Clinical Trial

Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)

Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-10-10; most recent amendment 2025-05-16.
Status change: Not Yet Recruiting → Recruiting 2025-04-04
Trial Details
NCT Number NCT06640491
Lead Sponsor The Methodist Hospital Research Institute
Conditions Total Knee Arthroplasty
Enrollment 40 participants
Start Date 2025-05-15
Primary Completion 2030-12-01 (estimated)
Study Completion 2035-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-18