Antibiotic Elution in Total Knee Arthroplasty

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: Total Knee Replacement
• Intervention / Treatment: Device: pre-mixed tobramycin; Drug: hand mixed tobramycin; Drug: hand mixed vancomycin

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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	We wanted to measure the effect of elution level of vancomycin and tobramycin together	24 hours

Collaborators and Investigators

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

Study record dates

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: Anti-Infective Agents; Vancomycin; Anti-Bacterial Agents; Tobramycin
• 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