search
Back to results

Image Quality of EOSedge for Radiographic Evaluation of Hip Implant (PreHIPEOS)

Primary Purpose

Hip Osteoarthritis, Hip Prosthesis Infection

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EOSedge imaging
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hip Osteoarthritis focused on measuring EOS, Radiography, Hip, Hip replacement, Image quality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient 18 years of age or older Came to the imaging department to perform a preoperative assessment for hip replacement or revision Exclusion Criteria: Patient under guardianship or curatorship Patient participating in an interventional study Patient unable to read and/or write

Sites / Locations

  • Departement of Medical Imaging

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EOSedge imaging

Arm Description

Single arm study : All subjects include in the study underwent micro-dose EOS x-ray and digital radiography for radiographic evaluation of hip implant

Outcomes

Primary Outcome Measures

Score of Image quality
Each criteria is quantitative and combined to obtain a final quantitative score : Perfect reproduction = 2 / Moderate reproduction = 1 / Poor or uninterpretable reproduction = 0 Artifacts ? = no or absence of periprosthetic material = 1; YES = 0 X-ray image acceptable ? = Fully acceptable = 2; Acceptable only under limited clinical conditions = 1; Unacceptable (indicate why) = 0; OUTOCOME = FINAL SCORE European C, Directorate-General for R, Innovation, Carmichael J, Moores B, Maccia C. Guide européen relatif aux critères de qualité des clichés de radiodiagnostic: Publications Office, 2000. Kogon PL, Lumsden R. How do you critique your radiographs? The Journal of the Canadian Chiropractic Association. 1993; 37(4):230-232. Cook JV, Kyriou JC, Pettet A, Fitzgerald MC, Shah K, Pablot SM. Key factors in the optimization of paediatric X-ray practice. The British journal of radiology. 2001; 74(887):1032-1040.

Secondary Outcome Measures

Dosimetry
The X-ray exposure dose induced by standard radiography and EOSedge will be compared. The radiation delivered to the patient during standard and EOSedge radiography will be quantified according to the dose × area product (DAP) [Gy.cm2] (dose * area product), for each exposure
Dosimetry
The X-ray exposure dose induced by standard radiography and EOSedge will be compared. The radiation delivered to the patient during standard and EOSedge radiography will be quantified according to the entry dose [mGy]

Full Information

First Posted
October 27, 2022
Last Updated
September 18, 2023
Sponsor
University Hospital, Montpellier
search

1. Study Identification

Unique Protocol Identification Number
NCT05615701
Brief Title
Image Quality of EOSedge for Radiographic Evaluation of Hip Implant
Acronym
PreHIPEOS
Official Title
Image Quality of the EOSedge Radiographic System Versus a Standard Digital Radiographic (DR) System for Preoperative Assessment for Hip Replacement or Revision Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Sufficient number of subjects included for analyzes
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
May 5, 2023 (Actual)
Study Completion Date
May 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

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

5. Study Description

Brief Summary
EOSedge is a precise, low dose imaging system that delivers full body, high-quality images covering the full set of musculoskeletal and orthopedic exams. The objective of the study is to evaluate the quality of the focused pelvis/hip X-ray images on EOSedge compared to those performed on DR (current practice) to perform a preoperative radiographic evaluation of hip implant, A sufficient image quality on focused X-ray images performed on EOSedge would allow (1) to avoid the passage on two different radiographic systems (saving time) (2) to reduce the patient's x-ray radiation dose

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Hip Prosthesis Infection
Keywords
EOS, Radiography, Hip, Hip replacement, Image quality

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EOSedge imaging
Arm Type
Other
Arm Description
Single arm study : All subjects include in the study underwent micro-dose EOS x-ray and digital radiography for radiographic evaluation of hip implant
Intervention Type
Diagnostic Test
Intervention Name(s)
EOSedge imaging
Intervention Description
Hip X-ray evaluation in an EOSedge imaging for preoperative assessment for hip replacement or revision surgery
Primary Outcome Measure Information:
Title
Score of Image quality
Description
Each criteria is quantitative and combined to obtain a final quantitative score : Perfect reproduction = 2 / Moderate reproduction = 1 / Poor or uninterpretable reproduction = 0 Artifacts ? = no or absence of periprosthetic material = 1; YES = 0 X-ray image acceptable ? = Fully acceptable = 2; Acceptable only under limited clinical conditions = 1; Unacceptable (indicate why) = 0; OUTOCOME = FINAL SCORE European C, Directorate-General for R, Innovation, Carmichael J, Moores B, Maccia C. Guide européen relatif aux critères de qualité des clichés de radiodiagnostic: Publications Office, 2000. Kogon PL, Lumsden R. How do you critique your radiographs? The Journal of the Canadian Chiropractic Association. 1993; 37(4):230-232. Cook JV, Kyriou JC, Pettet A, Fitzgerald MC, Shah K, Pablot SM. Key factors in the optimization of paediatric X-ray practice. The British journal of radiology. 2001; 74(887):1032-1040.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Dosimetry
Description
The X-ray exposure dose induced by standard radiography and EOSedge will be compared. The radiation delivered to the patient during standard and EOSedge radiography will be quantified according to the dose × area product (DAP) [Gy.cm2] (dose * area product), for each exposure
Time Frame
Day 0
Title
Dosimetry
Description
The X-ray exposure dose induced by standard radiography and EOSedge will be compared. The radiation delivered to the patient during standard and EOSedge radiography will be quantified according to the entry dose [mGy]
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient 18 years of age or older Came to the imaging department to perform a preoperative assessment for hip replacement or revision Exclusion Criteria: Patient under guardianship or curatorship Patient participating in an interventional study Patient unable to read and/or write
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine c-cyteval@chu-montpellier.fr, MD, PhD
Organizational Affiliation
Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Medical Imaging
City
Montpellier
State/Province
Occitanie
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Learn more about this trial

Image Quality of EOSedge for Radiographic Evaluation of Hip Implant

We'll reach out to this number within 24 hrs