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Image Quality of EOSedge for Radiographic Evaluation of Hip Implant

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05615701
Acronym
PreHIPEOS
Enrollment
97
Registered
2022-11-14
Start date
2022-11-16
Completion date
2023-05-05
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis, Hip Prosthesis Infection

Keywords

EOS, Radiography, Hip, Hip replacement, Image quality

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

Interventions

DIAGNOSTIC_TESTEOSedge imaging

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Score of Image qualityDay 0Each 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

MeasureTime frameDescription
DosimetryDay 0The 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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORCatherine c-cyteval@chu-montpellier.fr, MD, PhD

Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026