Image Quality of the EOSedge Radiographic System Versus a Standard Digital Radiographic (DR) System for Preoperative Assessment for Hip Replacement or Revision Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 97
- Locations
- 2
- Primary Endpoint
- Score of Image quality
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
EOSedge imaging
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: EOSedge imaging (Diagnostic Test)
Outcomes
Primary Outcomes
Score of Image quality
Time Frame: Day 0
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 1. 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. 2. Kogon PL, Lumsden R. How do you critique your radiographs? The Journal of the Canadian Chiropractic Association. 1993; 37(4):230-232. 3. 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 Outcomes
- Dosimetry(Day 0)