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NCT06384651 · ClinicalTrials.gov registry record · Phase 4
Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
A Phase 4 study of Infections and Ankle Arthritis, sponsored by The Methodist Hospital Research Institute.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06384651: Recruiting Phase 4 study of Infections and Ankle Arthritis, sponsored by The Methodist Hospital Research Institute.
NCT06384651 is a Phase 4 study of Infections and Ankle Arthritis that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 40 participants, below the 3,406-participant average among 26 other Infections trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06384651, a Phase 4 study of Infections and Ankle Arthritis, is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA). Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups. Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.
Conditions Studied
Interventions
- DRUG Intraosseous Vancomycin Injection
- DRUG Intravenous Vancomycin
Study Locations (1)
Texas
- Houston Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-12-03 |
| Est. Completion | 2027-12 |
| Phase | Phase 4 |
What NCT06384651 shows while recruiting
NCT06384651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 3,406-participant average among 26 other Infections trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Infections appearing as the primary indexed condition, and to 2 interventions - of which Intraosseous Vancomycin Injection is the first listed.
NCT06384651 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06384651 about?
NCT06384651 is a clinical study titled "Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty". The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA). Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups. Secondary Objective: Compare 30 day an...
What is the current status of trial NCT06384651?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2024-12-03. Estimated completion is 2027-12.
What conditions does trial NCT06384651 study?
This clinical trial studies the following conditions: Infections, Ankle Arthritis.
What interventions are being tested in trial NCT06384651?
The interventions under investigation include: Intraosseous Vancomycin Injection (DRUG), Intravenous Vancomycin (DRUG).
Who is sponsoring clinical trial NCT06384651?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06384651 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06384651's enrollment target sits among peer trials
40 20th of 26 higher than 7 of 26 other Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infections 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.
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