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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Methylene Blue 10 MG/ML (intra-articular application)
Drug10 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)
Procedure/SurgeryStandard of care surgical procedure performed for documented periprosthetic joint infection
Primary Total Knee Arthroplasty
Procedure/SurgeryStandard of care surgical procedure performed for severe knee osteoarthritis
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Revision Arthroplasty with Documented PJI (DAIR)Experimental treatment 2 interventions
Group B: Primary Total Knee ArthroplastyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Irrigation Volume Required for Clearance of Methylene Blue Dye
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
Time frame
Within 15 minutes intraoperatively, immediately following methylene blue dye application and completion of irrigation procedureSponsors and contacts
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Source ClinicalTrials.gov