Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402591
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-04-07
Brief Title:
Results of Extended Versus Single Dose Antibiotic Prophylaxis In Orthopedic Revision Arthroplasty in Nijmegen
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Multiple Doses Versus Single Dose of Cefazolin to Prevent Periprosthetic Joint Infection After Revision Arthroplasty a Multicenter Open-label Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REViSION
Brief 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 questions 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 theyll 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
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 theyll 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
Detailed Description:
Periprosthetic joint infection PJI is an important complication of total joint arthroplasty of the hip and knee and occurs in 1-2 after primary arthroplasty and in 10-15 after revision arthroplasty To prevent a PJI peri-operative antibiotic prophylaxis is given Theres inadequate evidence for a recommendation about the optimal duration of prophylaxis especially in revision arthroplasty The aim of this multicenter open-label randomized controlled 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 Patients will be recruited at the orthopedic departments of two Dutch hospitals University Medical Center Radboudumc Nijmegen Radboudumc and Sint Maartenskliniek in Nijmegen SMK Patients will be included if they will undergo revision arthroplasty of the hip or knee with exclusion of patients with a proven PJI at baseline A total of 780 subjects will be randomized between 2 prophylactic strategies A Cefazolin at a single dose of 2 grams intravenously 15-60 minutes before incision B Cefazolin at a dose of 2 grams intravenously 15-60 minutes before incision followed by cefazolin 1 gram intravenously tid until five days post-surgery The primary endpoint is the difference in proportion of infectious-free implant survival between both groups within 1 year of follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None