An interventional study of BIXAM in Diagnoses Disease, sponsored by Centre de l'arthrose, Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by Centre de l'arthrose, Paris · Not applicable, Interventional, and Diagnostic
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).
293 studies on the registry are indexed under Femoral Fractures; 47 are open to participants now.
This study's planned enrollment of 20 is below the median of 64 across 182 interventional studies indexed under Femoral Fractures.
Browse Femoral Fractures studies →Centre de l'arthrose, Paris is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Twenty fifth-year medical students were asked to participate in the study
Diagnostic Test: BIXAM
As controls, we asked 3 independent board-certified orthopedic surgeons to participate in the study following the same conditions as described previously.
Diagnostic Test: BIXAM
Series two consisted of inverted and conventional X-rays of the same subject (BIXAM) shown together
accuracy
accuracy was compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test
Time frame: 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
Time frame: one month
Plan to share: No
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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Centre de l'arthrose, Paris