Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)
Recruiting now · Phase 1/Phase 2
Conditions studied: Total Knee Arthroplasty
In brief
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.
Key facts
- Study ID
- NCT06640491
- Run by
- The Methodist Hospital Research Institute
- People needed
- 40
- Starts
- 2025-05-15
- Expected to finish
- 2035-12-01
- Last updated by the study team
- 2025-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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.
Where it is running
- Houston Methodist Hospital — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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