IO Vancomycin in TSA

NCT05831774 | Active Not Recruiting Phase 4 Results FDA Drug

• 1 other identifier: PRO00036529
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Injuries

Keywords

total shoulder arthroplasty

Outcome Measures

Primary Outcomes (9)

• Systemic Levels of Vancomycin

  Comparable levels of vancomycin will be found in systemic samples between patient groups.

  24 hours

• Vancomycin Levels in the Initial Deltoid

  Comparable levels of vancomycin will be found in the initial deltoid samples between patient groups.

  24 hours

• Vancomycin Levels in the Humeral Head

  Comparable levels of vancomycin will be found in humeral head samples between patient groups.

  24 hours

• Levels of Vancomycin in Synovium

  Comparable levels of vancomycin will be found in synovium samples between patient groups.

  24 hours

• Levels of Vancomycin in Labrum

  Comparable levels of vancomycin will be found in labrum samples between patient groups.

  24 hours

• Levels of Vancomycin in Glenoid Reaming

  Comparable levels of vancomycin will be found in glenoid reaming samples between patient groups.

  24 hours

• Levels of Vancomycin in Bicep Tendon

  Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.

  24 hours

• Levels of Vancomycin in End Deltoid

  Comparable levels of vancomycin will be found in end deltoid samples between patient groups.

  24 hours

• Vancomycin Levels in Bicep Tendon

  Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.

  24 hours

Secondary Outcomes (1)

• Post-operative Complication (Infection) Rates

  30 days, 90 days

Study Arms (2)

Control - Standard IV administration of vancomycin

PLACEBO COMPARATOR

Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).

Drug: Control - Standard IV administration of vancomycin

Intervention - Intraosseous (IO) administration of vancomycin

EXPERIMENTAL

* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision * IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS). * Injection will take place into the proximal humerus

Drug: Intervention - Intraosseous (IO) administration of vancomycin

Interventions

Intervention - Intraosseous (IO) administration of vancomycin DRUG

* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision * IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS). * Injection will take place into the proximal humerus

Intervention - Intraosseous (IO) administration of vancomycin

Control - Standard IV administration of vancomycin DRUG

Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).

Control - Standard IV administration of vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Shoulder Injuries

Interventions

Jupiter

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Planets; Solar System; Astronomical Objects; Astronomical Phenomena; Physical Phenomena

Results Point of Contact

• Title: Haley Goble
• Organization: Houston Methodist Hospital

hmgoble@houstonmethodist.org

713-441-3930

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2 groups - one control, one treatment

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 26, 2023
• Study Start: June 1, 2023
• Primary Completion: July 15, 2024
• Study Completion: March 10, 2026
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)