Recruiting

Synovasure Tests

Sponsor:

CD Diagnostics

Code:

NCT02868736

Conditions

Periprosthetic Joint Infection

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Synovasure PJI Lateral Flow test and Synovasure PJI ELISA Test

Study Details

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

Study ID

NCT02868736

Start date

Jul, 2016

Status verified date

Aug, 2016

Completion date

May, 2017

Anticipated

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

Suspected Periprosthetic Joint Infection

Individuals who are suspected of having Periprosthetic Joint Infection (PJI)

Interventions

Synovasure PJI Lateral Flow test and Synovasure PJI ELISA Test

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Page Abdelaty

abdelaty.page@mayo.edu

More Information

Sponsor

CD Diagnostics

Last update posted

Aug 16, 2016

Last verified

Aug, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CD Diagnostics on 2016-08-16.