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Antibiotic Prophylaxis for Knee Replacement Surgery
Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am scheduled for knee replacement surgery due to arthritis or injury.
Select...
I do not have an infection in the leg or joint that needs surgery.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of periprosthetic infection (PJI) as measured by chart review
Secondary outcome measures
Costs of antibiotic treatment as measured by costs summed over all patients and divided by group size
Other outcome measures
Rate of periprosthetic infection (PJI) as measured by phone call, email, letter and/or secured messaging via electronical medical record system
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
~4720
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,360 Previous Clinical Trials
3,412,330 Total Patients Enrolled
1 Trials studying Knee Arthropathy
7 Patients Enrolled for Knee Arthropathy
American Association of Hip and Knee SurgeonsUNKNOWN
2 Previous Clinical Trials
400 Total Patients Enrolled
1 Trials studying Knee Arthropathy
300 Patients Enrolled for Knee Arthropathy
Orthopedic Research and Education FoundationOTHER
19 Previous Clinical Trials
3,400 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not used antibiotic powder or beads in my surgical wound.I am scheduled for knee replacement surgery due to arthritis or injury.I have had a knee infection in the past.I did not need extra doses of medication during surgery unless I lost a lot of blood.I do not have an infection in the leg or joint that needs surgery.I am 18 years old or older.I have no open wounds on my leg that needs surgery.I am 18 years old or younger.My health is critically poor and I am not expected to survive without surgery.I have an active infection in my leg or joint where surgery is planned.I need urgent knee surgery due to a severe injury.I do not use illegal drugs, but I may use prescribed cannabinoids.I have been diagnosed with severe dementia.
Research Study Groups:
This trial has the following groups:- Group 1: Study Group 1
- Group 2: Study Group 2
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial have any presence in the United States besides its primary location?
"10 medical centres are hosting this clinical trial, including Ohio State University in Columbus, Duke University Medical Center in Durham and University Orthopaedic Associates, LLC in Somerset. Additionally, there are 7 other sites offering their services."
Answered by AI
Are there any positions currently available to partake in this research trial?
"Affirmative. Clinicaltrials.gov's data proves that this research effort, which was first established on October 24th 2017, is currently recruiting participants. The project requires 8000 individuals to be enlisted from 10 distinct medical centres."
Answered by AI
Has the Federal Drug Administration certified Cefazolin?
"Cefazolin has been deemed safe, as it is a Phase 4 trial. As such, this medication achieved an impressive 3 rating on our team's safety scale."
Answered by AI
What is the aggregate amount of individuals participating in this experiment?
"Affirmative. According to the information found on clinicaltrials.gov, this trial is currently open for recruitment and began accepting patients since October 24th 2017. The study seeks 8000 participants from 10 different medical centres by November 21st 2022 ."
Answered by AI
What medical conditions typically necessitate the use of Cefazolin?
"Cefazolin is clinically recommended for the preoperative prevention of infection, to combat skin and subcutaneous tissue infections caused by susceptible bacteria, as well as for general bacterial infections."
Answered by AI
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