Prospective, Observational, Open-label, Clinical Investigation of Intra-articular Arthrosamid® Injection in Subjects With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 201
- 试验地点
- 11
- 主要终点
- Number of adverse events
研究概览
简要总结
This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee osteoarthritis who is eligible for treatment with Arthrosamid® according to the Instruction for Use.
详细描述
This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee OA who is eligible for treatment with Arthrosamid® according to the Instruction for Use (IFU).
All subjects will be followed over an observational period of five years with yearly follow-up check points. The first follow-up visit should be six months after the treatment. All follow up visits can be performed as telephone visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged ≥ 18 years
- •Clinical diagnosis of knee OA
排除标准
- •If an active skin disease or infection is present at or near the injection site
- •If the joint is infected or severely inflamed
- •If a degradable intra-articular injectable such as hyaluronic acid is present, it must be expected to be absorbed according to manufacturer's information for the specific product, before injection with Arthrosamid®
- •If the patient has previously received treatment with a different non-absorbable injectable/implant
- •If the patient has received a knee alloplasty or has any foreign material in the knee
- •If the patient has undergone knee arthroscopy within the last 6 months
- •If the patient has haemophilia or is in uncontrolled anticoagulant treatment
结局指标
主要结局
Number of adverse events
时间窗: 5 years
The total number of treatment emergent adverse events
次要结局
- WOMAC stiffness subscale(6, 12, 24, 36, 48 and 60 months)
- WOMAC pain subscale(6, 12, 24, 36, 48 and 60 months)
- WOMAC physical function subscale(6, 12, 24, 36, 48 and 60 months)
- Patient's global assessment of impact of osteoarthritis(6, 12, 24, 36, 48 and 60 months)