Antibiotic Elution in Total Knee Arthroplasty

October 8, 2020 updated by: Washington University School of Medicine

Prospective Randomized Study Investigating the Characterization of Antibiotics From Antibiotic Impregnated Cement After 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63019
        • Washington University Orthopedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 18
  • Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.

  • Primary diagnosis of knee osteoarthritis

    • Exclusion Criteria:
  • Diminished mental capacity
  • Vancomycin allergy
  • Tobramycin allergy
  • Patient history requiring IV administration of vancomycin or tobramycin perioperatively
  • Chronic kidney disease stage III and stage IV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Pre-mixed tobramycin
patients will receive pre-mixed tobramycin cement
Device: pre-mixed tobramycin
this cement is already pre-mixed with tobramycin
Other Names:
  • Antibiotic PMMA bone cement
ACTIVE_COMPARATOR: hand mixed tobramycin
patients will receive hand mixed tobramycin cement
Drug: hand mixed tobramycin
hand mixed tobramycin into cement
Other Names:
  • Tobramycin
ACTIVE_COMPARATOR: hand mixed vancomycin
patients will receive hand mixed vancomycin cement
Drug: hand mixed vancomycin
hand mixed vancomycin powder into cement
Other Names:
  • Vancomycin
EXPERIMENTAL: hand-mixed vancomycin and tobramycin
patients will receive hand mixed vancomycin and tobramycin
Drug: hand mixed tobramycin
hand mixed tobramycin into cement
Other Names:
  • Tobramycin
Drug: hand mixed vancomycin
hand mixed vancomycin powder into cement
Other Names:
  • Vancomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty
Time Frame: 24 hours
We wanted to measure the effect of elution level of vancomycin and tobramycin together
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Charles Lawrie, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 28, 2019

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

April 24, 2019

First Posted (ACTUAL)

April 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201811101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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