Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty (NCT04399642) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty
Canada1,832 participantsStarted 2019-07-05
Plain-language summary
The purpose of this study is to compare infection rates when patients, elected for primary or aseptic revision THA / TKA, have a single intravenous antibiotic dose versus one single intravenous antibiotic dose in combination with intra-articular antibiotics. This is a prospective, randomized clinical survey on selected outcome measurements on 1834 subjects who will be recruited in a period of about 2 years.
Who can participate
Age range
18 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:
* Standard criteria for the implantation of primary total hip or knee replacement
* Revision of an aseptic THA or TKA.
* Adults \>18 years of age
* Diagnosis of Osteoarthrosis (OA), Osteonecrosis (ON), Arthritis; or aseptic loosening of THA/TKA.
* Subject is willing to consent to participate in the study
* Subject is available for follow-up through at least 2 years
* Subject has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk.
* Subject who are fluent in English and / or French and able to understand their role in the study
Exclusion Criteria:
* Active, local infection or systemic infection.
* Participation in any other pharmaceutical, biologic or medical device clinical investigation
* Subjects with known allergy to vancomycin
* Subjects unable to consent
* Patient with skin pathology
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Acute Infection rate
Timeframe: 3 months
Trial details
NCT IDNCT04399642
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal