Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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 perioperative intravenous 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Group A - antibiotic group Patients will be given 7-days of an oral antibiotic (either cephalexin or doxycycline) to be started after completion of standard perioperative intravenous antibiotics following primary hip or knee arthroplasty |
Drug: Cephalexin Oral Tablet
Default oral antibiotic option for participants in Group A.
Other Names:
Drug: Doxycycline Hyclate
Oral antibiotic option for participants in Group A if they have preoperative nasal colonization of methicillin-resistant Staphylococcus aureus, allergy to cephalosporins or a creatinine clearance less than 60 mL/min.
Other Names:
|
No Intervention: Group B - no additional antibiotic No antibiotics will be prescribed following standard perioperative IV antibiotics following primary hip or knee arthroplasty. |
Outcome Measures
Primary Outcome Measures
- Periprosthetic joint infections [Within 90-days primary hip or knee arthroplasty]
Defined by Musculoskeletal Infection Society (MSIS) criteria
- Periprosthetic joint infections [Within 1-year of primary hip or knee arthroplasty]
Defined by Musculoskeletal Infection Society (MSIS) criteria
Secondary Outcome Measures
- Wound complication [Within 90 days of primary hip or knee arthroplasty]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Undergoing elective, primary total hip or total knee arthroplasty
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Between the ages of 18-99
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Has one or more of the following high risk criteria: body mass index (BMI) greater than 35kg/m^2, diagnosis of diabetes, active tobacco user, chronic kidney disease (estimated glomerular filtration (eGFR) < 60 mL/min/1.73 m2), nasal colonization of MRSA and/or MSSA or autoimmune/inflammatory disease.
Exclusion Criteria:
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Younger than 18 years old
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Undergoing a revision hip or knee arthroplasty
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Will have a subsequent total joint arthroplasty performed within 12 weeks of study enrollment
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Patient is discharged the same day as primary THA or TKA
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History of clostridium difficile colitis
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Undergoing non-elective procedure
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Hemiarthroplasty
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Unicompartmental knee arthroplasty
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Simultaneous bilateral total hip or knee arthroplasty
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Pregnant
-
Unable to provide written consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
2 | University of Iowa Hospitals & Clinics | Iowa City | Iowa | United States | 52242 |
3 | Mayo Clinic | Rochester | Minnesota | United States | 55902 |
4 | West Virginia University | Morgantown | West Virginia | United States | 26506 |
Sponsors and Collaborators
- University of Iowa
Investigators
- Principal Investigator: Jacob Elkins, MD, University of Iowa Hospitals & Clinics
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 201912215