FractureNCT07421791
Clinical Validation of RBfracture for Diagnosing Trauma-related Musculoskeletal Injuries
An observational study of Fracture and Joint Dislocation, run by Radiobotics.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fracture, Joint Dislocation, Joint Effusion
- What is being tested?
- RBfracture
- How many people
- 415 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: X-ray exams of adult patients suspected of having trauma-related musculoskeletal injuries.
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Validation of RBfracture to Demonstrate Improved Diagnostic Performance of the Intended Users
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.
Read the detailed description
RBfracture, developed by Radiobotics (Copenhagen, Denmark), is a decision-support software solution for computerized detection and diagnosis of acute fractures, joint dislocations, joint effusion, and lipohemarthrosis. To demonstrate improved diagnostic performance of the intended users when assisted by RBfracture, a fully-crossed multi-reader multi-case (MRMC) study will be conducted. 415 study exams will be retrospectively obtained through stratified sampling with enrichment to represent all anatomical regions supported by the software. Sixteen independent clinicians representing various clinical roles and years of experience will participate as study readers.
The reference standard will be established by American Board of Radiology (ABR)-certified radiologists with a minimum of 3 years of experience post certification. All exams will be reviewed and annotated by two musculoskeletal (MSK) radiologists, independently. Annotations will be done in a medical-grade reading environment, using diagnostic quality monitors. If required, any disagreement will be adjudicated by a third specialized radiologist.
In both assisted and unassisted sessions, readers will localize every unique fracture, joint dislocation, joint effusion, and lipohemarthrosis. For each finding, readers will provide a bounding box and a confidence score (1-5). Additionally, at the exam level, readers will indicate the presence or absence of each injury type along with a confidence score (0-100).
At the case level, ROC curves will be generated for each reader under both device-assisted and unassisted reading scenarios. The AUC of the ROC curve per reader in each reading scenario, and the difference in the reader-averaged AUC between device-assisted and unassisted reading scenarios will be calculated. The difference in reader-averaged AUC between the two reading scenarios will be reported as the primary outcome to demonstrate improved diagnostic performance of the intended users. Exam-level sensitivity, specificity, and average false positives, and injury-level sensitivity and AUC-AFROC will be presented as secondary outcomes.
- Conditions
- Fracture, Joint Dislocation, Joint Effusion, Knee Lipohemarthrosis
- Being tested
- RBfracture
- Medical subject headings
- Fractures, Bone, Joint Dislocations, Hydrarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBfractureDiagnostic test
RBfracture is a decision support software designed to assist the intended user in diagnosing fracture, joint dislocation, joint effusion, and lipohemarthrosis.
| Study group | Role | What they receive |
|---|---|---|
| device-assisted | In the device-assisted modality, study readers will interpret patient X-ray exams with RBfracture assistance. Receives: Diagnostic Test: RBfracture | |
| device-unassisted | In the device-unassisted modality, study readers will interpret patient X-ray exams without RBfracture assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diagnostic accuracy between device-assisted and device-unassisted readers at the exam level.
The difference in the reader-averaged AUC between device-assisted and device-unassisted readers is significant at a one-sided p value of 0.025.
Measured: one month
Secondary outcomes (3)
Change in diagnostic accuracy between device-assisted and device-unassisted readers at the exam level.
The difference in reader-averaged sensitivity and specificity between device-assisted and device-unassisted readers.
Measured: one month
Change in diagnostic accuracy between device-assisted and device-unassisted readers at the injury level.
The difference in reader-averaged AUC-AFROC, sensitivity, and false positives per exam between device-assisted and device-unassisted readers.
Measured: one month
Generalizability of device performance across demographic and technical factors
At the exam level, the difference in AUC, sensitivity, and specificity between device-assisted and device-unassisted readers, with data stratified by reader qualification, patient sex, patient ethnicity (if available), and radiographic machine manufacturer.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiobotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421791
- Sponsor's protocol ID
- 20254568
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of RBfracture to Demonstrate Improved Diagnostic Performance of the Intended Users
- ClinicalTrials.gov ID
- NCT07421791
- Acronym / sponsor ID
- 20254568
- Conditions
- Fracture, Joint Dislocation, Joint Effusion, Knee Lipohemarthrosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 415 participants (estimated)
- Lead sponsor
- RadioboticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RBfracture, developed by Radiobotics (Copenhagen, Denmark), is a decision-support software solution for computerized detection and diagnosis of acute fractures, joint dislocations, joint effusion, and lipohemarthrosis. To demonstrate improved diagnostic performance of the intended users when assisted by RBfracture, a fully-crossed multi-reader multi-case (MRMC) study will be conducted. 415 study exams will be retrospectively obtained through stratified sampling with enrichment to represent all anatomical regions supported by the software. Sixteen independent clinicians representing various clinical roles and years of experience will participate as study readers.
The reference standard will be established by American Board of Radiology (ABR)-certified radiologists with a minimum of 3 years of experience post certification. All exams will be reviewed and annotated by two musculoskeletal (MSK) radiologists, independently. Annotations will be done in a medical-grade reading environment, using diagnostic quality monitors. If required, any disagreement will be adjudicated by a third specialized radiologist.
In both assisted and unassisted sessions, readers will localize every unique fracture, joint dislocation, joint effusion, and lipohemarthrosis. For each finding, readers will provide a bounding box and a confidence score (1-5). Additionally, at the exam level, readers will indicate the presence or absence of each injury type along with a confidence score (0-100).
At the case level, ROC curves will be generated for each reader under both device-assisted and unassisted reading scenarios. The AUC of the ROC curve per reader in each reading scenario, and the difference in the reader-averaged AUC between device-assisted and unassisted reading scenarios will be calculated. The difference in reader-averaged AUC between the two reading scenarios will be reported as the primary outcome to demonstrate improved diagnostic performance of the intended users. Exam-level sensitivity, specificity, and average false positives, and injury-level sensitivity and AUC-AFROC will be presented as secondary outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| device-assisted | – | Diagnostic Test: RBfractureIn the device-assisted modality, study readers will interpret patient X-ray exams with RBfracture assistance. |
| device-unassisted | – | –In the device-unassisted modality, study readers will interpret patient X-ray exams without RBfracture assistance. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- X-ray exams of adult patients suspected of having trauma-related musculoskeletal injuries.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBfractureRBfracture is a decision support software designed to assist the intended user in diagnosing fracture, joint dislocation, joint effusion, and lipohemarthrosis. | Diagnostic test | device-assisted |
Primary outcome
Change in diagnostic accuracy between device-assisted and device-unassisted readers at the exam level.
Time frame: one month
The difference in the reader-averaged AUC between device-assisted and device-unassisted readers is significant at a one-sided p value of 0.025.
3 secondary outcomes
Change in diagnostic accuracy between device-assisted and device-unassisted readers at the exam level.
Time frame: one month
Change in diagnostic accuracy between device-assisted and device-unassisted readers at the injury level.
Time frame: one month
Generalizability of device performance across demographic and technical factors
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture and Joint Dislocation, run by Radiobotics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janitha M Mudannayake, PhD (+46708412511, jm@radiobotics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diagnostic accuracy between device-assisted and device-unassisted readers at the exam level. (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.