Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of HyaleXo for Pain Relief in Patients Suffering From Osteoarthritis or Degenerative Joint Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Functional assessment of HyaleXo by KOOS
研究概览
简要总结
Hyaluronic acid is a polysaccharide naturally present in several human tissues such as cartilage. It is the major constituent of synovial fluid and provides its viscosity and elasticity. In traumatic and degenerative joint diseases, the amount of hyaluronic acid is reduced. The consequent loss of viscosity by the synovial fluid may be the cause of painful symptoms. HyaleXo action, according to its composition (sodium hyaluronate of very high molecular weight), may restore the viscoelastic properties of synovial fluid, attenuate pain and improve the mobility of the joint. These characteristics allow HyaleXo to be used for the symptomatic relief of pain in patients suffering from osteoarthritis (OA) or degenerative joint diseases causing an alteration of the functionality of the synovial fluid.
The patient will be treated with HyaleXo as reported in the Instruction for use (IFU) of the device: via injection once a week for 3 weeks using standard technique. The patient pain management strategy should be according to the standard clinical practices and remains at the discretion of the investigator.
The Research Question of the present study is the following: in a population of men and women suffering from painful knee osteoarthritis or degenerative joint disease will very high molecular weight fraction of sodium Hyaluronate (HyaleXo) significantly decrease and / or relieve the pain after 1,6,12 weeks and 6 months of the third injection?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years old (inclusive ≥ 18 years).
- •Men or women.
- •Patients suffering from painful chronic idiopathic symptomatic degenerative joint diseases (clinical evidence) OR knee osteoarthritis (as defined by the American College of Rheumatology (ACR) criteria); for patients with OA at both knees, only the most painful one will be included in the study.
- •VAS knee pain ≥ 40 mm at screening and 30 days before.
- •Patients willing and able to comply with study terms.
- •Patients willing to discontinue all other OA treatments
排除标准
- •Patients that are unable or unwilling to provide informed consent, and/or patients participating in a concurrent clinical trial and/or patients who have participated in a similar clinical trial within the last days.
- •Patients with known hypersensitivity to any components of investigational product.
- •Patients who are pregnant or breastfeeding. Patients with infected or severely inflamed joints.
- •Patients with skin diseases or infections in the area of the injection site.
- •Patients with hepatic failure or history thereof.
研究组 & 干预措施
Patients that meet inclusion/exclusion criteria.
Patients that meet inclusion/exclusion criteria.
干预措施: HyaleXo (Other)
结局指标
主要结局
Functional assessment of HyaleXo by KOOS
时间窗: 12 weeks
Functional assessment of HyaleXo by KOOS (Knee Injury and Osteoarthritis Outcome score) for Pain subscale at 12 weeks after the last administration of the investigational product, compared to the baseline.
次要结局
- Visual Analgoue Sclae(1,6,12 weeks and 6 months)
- Functional assessment of HyaleXo by KOOS(1,6 weeks and 6 months)
- Patient Global Pain Assessment(1,6,12 weeks and 6 months)
- Functional assessment of HyaleXo by KOOS(1,6,12 weeks and 6 months)