Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT03283878
PHASE4

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

Sponsor: Duke University

View on ClinicalTrials.gov

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

DRUG

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