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临床试验/CTRI/2024/08/072559
CTRI/2024/08/072559尚未招募4 期

Intra-articular Platelet Rich Plasma vs. Corticosteroid vs. Hyaluronic Acid in the Treatment of Mild and Moderate Osteoarthritis of knee

SRM Medical College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年8月26日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
105
试验地点
1
主要终点
Assessment of pain relief by the Visual Analogue Score (VAS).

研究概览

简要总结

A total of 105 patients of age group between 45-75 of both genders will be assessed on the basis of kellgren Lawrence classification of osteoarthritis of knee. Patients will be divided into 3 groups . First group will be receiving 6 ml of rich autologous platelet rich plasma , Second group will receive 40mg of Triamcinilone Acetonide injection , Third group will receive 6 ml of Hyaluronic acid, all into the medial joint space of the knee under sterile aseptic conditions. Variations in VAS scoring system will be the primary outcome where 0 - no pain and 10- worst pain. Variations in the WOMAC scores will be the secondary outcomes where the patients daily activities of living will be scored based on their tolerance , 0 giving the best outcome and 96 giving the worst outcome. Data collection will be done by observation and various parameters.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
45.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patient having old to moderate osteoarthritis of knee (kellgran lawrence classification grades 1,2,&3) .
  • All patients above the age of 45 years.

排除标准

  • Patients having secondary osteoarthritis of knee, having history of any previous knee surgeries for ligaments injuries / intra articular fractures.
  • Any history of infections like TB/bacterial (post Septic Sequelae ).

结局指标

主要结局

Assessment of pain relief by the Visual Analogue Score (VAS).

时间窗: 1 month, 3months, 6 months, 12 months.

Where 0 points equal to no pain and 10 points equal to worst pain

时间窗: 1 month, 3months, 6 months, 12 months.

次要结局

  • Variations in the WOMAC scores ( Western Ontario and McMaster Universities Arthritis Index )(Where 0 points gives the best outcome and 96 points gives the worst outcome)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Anooj Pravin Chheda

SRM Institute of Science and Technology

研究点 (1)

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