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NCT Number: NCT02664870

Evaluation of Biomarkers in Human Synovial Fluid

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke Orthopaedic Clinics

Durham, North Carolina, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients ( > 18 years old)
  • Patient is eligible for general anesthesia and either arthroscopy or arthroplasty.
  • Patient needs standard of care arthroscopy or arthroplasty of either shoulder, hip or knee joint for osteoarthritis or prearthritic conditions.
  • 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

  • Active Joint Infection within last 6 months.
  • Previous arthroplasty in the joint undergoing arthroplasty
  • History of auto-immune arthropathies.
  • History of HIV or Hepatitis C

Treatment and study plan

Arthroscopy

Procedure

Arthroscopic Surgery on the hip, shoulder, or knee

Arthroplasty

Procedure

Total hip, shoulder, or knee arthroplasty

Primary outcomes

  1. Feasibility of biobank data collection as measured by percentage of patients with a complete data set one year post-operation

    Time frame: 1 year

    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.

Secondary outcomes

  1. Number of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis

    Time frame: 3-5 years

    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.

  2. Types of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis

    Time frame: 3-5 years

    Types of biomarkers include the following: chemokines, cytokines, inflammatory, angiogenesis, and vascular injury.

  3. Number of patients who responded to non-arthroplasty intervention based on biomarker analysis and measured with questionnaires

    Time frame: 1-10 years

  4. Number of patients who did not respond to non-arthroplasty intervention based on biomarker analysis and measured with questionnaires

    Time frame: 1-10 years

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2028
First posted
Jan 27, 2016
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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