Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Vancomycin | Active Comparator | Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA 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 generally 1000-1750mg in 500mL normal saline (NS)) |
|
| Intraosseous Vancomycin | Experimental | IV antibiotics per physician's standard of care: Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be given preoperatively in this group. IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS). IO Injection will take place into the medial malleolus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraosseous Vancomycin Injection | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Sample Vancomycin Tissue Concentration - Start of Case | perioperatively | |
| Systemic Sample Vancomycin Tissue Concentration - End of Case | perioperatively | |
| Capsule or Synovium Sample Vancomycin Tissue Concentration | immediately after the procedure | |
| Distal Tibia Sample Vancomycin Tissue Concentration | immediately after the procedure | |
| Talar Bone Sample Vancomycin Tissue Concentration | immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 90 day post-operative wound complication and infection rates | 90 days after the procedure |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas C Sullivan, BS | Contact | 346-238-1603 | tsullivan@houstonmethodist.org | |
| Blesson Varghese, BS | Contact | 713-441-3814 | bvarghese6@houstonmethodist.org |
| Name | Affiliation | Role |
|---|---|---|
| Jason S Ahuero, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
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
Not provided
Not provided
single blind patient is blinded. Surgeon is not blinded. Lab technician measuring tissue concentrations are blinded. Research coordinator is not blinded.
| Intravenous Vancomycin | Drug | • Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA 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 generally 1000-1750mg in 500mL normal saline (NS)) |
|