Results of Extended Versus Single Dose Antibiotic Prophylaxis In Orthopedic Revision Arthroplasty… (NCT06402591) | Clinical Trial Compass
UnknownPhase 3
Results of Extended Versus Single Dose Antibiotic Prophylaxis In Orthopedic Revision Arthroplasty in Nijmegen.
Netherlands751 participantsStarted 2019-01-01
Plain-language summary
The goal of this randomized control trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee. The main question\[s\] it aims to answer are:
* Is an extended regimen compared to a single dose of cefazolin associated with an increased infection-free implant survival within one year after index revision arthroplasty of the hip or knee?
* What are the incidence, risk factors, treatment outcome and prognosis of surgical site infections and periprosthetic joint infection during follow-up?
* What is the safety and tolerance of the antimicrobial prophylaxis regimens used?
* What are the antimicrobial susceptibility patterns of micro-organisms causing PJI during follow-up?
* What is the patient' physical performance and satisfaction of subjects within 1 year after the index revision arthroplasty, using patient related outcome measurements (PROMS)?
\[question 2\] Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 years or older.
. Planned revision arthroplasty of the hip or knee prosthesis (index revision arthroplasty), with revision of one or more fixed components.
Exclusion criteria
. If the index revision arthroplasty has been cancelled.
. Revision of single mobile parts only.
. PJI on baseline, based on 'definite infection' score according to the Philadelphia consensus definition 2018
. PJI on baseline, based on a positive culture of a single synovial fluid or tissue sample yielding a high virulence micro-organism (S. aureus, Enterobacterales, Pseudomonas spp, Acinetobacter spp, Candida spp).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing a single dose of antibiotics before surgery versus an extended course — given my specific situation with a prosthetic hip or knee infection, which approach does my surgeon currently use, and how might being in this trial affect that?
2Since this is a Phase 3 trial, it sounds like earlier research has already been done on safety — can you help me understand what is already known about the risks of extended versus single-dose antibiotic prophylaxis in revision joint replacement surgery?
3The trial's recruitment status is listed as unknown — is this study actually enrolling patients right now at the Nijmegen center or elsewhere, and if not, are there similar studies I could look into?
4The main thing this trial is measuring is whether the revision surgery ultimately succeeds without re-infection — how do doctors define 'success' in this context, and how does that match what I personally hope to achieve from revision surgery?
5Before considering a trial like this, should I think about whether standard antibiotic prophylaxis protocols outside of a trial might be a better first step for me, and what would my doctor recommend if I chose not to participate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.