Effectiveness of autologous platelet rich plasma in grade 2 and grade 3 osteoarthritis knee in terms of controlling pain, improving functions and structural outcome - A prospective interventional study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Improvement in terms of pain control, functional improvement, and cartilage growth.
研究概览
简要总结
This is prospective interventional single arm study to know the effectiveness of autologous platelet rich plasma therapy in grade 2 and grade 3 osteoarthritis knee in terms of controlling the pain, improving functions and structural outcome.
Eligible candidates undergo radiographic screening,blood screening. candidates are explained about the whole protocol and consent is taken for the same. baseline assesment is done with VAS, 6MWT, WOMAC SCORES and MRI SCANS.
Four doses of PLATELET RICH PLASMA is given into the affected knee joint each one week apart. VAS, 6MWT, WOMAC SCORES are assessed at 4 weeks,8 weeks and 12 weeks after last dose of prp therapy. Structural outcome in knee joint is assessed with MRI sequences at the end of 12 weeks.
The main objective of this study is to quantify the effect of platelets rich plasma therapy on structural improvement of articular cartilage of knee joint using MRI sequencing in addition to pain relief, functional outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are willing for follow up, confirmed cases of osteoarthritis knee, kellgren Lawrence radiological grade 2 and grade 3 osteoarthritis knee.
排除标准
- •Patients with grade 1 and grade 4 osteoarthritis knee,patients with heart diseases using antiplatelets and anti-coagulation medications , secondary osteoarthritis knee, sepsis , platelets disorders or diseases , any intervention in last 3 months , any immunodeficiency, autoimmune, collagen vascular diseases , any contraindications for MRI , any contraindications to platelets rich plasma therapy.
结局指标
主要结局
Improvement in terms of pain control, functional improvement, and cartilage growth.
时间窗: after baseline evaluation patients are given PRP injections into the affected knee joint every week for 4 weeks,then they are followed up every month for 3 months. At follow up patients are asked about subjective improvement and assessed for functional improvement and at the end of 3 months post last dose of PRP INJECTION structural outcome is evaluated with the help of MRI.
次要结局
未报告次要终点
研究者
Dr Mohd Abdul Aziz
Esic medical College and hospital