Actively Recruiting
Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)
Led by The Methodist Hospital Research Institute · Updated on 2025-05-18
40
Participants Needed
1
Research Sites
550 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the efficacy of intravenous (IV) and intraosseous (IO) antibiotic administration techniques during primary total knee arthroplasty (TKA) in adults undergoing a TKA procedure at Houston Methodist Hospital. The main questions it aims to answer are: Does IO administration of vancomycin and cefazolin protect against perioperative exposure risks? Is there a difference in post-operative complication rates between IV and IO administration of these drugs? Participants will be randomized to receive either the standard of care IV administration of Vancomycin and Cefazolin, or the IO administration of Vancomycin and Cefazolin.
CONDITIONS
Official Title
Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is scheduled to undergo an elective primary total knee arthroplasty.
- Patient is able to understand the study design and intervention and gives informed consent to participate in the study.
- Patient is 18 years or older.
You will not qualify if you...
- Contraindication to receiving vancomycin or cefazolin.
- Body mass index (BMI) > 40.
- Uncontrolled Diabetes (defined as A1c > 7.5%).
- Patient received or is scheduled to receive IV vancomycin or cefazolin within 7 days prior to their planned procedure.
- Any hardware, condition, or anatomic status that prevents the tibial tubercle from being a viable intraosseous injection site.
- Refusal to participate
- Any condition, in the opinion of the primary investigator, that deems the participant unsuitable for participation in the research study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Thomas Sullivan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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