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Antibiotic Prophylaxis for High-Risk Joint Replacement Patients

This study is looking at whether taking an antibiotic for 7 days after hip or knee replacement surgery can lower the risk of infection. You might be able to join if you are having a total hip or knee replacement and are considered high-risk for infection. This includes people with a high body mass index (BMI over 35), diabetes, chronic kidney disease, or who smoke. The study will test if taking Cephalexin, Doxycycline, or Cefadroxil after surgery helps prevent periprosthetic joint infections (infections around the artificial joint) and wound problems. Researchers will check for these infections within 90 days and one year after your surgery. The current status of this study is unclear.

Study design
This study plans to enroll 4618 participants. Participants will be randomly assigned to receive a 7-day course of an oral antibiotic or no additional antibiotic after surgery.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants for up to one year after surgery to check for infections.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04297592

Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Enrolling by Invitation
PHASE4Ages 18–99InterventionalPrevention
Mayo Clinic
~4,618 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:CephalexinDoxycyclineCefadroxil

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Periprosthetic joint infections
Measured over Within 90-days primary hip or knee arthroplasty
+1 more outcome measured

Conditions

Infections Joint Prosthetic
Overweight or Obesity
MSSA Colonization
MRSA
Chronic Kidney Diseases
Diabetes
Autoimmune Diseases
Inflammatory Disease
Tobacco Use

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NCT04297592

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Rochester, Minnesotano site contact published

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nicholas Bedard, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Periprosthetic joint infectionsWithin 90-days primary hip or knee arthroplasty

    Defined by Musculoskeletal Infection Society (MSIS) criteria

  • Periprosthetic joint infectionsWithin 1-year of primary hip or knee arthroplasty

    Defined by Musculoskeletal Infection Society (MSIS) criteria