Antibiotics in Joint Replacement for Preventing Infections

Overseen By Benoit Benoit, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Disqualifiers: Active infection, Allergy to vancomycin, others

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

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

Compensation: Varies

Number of Visits: 1

Duration: Surgery day

1832 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to compare infection rates when patients, elected for primary or aseptic revision THA / TKA, have a single intravenous antibiotic dose versus one single intravenous antibiotic dose in combination with intra-articular antibiotics. This is a prospective, randomized clinical survey on selected outcome measurements on 1834 subjects who will be recruited in a period of about 2 years.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is vancomycin powder safe for use in joint replacement surgeries?

Vancomycin powder has been shown to be safe in reducing infections after surgeries, such as spine surgeries, and studies suggest it may also be safe for use in joint replacement surgeries to prevent infections. ^{1 2 3 4 5}

How is the drug Intra-articular Vancomycin Powder different from other treatments for preventing infections in joint replacement?

Intra-articular Vancomycin Powder is unique because it is applied directly into the surgical wound during joint replacement, which may help reduce the risk of infection more effectively than standard systemic antibiotics alone. This direct application targets the area most at risk for infection, potentially offering a more focused approach to preventing infections in joint replacements. ^{1 2 4 5 6}

What data supports the effectiveness of the drug Intra-articular Vancomycin Powder in preventing infections in joint replacement surgeries?

Research shows that using vancomycin powder directly in the surgical wound during joint replacement can significantly reduce early joint infections, especially in revision surgeries, compared to standard antibiotic treatments. ^{1 2 3 4 7}

Who Is on the Research Team?

Benoit Benoit, MD

Principal Investigator

CIUSSS du Nord de l'Île de Montreal

Are You a Good Fit for This Trial?

Adults over 18 needing a new hip or knee joint (arthroplasty) due to osteoarthritis, bone death, arthritis, or previous joint replacement issues can join. They must be in good health for surgery and able to follow up for 2 years. People with skin diseases, infections, vancomycin allergies, or enrolled in other trials cannot participate.

Inclusion Criteria

Subject is willing to consent to participate in the study

I am having a revision of my hip or knee replacement due to non-infection reasons.

I meet the requirements for a first-time hip or knee replacement.

Exclusion Criteria

I do not have any ongoing infections.

I have a skin condition.

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of IV cefazolin and, for some, an additional intra-articular vancomycin powder during knee or hip arthroplasty

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for infection rates and other outcomes after surgery

3 months

Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are monitored for long-term infection rates and other outcomes

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Intra-articular Vancomycin Powder

Trial Overview This study is testing if adding intra-articular antibiotics to the usual single IV antibiotic dose lowers infection rates after hip/knee replacements. It's a randomized trial involving 1834 patients who will be observed for outcomes over about two years.

How Is the Trial Designed?

Group I: Vanco Experimental Treatment 1 Intervention

Patients receiving a single dose of IV cefazolin (2 grams if \< 120kg; 3 grams if \>120kg) 10-60 minutes before incision + a single dose of intra-articular vancomycin powder (1 gram) before articulation (hip or knee) closure

Group II: Standard Active Control 1 Intervention

Patients receiving single dose of IV cefazolin (2 grams if \< 120kg; 3 grams if \>120kg) 10-60 minutes before incision

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

Approved in United States as Vancomycin for:

• Severe bacterial infections
• MRSA infections
• Clostridium difficile-associated diarrhea and enterocolitis

Approved in European Union as Vancomycin for:

• Severe bacterial infections
• MRSA infections
• Endocarditis
• Peritonitis

Approved in Canada as Vancomycin for:

• Severe bacterial infections
• MRSA infections
• Clostridium difficile-associated diarrhea and enterocolitis

Approved in Japan as Vancomycin for:

• Severe bacterial infections
• MRSA infections

Who Is Running the Clinical Trial?

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Lead Sponsor

Trials

17

Recruited

4,600+

Published Research Related to This Trial

The use of intrawound vancomycin powder during joint arthroplasty significantly reduced the overall rate of early prosthetic joint infections (PJI) from 1.57% in the control group to 0.49% in the treatment group, based on a study of 1640 patients over two years.

Specifically, in revision arthroplasty procedures, the vancomycin group showed a notable decrease in early PJIs from 3.89% to 0%, indicating that intrawound vancomycin may be particularly effective in this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrawound Vancomycin Powder Reduces Early Prosthetic Joint Infections in Revision Hip and Knee Arthroplasty. Otte, JE., Politi, JR., Chambers, B., et al.[2022]

In a study of 98 patients undergoing total knee arthroplasty, the use of intraoperative vancomycin powder did not significantly reduce the risk of surgical site infections compared to a control group.

The results suggest that vancomycin powder may not be an effective intervention for preventing infections in primary total knee arthroplasty, as indicated by a p-value of 0.31.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of vancomycin powder in total knee arthroplasty: A single-center study. Aljuhani, WS., Alanazi, AM., Alghafees, MA., et al.[2022]

In a randomized controlled trial involving 165 patients undergoing total knee arthroplasty, the use of intrawound vancomycin powder was found to be less effective than standard postoperative intravenous antibiotics in preventing periprosthetic joint infections (PJIs).

The trial was stopped early after one year due to a significantly higher incidence of PJIs in the vancomycin group (3.75%) compared to the control group (0%), indicating that intrawound vancomycin may not be a safe alternative to standard antibiotic protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Topical Vancomycin an Option? A Randomized Controlled Trial to Determine the Safety of the Topical Use of Vancomycin Powder in Preventing Postoperative Infections in Total Knee Arthroplasty, as Compared With Standard Postoperative Antibiotics. Abuzaiter, W., Bolton, CA., Drakos, A., et al.[2023]

In a study involving 32 rats with contaminated knee implants, the combination of intra-articular vancomycin powder and systemic vancomycin completely eliminated methicillin-resistant Staphylococcus aureus (MRSA) contamination, while systemic vancomycin alone did not.

No adverse effects or toxicity were observed in any treatment group, indicating that the use of intra-articular vancomycin powder is safe and warrants further investigation in clinical settings to prevent periprosthetic joint infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-Articular Vancomycin Powder Eliminates Methicillin-Resistant S. aureus in a Rat Model of a Contaminated Intra-Articular Implant. Edelstein, AI., Weiner, JA., Cook, RW., et al.[2022]

Topical vancomycin (vancomycin powder) did not show a significant reduction in the risk of periprosthetic joint infection (PJI) after hip and knee arthroplasty, with only one out of nine studies indicating any benefit.

There was no increase in overall complication risks associated with the use of topical vancomycin compared to standard infection prevention methods, but the studies were underpowered to detect rare complications, suggesting that more robust research is needed before routine use can be recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Hip and Knee Arthroplasty? A Systematic Review. Wong, MT., Sridharan, SS., Davison, EM., et al.[2023]

In a study of 16 patients with prosthetic joint infection (PJI), intra-articular (IA) infusion of vancomycin at 0.5 g daily effectively maintained high concentrations of the drug in the synovial fluid, which is crucial for treating infections in the joint area.

Combining IA vancomycin with intravenous (IV) administration resulted in good trough concentrations in both serum and synovial fluid, although IV vancomycin alone did not achieve detectable levels in the synovial fluid, highlighting the importance of IA infusion for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum and Synovial Vancomycin Concentrations in Patients with Prosthetic Joint Infection after Intra-articular Infusion. He, JW., Wang, J., Cao, L., et al.[2022]

In a study of 460 total hip and knee arthroplasties, the use of intrawound vancomycin significantly reduced the overall infection rate from 2.7% to 0.57% and the periprosthetic joint infection (PJI) rate from 2.7% to 0.29%.

The addition of intrawound vancomycin did not increase the risk of ototoxicity or acute kidney injury, suggesting it is a safe option for reducing infection rates in arthroplasty surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrawound vancomycin in primary hip and knee arthroplasty: a safe and cost-effective means to decrease early periprosthetic joint infection. Patel, NN., Guild, GN., Kumar, AR.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Intrawound Vancomycin Powder Reduces Early Prosthetic Joint Infections in Revision Hip and Knee Arthroplasty. [2022]

2. Saudi Arabia pubmed.ncbi.nlm.nih.gov

The efficacy of vancomycin powder in total knee arthroplasty: A single-center study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Is Topical Vancomycin an Option? A Randomized Controlled Trial to Determine the Safety of the Topical Use of Vancomycin Powder in Preventing Postoperative Infections in Total Knee Arthroplasty, as Compared With Standard Postoperative Antibiotics. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Intra-Articular Vancomycin Powder Eliminates Methicillin-Resistant S. aureus in a Rat Model of a Contaminated Intra-Articular Implant. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Hip and Knee Arthroplasty? A Systematic Review. [2023]

6. France pubmed.ncbi.nlm.nih.gov

Serum and Synovial Vancomycin Concentrations in Patients with Prosthetic Joint Infection after Intra-articular Infusion. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Intrawound vancomycin in primary hip and knee arthroplasty: a safe and cost-effective means to decrease early periprosthetic joint infection. [2022]