drugset / Trial / NCT03283878

Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty- Multi-center Trial

NCT03283878

RandomizedParallel-groupOpen-labelTreatment

Summary

The Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty (TKA): Multi-Center Trial is a study that will compare the effectiveness of various perioperative strategies for antibiotic delivery as prophylaxis for periprosthetic joint infections (PJI) and surgical site infection in elective primary TKA. The investigators hypothesize that a single dose of prophylactic antibiotic administered within 60 minutes before the incision is not an effective way to prevent PJI in elective primary total knee arthroplasty (TKA). The investigators also hypothesize that the prolonged delivery (24 hours) of antibiotic prophylaxis after surgery does not further reduce the incidence of PJI in elective primary TKA. Duke University is the only site recruiting both primary total knee arthroplasty and unilateral knee arthroplasty.

Timeline

Start
2017-10-24
Primary completion
2024-11-20
Completion
2025-08-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Cefazolin Small molecule 2 g Intravenous
Subject Cefazolin Small molecule 3 g Intravenous

Indications