Preoperative Antibiotic Dosing for Total Knee Arthroplasty

Study Overview
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Brief Summary
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To directly compare acute infection rates in patients undergoing total knee replacement with intraosseous regional administration or systemic intravenous administration of prophylactic antibiotics.

Detailed Description
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Subjects will be prospectively enrolled into the Intraosseous Regional Administration (IORA) group, and the investigators will use historical controls for the Systemic Intravenous Administration (SIA) group, to include a matched group of patients from 6 months prior to enrollment. SIA group will receive systemic dosing of cefazolin within one hour of the incision, which is the current standard of care. IORA group will receive intraosseous dosing after the tourniquet is inflated to 300-350mm/Hg. Cefazolin 1 gram will be given through an intraosseous cannula, placed into the medial aspect of the proximal tibia, after draping and before skin incision. The cefazolin will be administered as a bolus in 200 mL of normal saline. Incision will be made immediately after infusion. Subjects in both groups will receive routine care following the procedure. Primary outcome will be acute surgical site infection, which is defined as within 3 weeks after the surgical procedure. Secondary outcomes will include correlation of clinical comorbidities to the primary outcome, report complications, and compare surgery specific information (tourniquet time, blood loss). Subjects with a penicillin allergy will receive a 200mg cefazolin test dose via a systemic intravenous route, which is the current standard of care. If no adverse reaction is observed, then the investigators will proceed with administration of 1g cefazolin via the intraosseus route.

Official Title
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Preoperative Antibiotic Dosing for Total Knee Arthroplasty: Intraosseous Versus Systemic Infusion

Conditions
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Acute Infection of Total Knee Replacement

Intervention / Treatment
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* Device: New Intraosseous
* Drug: Cefazolin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: •primary diagnoses of osteoarthritis Exclusion Criteria: history of compartment syndrome allergy to an antibiotic in the study venous stasis peripheral vascular disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intraosseous Administration<br>Cefazolin 1 gram will be given through an intraosseous cannula, placed into the medial aspect of the proximal tibia, after draping and before skin incision. The cefazolin will be administered as a bolus in 200 mL of normal saline. | Device: New Intraosseous<br>* Intraosseous administration of prophylactic antibiotics<br>Drug: Cefazolin<br>* Cefazolin 1 gram will be given through an intraosseous cannula, placed into the medial aspect of the proximal tibia, after draping and before skin incision. The cefazolin will be administered as a bolus in 200 mL of normal saline.<br>|
| No Intervention: Systemic Intravenous Administration<br>Historical controls will be used and will have received systemic dosing of cefazolin within one hour of the incision. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of acute surgical site infection |  | defined as within 3 weeks after the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of clinical comorbidities to acute infection rates |  | 1 year post surgical intervention | 
| number of complications |  | 1 year post surgical intervention | 
| tourniquet time |  | during procedure, up to approximately 2.5 hours | 
| blood loss |  | during procedure, up to approximately 2.5 hours |