drugset / Trial / NCT06402591

Results of Extended Versus Single Dose Antibiotic Prophylaxis In Orthopedic Revision Arthroplasty in Nijmegen.

NCT06402591

RandomizedSingle-groupOpen-labelPrevention

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 \[insert effects\].

Timeline

Start
2019-01-01
Primary completion
2023-12-01
Completion
2024-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cefazolin Small molecule 1 g Intravenous
Subject Cefazolin Small molecule 2 g Intravenous