Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty- Multi-center Trial

NCT03283878 | Completed Phase 4 FDA Drug

• 1 other identifier: Pro00086892
• Study Type: interventional
• Target: 1,770
• Locations: 1 country
• Sites: 14

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.

Conditions

Arthropathy of Knee; Antibiotic Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Rate of periprosthetic infection (PJI) as measured by chart review

  90 day post-op

Secondary Outcomes (1)

• Costs of antibiotic treatment as measured by costs summed over all patients and divided by group size

  up to 1 year

Other Outcomes (1)

• Rate of periprosthetic infection (PJI) as measured by phone call, email, letter and/or secured messaging via electronical medical record system

  12 months post-op

Study Arms (2)

Study Group 1

EXPERIMENTAL

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

Study Group 2

EXPERIMENTAL

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

Interventions

Cefazolin DRUG

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.

Also known as: Ancef

Study Group 1; Study Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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. 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

Sponsors & Collaborators

• Duke University: lead
• American Association of Hip and Knee Surgeons: collaborator
• Orthopedic Research and Education Foundation: collaborator

Study Sites (14)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Maryland St. Joseph Medical Center & Orthopedic Associates

Towson, Maryland, 21204, United States

Location

University Of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Mississippi Bone and Joint Clinic

Starkville, Mississippi, 39759, United States

Location

University Orthopaedic Associates, LLC

Somerset, New Jersey, 08873, United States

Location

NYU School of Medicine

New York, New York, 10003, United States

Location

Duke University Medical Center

Durham, North Carolina, 27703, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

BaylorScott&White Research Institute

Temple, Texas, 76508, United States

Location

Augusta Health

Fishersville, Virginia, 22939, United States

Location

MeSH Terms

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Thorsten Seyler, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 14, 2017
• Study Start: October 24, 2017
• Primary Completion: November 20, 2024
• Study Completion: August 22, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (14)