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Antibiotic Prophylaxis for Knee Replacement Surgery

Phase 4

Waitlist Available

Led By Thorsten Seyler, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

No application of topical antibiotic powder such as vancomycin or antibiotic beads in surgical wound

History of prior native septic knee arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial 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 total knee arthroplasty (TKA).

Who is the study for?

This trial is for adults over 18 without open wounds or active infections on the leg where knee replacement surgery will happen. It's not for those unable to consent, with severe dementia, drug abuse (except prescription cannabinoids), extreme surgical risk (ASA score of 5 & 6), emergency cases, prior septic arthritis, pregnancy, certain psychiatric conditions, or if they can't follow the study plan.

What is being tested?

The study tests if giving antibiotics within an hour before cutting or continuing them for a day after knee replacement surgery prevents joint and site infections better. Duke University recruits patients undergoing elective primary TKA and unilateral knee arthroplasty.

What are the potential side effects?

Cefazolin may cause allergic reactions ranging from rash to more serious effects like difficulty breathing. Other possible side effects include digestive issues such as diarrhea and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for knee replacement surgery due to arthritis or injury.

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I do not have an infection in the leg or joint that needs surgery.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not used antibiotic powder or beads in my surgical wound.

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I have had a knee infection in the past.

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I am 18 years old or younger.

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My health is critically poor and I am not expected to survive without surgery.

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I have an active infection in my leg or joint where surgery is planned.

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I need urgent knee surgery due to a severe injury.

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I have been diagnosed with severe dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Study Group 2Experimental Treatment1 Intervention

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.).

Group II: Study Group 1Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cefazolin

2017

Completed Phase 4

~4610

0 / 10Eligibility criteria met