Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

22-001273

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.

2020-06-11

2025-06-01

2025-06-01

Early phase I

4618

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 4618, 'type': 'ESTIMATED'}}

2023-06-28