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

May 11, 2026 updated by: University Hospital, Montpellier

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetry
Time Frame: 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
Day 0
Dosimetry
Time Frame: 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]
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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