Methylene Blue in Total Knee Arthroplasty (TKA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Total Knee Arthroplasty; Prosthetic-joint Infection; Irrigation
• Intervention / Treatment: Drug: Methylene Blue 10 MG/ML (intra-articular application); Procedure: Revision Arthroplasty for PJI (DAIR); Procedure: Primary Total Knee Arthroplasty

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Andrew R Moya, MD; Phone Number: 305-243-3000; Email: arm577@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33125
      • Recruiting
      • UHealth Tower
      • Contact: Andrew R Moya, MD; Phone Number: 305-243-3000; Email: arm577@miami.edu
      • Principal Investigator: Colin A McNamara, MD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Revision Arthroplasty with Documented PJI (DAIR); Participants undergoing revision total knee arthroplasty for periprosthetic joint infection will receive standard of care revision surgery. During the procedure, methylene blue dye will be applied intra-articularly via soaked gauze to simulate contaminant presence. Irrigation will be performed in 2,000 mL increments until macroscopic clearance is achieved, documented intraoperatively.	Drug: Methylene Blue 10 MG/ML (intra-articular application); 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; Procedure: Revision Arthroplasty for PJI (DAIR); Standard of care surgical procedure performed for documented periprosthetic joint infection
Active Comparator: Primary Total Knee Arthroplasty; Participants undergoing primary total knee arthroplasty will receive standard of care primary surgery. During the procedure, methylene blue dye will be applied intra-articularly via soaked gauze to simulate contaminant presence. Irrigation will be performed in 2,000 mL increments until macroscopic clearance is achieved, which will be documented intraoperatively.	Drug: Methylene Blue 10 MG/ML (intra-articular application); 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; Procedure: Primary Total Knee Arthroplasty; Standard of care surgical procedure performed for severe knee osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irrigation Volume Required for Clearance of Methylene Blue Dye	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	Within 15 minutes intraoperatively, immediately following methylene blue dye application and completion of irrigation procedure

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Colin A McNamara, MD, MBA, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Phenothiazines; Methylene Blue
• Other Study ID Numbers: 20250901 (Jiangsu Jicui Medical Engineering Cross Technology Research Institute Co., Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No