ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures

• Conditions: Fractures Bone

• Registration Number: NCT05528432
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

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 Timeline

• Study Start: 2021-02-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-08-31
• Last Update Submitted: 2022-09-05
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-08
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Any adult patient with acute ankle trauma

• one or more criteria of the Ottawa ankle rules :

• Inability to walk 4 steps immediately after the trauma or in the emergency room,
• pain at the level of the internal or external malleolus (the distal 6 cm) or the base of the 5th metatarsal bone.

Exclusion Criteria

• Any patient under the age of 18 years
• Any patient unable to sign the informed consent
• Skin lesions contraindicating sonography (e.g. open fracture wound, ... )
• An unstable patient whose inclusion in the study would delay vital treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Negative predictive value	at inclusion	Negative predictive value of ultrasound compared to standard radiography in the detection of long bone fractures

Secondary Outcome Measures

Name	Time	Method
Specificity	at inclusion	of ultrasound compared to standard radiography in the detection of long bone fractures
Sensitivity	at inclusion	of ultrasound compared to standard radiography in the detection of long bone fractures

Trial Locations

Locations (1)

FREZALS Laeticia Vaiana; 🇧🇪 Bruxelles, Belgium