Multicenter Real-World Evidence (RWE) Study: Evaluation of Platelet-Rich Plasma (PRP) Treatment in Tendinopathies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 5
- 主要终点
- Visual Analog Scale
研究概览
简要总结
This multicenter, prospective, observational study, based on real-world evidence (RWE), aims to evaluate the efficacy and safety of Platelet-Rich Plasma (PRP) treatment across four types of tendinopathies: patellar, Achilles, epicondylar, and plantar fasciosis. Data collection and analysis will be conducted using the BioSmartData® platform, including hematology analyzers for PRP characterization, clinical variables, treatment protocols, and longitudinal assessment of therapeutic response.
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
- •Clinical and/or ultrasound diagnosis of chronic tendinopathy (duration >6 weeks)
- •Age >18 years
- •Provision of written informed consent
- •Willingness and ability to complete follow-up assessments for 12 months
排除标准
- •Surgical treatment of the affected tendon within the previous 6 months
- •Corticosteroid injection within the last month
- •Systemic inflammatory disease (e.g., rheumatoid arthritis)
- •Coagulopathies or ongoing anticoagulant therapy
- •Complete blood count showing a platelet concentration <100 × 10⁹/L (to exclude patients with potential thrombocytopenia)
- •Pregnancy or breastfeeding
研究组 & 干预措施
Patellar tendinopathy
Patellar tendinopathy treated with PRP
干预措施: Platelet rich plasma (PRP) (Biological)
Achilles tendinopathy
Achilles tendinopathy treated with PRP
干预措施: Platelet rich plasma (PRP) (Biological)
Plantar fasciosis
Plantar fasciosis treated with PRP
干预措施: Platelet rich plasma (PRP) (Biological)
Chronic epycondylitis
Chronic epycondylitis treated with PRP
干预措施: Platelet rich plasma (PRP) (Biological)
结局指标
主要结局
Visual Analog Scale
时间窗: From baseline up to 12 months post-treatment
VISA-P
时间窗: baseline, 1 month, 3 months, 6 months and 12 months
Change in pain and functional limitation assessed using the Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire. Scores range from 0 to 100, with higher scores indicating better function and lower pain levels.
VISA-A
时间窗: baseline, 1 month, 3 months, 6 months and 12 months
The VISA-A is an eight item questionnaire measures Achilles tendon pain and function, with scores ranging from 0 to 100 (higher scores indicating better function).
Patient Rated Tennis Elbow Evaluation Scale
时间窗: baseline, 1 month, 3 months, 6 months and 12 months
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a 15-item self-report questionnaire designed to measure pain and functional disability in patients with lateral epicondylitis (tennis elbow). It includes a 5-item pain subscale and a 10-item function subscale, providing a total score out of 100 to assess, evaluate, and monitor recovery.
Foot Function Index
时间窗: baseline, 1 month, 3 months, 6 months and 12 months
The Foot Function Index (FFI) is a 23-item, self-administered questionnaire designed to measure the impact of foot pathology on function, assessing pain, disability, and activity limitation. It uses a 0-10 Likert scale for items within three subscales, with higher total percentages (0-100%) indicating greater, more severe pain and dysfunction.
次要结局
- Adverse events(1 month, 3 months, 6 months, 12 months)
- Predictive factors of response to PRP treatment(baseline)