Study of the Composition of Platelet-rich Plasma and Its Clinical and Molecular Effect in the Biological Treatment of Knee Arthrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
This is a prospective, observational cohort study involving 40 patients with primary knee osteoarthritis hospitalized in a rehabilitation hospital in Cluj-Napoca. All participants will receive intra-articular platelet-rich plasma (PRP) injections. The study aims to analyze PRP composition and inflammatory biomarkers to better understand disease mechanisms and evaluate treatment effectiveness.
详细描述
The study is designed as an observational, longitudinal, prospective cohort investigation focused on patients with primary degenerative pathology of the knee joint, specifically primary gonarthrosis. The target population includes individuals diagnosed with knee osteoarthritis, while the accessible population consists of patients admitted to the Clinical Rehabilitation Hospital in Cluj-Napoca.
A total of 40 consecutive patients meeting inclusion criteria will be enrolled. Each participant will undergo treatment consisting of an intra-articular injection of platelet-rich plasma (PRP) at the knee level. The consecutive inclusion approach reduces selection bias and reflects routine clinical practice.
A central component of the study is the biological characterization of PRP. The investigators will analyze its composition, particularly focusing on growth factors such as platelet-derived growth factor (PDGF), transforming growth factor beta 1 (TGF-β1), and insulin-like growth factor 1 (IGF-1). This analysis is intended to contribute to the standardization of PRP therapy in knee osteoarthritis.
In parallel, the study will assess systemic inflammatory status by measuring circulating biomarkers, including interleukins (IL-1β, IL-8, IL-18) and tumor necrosis factor alpha (TNF-α). Monitoring these biomarkers allows evaluation of the inflammatory response and provides insight into the biological effects of PRP on the intra-articular environment.
Overall, the study seeks to clarify both the pathophysiological mechanisms underlying knee osteoarthritis and the therapeutic mechanisms of PRP, while also assessing its clinical effectiveness through changes in inflammatory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 80 years
- •Diagnosis of unilateral or bilateral gonarthrosis radiological grade 2-3 Kellgren-Lawrence
- •Knee joint pain greater than 4 on the VAS scale
- •History of knee joint pain for at least 6 months
- •Patients who are to receive an inpatient PRP injection
排除标准
- •Diagnosis of secondary gonarthrosis
- •History of inflammatory rheumatological disease or gout
- •History of recent minor (1 month) or major (2 years) trauma to the knee joint
- •History of knee surgery or arthroscopy
- •Infiltrations, physiotherapy or other knee treatments in the last 3 months
- •Diagnosis of neoplasia, hematological or immunological diseases
- •Clinical or biological signs of acute infection
- •Coagulation disorders
研究组 & 干预措施
40 patients with knee arthrosis receiving an infiltration with plasma rich in platelets
intra-articular administration of plasma rich in platelets (PRP)
干预措施: intra-articular administration of plasma rich in platelets (PRP) (Procedure)
结局指标
主要结局
Pain intensity
时间窗: Baseline and at 4 weeks
Pain intensity assessed using the Visual Analogue Scale (VAS)
Functional status and symptom severity
时间窗: Basline and at 4 weeks
Functional status and symptom severity measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire Health-related quality of life evaluated with the SF-36 questionnaire
Systemic inflammatory markers
时间窗: Baseline and at 4 weeks
Systemic inflammatory markers: IL-1β, IL-8, IL-18, TNF-α
General inflammatory indicators
时间窗: Baseline and at 4 weeks
General inflammatory indicators: erythrocyte sedimentation rate (ESR)
General inflammatory indicators 2
时间窗: Baseline and at 4 weeks
General inflammatory indicators: C-reactive protein (CRP)
Growth factor profile of PRP
时间窗: Baseline
transforming growth factor beta (TGF-β), platelet-derived growth factor (PDGF), insulin-like growth factor 1 (IGF-1), and vascular endothelial growth factor (VEGF)
次要结局
未报告次要终点
研究者
Viorela Mihaela Ciortea
Associate professor
Iuliu Hatieganu University of Medicine and Pharmacy