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Methylene Blue in Total Knee Arthroplasty (TKA)

Impact of Irrigation Volumes in Revision Total Knee Arthroplasty (TKA) Surgical Washout: A Pilot Study

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* Primary Total Knee Arthroplasty (TKA) or Primary Total Knee Arthroplasty (TKA) with Prosthetic Joint Infection (PJI)
* 18 years
* Able to provide informed consent

Exclusion Criteria:

* Incomplete irrigation documentation
* Patients with severe immunosuppression (example: chemotherapy, neutropenia, Human Immunodeficiency Virus \[HIV\], steroid use)
* Positive fungal, parasitic, or mycobacterial cultures
* Methylene Blue allergy
* Patients on Monoamine Oxidase (MAO) inhibitors, Selective Serotonin Reuptake Inhibitors (SSRI), Selective Norepinephrine Reuptake Inhibitors (SNRI), and/or Tricyclic Antidepressants (TCA)
* History of methemoglobinemia
* Glucose-6-Phosphate (G6P) Enzyme Deficiency
* Chronic Kidney disease or Glomerular Filtration Rate (GFR) less than 30mL/min
* Prisoners
* Pregnant Woman

About the study

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.

What is being tested

• Methylene Blue 10 MG/ML (intra-articular application) (drug)
• Revision Arthroplasty for PJI (DAIR) (procedure)
• Primary Total Knee Arthroplasty (procedure)

Sponsor: University of Miami · Participants: 20 · Started: Feb 4, 2026

Contact the study team

• Andrew R Moya, MD · Phone: 305-243-3000

Official record on ClinicalTrials.gov — NCT07324954

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.