Evaluation of Biomarkers in Human Synovial Fluid

Osteoarthritis Clinical Trial

Official title:

Prospective Biological and Clinical Databank for the Evaluation of Biomarkers in Human Synovial Fluid

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02664870
• Other study ID #: Pro00066468
• Status: Active, not recruiting
• Start date: January 2016
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Osteoarthritis is a condition that causes joints in the human body to deteriorate over time. This condition affects more than 250 million people around the globe. Currently, the goal of treating osteoarthritis involves reducing the severity and pain that results from the disease. The ultimate goal of this study is to identify patients with pre-arthritic joints (before symptoms or disease characteristics appear) in an effort to find and use treatments that stop or slow the disease. Joints are filled with a naturally occurring liquid known as synovial fluid. Molecules (biomarkers) and genetic expression of various cell types within synovial joint fluid may serve as measures of onset and progression of osteoarthritis. These samples have the potential to improve diagnosis, classification, and treatment, possibly changing the natural history of this debilitating disease. The purpose of this study is to develop a collection of synovial fluid samples from the shoulder, hip and knee for the analysis of biomarkers and cellular and genetic components therein to better understand the pre-arthritic joint, progression to disease, and response to interventions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 149
• Est. completion date: January 1, 2025
• Est. primary completion date: January 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients ( > 18 years old)

2. Patient is eligible for general anesthesia and either arthroscopy or arthroplasty.

3. Patient needs standard of care arthroscopy or arthroplasty of either shoulder, hip or knee joint for osteoarthritis or prearthritic conditions.

4. Patient must have signed an IRB approved informed consent document for the arthrocentesis procedure which will be performed during the arthroscopic or arthroplastic procedure.

Exclusion Criteria:

1. Active Joint Infection within last 6 months.

2. Previous arthroplasty in the joint undergoing arthroplasty

3. History of auto-immune arthropathies.

4. History of HIV or Hepatitis C

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Arthroscopy
Arthroscopic Surgery on the hip, shoulder, or knee
• Arthroplasty
Total hip, shoulder, or knee arthroplasty

Locations

Country	Name	City	State
United States	Duke Orthopaedic Clinics	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of biobank data collection as measured by percentage of patients with a complete data set one year post-operation	Study participants will be enrolled over an anticipated time frame of 2 years. One year following the last participant's enrollment prompts an anticipated three year time frame to determine the feasibility of biobank data collection.	1 year
Secondary	Number of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis	Biomarkers for study include the following: CRP, Eotaxin, Eotaxin-3, FGF (basic), Flt-1/VEGFR1, GM-CSF, ICAM-1, IFN-?, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-1a, IL-1ß, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IP-10, MCP-1, MCP-4, MDC, MIP-1a, MIP-1ß, PlGF, SAA, TARC, Tie-2, TNF-a, TNF-ß, VCAM-1, VEGF-A, VEGF-C, VEGF-D, clusterin, lubricin, and matrix molecules.	3-5 years
Secondary	Types of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis	Types of biomarkers include the following: chemokines, cytokines, inflammatory, angiogenesis, and vascular injury.	3-5 years
Secondary	Number of patients who responded to non-arthroplasty intervention based on biomarker analysis and measured with questionnaires		1-10 years
Secondary	Number of patients who did not respond to non-arthroplasty intervention based on biomarker analysis and measured with questionnaires		1-10 years