Irrigation, Prosthetic-joint Infection, Total Knee Arthroplasty
Conditions
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.
Interventions
DRUGMethylene 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
PROCEDURERevision Arthroplasty for PJI (DAIR)
Standard of care surgical procedure performed for documented periprosthetic joint infection
PROCEDUREPrimary Total Knee Arthroplasty
Standard of care surgical procedure performed for severe knee osteoarthritis
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Irrigation Volume Required for Clearance of Methylene Blue Dye | 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 |
Countries
United States
Contacts
CONTACTAndrew R Moya, MD
PRINCIPAL_INVESTIGATORColin A McNamara, MD, MBA
University of Miami
Outcome results
None listed