Methylene Blue in Total Knee Arthroplasty (TKA)

NCT07324954 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 20250901
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Irrigation; Total Knee Arthroplasty; Prosthetic-joint Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Revision Arthroplasty with Documented PJI (DAIR)

EXPERIMENTAL

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); Procedure: Revision Arthroplasty for PJI (DAIR)

Primary Total Knee Arthroplasty

ACTIVE COMPARATOR

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); Procedure: Primary Total Knee Arthroplasty

Interventions

Primary Total Knee Arthroplasty PROCEDURE

Standard of care surgical procedure performed for severe knee osteoarthritis

Primary Total Knee Arthroplasty

Revision Arthroplasty for PJI (DAIR) PROCEDURE

Standard of care surgical procedure performed for documented periprosthetic joint infection

Revision Arthroplasty with Documented PJI (DAIR)

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

Primary Total Knee Arthroplasty; Revision Arthroplasty with Documented PJI (DAIR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary Total Knee Arthroplasty (TKA) or Primary Total Knee Arthroplasty (TKA) with Prosthetic Joint Infection (PJI)
• years
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

UHealth Tower

Miami, Florida, 33125, United States

RECRUITING

MeSH Terms

Interventions

Methylene Blue

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Colin A McNamara, MD, MBA

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew R Moya, MD

CONTACT

305-243-3000; arm577@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 8, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)