Methylene Blue in Total Knee Arthroplasty (TKA)

University of Miami

Status and phase: Not yet enrolling; Phase 1

Conditions: Irrigation; Prosthetic-joint Infection; Total Knee Arthroplasty

Treatments: Procedure: Revision Arthroplasty for PJI (DAIR); Drug: Methylene Blue 10 MG/ML (intra-articular application); Procedure: Primary Total Knee Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT07324954

20250901

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Revision Arthroplasty with Documented PJI (DAIR)

Experimental group

Description:

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.

Treatment:

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

Procedure: Revision Arthroplasty for PJI (DAIR)

Primary Total Knee Arthroplasty

Active Comparator group

Description:

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.

Treatment:

Procedure: Primary Total Knee Arthroplasty

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