Image Quality of EOSedge for Radiographic Evaluation of Hip Implant

Not Applicable

Terminated

• Conditions: Hip Osteoarthritis; Hip Prosthesis Infection
• Interventions: Diagnostic Test: EOSedge imaging

• Registration Number: NCT05615701
• Lead Sponsor: University Hospital, Montpellier

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Study Start: 2022-11-16
• Primary Completion: 2023-05-05
• Study Completion: 2023-05-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EOSedge imaging	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

Primary Outcome Measures

Name	Time	Method
Score of Image quality	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 Outcome Measures

Name	Time	Method
Dosimetry	Day 0	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 \[mGy\]

Trial Locations

Locations (1)

Departement of Medical Imaging; 🇫🇷 Montpellier, Occitanie, France