Image Quality of EOSedge for Radiographic Evaluation of Hip Implant

Hip Osteoarthritis Clinical Trial

— PreHIPEOS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05615701
• Other study ID #: RECHMPL22_0298
• Status: Terminated
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: May 5, 2023

Study information

• Verified date: September 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: May 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Hip Prosthesis Infection
• Osteoarthritis, Hip

Intervention

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

Locations

Country	Name	City	State
France	Departement of Medical Imaging	Montpellier	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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.	Day 0
Secondary	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
Secondary	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