Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Last updated: June 30, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Enrolling

Phase

4

Condition

Diabetic Kidney Disease

Diabetic Gastroparesis

Ulcerative Colitis (Pediatric)

Treatment

Doxycycline

Cefadroxil

Cephalexin

Clinical Study ID

NCT04297592
22-001273
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is a candidate for elective, primary total hip arthroplasties (THA) or totalknee 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) ormethicillin-sensitive Staphylococcus aureus (MSSA).

Exclusion

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.

Study Design

Total Participants: 4618
Treatment Group(s): 3
Primary Treatment: Doxycycline
Phase: 4
Study Start date:
June 11, 2020
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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