Evaluation of Biomarkers in Human Synovial Fluid

Active, not recruiting

• Conditions: Osteoarthritis
• Interventions: Procedure: Arthroscopy; Procedure: Arthroplasty

• Registration Number: NCT02664870
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Primary Completion: 2019-01-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 149

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hip Patients	Arthroplasty	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
Knee Patients	Arthroscopy	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
Shoulder Patients	Arthroscopy	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
Shoulder Patients	Arthroplasty	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
Hip Patients	Arthroscopy	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
Knee Patients	Arthroplasty	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

Primary Outcome Measures

Name	Time	Method
Feasibility of biobank data collection as measured by percentage of patients with a complete data set one year post-operation	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 Outcome Measures

Name	Time	Method
Number of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis	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.
Types of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis	3-5 years	Types of biomarkers include the following: chemokines, cytokines, inflammatory, angiogenesis, and vascular injury.
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

Trial Locations

Locations (1)

Duke Orthopaedic Clinics; 🇺🇸 Durham, North Carolina, United States