drugset / Trial / NCT07324954

Methylene Blue in Total Knee Arthroplasty (TKA)

NCT07324954

Phase 1 Recruiting 20 enrolled University of Miami
Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2026-02-04
Primary completion
2027-02-01
Completion
2027-02-01

Drugs

EvaluationDrugModalityDoseRoute
Background Methylene Blue Diagnostic / imaging agent 0.25 % Other
Background Methylene Blue Diagnostic / imaging agent 10 mg/ml Other
Background Methylene Blue Diagnostic / imaging agent 10 ml Other