Methylene Blue for Prosthetic Joint Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the amount of liquid needed to clean a knee joint during surgery for a prosthetic joint infection (when a knee replacement becomes infected). Researchers use a blue dye, Methylene Blue, to determine when the joint is clean. The study aims to help doctors determine the right amount of liquid for future treatments. It is suitable for individuals undergoing knee replacement surgery, particularly those with an infected knee joint. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to contribute to groundbreaking medical knowledge.
Do I have to stop taking my current medications for the trial?
If you are taking Monoamine Oxidase (MAO) inhibitors, Selective Serotonin Reuptake Inhibitors (SSRI), Selective Norepinephrine Reuptake Inhibitors (SNRI), or Tricyclic Antidepressants (TCA), you cannot participate in the trial. The protocol does not specify about other medications.
What prior data suggests that methylene blue is safe for use in this procedure?
Research has shown that methylene blue is usually safe for use in surgeries. In studies on its application during knee surgeries, patients reported no major side effects. Surgeons use methylene blue as a dye to better visualize and remove infected tissue. Although some evidence suggests it might affect certain lab tests, this does not impact surgical safety. Overall, methylene blue appears to be a useful tool in surgeries without serious safety concerns.12345
Why are researchers excited about this trial?
Most treatments for prosthetic joint infections involve antibiotics and surgical cleaning, but methylene blue offers a unique twist. Researchers are excited because methylene blue is applied directly during surgery to highlight and help remove contaminants more effectively. This dye acts as a visual aid, potentially improving the thoroughness of the cleaning process compared to standard procedures. By enhancing visibility, methylene blue could lead to better outcomes and fewer repeat surgeries for patients.
What evidence suggests that methylene blue is effective for prosthetic joint infection?
This trial studies methylene blue for its potential to assist during surgery by highlighting areas needing cleaning in prosthetic joint infection (PJI) cases. Participants in the "Revision Arthroplasty with Documented PJI (DAIR)" arm receive methylene blue during revision surgery to simulate contaminant presence, aiding in identifying infected areas for thorough cleaning. Similarly, in the "Primary Total Knee Arthroplasty" arm, methylene blue enhances visibility of areas requiring cleaning. Research has shown that methylene blue acts as a visible guide, marking infected areas to ensure thorough cleaning. Studies have found it particularly useful when determining if an infection is deep or just on the surface is difficult. By using this dye, surgeons can more easily see and remove infected tissue, potentially improving the surgery's success. This approach aims to make surgeries more efficient and effective in treating joint infections.23467
Who Is on the Research Team?
Colin A McNamara, MD, MBA
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for individuals undergoing a knee replacement surgery or those with infections around their knee prosthesis. It's designed to find out how much washing out (irrigation) is needed during infection cleaning procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Procedure
Participants undergo revision or primary total knee arthroplasty with methylene blue dye application and irrigation until macroscopic clearance is achieved
Follow-up
Participants are monitored for safety and effectiveness after the surgical procedure
What Are the Treatments Tested in This Trial?
Interventions
- Methylene Blue
Trial Overview
The study tests the use of Methylene Blue dye to simulate contaminants in knee surgery. The goal is to determine the right amount of fluid needed to wash away these simulated contaminants by taking photos after every 2 liters used.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants undergoing revision total knee arthroplasty for periprosthetic joint infection will receive standard of care revision surgery. During the procedure, methylene blue dye will be applied intra-articularly via soaked gauze to simulate contaminant presence. Irrigation will be performed in 2,000 mL increments until macroscopic clearance is achieved, documented intraoperatively.
Participants undergoing primary total knee arthroplasty will receive standard of care primary surgery. During the procedure, methylene blue dye will be applied intra-articularly via soaked gauze to simulate contaminant presence. Irrigation will be performed in 2,000 mL increments until macroscopic clearance is achieved, which will be documented intraoperatively.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Citations
Methylene Blue-Guided Debridement as an Intraoperative ...
These results suggest a role for methylene blue in providing a visual index of surgical debridement in the treatment of PJI.
Methylene Blue in Total Knee Arthroplasty (TKA)
The purpose of this pilot study is to determine the volume of irrigation required to achieve macroscopic clearance of contaminants during a ...
Methylene Blue Infiltration As a Method for Distinguishing ...
Infiltrating methylene blue in a prosthetic hip is useful in differentiating between superficial or deep infections where PJI workup is indeterminate.
Infection Methylene Blue–Guided Debridement as an ...
Our results indicate that methylene blue may be a useful adjunct for the treatment of PJI during the resection stage of 2-stage revision surgery.
Periprosthetic joint infection: current concepts and outlook in
Characteristics and treatment outcomes of 69 cases with early prosthetic joint infections of the hip and knee. Infection 2014; 42: 511–519 .
Principles of mechanical and chemical debridement with ...
Periprosthetic joint infection (PJI) is one of the most common causes of early revision for total hip and knee arthroplasty.
Does methylene blue affect culture yield in total knee ...
While MB use did not affect overall culture positivity, it could interfere with intraoperative pathogen detection in patients with negative preoperative ...
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