Methylene blue dye to measure how much irrigation clears contamination during knee replacement procedures
Official title: Impact of Irrigation Volumes in Revision Total Knee Arthroplasty (TKA) Surgical Washout: A Pilot Study
Run by University of Miami · NCT07324954 · Data updated 2026-11-12
We will test whether putting methylene blue dye into the knee during replacement or DAIR procedures can show how much irrigation is needed to wash out contaminants.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | February 4, 2026 |
| Main results expected | February 1, 2027 |
| Study ends | February 1, 2027 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT07324954 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older undergoing primary total knee arthroplasty or DAIR for periprosthetic knee infection who can give informed consent and do not meet exclusion criteria are appropriate candidates.
✕Probably not a fit
Patients who are pregnant, prisoners, severely immunosuppressed, have fungal/parasitic/mycobacterial infection, are on contraindicated antidepressants or MAO inhibitors, have a methylene blue allergy, G6PD deficiency, history of methemoglobinemia, or GFR <30 mL/min are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1 pilot uses methylene blue applied intraoperatively during primary total knee arthroplasty or during debridement, antibiotics, and implant retention (DAIR) for periprosthetic joint infection to simulate contamination. Surgeons will perform serial irrigation with photographic documentation every 2,000 mL and continue until visible dye clearance is achieved. The protocol records the irrigation volumes associated with gross dye removal. Findings will be used to design and stratify a future randomized controlled trial comparing irrigation strategies in DAIR procedures.
Why it matters
Potential benefit: If successful, this could provide surgeons with evidence-based irrigation volume targets during DAIR, potentially improving contaminant removal and reducing reinfection risk.
How similar studies have gone: There is limited robust data on optimal irrigation volumes for DAIR and using methylene blue as a surrogate contaminant is a novel pilot approach rather than an established method.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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UHealth Tower
Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Colin A McNamara, MD, MBA — University of Miami
- Study coordinator: Andrew R Moya, MD
- Email: arm577@miami.edu
- Phone: 305-243-3000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.