Antibiotic Elution in Total Knee Arthroplasty

The Washington University

Status and phase: Completed; Phase 4

Conditions: Total Knee Replacement

Treatments: Drug: hand mixed vancomycin; Device: pre-mixed tobramycin; Drug: hand mixed tobramycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03928522

201811101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

Pre-mixed tobramycin

Active Comparator group

Description:

patients will receive pre-mixed tobramycin cement

Treatment:

Device: pre-mixed tobramycin

hand mixed tobramycin

Active Comparator group

Description:

patients will receive hand mixed tobramycin cement

Treatment:

Drug: hand mixed tobramycin

hand mixed vancomycin

Active Comparator group

Description:

patients will receive hand mixed vancomycin cement

Treatment:

Drug: hand mixed vancomycin

hand-mixed vancomycin and tobramycin

Experimental group

Description:

patients will receive hand mixed vancomycin and tobramycin

Treatment:

Drug: hand mixed tobramycin

Drug: hand mixed vancomycin