Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

  • STATUS
    Recruiting
  • End date
    Jun 24, 2025
  • participants needed
    956
  • sponsor
    University of Iowa
Updated on 24 March 2022
diabetes
body mass index
antibiotics
Accepts healthy volunteers

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.

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.

Details
Condition Infections Joint Prosthetic, Overweight or Obesity, MSSA Colonization, MRSA, Chronic Kidney Diseases, Diabetes, Autoimmune Diseases, Inflammatory Disease, Tobacco Use
Treatment Doxycycline Hyclate, Cephalexin Oral Tablet, Cephalexin Oral Tablet
Clinical Study IdentifierNCT04297592
SponsorUniversity of Iowa
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
Patient is discharged the same day as primary THA or TKA
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
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