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Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during tourniquetless total knee arthroplasty.
Primary Objective: Comparable levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues, as well as in systemic levels, between the intravenous and intraosseous administration groups.
Secondary Objective: Compare 30- and 90-day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) versus the interventional group (intraosseous administration of vancomycin). The research team hypothesizes that there will be no difference in complication (infection) rates between groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Vancomycin Administration | Active Comparator | Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty patients. This includes IV antibiotics (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 [12,13] generally 1000-1750mg in 500mL NS). |
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| Intraosseous Vancomycin Administration | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraosseous Vancomycin Injection | Drug | • IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS). |
| Measure | Description | Time Frame |
|---|---|---|
| Vancomycin Bone/Tissue Concentrations | Compare levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues, | immediate post-op |
| Systemic Vancomycin Concentrations | Compare systemic vancomycin levels between the intravenous and intraosseous vancomycin administration groups. | will be recorded day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 30 day & 90 day post-operative complication rates | Monitor charts and clinic visits during the study subject's standard of care postoperative visit schedule and monitor for adverse events including periprosthetic joint infection and wound issues. | 30 days post-op, 90 days post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas C Sullivan, BS | Contact | 346-238-1603 | tsullivan@houstonmethodist.org | |
| Haley Goble, MHA | Contact | 7134413930 | hmgoble@houstonmethodist.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital Outpatient Center | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38462143 | Derived | Wininger AE, Gurusamy P, Sullivan TC, Serpelloni S, Taraballi F, Park KJ, Brown TS. Intraosseous Versus Intravenous Vancomycin in Tourniquetless Primary Total Knee Arthroplasty: A Randomized Trial. J Arthroplasty. 2024 Sep;39(9 Suppl 2):S224-S228. doi: 10.1016/j.arth.2024.02.083. Epub 2024 Mar 8. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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This study is a prospective, randomized, single-blinded, controlled trial. The anticipated total number of participants in this study is 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 primary TKA between IO vs IV
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| Intravenous Vancomycin | Drug | IV Vancomycin will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL NS). |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |