Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children

Ankle Fracture Clinical Trial

Official title:

Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341015
• Other study ID #: 0094-10
• Status: Completed
• Phase: Phase 0
• First received: April 11, 2011
• Last updated: December 3, 2012
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2011
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Objectives:

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.

Research Procedures:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• age 2-18 years old

• ankle ray ordered in ER

Exclusion Criteria:

• open fracture

• multi-system trauma/other significant injuries

• history of ankle fractures? (Same ankle broken within past year)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ankle Fracture
• Ankle Fractures
• Fractures, Bone

Intervention

Other:
• Ultrasound
Single interventional group - patients agree to an ultrasound of potential ankle fracture, to be compared to standard of care xray.

Locations

Country	Name	City	State
United States	Hasbro Children's Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of ultrasound to xray shows identical read	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.	At ER visit (day 1)	No