Preoperative Antibiotic Dosing for Total Knee Arthroplasty

Duke University

Status and phase: Withdrawn; Phase 4

Conditions: Acute Infection of Total Knee Replacement

Treatments: Drug: Cefazolin; Device: New Intraosseous

Study type: Interventional

Funder types: Other

Identifiers

NCT02433704

Pro00061712

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

•primary diagnoses of osteoarthritis

Exclusion criteria

• history of compartment syndrome
• allergy to an antibiotic in the study
• venous stasis
• peripheral vascular disease

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intraosseous Administration

Active Comparator group

Description:

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.

Treatment:

Drug: Cefazolin

Device: New Intraosseous

Systemic Intravenous Administration

No Intervention group

Description:

Historical controls will be used and will have received systemic dosing of cefazolin within one hour of the incision.