PreHIPEOS: Image Quality of EOSedge for Radiographic Evaluation of Hip Implant

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT05615701

Collaborator

(none)

120

Enrollment

Location

Arm

23.6

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hip Osteoarthritis Hip Prosthesis Infection	Diagnostic Test: EOSedge imaging	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Nov 16, 2022

Anticipated Primary Completion Date :

Nov 3, 2024

Anticipated Study Completion Date :

Nov 3, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	Diagnostic Test: EOSedge imaging Hip X-ray evaluation in an EOSedge imaging for preoperative assessment for hip replacement or revision surgery

Arm

Intervention/Treatment

Other: 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

Diagnostic Test: EOSedge imaging

Hip X-ray evaluation in an EOSedge imaging for preoperative assessment for hip replacement or revision surgery

Outcome Measures

Primary Outcome Measures

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 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 [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 dose × area product (DAP) [Gy.cm2] (dose * area product), for each exposure
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Departement of Medical Imaging	Montpellier	Occitanie	France	34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

Principal Investigator: Catherine c-cyteval@chu-montpellier.fr, MD, PhD, Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital