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Antibiotic Prophylaxis in Patients Undergoing Elective TKA- Multi-center Trial

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ClinicalTrials.gov Identifier: NCT03283878
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : February 21, 2021
Sponsor:
Collaborators:
American Association of Hip and Knee Surgeons
Orthopedic Research and Education Foundation
Information provided by (Responsible Party):
Duke University

Brief 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.


Condition or disease Intervention/treatment Phase
Arthropathy of Knee Antibiotic Prophylaxis Drug: Cefazolin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perioperative Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty: A Prospective, Randomized, Open-label, Controlled Multi-center Trial
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Study Group 1

Patients in Group #1 will receive a single weight-based dose of prophylactic cefazolin antibiotic that is administered intravenously within less than 60 minutes prior to skin incision in elective total knee arthroplasty. No further antibiotic administration will be given.

< 120 kg - patients will receive 2 grams of cefazolin

≥ 120 kg - patient will receive 3 grams of cefazolin

Patients with documented allergy/anaphylactic reaction to penicillin or cephalosporin may receive intravenous vancomycin monotherapy or dual therapy with vancomycin and gentamicin as an alternative. In addition, the use of clindamycin as an alternative is also permitted at a minimum recommended dose.

Drug: Cefazolin

Cefazolin will be administered intravenously within less than 60 minutes prior to skin incision in elective TKA for Group 1.

Cefazolin will be administered intravenously within less than 60 minutes prior to skin incision in elective TKA. In addition, two weight based doses of cefazolin will be administered within 24 hours postoperatively for Group 2.

Other Name: Ancef

Experimental: Study Group 2

Patients in Group #2 will receive a single weight-based dose of prophylactic cefazolin antibiotic that is administered intravenously within less than 60 minutes prior to skin incision in elective total knee arthroplasty. In addition, two weight-based doses of cefazolin will be administered within 24 hours postoperatively.

< 120 kg - patients will receive 2 grams of cefazolin

≥ 120 kg - patient will receive 3 grams of cefazolin

Patients with documented allergy/anaphylactic reaction to penicillin or cephalosporin may receive intravenous vancomycin monotherapy or dual therapy with vancomycin and gentamicin as an alternative. If allergic, patients will also receive two weight-based doses vancomycin postoperatively but not gentamicin postoperatively. In addition, the use of clindamycin as an alternative is also permitted. Vancomycin schedule: one dose preoperatively, one dose 8-12 h postoperatively, one dose 24 h postoperatively (opt.).

Drug: Cefazolin

Cefazolin will be administered intravenously within less than 60 minutes prior to skin incision in elective TKA for Group 1.

Cefazolin will be administered intravenously within less than 60 minutes prior to skin incision in elective TKA. In addition, two weight based doses of cefazolin will be administered within 24 hours postoperatively for Group 2.

Other Name: Ancef




Primary Outcome Measures :
  1. Rate of periprosthetic infection (PJI) as measured by chart review [ Time Frame: 90 day post-op ]

Secondary Outcome Measures :
  1. Costs of antibiotic treatment as measured by costs summed over all patients and divided by group size [ Time Frame: up to 1 year ]

Other Outcome Measures:
  1. Rate of periprosthetic infection (PJI) as measured by phone call, email, letter and/or secured messaging via electronical medical record system [ Time Frame: 12 months post-op ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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. Patients who use prescription cannabinoids are not excluded from enrollment.
  • ASA score of 5 & 6
  • No application of topical antibiotic powder such as vancomycin or antibiotic beads in surgical wound
  • Intra-operative re-dosing other than specified re-dosing intervals or without excessive blood loss (<1500mL)
  • History of prior native septic knee arthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283878


Contacts
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Contact: Jennifer Friend 919-668-4373 jennifer.friend@duke.edu
Contact: Carolyn Killelea carolyn.killelea@duke.edu

Locations
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Sponsors and Collaborators
Duke University
American Association of Hip and Knee Surgeons
Orthopedic Research and Education Foundation
Investigators
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Principal Investigator: Thorsten Seyler, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03283878    
Other Study ID Numbers: Pro00086892
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents