Preoperative Antibiotic Dosing for Total Knee Arthroplasty

Acute Infection of Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02433704
• Other study ID #: Pro00061712
• Status: Withdrawn
• Phase: Phase 4
• First received: April 10, 2015
• Last updated: July 27, 2017
• Start date: May 2015
• Est. completion date: June 2018

Study information

• Verified date: November 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

•primary diagnoses of osteoarthritis

Exclusion Criteria:

• history of compartment syndrome

• allergy to an antibiotic in the study

• venous stasis

• peripheral vascular disease

Related Conditions & MeSH terms

• Acute Infection of Total Knee Replacement

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Medical Plaza Page Road	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of acute surgical site infection		defined as within 3 weeks after the surgical procedure
Secondary	correlation of clinical comorbidities to acute infection rates		1 year post surgical intervention
Secondary	number of complications		1 year post surgical intervention
Secondary	tourniquet time		during procedure, up to approximately 2.5 hours
Secondary	blood loss		during procedure, up to approximately 2.5 hours