Methylene Blue in Total Knee Arthroplasty (TKA)

What Was Tested

This registered phase 1 trial tested Methylene blue (non-peptide stack partner).

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.

It had two arms (groups): Revision Arthroplasty with Documented PJI (DAIR) (experimental) and Primary Total Knee Arthroplasty (active comparator).

The registry classes the interventions as drug and procedure.

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Primary Total Knee Arthroplasty (TKA) or Primary Total Knee Arthroplasty (TKA) with Prosthetic Joint Infection (PJI). Able to provide informed consent.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: incomplete irrigation documentation; patients with severe immunosuppression (example: chemotherapy, neutropenia, human immunodeficiency virus \[hiv\], steroid use); positive fungal, parasitic, or mycobacterial cultures.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-02-04 with completion listed for 2027-02-01.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Irrigation Volume Required for Clearance of Methylene Blue Dye.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Methylene blue (non-peptide stack partner) in 20 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.