Methylene Blue in Total Knee Arthroplasty (TKA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methylene Blue 10 MG/ML (intra-articular application), Revision Arthroplasty for PJI (DAIR), Primary Total Knee Arthroplasty.
- Who it may be relevant to
- Registry conditions: Total Knee Arthroplasty, Prosthetic-joint Infection, Irrigation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Irrigation Volumes in Revision Total Knee Arthroplasty (TKA) Surgical Washout: A Pilot Study
Overview
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.
Interventions
- 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 - Procedure Primary Total Knee Arthroplasty
Standard of care surgical procedure performed for severe knee osteoarthritis
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- UHealth Tower — Miami
Identifiers
NCT: NCT07324954 · 20250901