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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05318378
Other study ID # BIXAM
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 31, 2022
Est. completion date April 30, 2022

Study information

Verified date March 2022
Source Centre de l'arthrose, Paris
Contact cedric maillot, msc
Phone 0611789158
Email cedric.maillot@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date April 30, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - fifth-year medical students Exclusion Criteria: - other medical students

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
BIXAM
Series two consisted of inverted and conventional X-rays of the same subject (BIXAM) shown together

Locations

Country Name City State
France Aphp Paris

Sponsors (1)

Lead Sponsor Collaborator
Centre de l'arthrose, Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary accuracy accuracy was compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test one month
Primary Sensibility, specificity, Sensibility, specificity were compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test one month
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