Clinical Validation of CD Diagnostics Synovasure PJI ELISA Test &

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02868736
Study type	Observational
Source	CD Diagnostics
Contact
Status	Recruiting
Phase	N/A
Start date	July 2016
Completion date	May 2017

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Validation of CD Diagnostics Synovasure PJI ELISA Test and Synovasure PJI Lateral Flow Test for Detection of Periprosthetic Joint Infection in Synovial Fluid

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms