Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07324954

Methylene Blue in Total Knee Arthroplasty (TKA)

Led by University of Miami · Updated on 2026-04-14

20

Participants Needed

1

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Methylene Blue in Total Knee Arthroplasty (TKA)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary Total Knee Arthroplasty (TKA) or Primary Total Knee Arthroplasty (TKA) with Prosthetic Joint Infection (PJI)
  • 18 years or older
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Incomplete irrigation documentation
  • Severe immunosuppression, such as chemotherapy, neutropenia, HIV, or steroid use
  • Positive fungal, parasitic, or mycobacterial cultures
  • Allergy to methylene blue
  • Use of MAO inhibitors, SSRIs, SNRIs, or tricyclic antidepressants
  • History of methemoglobinemia
  • Glucose-6-Phosphate (G6P) enzyme deficiency
  • Chronic kidney disease or GFR less than 30 mL/min
  • Prisoners
  • Pregnant women

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

UHealth Tower

Miami, Florida, United States, 33125

Actively Recruiting

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Research Team

A

Andrew R Moya, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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