Methylene Blue in Total Knee Arthroplasty (TKA)

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07324954
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Irrigation
  • Prosthetic-joint Infection
  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methylene Blue 10 MG/ML (intra-articular application) — DRUG
    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) — PROCEDURE
    Standard of care surgical procedure performed for documented periprosthetic joint infection
  • Primary Total Knee Arthroplasty — PROCEDURE
    Standard of care surgical procedure performed for severe knee osteoarthritis

Study Details

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.

Key Dates

Start date
Feb 4, 2026
Status verified
Apr 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Revision Arthroplasty with Documented PJI (DAIR)
    Participants undergoing revision total knee arthroplasty for periprosthetic joint infection will receive standard of care revision surgery. During the procedure, methylene blue dye will be applied intra-articularly via soaked gauze to simulate contaminant presence. Irrigation will be performed in 2,000 mL increments until macroscopic clearance is achieved, documented intraoperatively.
  • Active Comparator: Primary Total Knee Arthroplasty
    Participants undergoing primary total knee arthroplasty will receive standard of care primary surgery. During the procedure, methylene blue dye will be applied intra-articularly via soaked gauze to simulate contaminant presence. Irrigation will be performed in 2,000 mL increments until macroscopic clearance is achieved, which will be documented intraoperatively.

Primary Outcome Measure

Irrigation Volume Required for Clearance of Methylene Blue Dye [ Time Frame: Within 15 minutes intraoperatively, immediately following methylene blue dye application and completion of irrigation procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UHealth TowerMiamiFlorida33125
Andrew R Moya, MD
[email protected]
305-243-3000
Colin A McNamara, MD, MBA (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
UHealth Tower· Miami, FL

Related Studies