NCT03928522

Antibiotic Elution in Total Knee Arthroplasty

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Total Knee Replacement

Interventions

Type	Name	Description
DRUG	hand mixed vancomycin	hand mixed vancomycin powder into cement
DRUG	hand mixed tobramycin	hand mixed tobramycin into cement
DEVICE	pre-mixed tobramycin	this cement is already pre-mixed with tobramycin

Timeline

• Start date: 2019-01-28
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2019-04-26
• Last updated: 2020-11-02
• Results posted: 2020-11-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study