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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05528432
Enrollment
150
Registered
2022-09-06
Start date
2021-02-01
Completion date
2022-09-30
Last updated
2022-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures Bone

Keywords

Fracture ankle, Fracture foot, Frature metatarsus, Ultrasound, X-ray

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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire Saint Pierre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Negative predictive valueat inclusionNegative predictive value of ultrasound compared to standard radiography in the detection of long bone fractures

Secondary

MeasureTime frameDescription
Sensitivityat inclusionof ultrasound compared to standard radiography in the detection of long bone fractures
Specificityat inclusionof ultrasound compared to standard radiography in the detection of long bone fractures

Countries

Belgium

Contacts

Primary ContactLaeticia Vaiana FL Frezals, Médecin
laeticia.frezals@gmail.com0493481204
Backup ContactAlain PA Plumacker, Médecin
alain.plumacker@stpierre-bru.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026