Evaluation of Biomarkers in Human Synovial Fluid

Prospective Biological and Clinical Databank for the 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Arthroscopy; Procedure: Arthroplasty

• Study Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States
      • Duke Orthopaedic Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited at the Sports Medicine and Adult Reconstruction Clinics at Duke University Medical Center.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Shoulder Patients; Patients (1) without evidence of cartilage damage, (2) with molecular change, (3) physiologic change, or (4) with end-stage osteoarthritis, who require arthroscopy or arthroplasty	Procedure: Arthroscopy; Arthroscopic Surgery on the hip, shoulder, or knee; Procedure: Arthroplasty; Total hip, shoulder, or knee arthroplasty
Hip Patients; Patients (1) without evidence of cartilage damage, (2) with molecular change, (3) physiologic change, or (4) with end-stage osteoarthritis, who require arthroscopy (with or without periacetabular osteotomy (PAO)) or arthroplasty	Procedure: Arthroscopy; Arthroscopic Surgery on the hip, shoulder, or knee; Procedure: Arthroplasty; Total hip, shoulder, or knee arthroplasty
Knee Patients; Patients (1) without evidence of cartilage damage, (2) with molecular change, (3) physiologic change, or (4) with end-stage osteoarthritis, who require arthroscopy or arthroplasty	Procedure: Arthroscopy; Arthroscopic Surgery on the hip, shoulder, or knee; Procedure: Arthroplasty; Total hip, shoulder, or knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3-5 years
Number of patients who responded to non-arthroplasty intervention based on biomarker analysis and measured with questionnaires		1-10 years
Number of patients who did not respond to non-arthroplasty intervention based on biomarker analysis and measured with questionnaires		1-10 years

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Richard C. Mather, MD, MBA, Duke University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): January 24, 2019
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 7, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimated): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers; synovial fluid
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Orthopedic Procedures; Plastic Surgery Procedures; Arthroplasty; Arthroscopy
• Other Study ID Numbers: Pro00066468