Arthritis, Inflammatory Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Rothman Orthopaedic Institute | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Relationship between patient characteristics and panel results | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03942783 -
WORKWELL: Testing Work Advice for People With Arthritis
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N/A |