NCT06640491 · The Methodist Hospital Research Institute
Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)
What this study is about
The goal of this clinical trial is to compare the effectiveness of given through a vein (IV) (IV) and intraosseous (IO) antibiotic administration techniques during primary total knee arthroplasty (TKA) in adults undergoing a TKA procedure at Houston Methodist Hospital.
View original scientific description
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.
Interventions
DRUG
IO Administration of Cefazolin
Intraosseous injection of cefazolin to guard against infection.
DRUG
IO Administration of Vancomycin
Intraosseous injection of vancomycin to guard against infection.
DRUG
IV Administration of Cefazolin
Intravenous dose of cefazolin to guard against infection.
DRUG
IV Administration of Vancomycin
Intravenous dose of vancomycin to guard against infection.
Primary outcome measures
Rate of Postoperative Infections
Time frame: 30 days postop and 90 days postop
Participants charts will be reviewed at 30 days postop and 90 days postop to determine if there were any infections.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2025 · Source of record for eligibility and locations