Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT04297592
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04297592
Study Brief:
Protocol Section:
NCT04297592