CTRI/2024/01/061459尚未招募2 期
Comparison Of Ultrasound Guided Intraarticular Injection Of Platelet Rich Plasma Versus Hyaluronic Acid In Improving Cartilage Thickness And Physical Functions In Patients With Primary Osteoarthritis Of Knee: A Randomized Controlled Trial
No Primary Sponsor1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Knee cartilage thickness assessment by MSK ultrasound
研究概览
简要总结
Osteoarthritis of knee is a chronic disease with loss of joint surface cartilage. Pain, stiffness and joint deformity affecting ones day to day activities. The aim of the study is to compare ultrasound guided intra articular injection of platelet rich plasma versus hyaluronic acid in improving cartilage thickness and physical functions in patients with primary osteoarthritis of knee. Outcomes will be measured at the end of 12 weeks, 24 weeks and 36 weeks. Data will be analysed using SPSS 21 version. Chi-square test, student t test and ANOVA will be used and p value<0.05 will be taken as significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Age group 40 to 65 years
- •Patients with primary knee osteoarthritis fulfilling 2016 ACR(American college of Rheumatology) revised criteria for early diagnosis of knee osteoarthritis(clinical and radiographic)
- •Osteoarthritis of knee with Kellgren-Lawrence grade upto 3
- •Willingness to participate in the study and comply with treatment and follow up 5.VAS>4.
排除标准
- •Recent knee trauma or knee surgery
- •Knee deformity or knee infection
- •Metabolic disease of bone
- •Cognitive impairment
- •Uncontrolled diabetes mellitus
- •Thrombocytopenia(Platelet count<150000/mcl
- •Intraarticular steroid injection during past 3 months 8.
结局指标
主要结局
Knee cartilage thickness assessment by MSK ultrasound
时间窗: Baseline, 3 month, 6 month and 9 month
次要结局
- VAS score, WOMAC score(Baseline, 3 month, 6 month & 9 month)
研究者
研究点 (1)
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