Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Diabetes Clinical Trial

Official title:

Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04297592
• Other study ID #: 22-001273
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: June 11, 2020
• Est. completion date: June 2025

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4618
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cephalexin
500 mg oral tablet, 4 times daily for 7 days
• Doxycycline
100 mg oral tablet, 2 times daily for 7 days
• Cefadroxil
500 mg oral tablet, 2 times daily for 7 days

Locations

Country	Name	City	State
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (3)

Inabathula A, Dilley JE, Ziemba-Davis M, Warth LC, Azzam KA, Ireland PH, Meneghini RM. Extended Oral Antibiotic Prophylaxis in High-Risk Patients Substantially Reduces Primary Total Hip and Knee Arthroplasty 90-Day Infection Rate. J Bone Joint Surg Am. 2018 Dec 19;100(24):2103-2109. doi: 10.2106/JBJS.17.01485. — View Citation

Kurtz SM, Lau E, Watson H, Schmier JK, Parvizi J. Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2. — View Citation

Li B, Webster TJ. Bacteria antibiotic resistance: New challenges and opportunities for implant-associated orthopedic infections. J Orthop Res. 2018 Jan;36(1):22-32. doi: 10.1002/jor.23656. Epub 2017 Aug 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periprosthetic joint infections	Defined by Musculoskeletal Infection Society (MSIS) criteria	Within 90-days primary hip or knee arthroplasty
Primary	Periprosthetic joint infections	Defined by Musculoskeletal Infection Society (MSIS) criteria	Within 1-year of primary hip or knee arthroplasty
Secondary	Wound complication	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.	Within 90 days of primary hip or knee arthroplasty

External Links

•   Mayo Clinic Clinical Trials