Antibiotic Elution in Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Total Knee Replacement
• Interventions: Device: pre-mixed tobramycin; Drug: hand mixed tobramycin; Drug: hand mixed vancomycin

• Registration Number: NCT03928522
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

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 Timeline

• Study Start: 2019-01-28
• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-26
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Results First Submitted: 2020-09-14
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-08
• Last Update Submitted: 2020-10-08
• Results First Posted: 2020-11-02
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age over 18

• Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.

• Primary diagnosis of knee osteoarthritis

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-mixed tobramycin	pre-mixed tobramycin	patients will receive pre-mixed tobramycin cement
hand mixed tobramycin	hand mixed tobramycin	patients will receive hand mixed tobramycin cement
hand mixed vancomycin	hand mixed vancomycin	patients will receive hand mixed vancomycin cement
hand-mixed vancomycin and tobramycin	hand mixed vancomycin	patients will receive hand mixed vancomycin and tobramycin
hand-mixed vancomycin and tobramycin	hand mixed tobramycin	patients will receive hand mixed vancomycin and tobramycin

Primary Outcome Measures

Name	Time	Method
Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty	24 hours	We wanted to measure the effect of elution level of vancomycin and tobramycin together

Trial Locations

Locations (1)

Washington University Orthopedics; 🇺🇸 Saint Louis, Missouri, United States