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Completed

NCT Number: NCT03928522

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 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.

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Key information

Conditions

Total Knee Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University Orthopedics

St Louis, Missouri, 63019, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hand mixed vancomycin

Drug

hand mixed vancomycin powder into cement

Other names: Vancomycin

hand mixed tobramycin

Drug

hand mixed tobramycin into cement

Other names: Tobramycin

pre-mixed tobramycin

Device

this cement is already pre-mixed with tobramycin

Other names: Antibiotic PMMA bone cement

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Prospective Randomized Study Investigating the Characterization of Antibiotics From Antibiotic Impregnated Cement After Total Knee Arthroplasty

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2019
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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