Viewing Study NCT05528432


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Study NCT ID: NCT05528432
Status: UNKNOWN
Last Update Posted: 2022-09-08
First Post: 2022-08-30
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures
Sponsor: Centre Hospitalier Universitaire Saint Pierre
Organization:

Study Overview

Official Title: ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures
Status: UNKNOWN
Status Verified Date: 2022-08
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To investigate the diagnostic value of ultrasound performed by a lay experimenter compared to standard radiographic imaging (or standard x-ray) in the detection of fractures in patients with closed acute ankle trauma and positive Ottawa ankle rules
Detailed Description: Selection of patients is according to the criteria detailed below. If the patient is deemed eligible for the study, he will be asked to read and sign the informed consent. Besides standard history taking, physical examination and radiographic imaging, a standardized ultrasound examination of the ankle joint will be performed by a lay experimenter.

Care will be provided by the attending physician and, according to "standard of care", treatment decisions will be based on history taking, physical examination and conventional ankle x-ray series. Sonographic results will not be used for this purpose. All ankle x-ray series will be reviewed by a senior resident radiologist.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: