Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Thomas Vail

Description

Summary

The Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty (TKA): Multi-Center Trial is a study that will compare the effectiveness of various perioperative strategies for antibiotic delivery as prophylaxis for periprosthetic joint infections (PJI) and surgical site infection in elective primary TKA. The investigators hypothesize that a single dose of prophylactic antibiotic administered within 60 minutes before the incision is not an effective way to prevent PJI in elective primary total knee arthroplasty (TKA). The investigators also hypothesize that the prolonged delivery (24 hours) of antibiotic prophylaxis after surgery does not further reduce the incidence of PJI in elective primary TKA. Duke University is the only site recruiting both primary total knee arthroplasty and unilateral knee arthroplasty.

Official Title

Perioperative Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty: A Prospective, Randomized, Open-label, Controlled Multi-center Trial

Details

Total joint arthroplasty (TJA), is one of the most successful operations in modern medicine; however, it remains an expensive procedure in an era of constrained health care resources. Arthritis affects 49.9 million Americans with 21.1 million experiencing arthritis-attributable activity limitations. As these numbers are expected to increase significantly by 2030, the demand for primary total knee arthroplasties (TKA) by 673% to 3.48 million procedures/year. Periprosthetic joint infection (PJI), with its disastrous implications, continues to challenge the orthopaedic community. Practicing orthopaedic surgeons continue to invest efforts to minimize surgical site infection (SSI). Kamath et al. evaluated characteristics and resource utilization associated with revision arthroplasty for PJI using the Nationwide Inpatient Sample. The authors found that PJI was the most common indication for revision total knee arthroplasty (TKA), and the third most common reason for revision total hip arthroplasty (THA). Prophylactic antibiotics aim to provide protection against bacteria most likely to gain access to the surgical site during the procedure and in the perioperative period. The two most common bacteria causing contamination and subsequent deep infection in TKA are Staphylococcus aureus and coagulase-negative staphylococci.

While antibiotic regimens for antimicrobial prophylaxis might carry different risks and side-effect profiles, e.g., hypersensitivity reactions (including anaphylaxis), acute kidney injury, and Clostridium difficile infection, there are a number of studies which validate the importance of the preoperative dose of antibiotics in decreasing periprosthetic joint infection (PJI) and surgical site infection (SSI) in total joint arthroplasty (TJA). However, there are conflicting opinions as to the optimal timing of this dose and the optimal duration. The American Academy of Orthopaedic Surgeons (AAOS), the Centers for Disease Control (CDC), and SCIP guidelines recommend that prophylactic antibiotics be completely infused within one hour before the surgical incision. The US advisory statement recommends that antimicrobial prophylaxis be administered within one hour before incision and discontinued within 24 hours after the end of the operation, while European guidelines recommend a single dose within 30 minutes before incision.

Antibiotics have been a critical public health tool since the discovery of penicillin in 1928, saving the lives of millions of people around the world. Today, however, the emergence of drug resistance in bacteria is reversing the miracles of the past eighty years, with drug choices for the treatment of many bacterial infections becoming increasingly limited, expensive, and, in some cases, nonexistent. The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause two million illnesses and approximately 23,000 deaths each year in the United States alone. The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause two million illnesses and approximately 23,000 deaths each year in the United States alone (https://www.cdc.gov/drugresistance/). The National Action Plan for Combating Antibiotic-resistant Bacteria provides a roadmap to guide the Nation in rising to this challenge. Developed in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria - issued by President Barack Obama on September 18, 2014 - the National Action Plan outlines steps for implementing the National Strategy for Combating Antibiotic-Resistant Bacteria and addressing the policy recommendations with regard to antibiotic stewardship as outlined by the President's Council of Advisors on Science and Technology (PCAST). One of the goals of the National Action Plan is the implementation of evidence-based infection control practices can prevent the spread of resistant pathogens and questions the way surgeons use prophylactic antibiotics in the preoperative period.

The scientific rationale for antibiotic prophylaxis is to inhibit or eliminate contaminating microorganisms that gain access to the surgical site during the procedure. Thus, the goal of administering preoperative antibiotics is to allow for adequate tissue (blood, soft tissue, and bone) concentrations by the time of incision. Thus, these antibiotics should exceed the minimum inhibitory concentration (MIC) for the organisms most likely to be encountered for the duration of the operation. While the role of perioperative antibiotic prophylaxis is well established, controversy exists about best clinical practice guidelines with regard to antibiotic regimen and route of administration. The results of the proposed study will be used to establish a clinical practice guidelines for antimicrobial prophylaxis in elective total joint arthroplasty.

Keywords

Arthropathy of Knee Antibiotic Prophylaxis Joint Diseases Anti-Bacterial Agents Cefazolin Antibiotics, Antitubercular

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patient is ≥ 18 years of age
  • Patient has no open wounds on operative leg
  • Patient is scheduled to undergo elective total knee arthroplasty for posttraumatic,osteoarthritis, avascular necrosis, and/or inflammatory arthritis
  • Patient does not have active infection on the operative leg, the operative joint
  • Patient is willing to cooperate and follow study protocol and visit schedule

You CAN'T join if...

  • Patient is ≤ 18 years of age
  • Patient is pregnant
  • Patient is unable to provide written consent
  • Patient has psychiatric disorder that precludes safe study participation or that necessitates confinement in a custodial environment at home or in a chronic care facility
  • Patient has traumatic injury that requires emergent or urgent total knee arthroplasty(e.g. fracture)
  • Patient has active infections in the operative leg/joint
  • Patient has severe dementia
  • Suspicion of illicit drug abuse by patient
  • ASA score of 5 & 6

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Mississippi Bone and Joint Clinic accepting new patients
    Starkville Mississippi 39759 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Duke University
ID
NCT03283878
Phase
Phase 4
Lead Scientist
Thomas Vail
Study Type
Interventional
Last Updated