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Methylene Blue in Total Knee Arthroplasty (TKA)

RecruitingPhase 1Ages 18 Years - anyAllUniversity of Miami
NCT07324954 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
UHealth Tower
Miami, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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