Clinical Validation of CD Diagnostics Synovasure PJI ELISA Test and Synovasure PJI Lateral Flow T… (NCT02868736) | Clinical Trial Compass
UnknownNot Applicable
Clinical Validation of CD Diagnostics Synovasure PJI ELISA Test and Synovasure PJI Lateral Flow Test for Detection of Periprosthetic Joint Infection in Synovial Fluid
United States3,000 participantsStarted 2016-07
Plain-language summary
* To demonstrate the tests' performance when compared to the detection of PJI using the Musculoskeletal Infection Society (MSIS) criteria-based definition of PJI for diagnosing PJI.1 This criteria-based definition of PJI places emphasis on culture techniques that identify pathogens, but also provides for minor criteria that can be used to diagnose PJI;
* To calculate the tests' clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV).
Who can participate
Age range
22 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:
* • Subject has a total knee and/or hip joint arthroplasty.
* The subject will be evaluated for revision surgery.
o Operative samples are required for full MSIS classification.
* Subject is ≥22 years of age.
* Subject has had no recent injections or surgeries of the joint (within past 6 weeks).
* Subject has or will have all of the medical tests required to allow MSIS classification.
* Subject signs informed consent form.
Exclusion Criteria:
* • Subject does not have a total knee and/or hip joint arthroplasty.
* Healthy subjects without medical need for aspiration.
* Subject did not have a revision surgery.
* Subjects with a diagnostic synovial fluid specimen collection within the past 14 days.
* Subjects \<22 years of age.
* Subject has had an injection, lavage, or surgery of the joint within the past 6 weeks.
* Subject does not have all of the medical tests required for MSIS classification.
* Subject does not sign informed consent form.
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
Evaluation of laboratory results and physical findings required to diagnose PJI
Timeframe: Outcome is measured at time of aspiration and again at time of revision surgery.