The Relationship Between Clinical and Radiographic Severity of Knee Osteoarthritis and Serum Fetuin-A and COMP Levels: A Controlled Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Serum Fetuin-A Levels
研究概览
简要总结
The purpose of this study is to investigate the relationship between the clinical and radiographic severity of knee osteoarthritis (OA) and the serum levels of specific biomarkers, namely Fetuin-A and Cartilage Oligomeric Matrix Protein (COMP). Osteoarthritis is a degenerative joint disease characterized by cartilage breakdown and low-grade inflammation. Investigating these biomarkers may help healthcare providers better understand the disease pathology, potentially leading to earlier diagnosis and improved tracking of disease progression. The study will compare two distinct groups: a patient group consisting of 120 individuals diagnosed with Grade 2-4 knee osteoarthritis, and a control group of 60 age- and sex-matched healthy volunteers with no history of joint disorders. Participants will undergo radiographic evaluations using the Kellgren-Lawrence classification system, alongside clinical and functional assessments, including pain severity scales, mobility metrics, and functional questionnaires. Fasting blood samples will be collected from all participants to measure serum Fetuin-A and COMP levels via laboratory analysis, and the Systemic Inflammation Response Index (SIRI) will be calculated. The collected data will be statistically analyzed to determine if biomarker levels significantly correlate with the severity of knee joint degeneration and functional impairment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Diagnosis of knee osteoarthritis according to ACR (American College of Rheumatology) criteria. Knee osteoarthritis classified as Grade 2, 3, or 4 according to Kellgren-Lawrence (K-L) grading. Volunteering to participate and providing signed informed consent.
排除标准
- •Secondary post-traumatic knee osteoarthritis, history of major knee injury or joint infection. Signs of acute joint inflammation (swelling, heat increase, erythema). History of knee surgery (open or arthroscopic). Systemic inflammatory or autoimmune diseases. History of malignancy. Advanced renal or hepatic disease. Diagnosis of Diabetes Mellitus. Current use of systemic corticosteroids. Symptomatic osteoarthritis in other major joints (hip, hand, ankle, spine). Active systemic infection (fever ≥ 38, cough, diarrhea, dysuria, leukocytosis, or elevated CRP).
结局指标
主要结局
Serum Fetuin-A Levels
时间窗: Baseline (At the time of enrollment / single time point measurement)
Measurement of serum Fetuin-A concentration using a human-specific ELISA kit to evaluate its relationship with radiographic and clinical severity.
次要结局
- Radiographic Severity via Kellgren-Lawrence (K-L) Classification(Baseline)
- Clinical Severity and Functional Status via WOMAC Index(Baseline)
- Lower Extremity Muscle Strength via 5-Times Sit-to-Stand Test (5x STS)(Baseline)
- Serum COMP (Cartilage Oligomeric Matrix Protein) Levels(Baseline)
- Systemic Inflammation Response Index (SIRI)(Baseline)
- Pain Severity via Visual Analog Scale (VAS)(Baseline)
- Functional Mobility via 10-Meter Walk Test (10MWT)(Baseline)
研究者
Burak Karaman
MD, Resident of Physical Medicine and Rehabilitation
Antalya Training and Research Hospital