IO vs IV Antibiotics for Total Knee Replacement

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: The Methodist Hospital Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults scheduled for primary total knee replacement surgery at Houston Methodist Hospital. Participants must be eligible for the procedure and willing to receive antibiotics either through their veins (IV) or directly into the bone (IO). Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I understand the study and agree to participate.

I am 18 years old or older.

I am scheduled for a first-time knee replacement surgery.

Exclusion Criteria

I cannot take vancomycin or cefazolin due to health reasons.

My diabetes is not under control (A1c > 7.5%).

I have received or will receive IV antibiotics within 7 days before my procedure.

I am willing to participate in the clinical trial.

I cannot have injections in my shin bone due to a condition or hardware.

Participant Groups

The study compares two ways of giving antibiotics during knee replacement surgery: IV Vancomycin and Cefazolin versus IO Vancomycin and Cefazolin. It aims to see which method better prevents infection without increasing complications post-surgery.

2Treatment groups

Experimental Treatment

Active Control

Group I: Intraosseous Administration of Vancomycin and CefazolinExperimental Treatment2 Interventions

Intraosseous vancomycin plus cefazolin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep of the leg and draping has occurred prior to skin incision and after the tourniquet has been inflated. The injection will take place into the tibial tubercle, which is a known safe IO injection site. The IO injection will include 500mg of vancomycin and a 1g dose of cefazolin, previously used in prior IO studies of cefazolin.

Group II: Standard IV Administration of Vancomycin and CefazolinActive Control2 Interventions

Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty patients. This includes IV antibiotics cefazolin will be started in the pre-operative period approximately 1 hour prior to incision. The cefazolin dose is generally 2g if patient is under 120kg, and 3g is the patient is above 120kg in line with guidelines. Vancomycin IV administration will be dosing will be weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL NS.