Painful HipRAVIANCT04304742
Radiologist Diagnostic Performance Versus Artificial Intelligence (AI)
An observational study of Painful Hip and Fonctional Impotence After Minor Trauma (Fall), run by University Hospital, Montpellier at 1 site in France.
Trial summary
In France, femoral neck fracture is mainly detected with interpretation of pelvis/hip X-ray imaging (French Health Authority recommandation). However, up to 10% of fractures are not identified or misdiagnosed, especially in patients admitted to the emergency department. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Painful Hip, Fonctional Impotence After Minor Trauma (Fall)
- What is being tested?
- hip standard radiography/ CT scan/ MRI
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 30 Oct 2021
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 60 and older, admitted to emergency department for painful hip/fonctional impotence after minor trauma. Patients take at least a hip radiography
Who may be able to join
- Patients aged 60 and older
- Minor trauma
- Admitted in emergency department for painful hip/fonctional impotence after minor trauma
- Takes at least a hip radiography
Who cannot join
- Painful before the minor trauma
- Important trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study Comparing Radiologist Diagnostic Performance Versus Artificial Intelligence (AI) for Hip Fracture Suspicion in Elderly Patients
In France, femoral neck fracture is mainly detected with interpretation of pelvis/hip X-ray imaging (French Health Authority recommandation).
However, up to 10% of fractures are not identified or misdiagnosed, especially in patients admitted to the emergency department.
Read more
Indeed, radiologists may be subject to excessive work, wich cause the risk of inaccurate on X-rays diagnosis.
The Artificial intelligence (AI) begins study the detection of fratures on medical imaging.
In this retropective study, this technology developed by GLEAMER company is tested to evaluate the detection rate of hip fracture and specifically femoral neck fracture, compared to the radiologist diagnostic, in eldery patients admitted in emergency department.
AI could optimize the diagnostic performance of radiologists (increase of confidence level) and improve the efficiency of suspected fractures sorting from emergency department.
- Being tested
- hip standard radiography/ CT scan/ MRI
- Keywords
- Medical imaging diagnosis, Frature detection, Artificial intelligence, Femoral neck fracture, Hip, X-ray, Radiography
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip standard radiography/ CT scan/ MRIProcedure or surgery
hip standard radiography/ CT scan/ MRI
| Study group | Role | What they receive |
|---|---|---|
| Suspicion of hip fracture | Suspicion of hip fracture Receives: Procedure: hip standard radiography/ CT scan/ MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of femoral neck fracture
Detection rate of femoral neck fracture
Measured: 1 day
Secondary outcomes (1)
Detection rate of other hip fracture
Detection rate of other hip fracture
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Mar 2020
- Primary completion1 Apr 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful HipStudies 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine CYTEVAL, MD.PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304742
- Sponsor's protocol ID
- RECHMPL20_0126
- Acronym
- RAVIA
- Status last verified
- Apr 2022
- First submitted
- 9 Mar 2020
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study Comparing Radiologist Diagnostic Performance Versus Artificial Intelligence (AI) for Hip Fracture Suspicion in Elderly Patients
- ClinicalTrials.gov ID
- NCT04304742
- Acronym / sponsor ID
- RAVIA / RECHMPL20_0126
- Keywords
- Medical imaging diagnosis, Frature detection, Artificial intelligence, Femoral neck fracture, Hip, X-ray, Radiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 11 Mar 2020 (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.
In France, femoral neck fracture is mainly detected with interpretation of pelvis/hip X-ray imaging (French Health Authority recommandation).
However, up to 10% of fractures are not identified or misdiagnosed, especially in patients admitted to the emergency department.
Indeed, radiologists may be subject to excessive work, wich cause the risk of inaccurate on X-rays diagnosis.
The Artificial intelligence (AI) begins study the detection of fratures on medical imaging.
In this retropective study, this technology developed by GLEAMER company is tested to evaluate the detection rate of hip fracture and specifically femoral neck fracture, compared to the radiologist diagnostic, in eldery patients admitted in emergency department.
AI could optimize the diagnostic performance of radiologists (increase of confidence level) and improve the efficiency of suspected fractures sorting from emergency department.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicion of hip fracture | – | Procedure: hip standard radiography/ CT scan/ MRISuspicion of hip fracture |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 60 and older, admitted to emergency department for painful hip/fonctional impotence after minor trauma. Patients take at least a hip radiography
Key inclusion criteria (4 listed)
- Patients aged 60 and older
- Minor trauma
- Admitted in emergency department for painful hip/fonctional impotence after minor trauma
- Takes at least a hip radiography
Key exclusion criteria (2 listed)
- Painful before the minor trauma
- Important trauma
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 |
|---|---|---|
| hip standard radiography/ CT scan/ MRIhip standard radiography/ CT scan/ MRI | Procedure or surgery | Suspicion of hip fracture |
Primary outcome
Detection rate of femoral neck fracture
Time frame: 1 day
Detection rate of femoral neck fracture
1 secondary outcome
Detection rate of other hip fracture
Time frame: 1 day
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 14 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
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.
Catherine CYTEVAL, MD.PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Painful Hip and Fonctional Impotence After Minor Trauma (Fall), run by University Hospital, Montpellier 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 2 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 14 Apr 2022. 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?
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?
Detection rate of femoral neck fracture (time frame: 1 day). 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 14 Apr 2022; AzTrials last refreshed its copy on 27 Oct 2026.