Clinical Validation of CD Diagnostics Synovasure PJI ELISA Test and Synovasure PJI Lateral Flow Test for Detection of Periprosthetic Joint Infection in Synovial Fluid
Status unconfirmed
Conditions studied: Periprosthetic Joint Infection
In brief
* 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).
Key facts
- Study ID
- NCT02868736
- Run by
- CD Diagnostics
- People needed
- 3000
- Starts
- 2016-07-01
- Expected to finish
- 2017-05-01
- Last updated by the study team
- 2016-08-16
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- • 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.
You may not qualify if…
- • 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.
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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