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Search / Trial NCT04297592

Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Launched by MAYO CLINIC · Mar 3, 2020

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Total Hip Arthroplasty Total Knee Arthroplasty Hip Replacement Knee Replacement Periprosthetic Joint Infection Prophylaxis Antibiotics

ClinConnect Summary

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 col...

Gender

ALL

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.

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Little Rock, Arkansas, United States

Morgantown, West Virginia, United States

Rochester, Minnesota, United States

Iowa City, Iowa, United States

Patients applied

0 patients applied

Trial Officials

Nicholas Bedard, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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