Preoperative Antibiotic Dosing for Total Knee Arthroplasty

Phase 4

Withdrawn

• Conditions: Acute Infection of Total Knee Replacement
• Interventions: Device: New Intraosseous; Drug: Cefazolin

• Registration Number: NCT02433704
• Lead Sponsor: Duke University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-04-10
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-04
• Study First Posted: 2015-05-05
• Status Verified: 2015-11
• Primary Completion: 2017-05
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-28
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•primary diagnoses of osteoarthritis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraosseous Administration	New Intraosseous	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.
Intraosseous Administration	Cefazolin	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.

Primary Outcome Measures

Name	Time	Method
rate of acute surgical site infection	defined as within 3 weeks after the surgical procedure

Secondary Outcome Measures

Name	Time	Method
correlation of clinical comorbidities to acute infection rates	1 year post surgical intervention
blood loss	during procedure, up to approximately 2.5 hours
number of complications	1 year post surgical intervention
tourniquet time	during procedure, up to approximately 2.5 hours

Trial Locations

Locations (1)

Duke Medical Plaza Page Road; 🇺🇸 Durham, North Carolina, United States