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NCT07324954 · ClinicalTrials.gov registry record · Phase 1
Methylene Blue in Total Knee Arthroplasty (TKA)
A Phase 1 study, sponsored by University of Miami.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT07324954: Recruiting Phase 1 study, sponsored by University of Miami.
NCT07324954 is a Phase 1 study that is actively recruiting participants, run by University of Miami. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07324954, a Phase 1 study, is actively recruiting participants, sponsored by University of Miami.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
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.
Primary Outcome
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
Interventions
- DRUG Methylene Blue 10 MG/ML (intra-articular application)
- PROCEDURE Revision Arthroplasty for PJI (DAIR)
- PROCEDURE Primary Total Knee Arthroplasty
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-02-04 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 1 |
What NCT07324954 shows while recruiting
NCT07324954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Methylene Blue 10 MG/ML (intra-articular application) is the first listed.
NCT07324954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07324954 about?
NCT07324954 is a clinical study titled "Methylene Blue in Total Knee Arthroplasty (TKA)". 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 irr...
What is the current status of trial NCT07324954?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2026-02-04. Estimated completion is 2027-02-01.
What interventions are being tested in trial NCT07324954?
The interventions under investigation include: Methylene Blue 10 MG/ML (intra-articular application) (DRUG), Revision Arthroplasty for PJI (DAIR) (PROCEDURE), Primary Total Knee Arthroplasty (PROCEDURE).
Who is sponsoring clinical trial NCT07324954?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07324954's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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