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NCT Number: NCT07324954

Methylene Blue in Total Knee Arthroplasty (TKA)

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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Key information

Conditions

Total Knee Arthroplasty Irrigation Prosthetic-joint Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UHealth Tower

Miami, Florida, 33125, United States

Location status: Recruiting

Location contact

Andrew R Moya, MD

CONTACT

[email protected]

305-243-3000

Colin A McNamara, MD, MBA

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

10 mL of 0.25% methylene blue dissolved in 20 mL normal saline, applied intra-articularly via sterile gauze to simulate contaminant presence. Irrigation performed in 2,000 mL increments until macroscopic dye clearance is achieved. Used solely as a surrogate marker; no therapeutic intent

Revision Arthroplasty for PJI (DAIR)

Procedure

Standard of care surgical procedure performed for documented periprosthetic joint infection

Primary Total Knee Arthroplasty

Procedure

Standard of care surgical procedure performed for severe knee osteoarthritis

Primary outcomes

  1. Irrigation Volume Required for Clearance of Methylene Blue Dye

    Time frame: Within 15 minutes intraoperatively, immediately following methylene blue dye application and completion of irrigation procedure

    To determine the volume of irrigation fluid (mL) required to achieve complete macroscopic clearance of methylene blue dye from the surgical site. The irrigation volume will be recorded intraoperatively at each increment and clearance assessed by direct visual confirmation

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew R Moya, MD

CONTACT

[email protected]

305-243-3000

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Impact of Irrigation Volumes in Revision Total Knee Arthroplasty (TKA) Surgical Washout: A Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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