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New treatment option for Total Knee Arthroplasty
Official title Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)
ClinicalTrials.gov ID: NCT06640491
What this study is testing
What is IO Administration of Cefazolin?
IO Administration of Cefazolin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for total knee arthroplasty.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.