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NCT07324954PHASE1Recruiting

Methylene Blue in Total Knee Arthroplasty (TKA)

University of Miami

Start Date

2/4/2026

Completion Date

2/1/2027

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Methylene Blue 10 MG/ML (intra-articular application)

PROCEDURE

Revision Arthroplasty for PJI (DAIR)

PROCEDURE

Primary Total Knee Arthroplasty

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Conditions

Total Knee ArthroplastyProsthetic-joint InfectionIrrigation

Locations

UHealth Tower

Miami, Florida 33125

United States