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Preoperative Antibiotic Dosing for Total Knee Arthroplasty

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02433704
Enrollment
0
Registered
2015-05-05
Start date
2015-05-31
Completion date
2018-06-30
Last updated
2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Infection of Total Knee Replacement

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.

Interventions

DEVICENew Intraosseous

Intraosseous administration of prophylactic antibiotics

DRUGCefazolin

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.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

•primary diagnoses of osteoarthritis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
rate of acute surgical site infectiondefined as within 3 weeks after the surgical procedure

Secondary

MeasureTime frame
correlation of clinical comorbidities to acute infection rates1 year post surgical intervention
number of complications1 year post surgical intervention
tourniquet timeduring procedure, up to approximately 2.5 hours
blood lossduring procedure, up to approximately 2.5 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026