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
- 发起方
- 入组人数
- 54
- 主要终点
- KOOS for Pain at 12 weeks
研究概览
简要总结
This trial is a post marketing clinical follow up study, aiming to evaluate the performance and safety of Hyalexo for pain relief in patients suffering from osteoarthritis or degenerative joint diseases.
The study will involve 54 subjects, who will be enrolled in 4 centers in France. The performance outcomes will be evaluated by the koos score, and VAS for pain, while the safety outcomes will be assessed by a safety checklist and by collecting all the adverse events (Adverse Event/Adverse Device Effect/Serious Adverse Event/Serious Adverse Device Effect/Unanticipated Serious Adverse Device Effect/Device Deficiencies) at all visits.
详细描述
Design:
Open, non-randomised, non-comparative, single group assignment, multicentre study.
Chronogram of visits:
The study foresees the following visits per patient:
- Visit 1 day -3 to day -1: Screening.
- Visit 2 day 0: Baseline visit (1st injection).
- Visit 3 day 7 (± 1 day): Follow up visit and, 2nd injection.
- Visit 4 day 14 (± 2 days): Follow up visit and, 3rd injection.
- Visit 5 day 21 (± 2 days): Follow up visit.
- Visit 6 day 56 (± 2 days): Follow up visit.
- Visit 7 day 98 (± 2 days): Follow up visit.
- Visit 8 day 194 (± 4 days): Final visit.
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
- 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(inlcusive≥18years).
- •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 osteoarthritis at both knees, only the most painful one will be included in the study.
- •VAS knee pain≥40mm at screening and 30 days before.
- •Patients willing and able to comply with study terms.
- •Patients willing to discontinue all other degenerative joint diseases or knee osteoarthritis 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 that have participated in a similar clinical trial within the last 30 days.
- •Patients with known hypersensitivity to any components of investigational product.
- •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.
- •Protected persons defined in the following articles of the French Public Health Code:
- •L. 1121-5 pregnant women or breastfeeding.
- •L. 1121-6: persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social establishment for purposes other than that of research.
- •L. 1121-7: minors.
- •L. 1121-8: adults who are subject to legal protection measures or out of state to express their consent.
- •L. 1122-1-2: people in emergency situations who cannot give prior consent.
结局指标
主要结局
KOOS for Pain at 12 weeks
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. This was the endpoint used for the sample size calculation.
次要结局
- KOOS for Symptoms, Activity of Daily Living, Sport and Recreation and knee related Quality of life(1,6,12 weeks and 6 months)
- KOOS for Pain at 1, 6 weeks and 6 months(1, 6 weeks and 6 months)
- Changes is rest pain(VAS)(1,6,12 weeks and 6 months)
- Changes in motion pain(VAS)(1,6,12 weeks and 6 months)
- Global Pain Assessment(1,6,12 weeks and 6 months)
- Weight-bearing pain using a Visual Analogue Scale(VAS)(1,6,12 weeks and 6 months)