RISC Panel Remnant Sample Collection

NCT05778162 | Completed

• 1 other identifier: DTU2022-21DI
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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 and/or inflammation to be used for future research.

Conditions

Arthritis, Inflammatory

Outcome Measures

Primary Outcomes (1)

• Rate of agreement

  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 Outcomes (1)

• Relationship between patient characteristics and panel results

  2 years

Interventions

Synovasure® RISC™ Panel DIAGNOSTIC_TEST

The Synovasure® RISC™ Panel is a laboratory-developed test (LDT) panel (CD Laboratories, Clinical Laboratory Improvement Amendments \[CLIA\] Registration No.: 21D0216863) intended to provide indications for diagnosing different types of arthritis that may correspond to higher risk levels for postoperative complications in patients experiencing knee pain and/or inflammation prior to primary knee arthroplasty.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients experiencing knee pain and/or inflammation.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The study will collect synovial fluid remnant samples from up to 1000 patients with a painful and/or swollen knee(s) for which arthrocentesis is performed as part of the patient's standard of care. De-identified leftover remnant samples will be frozen for future research.

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Krista Toler

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: March 21, 2023
• Study Start: February 1, 2023
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: October 24, 2025

Record last verified: 2024-12

Locations

US (1)