Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- device performance
研究概览
简要总结
Patients who are to benefit from an injection of SYNOVIUM HCS as part of their care will be offered to participate in this study. Patients will need to sign a consent form to participate. Prior to SYNOVIUM HCS injection, patients will be asked a series of questions regarding their pain and disability. Data collected during follow-up visits can be compared to pre-injection data.
详细描述
Inclusion period: 6 months
Follow-up period:
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6-month follow-up, after intra-articular injection with extension
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1 single syringe of SYNOVIUM HCS (3 mL),
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Controls scheduled at 1 week, 1, 3, 6 months and up to 1 year
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Additional control (single) in the event of leaving the study if this takes place outside the scheduled visit dates and before 1 year, for medical reasons
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Duration of the study: Overall time estimated at 18 months
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In this open-label CI, the group itself is used as a control, by comparing the scores on inclusion with those of the various control 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient
- •Patient with radiologically characterized gonarthrosis (stages Kellgren & Lawrence grades I to III)
- •Patient with walking pain (WOMAC A1) at least equal to 2 on the Likert scale 0-4
- •Patient to benefit from an injection of SYNOVIUM HCS as part of his treatment
- •Patient agreeing to participate in the study
- •Patient affiliated to a social security scheme or benefiting from such a scheme
排除标准
- •Viscosupplementation less than 6 months old
- •Intra-articular corticosteroid injection less than 2 months old
- •Inflammatory arthritis or active infectious of the knee studied
- •History of surgery of the lower limb concerned
- •Kellgren & Lawrence grades not defined
- •Known hypersensitivity to hyaluronic acid or chondroitin sulfate
- •Pregnant or breastfeeding women
- •Patient under guardianship, curatorship or judicial safeguard
- •Patient participating in another clinical investigation, at the time of inclusion
结局指标
主要结局
device performance
时间窗: 6 months
evolution of the pain sub-score of the WOMAC (universities of Western Ontario and McMaster) index (A). The higher the score, the more the knee osteoarthritis has a functional impact.
次要结局
- responder patients(1 year)
- Evolution of the pain(1 year)
- Stiffness(1 year)
- Impact of the injection on concomitant treatments(1 year)
- Investigator's general assessment(1 year)
- Complication(1 year)
- recovery of autonomy(1 year)
- Function(1 year)
- long-term performance of the SYNOVIUM HCS device(1 year)