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Anti-bacterial agents

IO vs IV Antibiotics for Total Knee Replacement

Phase 1 & 2

Waitlist Available

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Contraindication to receiving vancomycin or cefazolin

Uncontrolled Diabetes (defined as A1c > 7.5%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days postop and 90 days postop

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if giving antibiotics directly into the bone (intraosseous - IO) during knee replacement surgery is as effective as giving them through a vein (intravenous - IV).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include allergic reactions, antibiotic resistance, or local site complications related to IV or IO administration methods. The exact side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study and agree to participate.

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take vancomycin or cefazolin due to health reasons.

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

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

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I am willing to participate in the clinical trial.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days postop and 90 days postop

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days postop and 90 days postop

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days postop and 90 days postop for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Postoperative Infections

Secondary study objectives

Postoperative Wound Complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 8Eligibility criteria met