Efficacy of a Single Intraarticular Injection of Platelet-Rich Plasma for the Treatment of Early Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- VAS pain
研究概览
简要总结
This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.
详细描述
Platelet-rich plasma (PRP) has been reported to be effective for the treatment of knee osteoarthritis (OA). This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.
In a prospective trial with 6-month follow-up, patients with early knee OA were recruited and received a single intraarticular PRP injection. Several outcomes were measured.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 20-70 years
- •symptomatic knee OA with pain for at least 6 months despite conservative treatment such as analgesics, NSAIDs and/or physical therapy
- •average knee pain of at least 30 mm on a 100-mm visual analog (VAS) scale
- •grade 1 or 2 knee OA according to the Kellgren-Lawrence grading system based on -radiographs taken within the previous 6 months
- •Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.
排除标准
- •previous orthopedic surgery on the spine or lower limbs
- •disabling OA of either hip or foot
- •knee instability or marked valgus/varus deformity
- •history of severe knee trauma; intraarticular injections into the knee in the past 6 months
- •infections or skin diseases around the target knee
- •women ascertained or suspected pregnancy or lactating
- •presence of malignancy, hematological disease, collagen vascular diseases, or autoimmune diseases;
- •therapy with anticoagulants or anti-aggregating agent
- •serious medical conditions that would interfere with the assessments during the study.
结局指标
主要结局
VAS pain
时间窗: 6 months
The primary outcome was the change from baseline in the VAS pain score at 6 months. The patient rated the average severity of knee pain on knee movement over the previous week on a 0-100 mm VAS (0=no pain to 100=worst possible pain)
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(6 months)
- Lequesne index(6 months)
- Single-leg stance test (SLS)(6 months)
- safety assessment(during the study, for 6 months)
- Patients satisfaction(6 months)
研究者
Shu-Fen Sun
Director of Neutorehabilitation, MD,Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital
Kaohsiung Veterans General Hospital.