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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06384651
The ClinicalTrials.gov registry entry for NCT06384651 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,406-participant average among 26 other Infections trials with a reported enrollment target (99% lower). The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.