Inverting Grayscale Improves Detection of Proximal Femur Fracture

Diagnoses Disease Clinical Trial

Official title:

Inverting Grayscale in Conventional Orthopedics X-rays Improves Detection of Proximal Femur Fracture Among Undergraduate Medical Students

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05318378
• Other study ID #: BIXAM
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diagnoses Disease
• Femoral Fractures

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