NCT07324954 Methylene Blue in Total Knee Arthroplasty (TKA)
| NCT ID | NCT07324954 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Miami |
| Condition | Total Knee Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-02-04 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-02-04 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Colin A McNamara, MD, MBA
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT07324954 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07324954 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07324954 currently recruiting?
Yes, NCT07324954 is actively recruiting participants. Contact the research team at arm577@miami.edu for enrollment information.
Where is the NCT07324954 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07324954 clinical trial?
NCT07324954 is sponsored by University of Miami. The principal investigator is Colin A McNamara, MD, MBA at University of Miami. The trial plans to enroll 20 participants.