The Effect of Intra Articular Platelet Rich Plasma Injection in Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. To assess and compare the functional outcome in patients of Knee Osteoarthritis before each PRP/NS
研究概览
简要总结
Patients will be recruited from the OPD after applying ACR criteria & KL Grade II and III on X-RAY KNEE AP/LAT (STANDING) and applying inclusion and exclusion criteria;.
Randomization will be done via a computer-generated random sequence and patient will be divided into 2 groups (Group A-PRP; Group B-NS)
VAS, WOMAC, Ser. Coll2-1NO2, X-Ray, MRI study {WORMS} Before 1stPRP/NS(Baseline) Intraarticular injection
Then USG-guided 1st Intraarticular injection of GFC/NS will be given
After 1 month VAS, WOMAC will be taken and USG-guided 2nd PRP/NS Intraarticular injection will be given After 6 month VAS, WOMAC will be taken
VAS, WOMAC, Ser. Coll2-1NO2, X-Ray, MRI study (WORMS) will be taken after 9 months to study the effect
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients over 18 years of age who had been diagnosed with osteoarthritis of the knee according to the American College of Rheumatology (ACR) 2019 criteria were included in this study.
- •Among these patients, only those diagnosed with Grade II and Grade III osteoarthritis of the knee joint, as classified by the Kellgren-Lawrence scale.
排除标准
- •Any known malignancy.
- •Gouty Arthritis /inflammatory arthritis, Secondary Osteoarthritis c.
- •Active knee infection.
- •Disorders of Bleeding e.
- •Uncontrolled Diabetes Mellitus f.
- •Ligamentous instability of knee (MRI DIAGNOSED) g.
- •Contraindication to MRI h.
- •Any history of previous intraarticular steroid injection.
结局指标
主要结局
1. To assess and compare the functional outcome in patients of Knee Osteoarthritis before each PRP/NS
时间窗: 1,2,6 and 9 month
Injection and at 6 months and at 9 months and study their effect.
时间窗: 1,2,6 and 9 month
2.To assess and compare the Radiological outcome with the help of WORMS score and X-Ray in patients of Knee Ostenarthritis and observe the chances at the end of 9 months.
时间窗: 1,2,6 and 9 month
次要结局
- To compare the change in biomarker of cartilage degeneration (serum Coll2-1No2)(8) values after IA PRP injection & IA NS injection with the clinical improvement seen after the intervention.(9 months)
- To compare the articular cartilage changes on specialized MRI sequences(WORMS)(9) before and after the intervention(Before intervention and after 9 month)
研究者
Dr Amit Saraf
Department of Orthopaedics Teerthanker Mahaveer Medical College and Research Centre