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

August 11, 2016 updated by: CD Diagnostics
  • 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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with a total knee and/or hip joint replacement and are being evaluated for revision surgery will be recruited for the trial.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Suspected Periprosthetic Joint Infection
Individuals who are suspected of having Periprosthetic Joint Infection (PJI)
Device: Synovasure PJI Lateral Flow test and Synovasure PJI ELISA Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of laboratory results and physical findings required to diagnose PJI
Time Frame: Outcome is measured at time of aspiration and again at time of revision surgery.
The clinical endpoint for the study is Adjudication Panel evaluation of the laboratory results and physical findings required to diagnose PJI. There are two major criteria, and five minor criteria in the MSIS definition of PJI. The existence of one positive major criterion is sufficient for the diagnosis of PJI. Similarly, the existence of any three of the five positive minor criteria is considered sufficient for the diagnosis of PJI.
Outcome is measured at time of aspiration and again at time of revision surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CD Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDD-CLI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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