FracturesNCT00652548
Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients
An observational study of Fractures, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Fractures
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children age 1-18 years presenting to a tertiary center pediatric emergency department complaining of recent traumatic shoulder injury.
Who may be able to join
- Age 1-18 years
- Pain from recent shoulder/clavicle injury
- Intact neurovascular exam
- Radiographs performed as part of normal ED evaluation
Who cannot join
- Hemodynamic instability
- Multisystem trauma
- Altered mental status
- Open wounds to injured shoulder
- Developmental delay
- Prior radiographs at another clinic/hospital for this injury
Show all 9Show fewer
- Previous clavicle fracture on the affected side
- Ultrasound gel allergy
- Non-English-speaking parents/child (unable to give informed consent)
Trial locations and contacts
1 site in 1 country.
United States1 site
Kosair Children's Hospital
Louisville, Kentucky, 40202
About this study
Official title: Utility of Bedside Ultrasound to Diagnose Clavicle Fractures in the Pediatric Emergency Department
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.
- Conditions
- Fractures
- Keywords
- Clavicle, Fracture, Ultrasound, Radiation
- Medical subject headings
- Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs
Measured: Single visit to emergency department
Secondary outcomes (3)
Unblinded real-time bedside US by the ED physician vs. radiographs
Measured: Single ED visit
Interoperator reliability between the blinded reviewer and bedside ED physician
Measured: Single ED visit
FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs
Measured: Single ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Cross, University of Louisville
- Investigators
- Keith P Cross, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652548
- Sponsor's protocol ID
- 08-0007
- Other IDs
- IRB #08-0007, NHRO #1310
- Status last verified
- Mar 2017
- First submitted
- 28 Mar 2008
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Bedside Ultrasound to Diagnose Clavicle Fractures in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT00652548
- Acronym / sponsor ID
- 08-0007
- Conditions
- Fractures
- Keywords
- Clavicle, Fracture, Ultrasound, Radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children age 1-18 years presenting to a tertiary center pediatric emergency department complaining of recent traumatic shoulder injury.
Key inclusion criteria (4 listed)
- Age 1-18 years
- Pain from recent shoulder/clavicle injury
- Intact neurovascular exam
- Radiographs performed as part of normal ED evaluation
Key exclusion criteria (9 listed)
- Hemodynamic instability
- Multisystem trauma
- Altered mental status
- Open wounds to injured shoulder
- Developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs
Time frame: Single visit to emergency department
3 secondary outcomes
Unblinded real-time bedside US by the ED physician vs. radiographs
Time frame: Single ED visit
Interoperator reliability between the blinded reviewer and bedside ED physician
Time frame: Single ED visit
FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs
Time frame: Single ED visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith P Cross, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs (time frame: Single visit to emergency department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.