Methylene Blue in Total Knee Arthroplasty (TKA)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
Qualifiers
Primary Total Knee Arthroplasty (TKA) or Primary Total Knee Arthroplasty (TKA) with Prosthetic Joint Infection (PJI)
18 years
Able to provide informed consent
Disqualifiers
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
Trial design
Treatments tested in this trial
- Methylene Blue 10 MG/ML (intra-articular application)
- Revision Arthroplasty for PJI (DAIR)
- Primary Total Knee Arthroplasty
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov