Phase 4 N=60 Randomized Single-blind Treatment

Antibiotic Elution in Total Knee Arthroplasty

Total Knee Replacement

Bottom Line

View on ClinicalTrials.gov: NCT03928522 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty — 23.9; 30.6; 12.6; 16.2 mg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: hand mixed vancomycin (Drug); hand mixed tobramycin (Drug); pre-mixed tobramycin (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty	23.9; 30.6; 12.6; 16.2; 1315	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03928522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.