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Antibiotic Elution in Total Knee Arthroplasty

NCT ID: NCT03928522

Last Updated: 2020-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-28

Study Completion Date

2019-09-30

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.

Conditions

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Total Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
patient will not know which antibiotic cement group they are in

Study Groups

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Pre-mixed tobramycin

patients will receive pre-mixed tobramycin cement

Group Type ACTIVE_COMPARATOR

pre-mixed tobramycin

Intervention Type DEVICE

this cement is already pre-mixed with tobramycin

hand mixed tobramycin

patients will receive hand mixed tobramycin cement

Group Type ACTIVE_COMPARATOR

hand mixed tobramycin

Intervention Type DRUG

hand mixed tobramycin into cement

hand mixed vancomycin

patients will receive hand mixed vancomycin cement

Group Type ACTIVE_COMPARATOR

hand mixed vancomycin

Intervention Type DRUG

hand mixed vancomycin powder into cement

hand-mixed vancomycin and tobramycin

patients will receive hand mixed vancomycin and tobramycin

Group Type EXPERIMENTAL

hand mixed vancomycin

Intervention Type DRUG

hand mixed vancomycin powder into cement

hand mixed tobramycin

Intervention Type DRUG

hand mixed tobramycin into cement

Interventions

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hand mixed vancomycin

hand mixed vancomycin powder into cement

Intervention Type DRUG

hand mixed tobramycin

hand mixed tobramycin into cement

Intervention Type DRUG

pre-mixed tobramycin

this cement is already pre-mixed with tobramycin

Intervention Type DEVICE

Other Intervention Names

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Vancomycin Tobramycin Antibiotic PMMA bone cement

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Lawrie, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University Orthopedics

St Louis, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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201811101

Identifier Type: -

Identifier Source: org_study_id