AI-Assisted Fracture Detection in Emergency Radiography (FAIR)

August 13, 2026 updated by: Martin Breitwieser, Salzburger Landeskliniken

Artificial Intelligence-Assisted Fracture Detection in Emergency Radiography: A Multicentre Pragmatic Randomised Controlled Trial

This study evaluates whether artificial intelligence (AI) can support doctors who interpret X-rays for suspected fractures in emergency care.

In the participating hospitals, X-rays are usually interpreted first by the frontline treating physician, while the formal radiology report is generally available later and not before the patient leaves the emergency department. AI may therefore provide an immediate additional assessment while clinical decisions are being made.

Patients were randomly assigned to one of two groups. In the AI-assisted group, physicians interpreted the X-rays with support from an AI system. In the control group, physicians interpreted the same type of X-rays without AI support. All final diagnoses and treatment decisions remained with the treating physician.

The main question is whether AI assistance affects the time from triage to completion of emergency department treatment. The study also evaluates whether AI influences physician diagnostic confidence, the use of additional imaging, missed fractures, and diagnostic accuracy.

The study includes patients aged 2 years or older presenting after trauma with a suspected fracture requiring X-ray imaging. No additional imaging or treatment was required solely because of study participation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The FAIR (Fracture detection with AI in emergency Radiography) Trial is a prospective, international, multicentre, pragmatic randomized controlled trial evaluating the clinical impact of AI-assisted interpretation of emergency radiographs.

The study was conducted at three hospitals in Austria and Germany: University Hospital Salzburg, Regional Hospital Hallein, and University Hospital Nuremberg.

Clinical setting

In the participating departments, plain radiographs of patients with suspected fractures are routinely interpreted by frontline orthopaedic trauma or paediatric physicians, who make immediate diagnostic and treatment decisions. Formal radiology reports are generally available later and are usually not available before completion of the emergency department encounter.

The study therefore evaluates AI as an immediate diagnostic decision-support tool during the period in which frontline physicians make clinical decisions, rather than as a replacement for formal radiological interpretation.

Study design

Eligible patient encounters were randomized in a 1:1 ratio to one of two parallel groups:

Control group: radiographs were interpreted by the treating physician without access to AI output.

AI-assisted group: radiographs were interpreted by the treating physician with access to real-time AI output.

The randomization sequence was generated by the trial statistician as one global sequence. Allocation was concealed during recruitment using folded sequential study forms on which only the study number was visible on the front and the treatment allocation was printed on the reverse. Allocation was revealed after radiography, when the triage nurse opened the study form and directed the patient to the corresponding treatment pathway.

All final diagnoses, decisions regarding additional imaging, treatment decisions, and discharge decisions remained the responsibility of the treating physician.

AI intervention

The AI system used was BoneView version 2.3.8 (Gleamer, Paris, France). BoneView analyzes DICOM radiographs and provides visual annotations and classifications for supported musculoskeletal findings.

In addition to fracture-related findings, other BoneView outputs supported by the system, including dislocations, joint effusions, and focal bone lesions, could be visible to physicians in the AI-assisted group. However, the main clinical outcomes of the FAIR Trial focus on fracture-related emergency care.

At University Hospital Salzburg and Regional Hospital Hallein, BoneView was provided through the Aidoc aiOS platform. At University Hospital Nuremberg, BoneView was integrated directly into the local imaging workflow.

Participating physicians received standardized onboarding consisting of a lecture and practical demonstration of the AI system before study implementation.

Study population

Patients were eligible if they were aged 2 years or older, presented after trauma with a suspected fracture requiring plain radiography, and had an injury involving a single anatomical region within the supported scope of the AI system.

Major exclusions included injuries involving multiple anatomical regions, head or cervical spine injuries, previous imaging or medical assessment for the same injury, contraindications to X-ray imaging, and lack of informed consent.

The unit of observation is the patient encounter. The same individual could therefore participate more than once if they presented with separate and unrelated injuries during the study period.

Outcomes

During ongoing recruitment in March 2026, following methodological review and before comparative outcome analysis, the outcome hierarchy was revised to prioritize patient- and physician-centered measures of clinical utility.

The primary outcome is time from triage to completion of emergency department treatment.

Key secondary outcomes include:

physician diagnostic confidence; additional imaging requested during the index emergency department encounter.

Secondary clinical outcomes include:

missed fractures; diagnostic performance compared with an expert-adjudicated reference standard, including sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.

The originally registered outcome hierarchy placed greater emphasis on diagnostic performance. The registry record was not updated at the time of the March 2026 methodological revision and is being updated retrospectively to reflect the final analysis plan.

Reference standard

The reference standard for whether a fracture was visible on the index radiograph is established through expert review by a senior radiologist and a senior orthopaedic trauma surgeon. Reviewers can use the available imaging and clinical information when adjudicating each case.

The adjudication specifically determines whether a fracture was visible on the original radiograph. A fracture identified on subsequent CT or other imaging but considered occult on the original radiograph is therefore classified as no fracture visible on the index radiograph.

Disagreements between the two reviewers are resolved by discussion. If consensus cannot be reached, a third expert reviewer determines the final classification.

Study duration

Patient recruitment was conducted during predefined study periods between October 2025 and April 2026. Recruitment ended after completion of the planned site-specific recruitment periods and the available funded period of AI access, rather than because of observed treatment effects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1667

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Hallein, Austria, 5400
        • Landesklinik Hallein, Salzburger Landeskliniken
      • Salzburg, Austria, 5020
        • University Hospital Salzburg, Salzburger Landeskliniken
  • Germany
      • Nuremberg, Germany, 90471
        • University Hosptial Nuremberg, Klinikum Nürnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 2 years or older.
  • Presentation to the emergency department following trauma requiring plain radiographic imaging.
  • Injury involving a single anatomical region within the supported anatomical scope of the AI system.
  • Written informed consent provided by the participant or legally authorized representative, with age-appropriate assent where applicable.

Exclusion Criteria:

  • Age younger than 2 years.
  • Injuries involving multiple anatomical regions.
  • Head or cervical spine injuries.
  • Previous radiographic imaging or medical assessment for the same injury before the index presentation.
  • Contraindication to X-ray imaging, including pregnancy.
  • Lack of informed consent.

Reduced image quality was not an exclusion criterion. Multiple fractures within the same anatomical injury region were eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard Radiograph Interpretation Without AI
Plain radiographs are interpreted by the frontline treating physician according to routine clinical practice without access to AI output. All diagnostic, imaging, treatment, consultation, and discharge decisions remain the responsibility of the treating physician. Formal radiology reports are generally available later and are not routinely available before completion of the emergency department encounter.
Experimental: AI-Assisted Radiograph Interpretation
Plain radiographs are interpreted by the frontline treating physician with access to real-time output from BoneView version 2.3.8 (Gleamer, Paris, France). The AI output is used as diagnostic decision support only; all final diagnostic, imaging, treatment, consultation, and discharge decisions remain the responsibility of the treating physician.
Diagnostic test: BoneView AI-Assisted Radiograph Interpretation

BoneView version 2.3.8 (Gleamer, Paris, France) analyzes DICOM radiographs and provides real-time visual annotations and classifications for supported musculoskeletal abnormalities. Physicians in the intervention group could view fracture-related findings as well as other supported outputs, including dislocations, joint effusions, and focal bone lesions.

At University Hospital Salzburg and Regional Hospital Hallein, BoneView was delivered through the Aidoc aiOS platform (version 3.24.0). At University Hospital Nuremberg, BoneView was integrated directly into the local imaging workflow.

BoneView was used as a decision-support tool and did not replace physician interpretation or the subsequent formal radiology report.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of Fracture/Dislocation/Effusion/Bone Lesion Detection
Time Frame: At the time of initial diagnosis, within 2 hours of patient presentation to the orthopedic emergency unit
The primary outcome measures the diagnostic accuracy of detecting broken bones/dislocations/effusions/bone lesions using sensitivity, specificity, and the area under the receiver operating characteristic curve (AUC). Diagnostic accuracy will be compared between the AI-assisted diagnostic approach and the standard physician-only approach. The gold standard for comparison will be determined by expert consensus based on independent review by a radiologist and an orthopedic specialist.
At the time of initial diagnosis, within 2 hours of patient presentation to the orthopedic emergency unit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Diagnosis
Time Frame: During the patient's emergency department visit, typically within 4 hours of presentation.
The time required to establish a diagnosis, measured from the moment the patient undergoes X-ray imaging to the time the final diagnosis is recorded. This will compare the efficiency of the AI-assisted diagnostic workflow with the standard physician-only workflow.
During the patient's emergency department visit, typically within 4 hours of presentation.
Physician Diagnostic Confidence
Time Frame: Measured immediately after the diagnosis
The level of confidence reported by physicians in their diagnostic decisions, measured on a Likert scale (1-10). This will compare how confident physicians feel when using AI assistance versus relying solely on their expertise.
Measured immediately after the diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Salzburger Landeskliniken

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Klinikum Nürnberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KI-FRACTURE_001_2024-11-27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in the primary publication will be made available to qualified researchers upon reasonable written request.

Shared data may include participant demographics, anatomical injury region, frontline physician diagnosis, AI findings, expert-adjudicated reference-standard findings, diagnostic confidence, additional imaging, and timing data used to derive the primary endpoint.

Data will be shared only for scientifically justified research purposes following review and approval of the proposed project by the study investigators and execution of an appropriate data-sharing agreement. Data sharing will comply with applicable institutional requirements, the General Data Protection Regulation (GDPR), and relevant Austrian and German data-protection legislation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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