New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Promedon
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Pain assessment: Percentage of pain reduction using a visual analogue scale
研究概览
简要总结
Prospective, multicenter study, unmasked, single-arm, to study the safety and efficacy of a new hydroxyethyl cellulose hydrogel for the treatment of the knee pain caused by osteoarthritis.
详细描述
Prospective, multicenter study, unmasked, single-arm, to study the safety and efficacy of a new hydroxyethyl cellulose hydrogel for the treatment of the knee pain caused by osteoarthritis. The working hypothesis is that the effect of hydrogel use on the study population will result in a reduction in pain in the knees affected by symptomatic OA.
The general objective of this study is to generate clinical evidence of the safety and efficacy of the new hydrogel used as a treatment of symptomatic knee osteoarthritis.
The patient's perception of the pain caused by osteoarthritis in the knee joint before and after the treatment under evaluation will be quantify. Subjects' quality of life before and after treatment will also be evaluated. Monitoring of the adverse events associated with the use of the device under evaluation will be determined. Subjects will be follow-up for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with osteoarthritis of unilateral or bilateral knee osteoarthritis who meet the criteria defined by the American College of Rheumatology for at least 4 months prior to the study. In bilateral knee osteoarthritis, only the knee with more symptoms will be treated.
- •Arthrosis grade 2 or 3 according to the Kellgren - Lawrence Classification System (radiological classification)
- •Persistence of symptoms despite conservative treatment (NSAIDS, Physical Therapy, lifestyle changes, etc.) for more than 4 months
- •Subjects aged between 40 and 70 years
- •BMI (Kg/m²) 20-32
- •For female subjects: postmenopausal women with at least 1 year documented in the medical record.
排除标准
- •Arthrosis grade 0 or 4 according to the Kellgren - Lawrence Classification
- •History of allergy to any of the Hydrogel components
- •History of previous treatment with corticosteroid injections less than 4 months prior to entry into this clinical study
- •History of previous treatment with hyaluronic acid viscosupplementation
- •History of open or arthroscopic surgery in the knee to be treated less than 9 months
- •Severe chronic progressive disease
- •Insulin-requiring diabetes
- •Rheumatic diseases (rheumatoid arthritis, psoriasis, gout, pseudo-gout, fibromyalgia)
- •History of septic arthritis
- •History of psychiatric illness that makes it impossible to understand and sign the informed consent
- •History or presence of severe peripheral vascular disease
- •Deseje over 15° valgus or varus movement
- •Pregnant or breastfeeding women
- •BMI (kg/m²)> 32
结局指标
主要结局
Pain assessment: Percentage of pain reduction using a visual analogue scale
时间窗: Change from Baseline at postoperative 12 months follow-up
Percentage of pain reduction using a visual analogue scale (Wong-Baker scale) where Face 0: does not hurt at all and Face 10: hurts as much as you can imagine
次要结局
- Rate of Adverse Events(At injection, at three days after injection, postoperative at 1, 3, 6 and 12 months follow-up)
- Improvement of Health status(Change from Baseline at postoperative at 1, 3, 6 and 12 months follow-up)
- Improvement of Quality of life: KOOS(Baseline, and postoperative at 1, 3, 6 and 12 months follow-up)
- Patient Global Impression(Change from Baseline, up to three days after injection, postoperative at 1, 3, 6 and 12 months follow-up)