Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of ORTHIX PLUS 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 ORTHIX PLUS for pain relief in patients suffering from osteoarthritis or degenerative joint diseases.
The study will involve 54 subjects, who will be enrolled in 2 centers in Turkey. The primary objective is to evaluate the overall performance of ORTHIX PLUS in providing relief in patients suffering from painful knee ostearthritis or degenerative joint diseases when used according to indications for use.
The first secondary objective is to evaluate the overall performance of ORTHIX PLUS in providing relief when used according to indications for use, at different time points. The other secondary objective is to evaluate the overall safety during the study period.
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.
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)
- Weight-bearing pain using a Visual Analogue Scale(VAS)(1,6,12 weeks and 6 months)
- Changes in motion pain(VAS)(1,6,12 weeks and 6 months)
- Changes is rest pain(VAS)(1,6,12 weeks and 6 months)
- Global Pain Assessment(1,6,12 weeks and 6 months)