Wright Foot & Ankle Post-Market Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 119
- 试验地点
- 5
- 主要终点
- EuroQol (EQ-5D-5L).
研究概览
简要总结
WRIGHT FOOT & ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device
详细描述
The selected design is a global, multi-center, non-randomized, prospective observational study. The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.
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
- 是
入选标准
- •Willing and able to consent to participate (written, informed consent);
- •Willing and able to attend/complete the requested follow-up visits;
- •Considered for treatment with one or more approved or cleared Wright Medical products included in this study
排除标准
- •Subjects determined, by the investigator, to be an inappropriate candidate for the procedure indicated;
- •Unable to consent to participate (written, informed consent);
- •Unable to attend/complete the requested follow-up visits
结局指标
主要结局
EuroQol (EQ-5D-5L).
时间窗: 1 year
Comparing the changes in patient-reported pain and social interaction for quality of life from pre-op through post-operatively, assessed by the EuroQol (EQ-5D-5L). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. Health utility values generated from the EQ-5D generally range from 0 (death) to 1 (perfect health). But health utility values less than 0 are possible, and represent health states considered worse than death. The EQ VAS records the patient's self-rated health on a VAS (0-100), where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
次要结局
- Patient Survey(1 year)
- Foot and Ankle Ability Measure (FAAM)(1 year)
- Safety Assessment(1 year)
- Surgeon Survey(1 year)