By InvitationPhase 4

Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

United States4,618 participantsStarted 2020-06-11

Plain-language 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 arthroplasty in a high-risk patient population.

Who can participate

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Periprosthetic joint infections

Timeframe: Within 90-days primary hip or knee arthroplasty

Periprosthetic joint infections

Timeframe: Within 1-year of primary hip or knee arthroplasty

Trial details

NCT IDNCT04297592

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Infections Joint Prosthetic trials