Clinical Validation of RBfracture for Diagnosing Trauma-related Musculoskeletal Injuries (NCT07421791) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Validation of RBfracture for Diagnosing Trauma-related Musculoskeletal Injuries
415 participantsStarted 2026-02
Plain-language summary
The goal of this study is to determine if the computer software, RBfracture, developed by Radiobotics, helps primary care, emergency, and radiology clinicians more easily identify bone injuries caused by a traumatic impact (such as a fall or car collision). RBfracture uses artificial intelligence (AI) to analyze X-ray images of patients to identify fractures and joint dislocations visible on the X-ray images. RBfracture also identifies fluid buildup in the elbow and knee joints resulting from a fracture or dislocation.
Sixteen clinicians will review X-ray images from 415 adult patients, who may have sustained a bone injury, to diagnose any injuries visible on their X-ray images. First, the clinicians will review half of the images with and half of the images without the help of the RBfracture software. After a 4-week break, the clinicians will once again review the same images. This time, the software's help will be switched, so it is unavailable for the images the clinicians previously reviewed with it, and available for the images they reviewed without it.
The number of correct and incorrect diagnoses made by the clinicians when they were helped by the software will be compared to the number of correct and incorrect diagnoses made by the clinicians when they did not receive any help from the software. This comparison will reveal if using the software helps clinicians to diagnose more injuries and miss less injuries.
Who can participate
Age range
22 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:
* XR exams of a patient ≥22 years of age following a recent acute musculoskeletal trauma.
* Modality is digitally acquired radiographs (Computed Radiography or Digital Radiography)
Exclusion Criteria:
* XR exam types that are outside of the intended use (e.g., chest, abdomen, facial bones, cervical spine).
* Exams with missing patient age.
* Exams from follow-up patient examinations, e.g., post-surgical controls or evaluation of fracture healing.
* Any exams containing radiographs previously used in software development.
* Exams containing additional radiographs that are incoherent with the XR exam type (e.g., wrist radiograph in a hip and pelvis exam type).
* Radiograph views that are unsupported.
* Poor radiographic image quality, rendering radiograph clinically unsuitable (e.g., inappropriate selection of technical exposure factors, patient motion, presence of artefacts, and improper collimation of the radiographic beam).
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
Change in diagnostic accuracy between device-assisted and device-unassisted readers at the exam level.