Methylene Blue in Total Knee Arthroplasty (TKA)
Recruiting now · Phase 1
Conditions studied: Total Knee Arthroplasty, Prosthetic-joint Infection, Irrigation
In brief
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.
Key facts
- Study ID
- NCT07324954
- Run by
- University of Miami
- People needed
- 20
- Starts
- 2026-02-04
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-04-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Primary Total Knee Arthroplasty (TKA) or Primary Total Knee Arthroplasty (TKA) with Prosthetic Joint Infection (PJI)
- 18 years
- Able to provide informed consent
You may not qualify if…
- 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
Where it is running
- UHealth Tower — Miami, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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