Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Mayo Clinic

Status and phase: Invitation-only; Phase 4

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

Treatments: Drug: Cefadroxil; Drug: Doxycycline; Drug: Cephalexin

Study type: Interventional

Funder types: Other

Identifiers

NCT04297592

22-001273

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,618 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,618 participants in 2 patient groups

Additional Antibiotic Group

Active Comparator group

Description:

Patients will receive an oral antibiotic to be started after completion of standard perioperative antibiotics following primary hip or knee arthroplasty. Oral antibiotic will either be a first-generation cephalosporin (Cefadroxil or Cephalexin) or Doxycycline based upon patient allergies, kidney function and result of nasal colonization testing for MRSA.

Treatment:

Drug: Cephalexin

Drug: Doxycycline

Drug: Cefadroxil

Control Group - No Additional Antibiotic

No Intervention group

Description:

Patients will receive standard perioperative antibiotics following primary hip or knee arthroplasty and no additional antibiotics.