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NCT03283878 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Duke University.

Completed
Registry status
Phase 4
Development phase
1,770
Enrollment target

NCT03283878: Completed Phase 4 study, sponsored by Duke University.

NCT03283878 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 1,770 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (242% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03283878, a Phase 4 study, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 4
Development phase
1,770 participants
Enrollment target

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.

Interventions

  • DRUG Cefazolin

Trial Details

FieldValue
Enrollment Target 1,770 participants
Start Date 2017-10-24
Est. Completion 2025-08-22
Phase Phase 4
Duke University

1,725 total trials

What the finished NCT03283878 record still lists

NCT03283878 is an interventional study that assigns participants to a tested intervention. Its 1,770 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (242% higher).

The record links to 0 conditions, and to 1 intervention - of which Cefazolin is the first listed.

NCT03283878 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03283878 about?

NCT03283878 is a clinical study titled "Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty- Multi-center Trial". 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...

What is the current status of trial NCT03283878?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,770 participants. The study started on 2017-10-24. Estimated completion is 2025-08-22.

What interventions are being tested in trial NCT03283878?

The interventions under investigation include: Cefazolin (DRUG).

Who is sponsoring clinical trial NCT03283878?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03283878's enrollment target sits among peer trials

1,770 45th of 2000 higher than 1,956 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03283878, the US trial registry maintained by the National Library of Medicine. NCT03283878 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.