Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2023

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.

Interventions

  • Drug: Cephalexin Oral Tablet
    • Default oral antibiotic option for participants in Group A.
  • 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.

Arms, Groups and Cohorts

  • 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
  • No Intervention: Group B – no additional antibiotic
    • No antibiotics will be prescribed following standard perioperative IV antibiotics following primary hip or knee arthroplasty.

Clinical Trial Outcome Measures

Primary Measures

  • Periprosthetic joint infections
    • Time Frame: Within 90-days primary hip or knee arthroplasty
    • Defined by Musculoskeletal Infection Society (MSIS) criteria
  • Periprosthetic joint infections
    • Time Frame: Within 1-year of primary hip or knee arthroplasty
    • Defined by Musculoskeletal Infection Society (MSIS) criteria

Secondary Measures

  • Wound complication
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Undergoing elective, primary total hip or total knee arthroplasty
  • Between the ages of 18-99
  • 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

  • Younger than 18 years old
  • Undergoing a revision hip or knee arthroplasty
  • Will have a subsequent total joint arthroplasty performed within 12 weeks of study enrollment
  • History of clostridium difficile colitis
  • Undergoing non-elective procedure
  • Hemiarthroplasty
  • Unicompartmental knee arthroplasty
  • Simultaneous bilateral total hip or knee arthroplasty
  • Pregnant
  • Unable to provide written consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Iowa
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nicholas Bedard, Dr. Nicholas Bedard, MD – University of Iowa
  • Overall Official(s)
    • Nicholas Bedard, MD, Principal Investigator, University of Iowa Hospitals & Clinics
  • Overall Contact(s)
    • Lauren Keitel, BS, (319) 467-7128, lauren-keitel@uiowa.edu

References

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.

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.

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.

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