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Clinical Validation of RBfracture for Diagnosing Trauma-related Musculoskeletal Injuries

NCT07421791 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 415

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Fracture
  • Joint Dislocation
  • Joint Effusion
  • Knee Lipohemarthrosis

Interventions

DIAGNOSTIC_TEST

RBfracture

RBfracture is a decision support software designed to assist the intended user in diagnosing fracture, joint dislocation, joint effusion, and lipohemarthrosis.

Sponsors & Collaborators

  • Radiobotics

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-04-30
Completion
2026-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07421791 on ClinicalTrials.gov