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Results of Extended Versus Single Dose Antibiotic Prophylaxis In Orthopedic Revision Arthroplasty in Nijmegen.
Sponsor: Radboud University Medical Center
Summary
The goal of this randomized control trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee. The main question\[s\] it aims to answer are: * Is an extended regimen compared to a single dose of cefazolin associated with an increased infection-free implant survival within one year after index revision arthroplasty of the hip or knee? * What are the incidence, risk factors, treatment outcome and prognosis of surgical site infections and periprosthetic joint infection during follow-up? * What is the safety and tolerance of the antimicrobial prophylaxis regimens used? * What are the antimicrobial susceptibility patterns of micro-organisms causing PJI during follow-up? * What is the patient' physical performance and satisfaction of subjects within 1 year after the index revision arthroplasty, using patient related outcome measurements (PROMS)? \[question 2\] Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].
Official title: Multiple Doses Versus Single Dose of Cefazolin to Prevent Periprosthetic Joint Infection After Revision Arthroplasty: a Multicenter Open-label, Randomized Clinical Trial.
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
INTERVENTIONAL
Enrollment
751
Start Date
2019-01-01
Completion Date
2024-12-01
Last Updated
2024-05-07
Healthy Volunteers
No
Conditions
Interventions
Cefazolin
cefazolin extended prophylaxis 5 days (15 doses)
Locations (1)
Radboudumc
Nijmegen, Gelderland, Netherlands