Status:
ACTIVE_NOT_RECRUITING
Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty- Multi-center Trial
Lead Sponsor:
Duke University
Collaborating Sponsors:
American Association of Hip and Knee Surgeons
Orthopedic Research and Education Foundation
Conditions:
Arthropathy of Knee
Antibiotic Prophylaxis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty (TKA): Multi-Center Trial is a study that will compare the effectiveness of various perioperative strategies for anti...
Detailed Description
Total joint arthroplasty (TJA), is one of the most successful operations in modern medicine; however, it remains an expensive procedure in an era of constrained health care resources. Arthritis affect...
Eligibility Criteria
Inclusion
- Patient is ≥ 18 years of age
- Patient has no open wounds on operative leg
- Patient is scheduled to undergo elective total knee arthroplasty for posttraumatic, osteoarthritis, avascular necrosis, and/or inflammatory arthritis
- Patient does not have active infection on the operative leg, the operative joint
- Patient is willing to cooperate and follow study protocol and visit schedule
Exclusion
- Patient is ≤ 18 years of age
- Patient is pregnant
- Patient is unable to provide written consent
- Patient has psychiatric disorder that precludes safe study participation or that necessitates confinement in a custodial environment at home or in a chronic care facility
- Patient has traumatic injury that requires emergent or urgent total knee arthroplasty (e.g. fracture)
- Patient has active infections in the operative leg/joint
- Patient has severe dementia
- Suspicion of illicit drug abuse by patient. Patients who use prescription cannabinoids are not excluded from enrollment.
- ASA score of 5 \& 6
- No application of topical antibiotic powder such as vancomycin or antibiotic beads in surgical wound
- Intra-operative re-dosing other than specified re-dosing intervals or without excessive blood loss (\<1500mL)
- History of prior native septic knee arthritis
Key Trial Info
Start Date :
October 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
1770 Patients enrolled
Trial Details
Trial ID
NCT03283878
Start Date
October 24 2017
End Date
December 1 2025
Last Update
November 24 2025
Active Locations (14)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Emory University
Atlanta, Georgia, United States, 30322
3
University of Maryland St. Joseph Medical Center & Orthopedic Associates
Towson, Maryland, United States, 21204
4
University Of Mississippi Medical Center
Jackson, Mississippi, United States, 39216