IO Vancomycin in TSA

• Status: Recruiting
• Trial end date: 2026-03-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Methodist Hospital Research Institute
• Treatments: Vancomycin

Criteria

Inclusion Criteria

• Patient is undergoing anatomic or reverse shoulder arthroplasty

• Patient is able to give informed consent to participate on the study. LAR consents will not be utilized for this study

• Age Range >18

Exclusion Criteria:

• Previous shoulder surgery

• BMI above 35

• Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).

• Inability to administer the IO infusion

• Refusal to participate

• Diabetes

• Immunocompromised or immunosuppressed patients (HIV, Hep C, ESRD, dialysis, transplant, chemo/radiation treatment in last 6 months, medications)