search
Back to results

Inverting Grayscale Improves Detection of Proximal Femur Fracture

Primary Purpose

Diagnoses Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BIXAM
Sponsored by
Centre de l'arthrose, Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diagnoses Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • fifth-year medical students

Exclusion Criteria:

  • other medical students

Sites / Locations

  • AphpRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

student

senior surgeon

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 30, 2022
Last Updated
April 7, 2022
Sponsor
Centre de l'arthrose, Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT05318378
Brief Title
Inverting Grayscale Improves Detection of Proximal Femur Fracture
Official Title
Inverting Grayscale in Conventional Orthopedics X-rays Improves Detection of Proximal Femur Fracture Among Undergraduate Medical Students
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre de l'arthrose, Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnoses Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
student
Arm Type
Experimental
Arm Description
Twenty fifth-year medical students were asked to participate in the study
Arm Title
senior surgeon
Arm Type
Active Comparator
Arm Description
As controls, we asked 3 independent board-certified orthopedic surgeons to participate in the study following the same conditions as described previously.
Intervention Type
Diagnostic Test
Intervention Name(s)
BIXAM
Intervention Description
Series two consisted of inverted and conventional X-rays of the same subject (BIXAM) shown together
Primary Outcome Measure Information:
Title
accuracy
Description
accuracy was compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test
Time Frame
one month
Title
Sensibility, specificity,
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: fifth-year medical students Exclusion Criteria: other medical students
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
cedric maillot, msc
Phone
0611789158
Email
cedric.maillot@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
cedric maillot
Organizational Affiliation
APHP
Official's Role
Study Director
Facility Information:
Facility Name
Aphp
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
maillot cedric, msc
Phone
0611789158

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Inverting Grayscale Improves Detection of Proximal Femur Fracture

We'll reach out to this number within 24 hrs