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

NCT03283878 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1770

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

  • Arthropathy of Knee
  • Antibiotic Prophylaxis

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.

Sponsors & Collaborators

  • American Association of Hip and Knee Surgeons

    collaborator OTHER

  • Orthopedic Research and Education Foundation

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Thorsten Seyler, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2024-11-20
Completion
2025-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03283878 on ClinicalTrials.gov