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Clinical Validation of RBfracture for Diagnosing Trauma-related Musculoskeletal Injuries
Sponsor: Radiobotics
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.
Official title: Clinical Validation of RBfracture to Demonstrate Improved Diagnostic Performance of the Intended Users
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
415
Start Date
2026-02
Completion Date
2026-04
Last Updated
2026-02-27
Healthy Volunteers
Yes
Interventions
RBfracture
RBfracture is a decision support software designed to assist the intended user in diagnosing fracture, joint dislocation, joint effusion, and lipohemarthrosis.