Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children

NCT ID: NCT01341015

Last Updated: 2012-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-12-31

Brief 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.

Conditions

Ankle Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ultrasound for fracture

All patients receive ultrasound for potential ankle fracture.

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: OTHER

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

Interventions

Ultrasound

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

Intervention Type: OTHER

Other Intervention Names

ultrasound for fractures

Eligibility Criteria

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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Otto Liebmann, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Hasbro Children's Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

0094-10

Identifier Type: -

Identifier Source: org_study_id