Inverting Grayscale Improves Detection of Proximal Femur Fracture

NCT ID: NCT05318378

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-04-30

Brief 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).

Conditions

Diagnoses Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

student

Twenty fifth-year medical students were asked to participate in the study

Group Type: EXPERIMENTAL

BIXAM

Intervention Type: DIAGNOSTIC_TEST

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

senior surgeon

As controls, we asked 3 independent board-certified orthopedic surgeons to participate in the study following the same conditions as described previously.

Group Type: ACTIVE_COMPARATOR

BIXAM

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

BIXAM

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• fifth-year medical students

Exclusion Criteria

• other medical students

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre de l'arthrose, Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

cedric maillot

Role: STUDY_DIRECTOR

APHP

Locations

Aphp

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

cedric maillot, msc

Role: CONTACT

cedric.maillot@aphp.fr

0611789158

Facility Contacts

maillot cedric, msc

Role: primary

0611789158

Other Identifiers

BIXAM

Identifier Type: -

Identifier Source: org_study_id