Clinical Trial

IO Vancomycin in TSA

Active, Not Recruiting Phase 4
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Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-04-14; most recent amendment 2025-09-18.
Status change: Recruiting → Active, Not Recruiting 2024-09-03
Trial Details
NCT Number NCT05831774
Lead Sponsor The Methodist Hospital Research Institute
Conditions Shoulder Injuries
Enrollment 33 participants
Start Date 2023-06-01
Primary Completion 2024-07-15 (estimated)
Study Completion 2026-03-10 (estimated)
Updated on ClinicalTrials.gov 2025-09-22