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Methylene Blue in Total Knee Arthroplasty (TKA)
Sponsor: University of Miami
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.
Official title: Impact of Irrigation Volumes in Revision Total Knee Arthroplasty (TKA) Surgical Washout: A Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-02-01
Completion Date
2027-02-01
Last Updated
2026-01-08
Healthy Volunteers
No
Interventions
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
Revision Arthroplasty for PJI (DAIR)
Standard of care surgical procedure performed for documented periprosthetic joint infection
Primary Total Knee Arthroplasty
Standard of care surgical procedure performed for severe knee osteoarthritis
Locations (1)
UHealth Tower
Miami, Florida, United States