Diagnoses DiseaseNCT05318378
Inverting Grayscale Improves Detection of Proximal Femur Fracture
A study testing BIXAM in people with Diagnoses Disease, run by Centre de l'arthrose, Paris at 1 site in France.
Trial summary
Proximal femur fractures (PFF) are a worldwide public health concern. A delay in the diagnosis and treatment worsens the prognosis. Inversion of grayscale is a tool available on most X-rays visualization software, and its use has been suggested to improve radiological diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnoses Disease
- What is being tested?
- BIXAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2022to 30 Apr 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fifth-year medical students
Who cannot join
- other medical students
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Aphp
Paris, 75018
maillot cedric, msc, 0611789158
About this study
Official title: Inverting Grayscale in Conventional Orthopedics X-rays Improves Detection of Proximal Femur Fracture Among Undergraduate Medical Students
Proximal femur fractures (PFF) are a worldwide public health concern. A delay in the diagnosis and treatment worsens the prognosis. Inversion of grayscale is a tool available on most X-rays visualization software, and its use has been suggested to improve radiological diagnosis. The study aims to determine if using inverted grayscale radiography results in better diagnoses of PFF among medical students.
Material and Methods. The investigators evaluated the detection of PFF by fifth-year medical students on a series of 30 pelvis X-rays. The series was composed of 20 X-rays with PFF and 10 X-rays without fracture. A first reading session was set up where X-rays were presented separately in conventional and inverted grayscale. A second session one month later showed both grayscale visualizations together (BIcontrast X-rays Analysis Method - BIXAM). X-rays' order of appearance was randomized. The investigators performed the same evaluation on senior orthopedic surgeons as a control. Finally, sensitivity, specificity, and accuracy were assessed for each method (conventional, inverted, and BIXAM) with the McNemar test. Subgroup analyses were performed on the fracture localization (femoral neck, trochanteric).
- Conditions
- Diagnoses Disease
- Being tested
- BIXAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIXAMDiagnostic test
Series two consisted of inverted and conventional X-rays of the same subject (BIXAM) shown together
| Study group | Role | What they receive |
|---|---|---|
| student | Experimental | Twenty fifth-year medical students were asked to participate in the study Receives: Diagnostic Test: BIXAM |
| senior surgeon | Active comparator | As controls, we asked 3 independent board-certified orthopedic surgeons to participate in the study following the same conditions as described previously. Receives: Diagnostic Test: BIXAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy
accuracy was compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test
Measured: one month
Sensibility, specificity,
Sensibility, specificity were compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test
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 posted8 Apr 2022
- Study start31 Jan 2022
- Primary completion31 Mar 2022
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnoses DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de l'arthrose, Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- cedric maillot, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318378
- Sponsor's protocol ID
- BIXAM
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- 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 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inverting Grayscale in Conventional Orthopedics X-rays Improves Detection of Proximal Femur Fracture Among Undergraduate Medical Students
- ClinicalTrials.gov ID
- NCT05318378
- Acronym / sponsor ID
- BIXAM
- Conditions
- Diagnoses Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre de l'arthrose, ParisUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 8 Apr 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.
Proximal femur fractures (PFF) are a worldwide public health concern. A delay in the diagnosis and treatment worsens the prognosis. Inversion of grayscale is a tool available on most X-rays visualization software, and its use has been suggested to improve radiological diagnosis. The study aims to determine if using inverted grayscale radiography results in better diagnoses of PFF among medical students.
Material and Methods. The investigators evaluated the detection of PFF by fifth-year medical students on a series of 30 pelvis X-rays. The series was composed of 20 X-rays with PFF and 10 X-rays without fracture. A first reading session was set up where X-rays were presented separately in conventional and inverted grayscale. A second session one month later showed both grayscale visualizations together (BIcontrast X-rays Analysis Method - BIXAM). X-rays' order of appearance was randomized. The investigators performed the same evaluation on senior orthopedic surgeons as a control. Finally, sensitivity, specificity, and accuracy were assessed for each method (conventional, inverted, and BIXAM) with the McNemar test. Subgroup analyses were performed on the fracture localization (femoral neck, trochanteric).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| student | Experimental | Diagnostic Test: BIXAMTwenty fifth-year medical students were asked to participate in the study |
| senior surgeon | Active comparator | Diagnostic Test: BIXAMAs controls, we asked 3 independent board-certified orthopedic surgeons to participate in the study following the same conditions as described previously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- fifth-year medical students
Key exclusion criteria (1 listed)
- other medical students
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 |
|---|---|---|
| BIXAMSeries two consisted of inverted and conventional X-rays of the same subject (BIXAM) shown together | Diagnostic test | senior surgeon, student |
Primary outcome
accuracy
Time frame: one month
accuracy was compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test
Sensibility, specificity,
Time frame: one month
Sensibility, specificity were compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- 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.
cedric maillot study director
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIXAM in people with Diagnoses Disease, run by Centre de l'arthrose, Paris 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 1 inclusion and 1 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 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cedric maillot, msc (0611789158, cedric.maillot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy (time frame: one month). The study lists 2 primary outcomes in all. 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 8 Apr 2022.