Vancomycin for Total Knee Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores ways to prevent infections after knee replacement surgery by comparing three methods of administering vancomycin, an antibiotic: directly into the joint, through a vein, or into the bone. The goal is to prevent infection while minimizing additional wounds, time, and costs. Candidates may be suitable if they plan to have a knee replacement for the first time and have no history of kidney issues or uncontrolled diabetes. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on immunomodulating medications or have certain health conditions, you may not be eligible to participate.
What is the safety track record for these treatments?
Research shows that both intraarticular and intraosseous vancomycin are generally well-tolerated. Studies have found that using vancomycin directly in the joint (intraarticular) effectively lowers infection rates in joint replacements. These studies reported no major safety concerns, indicating the treatment was well-received.
For vancomycin used in the bone (intraosseous), research highlights its effectiveness in preventing infections after knee replacement surgery. It has shown better results compared to the traditional intravenous method, with studies emphasizing its safety as a good alternative.
Both methods have a strong safety record, with no significant adverse events reported in the available studies. This suggests that these vancomycin treatments are safe options for those considering joining a clinical trial focused on knee replacement surgery.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments because they offer new ways to deliver Vancomycin during total knee replacement surgeries, potentially enhancing effectiveness and safety. Unlike the standard intravenous method, which relies on weight and other factors to determine dosage, the intraarticular (IA) Vancomycin is directly injected into the joint with a precise 500mg dose in saline. Similarly, the intraosseous (IO) Vancomycin is delivered into the bone itself, also using a 500mg dose but in a larger saline volume, which might improve distribution and absorption. These targeted delivery methods could lead to better infection control and fewer side effects compared to the traditional approach.
What evidence suggests that this trial's treatments could be effective for periprosthetic joint infection?
This trial will compare different methods of administering vancomycin to prevent infections after total knee replacement. Research has shown that injecting vancomycin directly into the joint (intraarticular), one method tested in this trial, can effectively reduce infections by delivering the antibiotic to the area that needs it most. Another method under study is injecting vancomycin into the bone (intraosseous), which has been found to lower the chance of infection by up to 69% compared to other methods. This approach offers a strong alternative to the traditional method of administering antibiotics through a vein (IV), which serves as a standard of care comparison in this trial. Both experimental methods show promise for preventing infections in knee replacements, potentially leading to better recovery outcomes for patients.12367
Are You a Good Fit for This Trial?
This trial is for patients undergoing total knee replacement surgery. It's designed to test if injecting the antibiotic vancomycin directly into the joint or bone, or giving it through a vein can prevent infections after surgery. Participants should not have any conditions that would exclude them from receiving vancomycin in these ways.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vancomycin through intraarticular, intraosseous, or intravenous administration during total knee arthroplasty
Follow-up
Participants are monitored for safety and effectiveness after the surgical procedure
What Are the Treatments Tested in This Trial?
Interventions
- Vancomycin
Trial Overview
The study compares three methods of administering vancomycin: directly into the knee joint (intraarticular), into the bone (intraosseous), and through a vein (intravenous). The goal is to see which method best prevents infection without additional wounds or costs.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
500mg dose Vancomycin (in 100mL saline)
500mg dose Vancomycin (in 30mL saline)
Standard of care dose based on patient weight, organ function, and clinical factors at the discretion of the treating physician
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Citations
Intra-articular Vancomycin Reduces Prosthetic Infection in ...
Intraarticular vancomycin powder is effective in preventing infections following total hip and knee arthroplasty. Sci Rep. 2020;10 doi: 10.1038/s41598-020 ...
Intraarticular Vancomycin Reduces Prosthetic Infection in ...
The study concluded that intraarticular vancomycin solution reduced infection rates after primary hip and knee arthroplasty, as reflected in the ...
Effectiveness of intra-articular vancomycin in preventing ...
This study aimed to evaluate the effectiveness and safety of intra-articular vancomycin powder in reducing prosthetic joint infections (PJIs) in primary hip and ...
Intraarticular vancomycin powder is effective in preventing ...
The main result of the present study is that intraarticular vancomycin powder lowers the infection rate after total knee arthroplasty and ...
Intraosseous Versus Intravenous Vancomycin in ...
In summary, this study shows that IO vancomycin results in a nonsignificant increase in bone vancomycin concentration levels during primary TKA, ...
A Prospective, Randomized Parallel Group Study of the ...
We proposed that intraarticular injection of vancomycin is non-inferior to intraosseous administration, thus reducing wounds, time, and cost. Official Title. A ...
Efficacy and safety of vancomycin for local application in the ...
Purpose. The aim of this systematic review and meta-analysis is to explore the effect of topical vancomycin powder (VP) in surgical site ...
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