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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 is a Phase 1 study that is actively recruiting participants, run by University of Miami. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07324954
The ClinicalTrials.gov registry entry for NCT07324954 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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