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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Intervention - Intraosseous (IO) administration of vancomycin | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention - Intraosseous (IO) administration of vancomycin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days, 90 days |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
We do not plan to share this information.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). 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). |
| FG001 | Intervention - Intraosseous (IO) Administration of Vancomycin |
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
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systemic Levels of Vancomycin | Comparable levels of vancomycin will be found in systemic samples between patient groups. | Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained. | Posted | Mean | Standard Error | ug/mL | 24 hours |
|
Through 90 days postop
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haley Goble | Houston Methodist Hospital | 713-441-3930 | hmgoble@houstonmethodist.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2023 | Aug 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D018538 | Jupiter |
| ID | Term |
|---|---|
| D016083 | Planets |
| D016082 | Solar System |
| D055587 | Astronomical Objects |
| D055580 | Astronomical Phenomena |
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2 groups - one control, one treatment
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Double blinded study
|
| 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). |
|
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 |
| BG001 | Intervention - Intraosseous (IO) Administration of Vancomycin |
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
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Intervention - Intraosseous (IO) Administration of Vancomycin |
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
|
|
|
| Primary | Vancomycin Levels in the Initial Deltoid | Comparable levels of vancomycin will be found in the initial deltoid samples between patient groups. | Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained. | Posted | Mean | Standard Error | ug/mL | 24 hours |
|
|
|
| Primary | Vancomycin Levels in the Humeral Head | Comparable levels of vancomycin will be found in humeral head samples between patient groups. | Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained. | Posted | Mean | Standard Error | ug/mL | 24 hours |
|
|
|
| Primary | Levels of Vancomycin in Synovium | Comparable levels of vancomycin will be found in synovium samples between patient groups. | Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained. | Posted | Mean | Standard Error | ug/mL | 24 hours |
|
|
|
| Primary | Levels of Vancomycin in Labrum | Comparable levels of vancomycin will be found in labrum samples between patient groups. | Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained. | Posted | Mean | Standard Error | ug/mL | 24 hours |
|
|
|
| Primary | Levels of Vancomycin in Glenoid Reaming | Comparable levels of vancomycin will be found in glenoid reaming samples between patient groups. | Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained. | Posted | Mean | Standard Error | ug/mL | 24 hours |
|
|
|
| Primary | Levels of Vancomycin in Bicep Tendon | Comparable levels of vancomycin will be found in bicep tendon samples between patient groups. | Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained. | Posted | Mean | Standard Error | ug/mL | 24 hours |
|
|
|
| Primary | Levels of Vancomycin in End Deltoid | Comparable levels of vancomycin will be found in end deltoid samples between patient groups. | Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained. | Posted | Mean | Standard Error | ug/mL | 24 hours |
|
|
|
| Primary | Vancomycin Levels in Bicep Tendon | Comparable levels of vancomycin will be found in bicep tendon samples between patient groups. | Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained. | Posted | Mean | Standard Error | ug/mL | 24 hours |
|
|
|
| Secondary | 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. | Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained. | Posted | Number | Postoperative Complications | 30 days, 90 days |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Intervention - Intraosseous (IO) Administration of Vancomycin |
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
| 0 | 15 | 0 | 15 | 0 | 15 |
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| D055585 |
| Physical Phenomena |