Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06402591
PHASE3

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

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

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

Interventions

DRUG

Cefazolin

cefazolin extended prophylaxis 5 days (15 doses)

Locations (1)

Radboudumc

Nijmegen, Gelderland, Netherlands