Image Quality of EOSedge for Radiographic Evaluation of Hip Implant

NCT05615701 | Terminated

• 1 other identifier: RECHMPL22_0298
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

Conditions

Hip Osteoarthritis; Hip Prosthesis Infection

Keywords

EOS; Radiography; Hip; Hip replacement; Image quality

Outcome Measures

Primary Outcomes (1)

• 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 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 Outcomes (2)

• Dosimetry

  Day 0

• Dosimetry

  Day 0

Study Arms (1)

EOSedge imaging

OTHER

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

Interventions

EOSedge imaging DIAGNOSTIC_TEST

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

EOSedge imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient 18 years of age or older
• Came to the imaging department to perform a preoperative assessment for hip replacement or revision

You may not qualify if:

• Patient under guardianship or curatorship
• Patient participating in an interventional study
• Patient unable to read and/or write

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Departement of Medical Imaging

Montpellier, Occitanie, 34295, France

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Catherine c-cyteval@chu-montpellier.fr, MD, PhD

  Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 14, 2022
• Study Start: November 16, 2022
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

FR (1)