RISC Panel Remnant Sample Collection

September 20, 2023 updated by: Zimmer Biomet

Evaluation of the Usability and Clinical Utility of the Synovasure® RISC Panel

The primary objective of this study is to evaluate the usability and clinical utility of the Synovasure® RISC™ Panel.

The secondary objective of this study is to create a repository of well-characterized synovial fluid samples from patients with knee pain and/or inflammation to be used for future research.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Synovasure® RISC Panel™ constitutes a single source of pre-operative biomarker testing with high predictive value for the diagnosis of single or multiple arthritis conditions, that may correspond to a relative level of inflammation and post-operative complication and infection risk in patients with knee pain and/or inflammation.

The aim of this clinical performance post-market clinical follow-up (PMCF) study is to evaluate the usability and clinical utility of the Synovasure® RISC Panel™ using comparative analyses between the suspected diagnosis, patient demographics, conditions, symptoms, medical history and the Synovasure® RISC Panel™ results. The secondary objective of this study is to create a repository of well-characterized synovial fluid samples from patients with knee pain and/or inflammation to be used for future research.

Investigators will perform arthrocentesis as part of the patient's standard of care. Remnant samples will be transferred in the tubes included with the Synovasure® Arthritis Specimen Transportation kit, in accordance with instructions and the requisition form. Additional case report forms (CRFs) to collect demographic, and clinical data beyond what is included in the requisition form and the Panel results accession identification (ID) will be provided. Sample collection and shipment to CD Laboratories (CDL) may be limited to Monday-Wednesday. A maximum of three samples per transportation kit will be shipped as soon as the samples are collected. CDL will perform RISC™ Panel testing and identifiable results will be provided to enable the centers to pair the test results with clinical outcome data. De-identified leftover remnant samples will be frozen and all data, including any available clinical outcome data, will also be entered into a de-identified database of results and made accessible to all participating investigators for research purposes.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

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

Study Contact

Study Contact Backup

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

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients experiencing knee pain and/or inflammation.

Description

Inclusion Criteria:

  • Patients with knee pain and/or inflammation and planned arthrocentesis

Exclusion Criteria:

  • Patient is unwilling or unable to give oral consent
  • Patient has any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study
  • Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant)
  • Patient had an arthrocentesis of the index joint less than 2 weeks from the planned arthrocentesis
  • Insufficient synovial fluid sample of < 1.5 mL
  • Patient age < 18 or > 89

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of agreement
Time Frame: 2 years
This study is intended to characterize the performance of the Synovasure® RISC™ Panel in a real-world environment. The primary endpoint of this study is the rate of agreement (positive and negative) of the test result with the suspected diagnosis. The suspected diagnosis of the index knee will be collected prior to the Synovasure® RISC™ Panel analyses to be subsequently matched to the Synovasure® RISC™ Panel results.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between patient characteristics and panel results
Time Frame: 2 years
The secondary endpoint will consist of an exploration of potential correlations between the subject characteristics and results of the RISC panel diagnostics. Analysis of Variance (ANOVA) will be used to test for associations, while chi-square tests or Fisher's exact tests will be used for categorical variables. Logistic regressions may be performed to examine diagnostic accuracy based on variables identified to be significant predictors (p-value ≤ 0.05) from the univariate analyses.
2 years

Collaborators and Investigators

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

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Krista Toler, Zimmer Biomet

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 (Actual)

February 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTU2022-21DI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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