at another clinic/hospital for this injury
  • Previous clavicle fracture on the affected side
  • Ultrasound gel allergy
  • Non-English-speaking parents/child (unable to give informed consent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Keith P Cross, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 3, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations

US(1)