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NCT03928522 · ClinicalTrials.gov registry record · Phase 4

Antibiotic Elution in Total Knee Arthroplasty

A Phase 4 study of Total Knee Replacement, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 4
Development phase
60
Enrollment target
1
Study location

NCT03928522 is a Phase 4 study of Total Knee Replacement that has completed, run by Washington University School of Medicine. The registered enrollment target is 60 participants, below the 209-participant average among 9 other Total Knee Replacement trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03928522, a Phase 4 study of Total Knee Replacement, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 4
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to characterize and quantify the level of antibiotics eluted from antibiotic laden cement after primary cemented total knee arthroplasty. Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria. Patients that qualify and sign consent will be randomized to 1 of 4 antibiotic cement groups which are pre-mixed tobramycin, hand-mixed tobramycin, hand mixed vancomycin, and hand-mixed tobramycin and hand mixed vancomycin. Study patients will be blinded to their study group. Intraoperative fluid from the knee prior to surgery and postoperative drain fluid from the knee postoperatively will be collected as well.

Conditions Studied

Total Knee Replacement

Interventions

  • DRUG hand mixed vancomycin
  • DRUG hand mixed tobramycin
  • DEVICE pre-mixed tobramycin

Study Locations (1)

Missouri

  • Washington University Orthopedics - St Louis

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2019-01-28
Est. Completion 2019-09-30
Phase Phase 4

Sponsor

Washington University School of Medicine

1,502 total trials

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What the Registry Record Tells You About NCT03928522

The ClinicalTrials.gov registry entry for NCT03928522 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 9 other Total Knee Replacement trials with a reported enrollment target (71% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Total Knee Replacement appearing as the primary indexed condition, and to 3 interventions - of which hand mixed vancomycin is the first listed.

NCT03928522 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT03928522 about?

NCT03928522 is a clinical study titled "Antibiotic Elution in Total Knee Arthroplasty". The purpose of the study is to characterize and quantify the level of antibiotics eluted from antibiotic laden cement after primary cemented total knee arthroplasty. Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria. Patients that qualify ...

What is the current status of trial NCT03928522?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2019-01-28. Estimated completion is 2019-09-30.

What conditions does trial NCT03928522 study?

This clinical trial studies the following conditions: Total Knee Replacement.

What interventions are being tested in trial NCT03928522?

The interventions under investigation include: hand mixed vancomycin (DRUG), hand mixed tobramycin (DRUG), pre-mixed tobramycin (DEVICE).

Who is sponsoring clinical trial NCT03928522?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03928522 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.