Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01341015
First received: April 11, 2011
Last updated: December 3, 2012
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Ankle Fracture
Other: Ultrasound
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • comparison of ultrasound to xray shows identical read [ Time Frame: At ER visit (day 1) ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ultrasound for fracture
All patients receive ultrasound for potential ankle fracture.
Other: Ultrasound
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

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341015

Locations
United States, Rhode Island
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Otto Liebmann, MD Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01341015     History of Changes
Other Study ID Numbers: 0094-10
Study First Received: April 11, 2011
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014