Clinical Validation of CD Diagnostics Synovasure PJI ELIS... | NCT02868736

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Apr 2017Estimated

Completion Date

May 2017Estimated

First Submitted Date

Aug 11, 2016

First Submission Date that Met QC Criteria

Aug 11, 2016

First Posted Date

Aug 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2016

Last Update Posted Date

Aug 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Synovasure PJI Lateral Flow test and Synovasure PJI ELISA Test	Device		Suspected Periprosthetic Joint Infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample