Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Rothman Institute Orthopaedics
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
aged ≥ 18 years
willing and able to give informed consent
primary THA or TKA diagnosed with PJI based on International Consensus Meeting criteria
1. A sinus communicating with the prosthesis OR
2. Two positive cultures obtained from the prosthesis OR
3. 3 of 5 criteria:
Elevated ESR (\>30mm/hr) and CRP (\>10mg/L)
Elevated synovial leukocyte count (\>3000 cells/µL) or change of ++ on leukocyte esterase strip
Elevated synovial neutrophil percentage (\>80%)
One positive culture
Positive histological analysis of periprosthetic tissue (\>5 neutrophils per high power field in 5 high power fields x400)
PJI treated by debridement and implant retention, or excision of the prosthetic joint (with or without planned reimplantation)
received ≤ 7 days of IV therapy after an appropriate surgical intervention
You may not be if
Previously treated for native septic arthritis or PJI in the same joint
S. aureus bacteremia on presentation or within the previous month
clinical, histological or microbiological evidence of mycobacterial, fungal or parasitic etiology of the infection
any other concomitant infection that, in the opinion of the clinician responsible for the patient, requires a prolonged course of IV antibiotic therapy (e.g. bacterial endocarditis, mediastinal infection, central nervous system infection)
septic shock or systemic features that, in the opinion of the clinician responsible for the patient, requires a course of IV antibiotic therapy (the patient could be re-evaluated if these features resolved)
an infection for which there are no suitable antibiotic choices to permit randomization between the two arms of the trial (e.g. when organisms are only sensitive to IV antibiotics or PO antibiotics)
unlikely to comply with trial requirements following randomization in the opinion of the investigator
