Intraarticular Antibiotic in TKA

Phase 4

Completed

• Conditions: Antibotics in Cementless Knees
• Interventions: Drug: Tobramycin Powder; Device: Vancomyscin

• Registration Number: NCT04297631
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

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

Study Timeline

• Study Start: 2020-02-14
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Primary Completion: 2020-08-01
• Study Completion: 2020-11-01
• Results First Submitted: 2021-08-04
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-07
• Last Update Submitted: 2021-09-07
• Results First Posted: 2021-10-05
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tobramycin Powder	Tobramycin Powder	All patients getting Tobramycin to see conceration after 24hrs in knee drain and serum levels.
Vancomycin Powder	Vancomyscin	All patients getting vancomycin to see concentration after 24hrs in knee drain and serum levels.

Primary Outcome Measures

Name	Time	Method
Concentration of Antibiotics in Cementless Knees Post op	1 hour, 4 hours, and 24 hours	1. Determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty.

Secondary Outcome Measures

Name	Time	Method
Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours.	1 hour, 4 hours, and 24 hours	2. Determine the serum concentrations of these antibiotics postoperatively

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States