ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of … (NCT05528432) | Clinical Trial Compass
UnknownNot Applicable
ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures
Belgium150 participantsStarted 2021-02-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Negative predictive value
Timeframe: at inclusion
Trial details
NCT IDNCT05528432
SponsorCentre Hospitalier Universitaire Saint Pierre