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OpenTrials
Completed

NCT Number: NCT04297631

Intraarticular Antibiotic in TKA

The purpose of the study is to determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty and determine the serum concentrations of these antibiotics postoperatively.

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Key information

Conditions

Antibotics in Cementless Knees

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, 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 have tobramycin and vancomycin antibiotic powder placed into the knee during surgery. Postoperative drain fluid from the knee will be collected.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age over 18
  • Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis

Exclusion criteria

  • Diminished mental capacity
  • Vancomycin allergy
  • Tobramycin allergy
  • Chronic kidney disease stage III and stage IV

Treatment and study plan

Tobramycin Powder

Drug

Everyone gets tobramycin powder.

Vancomyscin

Device

Everyone gets the vancomyscin powder.

Primary outcomes

  1. Concentration of Antibiotics in Cementless Knees Post op

    Time frame: 1 hour, 4 hours, and 24 hours

    • Determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty.

Secondary outcomes

  1. Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours.

    Time frame: 1 hour, 4 hours, and 24 hours

    • Determine the serum concentrations of these antibiotics postoperatively

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Prospective Study Investigating Antibiotic Elution From Free Intra-articular Vancomycin and Tobramycin After Cementless Total Knee Arthroplasty

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2020
Registry last updated
Oct 5, 2021

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.