Intraarticular Antibiotic in TKA

NCT ID: NCT04297631

Last Updated: 2021-10-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-14

Study Completion Date

2020-11-01

Brief Summary

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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

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

Conditions

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Antibotics in Cementless Knees

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vancomycin Powder

All patients getting vancomycin to see concentration after 24hrs in knee drain and serum levels.

Group Type EXPERIMENTAL

Vancomyscin

Intervention Type DEVICE

Everyone gets the vancomyscin powder.

Tobramycin Powder

All patients getting Tobramycin to see conceration after 24hrs in knee drain and serum levels.

Group Type EXPERIMENTAL

Tobramycin Powder

Intervention Type DRUG

Everyone gets tobramycin powder.

Interventions

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Tobramycin Powder

Everyone gets tobramycin powder.

Intervention Type DRUG

Vancomyscin

Everyone gets the vancomyscin powder.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Washington University School of Medicine

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

Document Type: Informed Consent Form

View Document

Other Identifiers

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201911147

Identifier Type: -

Identifier Source: org_study_id

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