Comparison of Effectiveness Between Platelet Lysate and Platelet-rich Plasma on Knee Osteoarthritis: a Prospective, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Pain score of the patient
研究概览
简要总结
This study will focus on grade I to III knee osteoarthritis by randomized controlled trials which comparing the effectiveness between placebo, autologous platelet rich plasma and autologous platelet lysate injections.
详细描述
The current methods for treating knee osteoarthritis include delaying the disease progression and joint replacement surgery. The usual treatment methods are mostly temporary, such as taking drug and hyaluronic acid injection. Therefore, finding the safe and effective methods will greatly reduce medical resource, medical expenses and surgery cost, etc., and restore the patient's quality of life. Platelet lysate is the product of complete activation from autologous platelet. It contains rich growth factors and cytokines such as PDGF, TGF-β, VEGF, EGF and IGF, etc. It can support cell growth and doesn't have any white blood cells in it. It is superior to the platelet rich plasma because of reducing the overall inflammatory response and pain of the patient during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 to 80 years old
- •Study Subjects must be willing to sign Informed Consent to participate in the study
- •In the past month, at least seven consecutive days in the squat, standing, walking or going up and down the stairs, the most serious degree of visual analogy of the knee pain (Visual Analogue Scale) is greater than or equal to 40 (the most pain is 100, not painful is 0)
- •Morning joint stiffness is less than 30 minutes
- •X-ray：Grade 1-3 radiographic OA as defined by the K-L classification
排除标准
- •Knee instability
- •The knee joint is obviously deformed (> 5 degree valgus or varus deviation on X-ray)
- •Clinical diagnosed as Pes tendinitis, Chondromalacia
- •Taking NSAIDs or steroids (including oral and injection) within one week
- •Using anticoagulant drugs for a long time
- •Platelet count is less than 150,000 / UL, or coagulation disorders, prothrombin time (PT value) is less than 11 seconds or greater than 16 seconds
- •Leukemia, sepsis, platelet dysfunction or other blood related diseases
- •tumors, infections or the trauma before the same site
- •Pregnancy
结局指标
主要结局
Pain score of the patient
时间窗: up to 24 weeks after surgery
Using Visual Analog Score (from 0 to 10, 0 indicate no pain and 10 indicate maximal pain) to evaluate pain of surgical wound of the patient
次要结局
- Knee functional score(up to 24 weeks after surgery)
- X-ray(up to 24 weeks after surgery)
- adverse events(up to 24 weeks after surgery)
- Ultrasonic image(up to 24 weeks after surgery)