NCT07324954

Methylene Blue in Total Knee Arthroplasty (TKA)

Impact of Irrigation Volumes in Revision Total Knee Arthroplasty (TKA) Surgical Washout: A Pilot Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Knee Arthroplasty
• Prosthetic-joint Infection
• Irrigation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-04
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2026-01-08
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study