joint prosthesis infection
Conditions
Interventions
Sponsors
CHU DE BORDEAUX
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged over 18 years old, - Patient adressed to reference center for joint prosthesis infection (CRIOA, infectious diseases unit and orthopedic surgery unit) for suspicion of first episode of artificial hip or knee infection. - Suspicion of artificial joint infection starting at least one month before evaluation. - Patient for who routine diagnosis includes screaning by both bone scintigraphy and polynuclear 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Patient with progressive cancer. - Patient with negative bone scintigraphy. - Patient who cannot stop antibiotic for 14 days because of his state of health. - 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 protocol. - Known contraindications to PET exam with radio tracer injection (hypersensitivity to radiopharmaceutical and/or to excipients).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Estimation of diagnostic accuracy of 68Ga citrate PET / CT in the diagnosis of chronic hip or knee joint prosthesis infection;Secondary Objective: - Estimation of the inter-observer reproducibility of the PET / CT reading at 68Ga citrate - Estimation of the diagnostic accuracy of the multinuclear scintigraphy in the diagnosis in chronic hip or knee joint prosthesis infection. - Estimation of the diagnostic accuracy of PET / CT with citrate 68Ga and scintigraphy with polymorphonuclear in the 2 patient subpopulations: knee or hip infection. - Comparison of the diagnostic accuracy of PET / CT with 68Ga citrate to that of scintigraphy using polymorphonuclear drugs in the diagnosis of chronic hip or knee joint prosthesis infection.;Primary end point(s): Diagnostic accuracy setting’s assessment of the 68Ga citrate PET/TDM for chronic infection diagnosis of artificial hip or knee (sensibility, specificity, predictive positive and negative value). ;Timepoint(s) of evaluation of this end point: 12 months after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Reproducibility inter- observers of 68Ga citrate PET/TDM interpretation. - Diagnostic accuracy setting’s assessment of marked polynuclear scintigraphy. - Diagnosis accuracy’s assessment of 68Ga citrate PET/TDM and marked polynuclear scintigraphy for both under-populations: artificial knee or hip infection. - Comparison of diagnostic accuracy setting of 68Ga citrate PET/TDM and marked polynuclear scintigraphy. - Kind of discrepancy between the two exams. ;Timepoint(s) of evaluation of this end point: 12 months after baseline | — |
Countries
France
Contacts
Public ContactResponsable d'Etudes Cliniques
CHU DE BORDEAUX
Outcome results
None listed