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Methylene Blue in Total Knee Arthroplasty (TKA)

NCT07324954 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Colin A McNamara, MD, MBA · University of Miami

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-04
Primary Completion
2027-02-01
Completion
2027-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07324954 on ClinicalTrials.gov