Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children

NCT01341015 | Completed Early Phase 1

• 1 other identifier: 0094-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

ultrasound for fracture

EXPERIMENTAL

All patients receive ultrasound for potential ankle fracture.

Other: Ultrasound

Interventions

Ultrasound OTHER

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

Also known as: ultrasound for fractures

ultrasound for fracture

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age 2-18 years old
• ankle ray ordered in ER

You may not qualify if:

• open fracture
• multi-system trauma/other significant injuries
• history of ankle fractures? (Same ankle broken within past year)

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Ankle Fractures

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Otto Liebmann, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 25, 2011
• Study Start: June 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 5, 2012

Record last verified: 2011-04

Locations

US (1)