Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT04938193
Eligibility Criteria:
Inclusion Criteria:
* Patient aged over 18 years old
* Patient referred for the first time to the South-Western France referral center for complex bone and joint infections (Crioac GSO, infectious diseases and orthopedic surgery units) for suspicion of prosthetic hip or knee infection.
* Suspicion of prosthetic joint infection evolving for more than one month.
* Patient for who routine diagnosis includes both bone scintigraphy and leukocytes scintigraphy.
* Patient with positive bone scintigraphy.
* Being affiliated to a health insurance system
* Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)
Exclusion Criteria:
* Patient with active cancer.
* Patient with negative bone scintigraphy.
* Patient who cannot stop antibiotics 14 days before exams.
* Pregnant or breastfeeding women.
* Women of childbearing age but not using effective means of contraception.
* Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
* Subject in relative exclusion period from another study protocol.
* Known contraindications to PET exam with radiopharmaceutical injection (hypersensitivity to radiopharmaceutical and/or to excipients).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04938193
Study Brief:
Protocol Section:
NCT04938193