Methylene Blue in Total Knee Arthroplasty (TKA)
Impact of Irrigation Volumes in Revision Total Knee Arthroplasty (TKA) Surgical Washout: A Pilot Study
University of Miami
20 participants
Feb 4, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- Primary Total Knee Arthroplasty (TKA) or Primary Total Knee Arthroplasty (TKA) with Prosthetic Joint Infection (PJI)
- years
- Able to provide informed consent
Exclusion Criteria10
- 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
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Interventions
10 mL of 0.25% methylene blue dissolved in 20 mL normal saline, applied intra-articularly via sterile gauze to simulate contaminant presence. Irrigation performed in 2,000 mL increments until macroscopic dye clearance is achieved. Used solely as a surrogate marker; no therapeutic intent
Standard of care surgical procedure performed for documented periprosthetic joint infection
Standard of care surgical procedure performed for severe knee osteoarthritis
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07324954