Evaluation of Biomarkers in Human Synovial Fluid

N/AActive Not RecruitingNCT02664870

Duke University149 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

149

Conditions

Osteoarthritis

Interventions

Arthroscopy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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-γ, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, VCAM-1, VEGF-A, VEGF-C, VEGF-D, clusterin, lubricin, and matrix molecules.

Time frame: 3-5 years

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.