Periprosthetic Joint Infection Clinical Trial
- 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).
A major disadvantage of the MSIS criteria-based definition of PJI is that two of the
essential criteria, tissue culture and histological analysis, are only available after
surgery. In cases where the surgical samples are critical for the diagnosis of infection,
the physician may need to adjust his or her treatment post operatively for the patient based
on the treatment provided. The availability of a preoperative test that correlates well with
the MSIS criteria could improve patient care. Currently, when a clinician is suspicious of
PJI due to pain or failure of an arthroplasty, it is considered the standard-of-care to
request blood and synovial fluid tests to begin the process of diagnosing infection. A
synovial fluid test for PJI that correlates with the final MSIS definition could be
requested at this early preoperative stage of the diagnostic process.
Synovasure® PJI ELISA Test is a qualitative in vitro diagnostic device intended as an
adjunct for the detection of periprosthetic joint infection (PJI) in synovial fluid from
patients being evaluated for revision surgery. Synovasure® PJI ELISA Test utilizes a test
that measures biomarkers, alpha-defensins 1-3, in the synovial fluid of joints that are
infected. Synovasure® PJI ELISA Test results are intended to be used in conjunction with
other clinical and diagnostic findings to aid in a patient's diagnosis of infection.
Synovasure® PJI Lateral Flow Test is a qualitative in vitro diagnostic device intended as an
adjunct for the detection of periprosthetic joint infection (PJI) in synovial fluid from
patients being evaluated for revision surgery. Synovasure® PJI Lateral Flow Test utilizes a
test that measures biomarkers, alpha-defensins 1-3, in the synovial fluid of joints that are
infected. Synovasure® PJI Lateral Flow Test results are intended to be used in conjunction
with other clinical and diagnostic findings to aid in a patient's diagnosis of infection.
;
Observational Model: Cohort, Time Perspective: Prospective
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