IO vs IV Vancomycin for Preventing Infection in Knee Surgery

Overseen By Haley Goble, MHA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Methodist Hospital Research Institute

Must not be taking: Immunosuppressants

Disqualifiers: Knee surgery, BMI >35, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-op

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether administering antibiotics through the bone (intraosseous) or through a vein (intravenous) more effectively prevents infections during knee replacement surgery. The focus is on using vancomycin, a common antibiotic, as part of the procedure. Suitable participants are those undergoing their first total knee replacement without a tourniquet and without certain health issues, such as uncontrolled diabetes or a history of knee surgeries. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients, offering participants a chance to contribute to improving care for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive medications, you may not be eligible to participate.

What is the safety track record for Vancomycin?

Research shows that using vancomycin directly in the bone (intraosseous or IO) during knee surgeries is safe. Studies indicate that IO vancomycin matches the safety of the more common intravenous (IV) method. Reports suggest that patients generally tolerate IO vancomycin well.

IV vancomycin, more commonly used, has a strong safety record and is often administered during various surgeries to prevent infections. Both methods aim to reduce infection risk during surgery and have proven effective and safe.

In summary, studies report that both IO and IV vancomycin treatments are safe for humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores a new method of delivering vancomycin to prevent infections during knee surgery. The trial compares intraosseous (IO) administration, where the drug is injected directly into the bone, to the standard intravenous (IV) approach. The IO method is unique because it might allow for faster and more localized delivery of the antibiotic, potentially leading to quicker, more effective infection control with less systemic exposure. This could mean fewer side effects and better outcomes for patients undergoing knee surgery.

What evidence suggests that this trial's treatments could be effective for preventing infection in knee surgery?

This trial will compare intraosseous (IO) vancomycin administration with intravenous (IV) vancomycin administration for preventing infections in knee surgery. Research has shown that IO vancomycin can effectively reduce infections after knee surgery. One study found that it lowered the chance of infection by 69% in total knee replacements. This method offers a safe and effective alternative to the more common IV method. IO administration may deliver the drug more directly to the target area, making this approach promising for preventing infections in knee surgeries. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having their first knee replacement surgery without a tourniquet. They must understand the study and agree to participate. It's not for people with weak immune systems, uncontrolled diabetes (Hemoglobin A1C >7.5), allergies to vancomycin or similar antibiotics, BMI over 35, or those who've had previous knee surgeries.

Inclusion Criteria

Patient is undergoing a primary total knee arthroplasty.

Patient is able to understand the study design and intervention and gives informed consent to participate in the study. No LAR consents will be utilized for this study.

You had knee surgery without the use of a tourniquet.

Exclusion Criteria

Immunocompromised or immunosuppressed patients (HIV, Hep C, End-Stage Renal Disease, dialysis, transplant, chemo/radiation treatment in last 6 months, and immunosuppresive medications)

Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C >7.5.

Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty with either intraosseous or intravenous vancomycin administration

Immediate post-op

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 30-day and 90-day post-operative complication rates

90 days

Multiple visits (in-person) as per standard of care

What Are the Treatments Tested in This Trial?

Interventions

• Vancomycin

Trial Overview The study compares two ways of giving antibiotics during knee replacement surgery: directly into the bone (intraosseous) vs. into a vein (intravenous). The goal is to see which method better prevents infections after surgery without using a tourniquet.

How Is the Trial Designed?

Group I: Intraosseous Vancomycin Administration Experimental Treatment 1 Intervention

* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be administered preoperatively in this group. * IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS). * Injection will take place into the tibial tubercle (within a pre-specified region) immediately prior to incision.

Group II: Intravenous Vancomycin Administration Active Control 1 Intervention

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 (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[12,13\] generally 1000-1750mg in 500mL NS).

Vancomycin is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Vancocin for:

• Severe infections caused by susceptible strains of methicillin-resistant staphylococci
• Enterocolitis caused by Staphylococcus aureus
• Staphylococcal endocarditis

Approved in European Union as Vancomycin for:

• Severe infections caused by Gram-positive bacteria
• Endocarditis
• Peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD)

Approved in Canada as Vancomycin for:

• Severe infections caused by susceptible strains of methicillin-resistant staphylococci
• Enterocolitis caused by Staphylococcus aureus

Approved in Japan as Vancomycin for:

• Severe infections caused by Gram-positive bacteria
• Endocarditis

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38862147/

[Intraosseous vancomycin in total knee arthroplasty] Intraosseous (IO) administration of vancomycin could enhance its effectiveness in total knee arthroplasty (TKA).

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352344125002651

Intraosseous Vancomycin in Total Knee Arthroplasty IOV is an effective adjunctive treatment for preventing infection in primary TKA, with this study showing a 69% decreased odds of infection when ...

3. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(25)00453-X/abstract

The AAHKS Best Podium Presentation Research Award Use of IO vancomycin infusion is a safe and effective alternative to IV administration for patients undergoing aseptic revision TKA.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40339929/

The AAHKS Best Podium Presentation Research Award Use of IO vancomycin infusion is a safe and effective alternative to IV administration for patients undergoing aseptic revision TKA.

5. mdpi.com mdpi.com/2079-6382/14/3/214

Effectiveness of Local Antibiotics for Infection Prevention in ... Our meta-analysis of 21 articles demonstrated that vancomycin powder effectively reduced the risk of deep wound infections or PJI in primary joint arthroplasty, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39297962/

Safety and effectiveness of intraosseous regional ... The latest meta-analysis reports that the use of IORA for antibiotics in TKA is as safe and effective as IV administration in preventing prosthetic joint ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06640491

Intraosseous (IO) Cefazolin and Vancomycin in Primary ... The goal of this clinical trial is to compare the efficacy of intravenous (IV) and intraosseous (IO) antibiotic administration techniques during primary ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7303475/

Clinical outcome evaluation of intraosseous vancomycin in ... IO vancomycin has an adequate safety profile in primary and revision TKA, eliminating the logistical challenge of timely prophylactic antibiotic administration.