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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopy | Procedure | Arthroscopic Surgery on the hip, shoulder, or knee |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited at the Sports Medicine and Adult Reconstruction Clinics at Duke University Medical Center.
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| Name | Affiliation | Role |
|---|---|---|
| Richard C. Mather, MD, MBA | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Orthopaedic Clinics | Durham | North Carolina | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D001182 | Arthroscopy |
| D001178 | Arthroplasty |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Biospecimen retention would include the collection and storage of synovial fluid samples from the hip, shoulder, and knee.
| Arthroplasty | Procedure | Total hip, shoulder, or knee arthroplasty |
|
| 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 |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019637 | Orthopedic Procedures |
| D019651 | Plastic Surgery Procedures |