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

NCT02868736 | Unknown

• 1 other identifier: CDD-CLI-001
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Periprosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• Evaluation of laboratory results and physical findings required to diagnose PJI

  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.

Study Arms (1)

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

Interventions

Synovasure PJI Lateral Flow test and Synovasure PJI ELISA Test DEVICE

Suspected Periprosthetic Joint Infection

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• CD Diagnostics: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

US (1)