At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Randomized Study Investigating the Characterization of Antibiotics From Antibiotic Impregnated Cement After Total Knee Arthroplasty
In Brief
A Phase 4 clinical trial evaluating hand mixed vancomycin, hand mixed tobramycin, and 1 other intervention for Total Knee Replacement. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
hand mixed vancomycin powder into cement
hand mixed tobramycin into cement
this cement is already pre-mixed with tobramycin