Antibiotic Elution in Total Knee Arthroplasty
Completed · Phase 4
Conditions studied: Total Knee Replacement
In brief
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.
Key facts
- Study ID
- NCT03928522
- Run by
- Washington University School of Medicine
- People needed
- 60
- Starts
- 2019-01-28
- Expected to finish
- 2019-09-30
- Last updated by the study team
- 2020-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Washington University Orthopedics — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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