Status:
ENROLLING_BY_INVITATION
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Lead Sponsor:
Mayo Clinic
Conditions:
Infections Joint Prosthetic
Overweight or Obesity
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
To determine the effectiveness of a 7-day course of an oral, prophylactic antibiotic on the incidence of periprosthetic joint infection and wound complications following primary total hip and knee art...
Detailed Description
The purpose of this research study is to investigate whether a 7-day course of an oral, prophylactic antibiotic following elective, primary total hip and knee arthroplasty effectively decreases the ri...
Eligibility Criteria
Inclusion
- Patient is a candidate for elective, primary total hip arthroplasties (THA) or total knee arthroplasties (TKA).
- Patient is considered high-risk for developing Periprosthetic joint infections (PJI) based on having at least one of the following criteria:
- Body mass index (BMI) \> 35 kg/m\^2;
- Diagnosis of diabetes mellitus;
- Active tobacco smoker;
- Chronic kidney disease;
- Autoimmune disease;
- Nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-sensitive Staphylococcus aureus (MSSA).
Exclusion
- Inability to consume oral antibiotics.
- Allergy to antibiotic alternatives in the protocol.
- History of clostridium difficile colitis.
- Revision hip or knee arthroplasty procedure.
- Non-elective surgery.
- Hemiarthroplasty.
- Unicompartmental knee arthroplasty.
- Simultaneous bilateral THA or TKA.
- Will have subsequent THA or TKA within 12 weeks of the index study procedure.
- Pregnant.
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
4618 Patients enrolled
Trial Details
Trial ID
NCT04297592
Start Date
June 11 2020
End Date
June 1 2026
Last Update
July 3 2025
Active Locations (2)
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1
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
2
Mayo Clinic
Rochester, Minnesota, United States, 55902