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Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty- Multi-center Trial
Sponsor: Duke University
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.
Official title: Perioperative Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty: A Prospective, Randomized, Open-label, Controlled Multi-center Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1770
Start Date
2017-10-24
Completion Date
2025-08-22
Last Updated
2026-07-16
Healthy Volunteers
No
Interventions
Cefazolin
Cefazolin will be administered intravenously within less than 60 minutes prior to skin incision in elective TKA for Group 1. Cefazolin will be administered intravenously within less than 60 minutes prior to skin incision in elective TKA. In addition, two weight based doses of cefazolin will be administered within 24 hours postoperatively for Group 2.
Locations (14)
University of California, San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
University of Maryland St. Joseph Medical Center & Orthopedic Associates
Towson, Maryland, United States
University Of Mississippi Medical Center
Jackson, Mississippi, United States
Mississippi Bone and Joint Clinic
Starkville, Mississippi, United States
University Orthopaedic Associates, LLC
Somerset, New Jersey, United States
NYU School of Medicine
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
University of South Carolina
Columbia, South Carolina, United States
BaylorScott&White Research Institute
Temple, Texas, United States
Augusta Health
Fishersville, Virginia, United States