Preoperative Antibiotic Dosing for Total Knee Arthroplasty

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

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

Study Overview

• Status: Withdrawn
• Conditions: Acute Infection of Total Knee Replacement
• Intervention / Treatment: Device: New Intraosseous; Drug: Cefazolin

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Duke Medical Plaza Page Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intraosseous Administration; 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; Intraosseous administration of prophylactic antibiotics; Drug: 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.
No Intervention: Systemic Intravenous Administration; Historical controls will be used and will have received systemic dosing of cefazolin within one hour of the incision.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: Pro00061712