NCT05227924招募中不适用
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
Dedienne Sante S.A.S.9 个研究点 分布在 1 个国家目标入组 747 人开始时间: 2021年9月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 747
- 试验地点
- 9
- 主要终点
- Survivorship of 13 individual SYMBOL orthopaedic components
研究概览
简要总结
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices. The study will evaluate the outcome of Total Hip Arthroplasty using medical devices from SYMBOL range over a period of 10 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient age > 18 years at implantation.
- •Patient who will undergo, during the study's period of inclusion, a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device (DEDIENNE Santé).
- •Patient informed of his/her participation and willing to participate in the study.
- •Patient able to read, write and understand French.
排除标准
- •Patient deprived of freedom, under guardianship/curatorship or placed under judicial protection
- •Patient unable to follow study procedures.
- •Patient who has already been included in the study for a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device.
结局指标
主要结局
Survivorship of 13 individual SYMBOL orthopaedic components
时间窗: 10 years post-operative
The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.
次要结局
- Survivorship of the SYMBOL STEM VARA CEM orthopaedic implant.(10 years post-operative)
- Radiographic assessment - Implant subsidence.(6 months, 18 months, 5 and 10 years post-operative)
- Radiographic assessment - Eterotopic ossifications.(6 months, 18 months, 5 and 10 years post-operative)
- Survivorship of all individual SYMBOL orthopaedic components(6 months, 18 months and 5 years post-operative)
- Adverse Device Effects.(Through study completion, an average of 10 years)
- Survivorship of the SYMBOL implants by component assembly (acetabular + femoral components)(Through study completion, an average of 10 years)
- Global patient satisfaction(18 months post-operative)
- Radiographic assessment - Osteolysis (granuloma).(6 months, 18 months, 5 and 10 years post-operative)
- Pain intensity (Numeric Rating Scale)(Pre-operative, 6 months, 18 months, 5 and 10 years post-operative)
- Radiographic assessment - Radiolucent lines.(6 months, 18 months, 5 and 10 years post-operative)
- Harris Hip Score (or modified Harris Hip Score) at each visit.(Pre-operative, 6 months, 18 months, 5 and 10 years post-operative)
- EQ-5D-5L score(Pre-operative, 18 months, 5 and 10 years post-operative)
- Hip joint patient satisfaction (Numeric Rating Scale)(5 years and10 years post-operative)
研究者
研究点 (9)
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