A Phase 4 interventional study of New Intraosseous and Cefazolin in Acute Infection of Total Knee Replacement, sponsored by Duke University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-07-28.
Sponsored by Duke University · Phase 4, Interventional, and Prevention
To directly compare acute infection rates in patients undergoing total knee replacement with intraosseous regional administration or systemic intravenous administration of prophylactic antibiotics.
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
•primary diagnoses of osteoarthritis
Exclusion Criteria:
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 · Drug: Cefazolin
Historical controls will be used and will have received systemic dosing of cefazolin within one hour of the incision.
Intraosseous administration of prophylactic antibiotics
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.
rate of acute surgical site infection
Time frame: defined as within 3 weeks after the surgical procedure
correlation of clinical comorbidities to acute infection rates
Time frame: 1 year post surgical intervention
number of complications
Time frame: 1 year post surgical intervention
tourniquet time
Time frame: during procedure, up to approximately 2.5 hours
blood loss
Time frame: during procedure, up to approximately 2.5 hours
This study is withdrawn, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Duke University