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IO Vancomycin in TSA

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results first posted: Sep 22, 2025 Primary endpoints: 1 to 9v6 Show 1 more changeShow less
    • Primary endpoints: 1 to 9

    See this version in full on ClinicalTrials.gov ↗

  2. Enrollment target: estimated 40 to confirmed 33 Secondary endpoint revisedv5 Show 1 more changeShow less
    • Secondary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of Mar 10, 2025 to Jul 15, 2024 · Site details revisedv4 Show 2 more changesShow less
    • Primary completion date changed from estimate of Mar 10, 2025 to Jul 15, 2024
    • Site details revised
  4. Re-verified, no change to tracked fieldsv3
  5. Start date: Apr 25, 2023 to Jun 1, 2023v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to compare two different antibiotic regimens and techniques during total shoulder arthroplasty. 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.
Trial Details
NCT Number NCT05831774
Lead Sponsor The Methodist Hospital Research Institute
Conditions Shoulder Injuries
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov