Clinical trial
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Invitation only · Phase 4 · 1 countries · Registry ID NCT04297592
Invitation onlyPhase 4Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 99 Years
SexAll
Healthy volunteersNot accepted
ConditionInfections Joint Prosthetic, Overweight or Obesity, MSSA Colonization, MRSA, Chronic Kidney Diseases, Diabetes, Autoimmune Diseases, Inflammatory Disease, Tobacco Use
Full registry 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.
Treatments and study arms
Cephalexin
Drug
500 mg oral tablet, 4 times daily for 7 days
Doxycycline
Drug
100 mg oral tablet, 2 times daily for 7 days
Cefadroxil
Drug
500 mg oral tablet, 2 times daily for 7 days
Primary outcomes
Periprosthetic joint infectionsWithin 90-days primary hip or knee arthroplasty
Defined by Musculoskeletal Infection Society (MSIS) criteria
Periprosthetic joint infectionsWithin 1-year of primary hip or knee arthroplasty
Defined by Musculoskeletal Infection Society (MSIS) criteria