Study Stopped
Difficulty with enrollment
Preoperative Antibiotic Dosing for Total Knee Arthroplasty
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJuly 28, 2017
November 1, 2015
2 years
April 10, 2015
July 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
rate of acute surgical site infection
defined as within 3 weeks after the surgical procedure
Secondary Outcomes (4)
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
Study Arms (2)
Intraosseous Administration
ACTIVE COMPARATORCefazolin 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.
Systemic Intravenous Administration
NO INTERVENTIONHistorical controls will be used and will have received systemic dosing of cefazolin within one hour of the incision.
Interventions
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.
Eligibility Criteria
You may qualify if:
- primary diagnoses of osteoarthritis
You may not qualify if:
- history of compartment syndrome
- allergy to an antibiotic in the study
- venous stasis
- peripheral vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke Medical Plaza Page Road
Durham, North Carolina, 27703, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Wellman, MD
Duke University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2015
First Posted
May 5, 2015
Study Start
May 1, 2015
Primary Completion
May 1, 2017
Study Completion
June 1, 2018
Last Updated
July 28, 2017
Record last verified: 2015-11