Efficacy of Platelet Rich Plasma in treatment of knee osteoarthritis: A single group Pre & Post intervention QUASI Experimental study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- pain will be assessed by WOMEC score and Visual Analogue Score
研究概览
简要总结
80 participants who will meet the inclusion criteria and giving informed written consent will be evaluated for their WOMAC score and radiological grading of knee joint. Under all aseptic precautions PRP will be prepared by taking 22 ml venous blood in single use PRP kit (PrecureCellTM) and single spin method at 3500 RPM for 15 minutes. PRP will be injected immediately after preparation to prevent any contamination. Under aseptic conditions, ultrasound guided Intraarticular injection through the suprapatellar approach 8 mL of platelet concentrate will be injected into a suprapatellar pouch through a supero lateral approach with an 22-gauge needle. The knees were immobilized for 10 min after injection. Data will be collected including baseline WOMAC score (Western Ontario and McMaster Universities Osteoarthritis Index) by an independent observer in each knee. Patient will be lied down in supine position for 2 h and monitored for HR, BP, SPO2 and any adverse events. Patients will be evaluated on 6 week, 3 months and 6 months after the first injection by a blinded observer for change in WOMAC score. Data will be collected and analysed using standard tests and p value of less than 0.05 will be considered significant
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
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 45-65 years with either side OA knees (ASA class I and II) of either gender History of pain in last month Those with imaging findings (X-ray) of degenerative changes of the joint without significant deformity (diagnosed by KL classification ( Grade 2 and 3).
排除标准
- •Patients with KL grading I ( doubtful disease) and grade 4 (Severe disease) Patient with history of diabetes mellitus On Immunosuppressive drugs Collagen vascular disorders Cancer or malignant disorders Active infection/ wound of knee Patients with autoimmune and platelet disorders Treatment with anticoagulant and antiplatelet medications within 10 days before injection Use of NSAIDs within 2 days before injection or unwilling to stop then post injection except paracetamol History of knee articular injection of corticosteroid during previous 3 months or use of systemic corticosteroids 2 weeks before PRP injection Patients with genu valgum/Varum greater than 20 degrees Human immunocompromised virus, Hepatitis B virus, Hepatitis C virus, venereal Disease Research Laboratory virus positive cases Knee surgery on affected side within last 12 months Systemic or inflammatory knee disease Presence of warm and tense joint effusion High chances of loss of follow-up History of trauma to affected knee.
结局指标
主要结局
pain will be assessed by WOMEC score and Visual Analogue Score
时间窗: Patients will be evaluated | on 6 week, 3 months and 6 months after the first injection by a blinded observer | for change in WOMAC score
次要结局
- VAS score(at baseline/ 6 week / 3 month and 6 months)
研究者
Dr Veena Mathur
JLN Medical College Ajmer