Shoulder InjuriesPhase 4NCT05831774
IO Vancomycin in TSA
A Phase 4 study testing Intervention - Intraosseous (IO) administration of vancomycin in people with Shoulder Injuries, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Injuries
- What is being tested?
- Intervention - Intraosseous (IO) administration of vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 10 Mar 2026
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- 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
- 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
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.
- Conditions
- Shoulder Injuries
- Being tested
- Intervention - Intraosseous (IO) administration of vancomycin, Control - Standard IV administration of vancomycin
- Keywords
- total shoulder arthroplasty
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention - Intraosseous (IO) administration of vancomycinDrug
- 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
Control - Standard IV administration of vancomycinDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Drug: Intervention - Intraosseous (IO) administration of vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Levels of Vancomycin
Comparable levels of vancomycin will be found in systemic samples between patient groups.
Measured: 24 hours
Vancomycin Levels in the Initial Deltoid
Comparable levels of vancomycin will be found in the initial deltoid samples between patient groups.
Measured: 24 hours
Vancomycin Levels in the Humeral Head
Comparable levels of vancomycin will be found in humeral head samples between patient groups.
Measured: 24 hours
Levels of Vancomycin in Synovium
Comparable levels of vancomycin will be found in synovium samples between patient groups.
Measured: 24 hours
Levels of Vancomycin in Labrum
Comparable levels of vancomycin will be found in labrum samples between patient groups.
Measured: 24 hours
Levels of Vancomycin in Glenoid Reaming
Comparable levels of vancomycin will be found in glenoid reaming samples between patient groups.
Measured: 24 hours
Levels of Vancomycin in Bicep Tendon
Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.
Measured: 24 hours
Levels of Vancomycin in End Deltoid
Comparable levels of vancomycin will be found in end deltoid samples between patient groups.
Measured: 24 hours
Vancomycin Levels in Bicep Tendon
Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.
Measured: 24 hours
Secondary outcomes (1)
Post-operative Complication (Infection) Rates
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.
Measured: 30 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Jun 2023
- Primary completion15 Jul 2024
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups - one control, one treatment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick McCulloch,MD, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831774
- Sponsor's protocol ID
- PRO00036529
- Status last verified
- Sep 2025
- First submitted
- 10 Mar 2023
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share this information.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraosseous vs. Intravenous Vancomycin Administration in Total Shoulder Arthroplasty: Changing the Paradigm
- ClinicalTrials.gov ID
- NCT05831774
- Acronym / sponsor ID
- PRO00036529
- Conditions
- Shoulder Injuries
- Keywords
- total shoulder arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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
- 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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 2 groups - one control, one treatment
| Arm | Type | Receives |
|---|---|---|
| Control - Standard IV administration of vancomycin | Placebo comparator | Drug: Control - Standard IV administration of vancomycinPatients 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 | Experimental | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
| Control - Standard IV administration of vancomycinPatients 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 |
Primary outcome
Systemic Levels of Vancomycin
Time frame: 24 hours
Comparable levels of vancomycin will be found in systemic samples between patient groups.
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.
Vancomycin Levels in the Humeral Head
Time frame: 24 hours
Comparable levels of vancomycin will be found in humeral head samples between patient groups.
Levels of Vancomycin in Synovium
Time frame: 24 hours
Comparable levels of vancomycin will be found in synovium samples between patient groups.
Levels of Vancomycin in Labrum
Time frame: 24 hours
Comparable levels of vancomycin will be found in labrum samples between patient groups.
Levels of Vancomycin in Glenoid Reaming
Time frame: 24 hours
Comparable levels of vancomycin will be found in glenoid reaming samples between patient groups.
Levels of Vancomycin in Bicep Tendon
Time frame: 24 hours
Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.
Levels of Vancomycin in End Deltoid
Time frame: 24 hours
Comparable levels of vancomycin will be found in end deltoid samples between patient groups.
Vancomycin Levels in Bicep Tendon
Time frame: 24 hours
Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.
1 secondary outcome
Post-operative Complication (Infection) Rates
Time frame: 30 days, 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We do not plan to share this information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intervention - Intraosseous (IO) administration of vancomycin in people with Shoulder Injuries, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Levels of Vancomycin (time frame: 24 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.