Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Launched by MAYO CLINIC · Mar 3, 2020

Keywords

ClinConnect Summary

This study is testing whether giving a 7-day course of an oral antibiotic after elective total hip or knee replacement helps further prevent infections around the new joint and wound problems in people who are already at higher risk. Participants are randomly assigned to receive either an additional oral antibiotic (one of Cephalexin, Doxycycline, or Cefadroxil chosen based on allergies, kidney function, and nasal MRSA/MSSA test results) after surgery, or to receive no extra antibiotic. All participants get the usual 24 hours of perioperative antibiotics; the main things researchers will look at are infections around the joint within 90 days and again within 1 year, plus any wound problems within 90 days.

Eligible participants are adults 18 to 99 planning an elective primary hip or knee replacement and who are considered high-risk for infection or wound issues due to at least one of these factors: BMI over 35, diabetes, chronic kidney disease, autoimmune disease, active tobacco use, or nasal colonization with MRSA/MSSA. Exclusions include not being able to take oral antibiotics, certain antibiotic allergies, history of C. difficile infection, revision or non-elective surgeries, certain bilateral procedures, or pregnancy. The study is sponsored by Mayo Clinic and is taking place at sites including Mayo Clinic (Rochester) and the University of Iowa; it is currently enrolling and is expected to complete in 2026.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.