Diabetes Clinical Trial
Official title:
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Verified date | June 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 4618 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals & Clinics | Iowa City | Iowa |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Inabathula A, Dilley JE, Ziemba-Davis M, Warth LC, Azzam KA, Ireland PH, Meneghini RM. Extended Oral Antibiotic Prophylaxis in High-Risk Patients Substantially Reduces Primary Total Hip and Knee Arthroplasty 90-Day Infection Rate. J Bone Joint Surg Am. 2018 Dec 19;100(24):2103-2109. doi: 10.2106/JBJS.17.01485. — View Citation
Kurtz SM, Lau E, Watson H, Schmier JK, Parvizi J. Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2. — View Citation
Li B, Webster TJ. Bacteria antibiotic resistance: New challenges and opportunities for implant-associated orthopedic infections. J Orthop Res. 2018 Jan;36(1):22-32. doi: 10.1002/jor.23656. Epub 2017 Aug 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Periprosthetic joint infections | Defined by Musculoskeletal Infection Society (MSIS) criteria | Within 90-days primary hip or knee arthroplasty | |
Primary | Periprosthetic joint infections | Defined by Musculoskeletal Infection Society (MSIS) criteria | Within 1-year of primary hip or knee arthroplasty | |
Secondary | Wound complication | Defined by at least one of the following: surgical wound dehiscence, skin necrosis at the surgical site, persistent surgical wound drainage (fluid extrusion from the operative site occurring beyond 72 hours from index surgery), superficial surgical site infection treated with new prescription of antibiotics or a change in study antibiotics but not meeting criteria for periprosthetic joint infection. | Within 90 days of primary hip or knee arthroplasty |
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