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Intraarticular Antibiotic in TKA

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The Washington University

Status and phase

Completed
Phase 4

Conditions

Antibotics in Cementless Knees

Treatments

Device: Vancomyscin
Drug: Tobramycin Powder

Study type

Interventional

Funder types

Other

Identifiers

NCT04297631
201911147

Details and patient eligibility

About

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.

Full 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 have tobramycin and vancomycin antibiotic powder placed into the knee during surgery. Postoperative drain fluid from the knee will be collected.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. Diminished mental capacity
  2. Vancomycin allergy
  3. Tobramycin allergy
  4. Chronic kidney disease stage III and stage IV

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Vancomycin Powder
Experimental group
Description:
All patients getting vancomycin to see concentration after 24hrs in knee drain and serum levels.
Treatment:
Device: Vancomyscin
Tobramycin Powder
Experimental group
Description:
All patients getting Tobramycin to see conceration after 24hrs in knee drain and serum levels.
Treatment:
Drug: Tobramycin Powder

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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