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

Image Quality of the EOSedge Radiographic System Versus a Standard Digital Radiographic (DR) System for Preoperative Assessment for Hip Replacement or Revision Surgery

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 Overview

• Status: Terminated
• Conditions: Hip Osteoarthritis; Hip Prosthesis Infection
• Intervention / Treatment: Diagnostic test: EOSedge imaging

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine CYTEVAL, MD, PhD; Phone Number: +33 0467338178; Email: c-cyteval@chu-montpellier.fr

Study Locations

• France
  • Occitanie
    • Montpellier, Occitanie, France, 34295
      • Departement of Medical Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

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 SCOREEuropean 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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Hip replacement; Hip; Radiography; EOS; Image quality
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: RECHMPL22_0298

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No