Assessment of Patients Quality of Life Suffering From Knee Osteoarthritis Treated With Three Intra-articular Injections of ARTHRUM H 2% Over a Period of Six Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 主要终点
- To measure the physical component summary (PCS) improvement, on patient quality of life suffering from knee osteoarthritis after treatment by three intraarticular injections of ARTHRUM H 2% from D0 (inclusion) to D180 (end of trial)
研究概览
简要总结
The reduction of functional limits and disablilities induced by knee osteoarthritis as well as improvement of patients quality of life is a public health need registered amongst the priorities established by the French law of August 9th 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products.
This clinical trial in real life on ARTHRUM H 2% device aims to analyse patients quality of life treated by intraarticular injections, eventually for several years, by difference of usual clinical trials.
This open, prospective, multicentric study aims to analyse, in patient care, the impact of three intraarticular injections of ARTHRUM H 2% on quality of life over a period of 6 months (D180) in the symptomatic treatment of knee osteoarthritis.
详细描述
Parameters used to determine treatment outcomes include: "Short-Form 12 Health Survey" (SF-12), Pain score of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC A)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged over 40;
- •Suffering from symptomatic knee osteoarthritis radiologically confirmed less than 12 months ago and stage I, II or III according to KELLGREN (knee in extension) and with minimal pain on walking (WOMAC A1) of two points on the LIKERT scale
- •Patient able to understand the trial procedure and give his/her consent to take part, in writing;
- •Patient geographically stable during the trial;
- •Patient affiliated to the French social security regime or benefiting from such a French regime.
排除标准
- •Inflammatory arthritis;
- •Progressive infectious condition of the knee being studied;
- •Previous treatment with viscosupplementation for at least one year;
- •Injection of corticoids into the knee studied for less than two months;
- •Known hypersensivity to hyaluronic acid or substances with similar activity;
- •Pregnant or breast-feeding women;
- •Patient under guardianship or tutorship or under juridicial protection;
- •Patient currently taking part in another clinical research study.
结局指标
主要结局
To measure the physical component summary (PCS) improvement, on patient quality of life suffering from knee osteoarthritis after treatment by three intraarticular injections of ARTHRUM H 2% from D0 (inclusion) to D180 (end of trial)
时间窗: 6 months
次要结局
- To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on physical component summary (PCS)(6 months)
- To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on mental component summary (MCS)(6 months)
- To study pain variation of score A from Western Ontario McMaster Universities Osteoarthritis (WOMAC A)(6 months)