Fractures, BoneFRACPEDNCT05187585
Assessment of the Contribution of an Artificial Intelligence Tool to Help the Diagnosis of Limb Fractures in Pediatric Emergencies
A study testing radiograph interpretation without the support of the RAYVOLVE app and radiograph interpretation with the support of the RAYVOLVE app in people with Fractures, Bone, run by Fondation Lenval at 1 site in France.
Trial summary
Limb fracture is a common pathology in children. It represents the first complaint in traumatology among children in developed countries. Failure to diagnose a fracture can have severe consequences in pediatric patients with growing bones, that can lead to delayed treatment, pain and poor functional recovery. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- radiograph interpretation without the support of the RAYVOLVE app and radiograph interpretation with the support of the RAYVOLVE app
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2022to 17 Feb 2024
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children under 18
- Showing signs that may suggest a limb fracture and justifying the realization of an X-ray (trauma with pain, deformation, edema, wound)
- Written informed consent from one of the two parents or the holder of parental authority signed
- Beneficiaries or members of a Health Insurance scheme
Who cannot join
- A sign (s) of vital distress
- Any other reason than that of a suspected limb fracture
- A diagnosis of a limb fracture before its management in the emergency room (x-ray made in pre-hospital)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Contribution of an Artificial Intelligence Tool to Help the Diagnosis of Limb Fractures in Pediatric Emergencies : an Interventional, Prospective, Single-center Study
Limb fracture is a common pathology in children. It represents the first complaint in traumatology among children in developed countries. Failure to diagnose a fracture can have severe consequences in pediatric patients with growing bones, that can lead to delayed treatment, pain and poor functional recovery.
X-ray is the first tool used by doctors to diagnose a fracture. However, the diagnosis of fracture in the emergency room can be challenging. Most images are interpreted and processed by emergency pediatricians before being reviewed by radiologists (most often the day after).
Read more
Previous studies have reported the rate of misdiagnosis in fracture by emergency physicians from 5% to 15%.
A tool to investigate in diagnosing limb fractures could be helpful for any emergency physicians exposed to this condition
Read the detailed description
Limb fracture is a common pathology in children with trauma. It represents the first complaint in traumatology among children in developed countries.
Failure to diagnose a fracture on an X-ray can have severe consequences in pediatric patients, with growing bones, that can lead to delayed treatment, pain and poor functional recovery (with risk of bone deformity and bad consolidation).
X-ray is the first tool used by doctors to diagnose a fracture. However, the diagnosis of fracture in the emergency room can be challenging. Most images are interpreted and processed by both residents and pediatricians before the radiologists proofread (most often the day after).
Previous studies have reported the rate of misdiagnosis in fracture by emergency physicians from 5 to 15%.
A tool to investigate in diagnosing limb fractures could be helpful for any clinician exposed to this condition.
Artificial intelligence (AI) in medicine is booming and has already proven its worth, in terms of prevention, monitoring and diagnosis.
AZMED has created RAYVOLVE®, a deep learning algorithm to help physicians in diagnosing fractures. The RAYVOLVE® tool connects to the PACS (Picture Archiving and Communication System) of any hospital and indicates, using a frame, the location of a potential fracture.
The tool has not yet been validated in pediatric patients.
The purpose of this research project is to evaluate the contribution of this artificial intelligence-based tool in the diagnosis of limb fracture in pediatric population.
The investigators will study the concordance in diagnosing limb fracture between the junior emergency physicians using the RAYVOLVE® application and senior radiologists, as the gold standard.
- Conditions
- Fractures, Bone
- Being tested
- radiograph interpretation without the support of the RAYVOLVE app, radiograph interpretation with the support of the RAYVOLVE app
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiograph interpretation without the support of the RAYVOLVE appDiagnostic test
Phase 1 does not involve any intervention: residents, emergency physicians, and radiologists will interpret the x-rays without the support of the RAYVOLVE application.
The emergency physician interprets the x-ray and manage the case as per protocol, all the x-rays will be reinterpreted by the radiologist only later, usually the day after. In case of missed fractures, the physician is notified of the error by the radiologist, and patients will be informed and recalled to the hospital to be reevaluated.
radiograph interpretation with the support of the RAYVOLVE appDiagnostic test
The residents interpret the X-ray with the RAYVOLVE application's support and indicate the presence or not of a fracture without sharing it with the senior emergency physician. A senior emergency physician manages the case as usual, and all the x-rays will be reinterpreted by the radiologist only later, usually the day after. In case of missed fractures, the physician is notified of the error by the radiologist, and patients will be informed and recalled to the hospital to be reevaluated
| Study group | Role | What they receive |
|---|---|---|
| radiograph interpretation without the support of the RAYVOLVE app | Sham comparator | Not described Receives: Diagnostic Test: radiograph interpretation without the support of the RAYVOLVE app |
| radiograph interpretation with the support of the RAYVOLVE app | Experimental | Not described Receives: Diagnostic Test: radiograph interpretation with the support of the RAYVOLVE app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis fracture with Rayvolve app compare to gold standard
Assess the statistical concordance between residents using the RAYVOLVE application tool and senior radiologists in diagnosing fractures of the extremities, as gold standard.
Criteria: binary: fracture Yes/No
Measured: at inclusion
Secondary outcomes (4)
Diagnosis fracture with Rayvolve app compare to diagnosis done by physicians
Assess the statistical concordance between residents using the RAYVOLVE application tool and pediatric emergency physicians in diagnosing fractures of the extremities Criteria: binary: fracture Yes/No
Measured: at inclusion
Diagnosis fracture without Rayvolve app compare to diagnosis done by physicians
Assess the statistical concordance between residents not using the RAYVOLVE application tool and pediatric emergency physicians in diagnosing fractures of the extremities Criteria: binary: presence or no fracture
Measured: at inclusion
collection of patient data to define risk factors associated with the discrepancy between residents using the RAYVOLVE application tool and senior radiologists not using the application
collection patient data such as patient's age, fracture location, fracture type, number of fractures, day and time of diagnosis. The goal is to define potential risk factors to explain diagnostic differences between residents and primary radiologists
Measured: at inclusion
satisfaction of the residents using the application assessed by Likert scale
measure of satisfaction by an in-house Likert scale: consisting of 4 questions with multiple choice answers on the use and ergonomics of the application. The answers range from not at all satisfied to very satisfied.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start10 Feb 2022
- Primary completion17 Feb 2024
- Study completion17 Feb 2024
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187585
- Sponsor's protocol ID
- 21-HPNCL-06
- Acronym
- FRACPED
- Status last verified
- Mar 2025
- First submitted
- 14 Dec 2021
- Last updated
- 1 Apr 2025
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Contribution of an Artificial Intelligence Tool to Help the Diagnosis of Limb Fractures in Pediatric Emergencies : an Interventional, Prospective, Single-center Study
- ClinicalTrials.gov ID
- NCT05187585
- Acronym / sponsor ID
- FRACPED / 21-HPNCL-06
- Conditions
- Fractures, Bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 17 Feb 2024 (actual)
- Study completion
- 17 Feb 2024 (actual)
- First posted
- 12 Jan 2022 (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.
Limb fracture is a common pathology in children. It represents the first complaint in traumatology among children in developed countries. Failure to diagnose a fracture can have severe consequences in pediatric patients with growing bones, that can lead to delayed treatment, pain and poor functional recovery.
X-ray is the first tool used by doctors to diagnose a fracture. However, the diagnosis of fracture in the emergency room can be challenging. Most images are interpreted and processed by emergency pediatricians before being reviewed by radiologists (most often the day after).
Previous studies have reported the rate of misdiagnosis in fracture by emergency physicians from 5% to 15%.
A tool to investigate in diagnosing limb fractures could be helpful for any emergency physicians exposed to this condition
Detailed description
Limb fracture is a common pathology in children with trauma. It represents the first complaint in traumatology among children in developed countries.
Failure to diagnose a fracture on an X-ray can have severe consequences in pediatric patients, with growing bones, that can lead to delayed treatment, pain and poor functional recovery (with risk of bone deformity and bad consolidation).
X-ray is the first tool used by doctors to diagnose a fracture. However, the diagnosis of fracture in the emergency room can be challenging. Most images are interpreted and processed by both residents and pediatricians before the radiologists proofread (most often the day after).
Previous studies have reported the rate of misdiagnosis in fracture by emergency physicians from 5 to 15%.
A tool to investigate in diagnosing limb fractures could be helpful for any clinician exposed to this condition.
Artificial intelligence (AI) in medicine is booming and has already proven its worth, in terms of prevention, monitoring and diagnosis.
AZMED has created RAYVOLVE®, a deep learning algorithm to help physicians in diagnosing fractures. The RAYVOLVE® tool connects to the PACS (Picture Archiving and Communication System) of any hospital and indicates, using a frame, the location of a potential fracture.
The tool has not yet been validated in pediatric patients.
The purpose of this research project is to evaluate the contribution of this artificial intelligence-based tool in the diagnosis of limb fracture in pediatric population.
The investigators will study the concordance in diagnosing limb fracture between the junior emergency physicians using the RAYVOLVE® application and senior radiologists, as the gold standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiograph interpretation without the support of the RAYVOLVE app | Sham comparator | Diagnostic Test: radiograph interpretation without the support of the RAYVOLVE app |
| radiograph interpretation with the support of the RAYVOLVE app | Experimental | Diagnostic Test: radiograph interpretation with the support of the RAYVOLVE app |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children under 18
- Showing signs that may suggest a limb fracture and justifying the realization of an X-ray (trauma with pain, deformation, edema, wound)
- Written informed consent from one of the two parents or the holder of parental authority signed
- Beneficiaries or members of a Health Insurance scheme
Key exclusion criteria (3 listed)
- A sign (s) of vital distress
- Any other reason than that of a suspected limb fracture
- A diagnosis of a limb fracture before its management in the emergency room (x-ray made in pre-hospital)
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 |
|---|---|---|
| radiograph interpretation without the support of the RAYVOLVE appPhase 1 does not involve any intervention: residents, emergency physicians, and radiologists will interpret the x-rays without the support of the RAYVOLVE application. The emergency physician interprets the x-ray and manage the case as per protocol, all the x-rays will be reinterpreted by the radiologist only later, usually the day after. In case of missed fractures, the physician is notified of the error by the radiologist, and patients will be informed and recalled to the hospital to be reevaluated. | Diagnostic test | radiograph interpretation without the support of the RAYVOLVE app |
| radiograph interpretation with the support of the RAYVOLVE appThe residents interpret the X-ray with the RAYVOLVE application's support and indicate the presence or not of a fracture without sharing it with the senior emergency physician. A senior emergency physician manages the case as usual, and all the x-rays will be reinterpreted by the radiologist only later, usually the day after. In case of missed fractures, the physician is notified of the error by the radiologist, and patients will be informed and recalled to the hospital to be reevaluated | Diagnostic test | radiograph interpretation with the support of the RAYVOLVE app |
Primary outcome
Diagnosis fracture with Rayvolve app compare to gold standard
Time frame: at inclusion
Assess the statistical concordance between residents using the RAYVOLVE application tool and senior radiologists in diagnosing fractures of the extremities, as gold standard. Criteria: binary: fracture Yes/No
4 secondary outcomes
Diagnosis fracture with Rayvolve app compare to diagnosis done by physicians
Time frame: at inclusion
Diagnosis fracture without Rayvolve app compare to diagnosis done by physicians
Time frame: at inclusion
collection of patient data to define risk factors associated with the discrepancy between residents using the RAYVOLVE application tool and senior radiologists not using the application
Time frame: at inclusion
satisfaction of the residents using the application assessed by Likert scale
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiograph interpretation without the support of the RAYVOLVE app and radiograph interpretation with the support of the RAYVOLVE app in people with Fractures, Bone, run by Fondation Lenval 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 4 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: finished, as of the sponsor's last update on 1 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis fracture with Rayvolve app compare to gold standard (time frame: at inclusion). 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 1 Apr 2025.