Fractures, BoneBoneview-EDNCT06013852
Boneview-ED - Impact of Artificial Intelligence Detecting Fractures in the Emergence Department : a Pragmatic Prospective Study
A study testing processing the radiography with the "Boneview" software in people with Fractures, Bone, run by University Hospital, Angers at 1 site in France.
Trial summary
Traumatic emergencies are the primary reason for consultation in emergency departments and standard radiography is the primary imaging exam for osteoarticular trauma. However, with the increase in the number of patients admitted to emergency departments and thus the increased workload for emergency room attendants… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- processing the radiography with the "Boneview" software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2024to 21 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient
- Admitted to the emergency department after trauma less than 48 hours
- Patient with an indication on an x-ray of the limbs or/and pelvis
- Express patient consent
- Affiliated patient or social security beneficiary
Who cannot join
- Polytraumatized patient
- X-ray of the corso-lumbar spine, skull, cervical spine (all parts of the body not affected by the intended use of the software)
- Pregnant, lactating or parturient patient
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Dr Damien COMBES
Angers, Maine Et Loire, 49933
Delphine DOUILLET, Dr, (0)2 41 35 37 15 ext. 33, delphine.douillet@chu-angers.fr
Christophe AUBE, Pr, (0)2 41 35 42 81 ext. 33, ChAube@chu-angers.fr
About this study
Traumatic emergencies are the primary reason for consultation in emergency departments and standard radiography is the primary imaging exam for osteoarticular trauma. However, with the increase in the number of patients admitted to emergency departments and thus the increased workload for emergency room attendants, Interpretation of radiographs in trauma emergencies is made more difficult, resulting in a high risk of misinterpretation.
The growing presence of artificial intelligence in the medical field, notably through the involvement of diagnostic software on imageries, makes its use more relevant in the aid of the replay of osteoarticular imageries.
Read more
A recent meta-analysis of 32 studies evaluating the performance of artificial intelligence in fracture detection found comparable performance between experienced radiologists and AI-based diagnosis. However, these were mainly retrospective studies, and thus more distant from the reality of its use in a care stream such as emergencies.
The objective of this study is therefore to prospectively validate the use of artificial intelligence software during its implementation in an emergency department for patients admitted for a suspicion of osteoarticular trauma.
Read the detailed description
After completing the X-ray requested, the senior emergency physician reads the X-ray (native image only), gives his diagnosis (fracture yes/ no and localization) and reports if he requests the specialist (orthopedist/ radiologist) or not and the reason why he asks for it (urgent management, doubt about a fracture). After processing the radiography with the "Boneview" software, the emergency physician makes a second reading taking into account the analysis of artificial intelligence. It indicates its result and its decision in the same way. Then, he performs the practical management of the patient: specialized call, exit, urgent management.
During the systematic rereading of the radiographs made in the emergency department the night before and night by the radiology intern, he makes a first reading of the native images and gives the result (fracture yes/ no and localization). Then, he makes a second reading assisted by "Boneview" and gives the result again.
A radiologist specialized in osteoarticular imaging will read the radiographs initially native. He will note the result (fracture yes/ no and localization) then read the radiographs annotated by the software. He will give the result again.
For the patient, there will be no additional imaging exams, but the x-ray will be read a secondary time with artificial intelligence assistance. This pet reading causes a change in patient management.
Indeed if a discrepancy is noted between the reading of the radiography by the internal radiology or the conclusion of the emergency physician and the reading of the senior radiologist specialized in osteoarticular imaging, the patient will be recalled and reconvoked to the emergency department if necessary
- Conditions
- Fractures, Bone
- Being tested
- processing the radiography with the "Boneview" software
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
processing the radiography with the "Boneview" softwareDiagnostic test
all X-Rays will be analysed with and without the software
| Study group | Role | What they receive |
|---|---|---|
| Unique arm | Other | Without and with Boneview software use for all included patients Receives: Diagnostic Test: processing the radiography with the "Boneview" software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ER support between X-ray reading without and with artificial intelligence
Compare ER support decisions without and with fracture diagnostic software
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start22 Jul 2024
- Primary completion21 Jan 2025 (estimated)
- Study completion21 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Damien Combes, Dr, Principal investigator, University hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013852
- Sponsor's protocol ID
- 49RC23_0343
- Acronym
- Boneview-ED
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2023
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boneview-ED - Impact of Artificial Intelligence Detecting Fractures in the Emergence Department : a Pragmatic Prospective Study
- ClinicalTrials.gov ID
- NCT06013852
- Acronym / sponsor ID
- Boneview-ED / 49RC23_0343
- Conditions
- Fractures, Bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 21 Jan 2025 (estimated)
- Study completion
- 21 Jan 2025 (estimated)
- First posted
- 28 Aug 2023 (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.
Traumatic emergencies are the primary reason for consultation in emergency departments and standard radiography is the primary imaging exam for osteoarticular trauma. However, with the increase in the number of patients admitted to emergency departments and thus the increased workload for emergency room attendants, Interpretation of radiographs in trauma emergencies is made more difficult, resulting in a high risk of misinterpretation.
The growing presence of artificial intelligence in the medical field, notably through the involvement of diagnostic software on imageries, makes its use more relevant in the aid of the replay of osteoarticular imageries.
A recent meta-analysis of 32 studies evaluating the performance of artificial intelligence in fracture detection found comparable performance between experienced radiologists and AI-based diagnosis. However, these were mainly retrospective studies, and thus more distant from the reality of its use in a care stream such as emergencies.
The objective of this study is therefore to prospectively validate the use of artificial intelligence software during its implementation in an emergency department for patients admitted for a suspicion of osteoarticular trauma.
Detailed description
After completing the X-ray requested, the senior emergency physician reads the X-ray (native image only), gives his diagnosis (fracture yes/ no and localization) and reports if he requests the specialist (orthopedist/ radiologist) or not and the reason why he asks for it (urgent management, doubt about a fracture). After processing the radiography with the "Boneview" software, the emergency physician makes a second reading taking into account the analysis of artificial intelligence. It indicates its result and its decision in the same way. Then, he performs the practical management of the patient: specialized call, exit, urgent management.
During the systematic rereading of the radiographs made in the emergency department the night before and night by the radiology intern, he makes a first reading of the native images and gives the result (fracture yes/ no and localization). Then, he makes a second reading assisted by "Boneview" and gives the result again.
A radiologist specialized in osteoarticular imaging will read the radiographs initially native. He will note the result (fracture yes/ no and localization) then read the radiographs annotated by the software. He will give the result again.
For the patient, there will be no additional imaging exams, but the x-ray will be read a secondary time with artificial intelligence assistance. This pet reading causes a change in patient management.
Indeed if a discrepancy is noted between the reading of the radiography by the internal radiology or the conclusion of the emergency physician and the reading of the senior radiologist specialized in osteoarticular imaging, the patient will be recalled and reconvoked to the emergency department if necessary
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unique arm | Other | Diagnostic Test: processing the radiography with the "Boneview" softwareWithout and with Boneview software use for all included patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major patient
- Admitted to the emergency department after trauma less than 48 hours
- Patient with an indication on an x-ray of the limbs or/and pelvis
- Express patient consent
- Affiliated patient or social security beneficiary
Key exclusion criteria (3 listed)
- Polytraumatized patient
- X-ray of the corso-lumbar spine, skull, cervical spine (all parts of the body not affected by the intended use of the software)
- Pregnant, lactating or parturient patient
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 |
|---|---|---|
| processing the radiography with the "Boneview" softwareall X-Rays will be analysed with and without the software | Diagnostic test | Unique arm |
Primary outcome
Change in ER support between X-ray reading without and with artificial intelligence
Time frame: 1 year
Compare ER support decisions without and with fracture diagnostic software
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Damien Combes, Dr principal investigator
University hospital of Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing processing the radiography with the "Boneview" software in people with Fractures, Bone, run by University Hospital, Angers at 1 site in France.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damien Combes, Dr ((0)2 41 35 42 81 ext. 33, damien.combe@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ER support between X-ray reading without and with artificial intelligence (time frame: 1 year). 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 26 Aug 2024.