Intraoperative Platelet Rich Plasma Injection in Arthroscopic Surgery for Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in knee function from baseline to postoperative 3 months
研究概览
简要总结
This study aimed to analyze the effect of platelet-rich plasma (PRP) on knee osteoarthritis. Eligible patients will undertake arthroscopic knee surgery plus intraoperative PRP and also receive second look surgery and intraoperative biopsy.
详细描述
Osteoarthritis is a chronic disease defined by progressive degradation of the joint as well as loss of cartilage on joint surfaces. The degeneration that occurs in the joint leads to changes in the catabolic and anabolic activity of chondrocytes. Osteoarthritis may induce pain, stiffness and limitation in range of motion of the joint and also may impact the quality of life. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. Although several studies have assessed the effects of PRP on knee osteoarthritis, a higher level of evidence has not been provided. This study aimed to analyze the effect of PRP on knee osteoarthritis. After performing arthroscopic knee surgery plus intraoperative PRP in eligible patients, a second look arthroscopic surgery with intraoperative biopsy will be arranged 6 months later. Pre- and post-operative imaging and clinical outcomes will also be compared.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 and 70 years
- •With diagnosis of osteoarthritis, grade II~grade IV, II-III medial compartment
排除标准
- •Lateral compartment and patellofemoral joint osteoarthritis
- •With prior history of knee surgery
- •Severe varus deformity
- •With current or prior history of traum or infection at the knee
- •With current or prior history of cancer
- •With current or prior history of hematological disease
- •Pregnancy
- •Patients who will not cooperate with one-year followup
研究组 & 干预措施
PRP group
Arthroscopic knee surgery plus intraoperative platelet-rich plasma
干预措施: Platelet-rich plasma (Other)
结局指标
主要结局
Change in knee function from baseline to postoperative 3 months
时间窗: 3-month postoperative
Knee function is evaluated using Oswestry Disability Index preoperatively and 3-month postoperatively.
次要结局
- Change in knee function from baseline to postoperative 6 months(6-month postoperative)
- Change in knee function from baseline to postoperative 12 months(12-month postoperative)
- Change in knee pain from baseline to postoperative 3 months(3-month postoperative)
- Change in knee pain from baseline to postoperative 6 months(6-month postoperative)
- Change in knee pain from baseline to postoperative 12 months(12-month postoperative)
- Percentage of patients with regenerated cartilage(12-month postoperative)
- Change in cartilage thickness from baseline to postoperative 6 months(6-month postoperative)
研究者
Pei-Yuan Lee, MD
Superintendent
Show Chwan Memorial Hospital