Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01341015|
Recruitment Status : Completed
First Posted : April 25, 2011
Last Update Posted : December 5, 2012
A lot of children who injure their ankles come to the emergency department for an evaluation, and often an X-ray of the ankle is obtained to determine if a bone fracture is present. In more than 85% of cases, however, the injury is a sprain and not a bone fracture and can be treated with rest, ice, elevation, and pain medications. X-rays obtained in the emergency departments are time consuming, often uncomfortable for the patient, and expose children to radiation, the long-term effects of which are not yet fully understand by doctors or scientists. Bedside ultrasound is a non-invasive and a non-painful device that does not produce radiation. It was been shown to determine the presence of bone fracture in childrens' wrists and forearms just as well as X-rays do. In our study, the investigators would like to determine if a bedside ultrasound can also be used to evaluate ankle fractures in children.
In our study, the investigators will ask the parents and children, who are scheduled to get an X-ray of their ankle in the emergency department, to examine their ankles with an ultrasound machine as well. Since the bedside ultrasound is not significantly time-consuming, does not require patients to remain still, and is readily available in the department, the procedure will be performed while kids are waiting to get an X-ray, getting registered, or awaiting further treatment. On the data collection form, the investigators will document the patients' names, birthdates, medical record numbers so that their X-ray results can be compared to the ultrasound results for the purpose of the study. The information will be stored in a secure cabinet in a locked office. The investigators will also document which side is injured, where the patient feels pain and what the ankle looks like to help perform the ultrasound. The results of both the ultrasound and X-ray will be documented for each patient.
|Condition or disease||Intervention/treatment||Phase|
|Ankle Fracture||Other: Ultrasound||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children|
|Study Start Date :||June 2010|
|Primary Completion Date :||September 2011|
|Study Completion Date :||December 2011|
Experimental: ultrasound for fracture
All patients receive ultrasound for potential ankle fracture.
Single interventional group - patients agree to an ultrasound of potential ankle fracture, to be compared to standard of care xray.
Other Name: ultrasound for fractures
- comparison of ultrasound to xray shows identical read [ Time Frame: At ER visit (day 1) ]Ultrasound and the radiograph findings for each patient will be reviewed. The agreement between ultrasound and radiography will be expressed as a percentage of total number of studies performed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341015
|United States, Rhode Island|
|Hasbro Children's Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Otto Liebmann, MD||Rhode Island Hospital|