Image Quality of EOSedge for Radiographic Evaluation of Hip Implant

Study Overview
=================
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

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

Conditions
-----------------
Hip Osteoarthritis, Hip Prosthesis Infection

Intervention / Treatment
-----------------
* Diagnostic Test: EOSedge imaging


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EOSedge imaging<br>Single arm study : All subjects include in the study underwent micro-dose EOS x-ray and digital radiography for radiographic evaluation of hip implant | Diagnostic Test: EOSedge imaging<br>* Hip X-ray evaluation in an EOSedge imaging for preoperative assessment for hip replacement or revision surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 0 | 
| 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] | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EOS, Radiography, Hip, Hip replacement, Image quality