The Effects of Intraarticular Injection of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee (in a Clinical Trial Phase III)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- pain
研究概览
简要总结
Osteoarthritis is the most common type of arthritis. The prevalence of osteoarthritis of the knee has significantly elevated in the elderly population and youth due to age and sport activities respectively. Our aims to treat the knee osteoarthritis are including; reduce knee pain and improve its function; return patients to normal daily activities and reduce health care costs.
The current treatments which are already being used for osteoarthritis of the knee patients include:
- Symptomatic therapy: conservative therapies, physiotherapy, analgesics and non-steroidal anti-inflammatory drugs.
- Intra-articular injections of corticosteroids and hyaluronic acid.
- Current Surgical Therapy: knee arthroplasty, osteotomy, arthrodesis and debridement.
As the low mitotic activity and lack of blood supply cause little ability for the articular cartilage to repair itself, so injection of platelet-rich plasma (PRP) has recently received much more attention due to its capacity to do self-healing in treatment of osteoarthritis of the knee.
PRP consists of several concentrated growth factors in platelets of autologous blood that are applied to the different parts of medicine such as reconstruction of damaged tissue. Although platelets are well-known to involve in the blood clots formation, but current studies have shown that they secrete many bio-proteins which attract macrophages, mesenchymal stem cells and osteoblasts to remove necrotic tissue in addition to participate in healing procedure.
This study is a prospective, randomized, controlled trial to assess The positive effects of platelet-rich plasma injection in 244 patients with osteoarthritis of the knee
详细描述
In this study all eligible patients (Based on the inclusion and exclusion criteria) were randomly allocated into two study groups by a Stratified Permuted Block randomization method: group A received platelet rich plasma, group B (control group) received only placebo.
All of the patients underwent a standard long protocol for knee osteoarthritis. All patients with grade II,III and IV of radiographic knee OA are selected. On average, in each instance, the amount of platelets in the peripheral blood is 4 to 6 times the baseline level.
Group A: 1-3 cc injection of placebo Group B: 1-3 cc injection of PRP All patients received monthly injection for 3 times.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years
- •Body mass index (BMI) ≤33 kg/m2
- •Grade 2And above imaging of osteoarthritis
- •History of knee pain or swelling should have at least 4 months
排除标准
- •treated with steroids and Anti-coagulant or anti-platelet aggregation
- •history of infectious, systemic diseases, Immune deficiency and coagulation disorders
- •Patients with Hb ≤11, Plt ≤ 150000
- •Varus > 10 , valgus > 10
研究组 & 干预措施
platelet reach plasma
The patients with osteoarthritis who underwent PRP injection.
干预措施: PRP injection (Biological)
placebo
The patients with osteoarthritis who underwent Normal Saline injection.
干预措施: Placebo (Biological)
结局指标
主要结局
pain
时间窗: 3 months
pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection
physical activity
时间窗: 3months
physical activity of patients which is measured by WOMAC scoring , before injection of PRP\& 3,6 and 12 months after last injection.
cartilage repair
时间窗: 12months
The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.
次要结局
- quality of life(3months)
- joint replacement(12months)