Antibiotic Elution in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Total Knee Replacement

Intervention / Treatment
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* Drug: hand mixed vancomycin
* Drug: hand mixed tobramycin
* Device: pre-mixed tobramycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-mixed tobramycin<br>patients will receive pre-mixed tobramycin cement | Device: pre-mixed tobramycin<br>* this cement is already pre-mixed with tobramycin<br>* Other names: Antibiotic PMMA bone cement;|
| Active Comparator: hand mixed tobramycin<br>patients will receive hand mixed tobramycin cement | Drug: hand mixed tobramycin<br>* hand mixed tobramycin into cement<br>* Other names: Tobramycin;|
| Active Comparator: hand mixed vancomycin<br>patients will receive hand mixed vancomycin cement | Drug: hand mixed vancomycin<br>* hand mixed vancomycin powder into cement<br>* Other names: Vancomycin;|
| Experimental: hand-mixed vancomycin and tobramycin<br>patients will receive hand mixed vancomycin and tobramycin | Drug: hand mixed vancomycin<br>* hand mixed vancomycin powder into cement<br>* Other names: Vancomycin;Drug: hand mixed tobramycin<br>* hand mixed tobramycin into cement<br>* Other names: Tobramycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty | We wanted to measure the effect of elution level of vancomycin and tobramycin together | 24 hours |