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RECRUITING Phase 4

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

NCT06384651 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Intraosseous Vancomycin Injection
  • DRUG Intravenous Vancomycin

Study Locations (1)

Texas

  • Houston Methodist Hospital — Houston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-12-03
Est. Completion 2027-12
Phase Phase 4

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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Methodist Hospital Research Institute, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06384651 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06384651?

The interventions under investigation include: Intraosseous Vancomycin Injection (DRUG), Intravenous Vancomycin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06384651?

This trial is sponsored by The Methodist Hospital Research Institute, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial