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OpenTrials
Enrolling by Invitation

NCT Number: NCT04297592

Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

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.

Enrolling by Invitation

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cephalexin

Drug

500 mg oral tablet, 4 times daily for 7 days

Other names: Keflex

Doxycycline

Drug

100 mg oral tablet, 2 times daily for 7 days

Cefadroxil

Drug

500 mg oral tablet, 2 times daily for 7 days

Other names: Duricef

Primary outcomes

  1. Periprosthetic joint infections

    Time frame: Within 90-days primary hip or knee arthroplasty

    Defined by Musculoskeletal Infection Society (MSIS) criteria

  2. Periprosthetic joint infections

    Time frame: Within 1-year of primary hip or knee arthroplasty

    Defined by Musculoskeletal Infection Society (MSIS) criteria

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Mar 5, 2020
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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