Artificial Intelligence Algorithm for the Interpretation of Traumatic Bone Radiographs (NCT07329881) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Artificial Intelligence Algorithm for the Interpretation of Traumatic Bone Radiographs
Tunisia500 participantsStarted 2025-11-01
Plain-language summary
This diagnostic study aims to compare the performance of an artificial intelligence (AI) algorithm designed to assist in the interpretation of traumatic bone radiographs (all anatomical regions excluding the thorax) with that of human readers, including emergency medicine and family medicine residents as well as senior physicians (one emergency medicine specialist and one orthopedic surgeon).
The study follows a paired reader study design: identical anonymized radiographic images are independently interpreted by the AI system and by human readers. The reference standard ("gold standard") will be defined by the consensus reading of the two senior physicians. Inter-observer agreement (kappa statistics) between the AI, residents, and senior reference readings will be estimated, and false negatives and false positives will be analyzed by lesion type and anatomical location.
Who can participate
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:
* Standard radiographs performed for suspected bone trauma (upper limbs, lower limbs, pelvis/hip, cervical/thoracolumbar spine) in the emergency setting.
* Adult and pediatric patients (informed consent by patient or legal guardian for minors).
* Acute trauma context.
Exclusion Criteria:
* Poor-quality images (motion artifact, underexposure preventing diagnostic interpretation).
* Cases lacking senior interpretation for gold standard reference.
* Patients referred with radiographs performed outside the hospital (external facilities).
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
Diagnostic sensitivity and specificity of the AI algorithm compared to human readers
Timeframe: At the end of image interpretation for each reader (expected within 1 month after image collection).