Prospective Biological and Clinical Databank for the Evaluation of Biomarkers in Human Synovial Fluid
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Feasibility of biobank data collection as measured by percentage of patients with a complete data set one year post-operation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Arthroscopy (Procedure)
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
干预措施: Arthroplasty (Procedure)
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
干预措施: Arthroscopy (Procedure)
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
干预措施: Arthroplasty (Procedure)
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
干预措施: Arthroscopy (Procedure)
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
干预措施: Arthroplasty (Procedure)
结局指标
主要结局
Feasibility of biobank data collection as measured by percentage of patients with a complete data set one year post-operation
时间窗: 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.
次要结局
- Number of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis(3-5 years)
- Types of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis(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)