Inverting Grayscale Improves Detection of Proximal Femur Fracture

Sponsor

Centre de l'arthrose, Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT05318378

Collaborator

(none)

Enrollment

Location

Arms

2.9

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Diagnoses Disease	Diagnostic Test: BIXAM	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

We built two series of images. Series one was composed of separated conventional and inverted images. Series two consisted of inverted and conventional X-rays of the same subject (BIXAM) shown together (Figure). An independent assessor randomly duplicated four and two images for series one and two, respectively, to evaluate the intra-observer agreement. The same assessor randomized the images' order of appearance for the two series with a free online available list randomizer (www.randomizer.org). The principal investigator was blinded to the randomization during the sessions.

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 31, 2022

Actual Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: student Twenty fifth-year medical students were asked to participate in the study	Diagnostic Test: BIXAM Series two consisted of inverted and conventional X-rays of the same subject (BIXAM) shown together
Active Comparator: senior surgeon 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

Arm

Intervention/Treatment

Experimental: student

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

Diagnostic Test: BIXAM

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

Active Comparator: senior surgeon

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

Outcome Measures

Primary Outcome Measures

accuracy [one month]
accuracy was compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test
Sensibility, specificity, [one month]
Sensibility, specificity were compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

fifth-year medical students

Exclusion Criteria:

other medical students

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aphp	Paris		France	75018

Sponsors and Collaborators

Centre de l'arthrose, Paris

Investigators

Study Director: cedric maillot, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre de l'arthrose, Paris

ClinicalTrials.gov Identifier:

NCT05318378

Other Study ID Numbers:

BIXAM

First Posted:

Apr 8, 2022

Last Update Posted:

Apr 8, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Femoral Fractures

Study Results

No Results Posted as of Apr 8, 2022