Clinical trial NCT04297592: Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Official title: Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Infections Joint Prosthetic
Overweight or Obesity
MSSA Colonization
MRSA
Chronic Kidney Diseases
Diabetes
Autoimmune Diseases
Inflammatory Disease
Tobacco Use
Keywords: total hip arthroplasty
total knee arthroplasty
hip replacement
knee replacement
periprosthetic joint infection
prophylaxis
antibiotics
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 4618
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: The purpose of this research study is to investigate whether a 7-day course of an oral, prophylactic antibiotic following elective, primary total hip and knee arthroplasty effectively decreases the risk of periprosthetic joint infection or wound complications following surgery in a patient population that is high-risk for these complications. Patient with one or more of the following risk factors are considered high-risk for periprosthetic joint infection and/or wound complications: body mass index over 35kg/m\^2, diagnosis of diabetes, chronic kidney disease, active tobacco user, nasal colonization of methicillin-resistant Staphylococcus aureus and/or methicillin-sensitive Staphylococcus aureus, or autoimmune/inflammatory disease.

Study participants will be randomized to either a 7-day course of an oral, prophylactic antibiotic following surgery or no additional antibiotic. All other standard perioperative total joint arthroplasty care will remain the same for both groups, including 24-hours of perioperative antibiotics. Outcomes assessed will include surgical wound complications occurring within 90-day of surgery and periprosthetic joint infection occurring within 90-day and 1-year of surgery.

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.

Primary outcomes:
measure: Periprosthetic joint infections
timeFrame: Within 90-days primary hip or knee arthroplasty
measure: Periprosthetic joint infections
timeFrame: Within 1-year of primary hip or knee arthroplasty
Secondary outcomes:
measure: Wound complication
timeFrame: Within 90 days of primary hip or knee arthroplasty
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nicholas Bedard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.