joint infection prosthetic joint infection
Conditions
Interventions
After obtaining informed consent, subjects will be randomized into 2
prophylactic groups:
A. Cefazolin at a single dose of 2 grams intravenously 15-60 minutes before
incision, with a repeat dose of
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: planned revision arthroplasty of the prosthesis of the hip or knee for non-infectious reason
Exclusion criteria
Exclusion criteria: periprosthetic joint infection on baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the difference in proportion of infection-free implant survival between the study groups within 1 year of follow-up, as assessed by the independent Data Review Committee, in the mITT population. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives include the determination of the incidence, risk factors, treatment outcome and prognosis of SSI and PJI during follow-up. The safety and tolerance of the regimens, and the antimicrobial susceptibility patterns of microorganisms will be described. Patient reported outcome measures (PROMs) will be used to evaluate physical performance and satisfaction of subjects within 1 year after the index revision arthroplasty. A cost-utility analysis will only be performed when the primary outcome has demonstrated superiority of the extended regimen. | — |
Countries
Netherlands
Outcome results
None listed