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NCT07324954
Methylene Blue in Total Knee Arthroplasty (TKA)
Phase 1 trial testing Methylene Blue 10 MG/ML (intra-articular application) in Total Knee Arthroplasty in 20 participants. Currently enrolling.
1 February 2027
Quick facts
| Lead sponsor | University of Miami |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 20 |
| Start date | 4 February 2026 |
| Primary completion | 1 February 2027 |
| Estimated completion | 1 February 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Methylene Blue 10 MG/ML (intra-articular application) — full drug profile →
- Revision Arthroplasty for PJI (DAIR)
- Primary Total Knee Arthroplasty
Conditions studied
- Total Knee Arthroplasty — all drugs for Total Knee Arthroplasty →
- Prosthetic-joint Infection — all drugs for Prosthetic-joint Infection →
- Irrigation — all drugs for Irrigation →
Sponsor
University of Miami
Who can join
18 and older, any sex, with Total Knee Arthroplasty or Prosthetic-joint Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07324954
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other University of Miami trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07324954 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Miami
- Last refreshed: 14 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07324954.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing