Methylene Blue for Prosthetic Joint Infection

Overseen By Andrew R Moya, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Miami

Must not be taking: MAO inhibitors, SSRIs, SNRIs, TCAs

Disqualifiers: Severe immunosuppression, Positive cultures, Methylene Blue allergy, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this pilot study is to determine the volume of irrigation required to achieve macroscopic clearance of contaminants during a debridement, antibiotics, and implant retention (DAIR) procedure for periprosthetic joint infection (PJI) of the knee. Given the lack of robust data guiding irrigation volume in this setting, the investigator proposes to use the application of methylene blue dye intraoperatively to simulate contaminant presence. Serial irrigation will be performed, with photographic documentation taken every 2,000mL until visible dye clearance is achieved. This study aims to identify the irrigation volumes that result in gross clearance of simulated contamination, thereby informing the design and stratification of a future randomized controlled trial (RCT) evaluating irrigation strategies in DAIR procedures.

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

Able to provide informed consent

I am having or have had a first-time knee replacement, with or without joint infection.

I am 18 years old or older.

Exclusion Criteria

Incomplete irrigation documentation

Positive fungal, parasitic, or mycobacterial cultures

I do not have severe immunosuppression from treatments or conditions like HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo revision or primary total knee arthroplasty with methylene blue dye application and irrigation until macroscopic clearance is achieved

Within 15 minutes intraoperatively

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure

4 weeks

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?

Group I: Revision Arthroplasty with Documented PJI (DAIR) Experimental Treatment 2 Interventions

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.

Group II: Primary Total Knee Arthroplasty Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+