Investigating the Impact of Ex Vivo Ozone Injection on Synovial Fluids in Patients Diagnosed With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Measurement of Total Oxidant Level (TOL)
研究概览
简要总结
The objective of this study is to examine the effect of varying ozone doses on the levels of pro-inflammatory cytokines in synovial fluid collected from individuals with knee osteoarthritis.
详细描述
In this study, synovial fluid samples will be collected from patients diagnosed with knee osteoarthritis for in vitro studies. The synovial fluid will be collected under sterile conditions by a joint puncture, and ultrasonography will be performed before sample collection. The synovial fluid samples will then be transferred to sterile urine culture tubes, with one containing only synovial fluid and the others containing synovial fluid and ozone gas. Afterward, the synovial fluid samples will be centrifuged, and the upper portion will be stored at -80°C for biochemical analyses. The total protein content will be measured using a commercial kit based on the Bradford method, and the total antioxidant level and Total oxidant levels will be measured using commercially purchased kits according to the manufacturer's instructions. The oxidative stress index will be calculated using the formula (TOS/TAS) and will be normalized to the total protein content measured in the synovial fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with knee osteoarthritis.
- •Giving consent to participate in the study.
排除标准
- •Not giving consent.
结局指标
主要结局
Measurement of Total Oxidant Level (TOL)
时间窗: 1 day
TOL refers to the total amount of oxidizing agents, such as ROS, in a substance or biological sample. Oxidative stress is caused by an imbalance between ROS production and antioxidant defense mechanisms, leading to cellular damage. Various lab assays, detecting biomarkers like MDA or protein carbonyls, can measure TOL, which can help diagnose and monitor diseases associated with oxidative stress, like cardiovascular disease and cancer. TOL levels of the samples will be measured using commercially purchased kits according to the manufacturer's instructions (Rel Assay Diagnostics, Mega Tıp, Gaziantep, Turkey).
Oxidative Stress Index (OSI)
时间窗: 1 day
OSI is a calculated value that assesses the balance between oxidative stress and antioxidant defense mechanisms in the body by dividing TOS by TAS. A higher OSI value indicates higher oxidative stress and lower antioxidant defense mechanisms. OSI measurement is helpful for diagnosing and monitoring diseases associated with oxidative stress like cardiovascular disease, diabetes, and cancer.
Protein Determination
时间窗: 1 day
The the total protein content in synovial fluid samples will be determined using a commercial kit based on the Bradford method (Coomassie Plus, Protein Assay, Thermofisher Scientific, Massachusetts, USA) and will be measured at 595 nm. A rapid and sensitive method will be used for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding. The Bradford protein test will be based on the principle that when protein molecules bind to Coomassie dye under acidic conditions, the color will change from brown to blue.
Measurement of Total Antioxidant Level (TAL)
时间窗: 1 day
TAL refers to the measurement of the total antioxidant capacity of a substance. This capacity measures a substance's ability to prevent harm from free radicals and reactive oxygen species. Measuring the total antioxidant capacity can be done using different laboratory assays and can be affected by various factors, such as diet, lifestyle, and environment.TAL levels of the samples will be measured using commercially purchased kits according to the manufacturer's instructions (Rel Assay Diagnostics, Mega Tıp, Gaziantep, Turkey).
次要结局
未报告次要终点
研究者
Mustafa Hüseyin Temel
Research Assistant
Uskudar State Hospital