Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05778162
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-01-23
Brief Title:
RISC Panel Remnant Sample Collection
Sponsor:
Zimmer Biomet
Organization:
Zimmer Biomet
Study Overview
Official Title:
Evaluation of the Usability and Clinical Utility of the Synovasure RISC Panel
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor inflammation to be used for future research
The secondary objective of this study is to create a repository of well-characterized synovial fluid samples from patients with knee pain andor inflammation to be used for future research
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 andor 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 andor inflammation to be used for future research
Investigators will perform arthrocentesis as part of the patients 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
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 andor inflammation to be used for future research
Investigators will perform arthrocentesis as part of the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None