IO Vancomycin in TSA

September 18, 2025 updated by: Patrick McCulloch,MD, The Methodist Hospital Research Institute

Intraosseous vs. Intravenous Vancomycin Administration in Total Shoulder Arthroplasty: Changing the Paradigm

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a prospective, randomized, single-blinded, controlled trial. 20 patients in each treatment arm: 20 patients will be given IV vancomycin, 20 patients will be given IO vancomycin. This sample size is based on previous studies examining vancomycin concentration in tourniquetless primary total knee arthroplasty between IO vs IV [12,13].

Once the participant has been enrolled, they will be randomized into either the control group or the experimental group by an excel-based software program prior to their procedure.

Control - Standard IV administration of vancomycin

1) 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).

Intervention - Intraosseous (IO) administration of vancomycin

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

All patients in both groups will be monitored during the surgery and immediately post-operatively for adverse injection reactions (i.e. Red Man Syndrome) as this is the standard of care.

All patients (IV and IO) will otherwise follow identical post-operative protocols (including post-operative antibiotic administration)

Intra-Op Sample Collection

Samples will be taken from the following locations at the following times:

Systemic Sample - Start of Case A vancomycin blood level will be drawn by the anesthesiologist staff (CRNA, MD) at the start of incision and should occur simultaneously with the final soft tissue sample collection below Soft tissue sample - Synovium Start A small soft tissue sample will be taken from the synovium upon entering the shoulder joint. This sample will only be taken if it is readily available for the surgeon to gather.

Bone Sample - Bone from Humeral Head After the humeral neck is cut with the "cookie cutter" instrument a portion of humeral head/neck will be removed and placed in a separate specimen jar (remainder of head will be sent to pathology as usual).

Soft Tissue Sample - Synovium End A small soft tissue sample will be taken from the synovium prior to initiation of wound closure. This sample will only be taken if it is readily available for the surgeon to gather.

Systemic Sample A vancomycin blood level will be drawn by the anesthesiologist staff (CRNA, MD) at the time of initiation of closure and should occur simultaneously with the final soft tissue sample collection above

Data Variables to be Recorded Age (calculated from DOB), date of surgery, discharge date, sex, laterality, study group, pre-op creatinine, post-op creatinine, systemic vancomycin level at incision, soft tissue vancomycin level (synovium start and synovium end), humeral head bone sample vancomycin level, and systemic vancomycin level at initiation of wound closure. Additionally, adverse local/systemic reactions as determined from patient's chart, 30-day complications, 90-day complications, cost, time from antibiotic administration to incision, operative time, and incision time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control - Standard IV administration of vancomycin
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
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).
Experimental: Intervention - Intraosseous (IO) administration of vancomycin
  • 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
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Systemic Levels of Vancomycin
Time Frame: 24 hours
Comparable levels of vancomycin will be found in systemic samples between patient groups.
24 hours
Vancomycin Levels in the Initial Deltoid
Time Frame: 24 hours
Comparable levels of vancomycin will be found in the initial deltoid samples between patient groups.
24 hours
Vancomycin Levels in the Humeral Head
Time Frame: 24 hours
Comparable levels of vancomycin will be found in humeral head samples between patient groups.
24 hours
Levels of Vancomycin in Synovium
Time Frame: 24 hours
Comparable levels of vancomycin will be found in synovium samples between patient groups.
24 hours
Levels of Vancomycin in Labrum
Time Frame: 24 hours
Comparable levels of vancomycin will be found in labrum samples between patient groups.
24 hours
Levels of Vancomycin in Glenoid Reaming
Time Frame: 24 hours
Comparable levels of vancomycin will be found in glenoid reaming samples between patient groups.
24 hours
Levels of Vancomycin in Bicep Tendon
Time Frame: 24 hours
Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.
24 hours
Levels of Vancomycin in End Deltoid
Time Frame: 24 hours
Comparable levels of vancomycin will be found in end deltoid samples between patient groups.
24 hours
Vancomycin Levels in Bicep Tendon
Time Frame: 24 hours
Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-operative Complication (Infection) Rates
Time Frame: 30 days, 90 days
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.
30 days, 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Methodist Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO00036529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share this information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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