Recruiting
Phase 1

Irrigation Volume

Sponsor:

University of Miami

Code:

NCT07324954

Conditions

Total Knee Arthroplasty

Prosthetic-joint Infection

Irrigation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Methylene Blue 10 MG/ML (intra-articular application)

Revision Arthroplasty for PJI (DAIR)

Primary Total Knee Arthroplasty

Study Details

Brief 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

Study ID

NCT07324954

Start date

Feb 4, 2026

Status verified date

Apr, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Primary Total Knee Arthroplasty (TKA) or Primary Total Knee Arthroplasty (TKA) with Prosthetic Joint Infection (PJI)
  • 18 years
  • Able to provide informed consent

Exclusion Criteria:

  • 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
  • Patients on Monoamine Oxidase (MAO) inhibitors, Selective Serotonin Reuptake Inhibitors (SSRI), Selective Norepinephrine Reuptake Inhibitors (SNRI), and/or Tricyclic Antidepressants (TCA)
  • History of methemoglobinemia
  • Glucose-6-Phosphate (G6P) Enzyme Deficiency
  • Chronic Kidney disease or Glomerular Filtration Rate (GFR) less than 30mL/min
  • Prisoners
  • Pregnant Woman

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

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

Revision Arthroplasty for PJI (DAIR)

Standard of care surgical procedure performed for documented periprosthetic joint infection

Primary Total Knee Arthroplasty

Standard of care surgical procedure performed for severe knee osteoarthritis

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 and Locations

Central contacts

Andrew R Moya, MD

305-243-3000arm577@miami.edu

Locations

UHealth Tower

Recruiting

Miami, Florida, United States, 33125

Contacts

Andrew R Moya, MD

305-243-3000arm577@miami.edu

Principal Investigator:

Colin A McNamara, MD, MBA

More Information

Sponsor

University of Miami

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-04-14.