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Completed Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT03283878

Public ClinicalTrials.gov record NCT03283878. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 3:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Perioperative Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty: A Prospective, Randomized, Open-label, Controlled Multi-center Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03283878
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Duke University
Other
Enrollment
1,770 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 24, 2017 (Actual)
Primary completion
Nov 20, 2024 (Actual)
Completion
Aug 22, 2025 (Actual)
Last update posted
Jul 16, 2026

2017 – 2025

United States locations

U.S. sites
14
U.S. states
12
U.S. cities
14
Facility City State ZIP Site status
University of California, San Francisco San Francisco California 94143 —
Emory University Atlanta Georgia 30322 —
University of Maryland St. Joseph Medical Center & Orthopedic Associates Towson Maryland 21204 —
University Of Mississippi Medical Center Jackson Mississippi 39216 —
Mississippi Bone and Joint Clinic Starkville Mississippi 39759 —
University Orthopaedic Associates, LLC Somerset New Jersey 08873 —
NYU School of Medicine New York New York 10003 —
Duke University Medical Center Durham North Carolina 27703 —
Cleveland Clinic Cleveland Ohio 44195 —
Ohio State University Columbus Ohio 43210 —
Rothman Institute Philadelphia Pennsylvania 19107 —
University of South Carolina Columbia South Carolina 29208 —
BaylorScott&White Research Institute Temple Texas 76508 —
Augusta Health Fishersville Virginia 22939 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03283878, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 16, 2026 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03283878 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →