Multicenter PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D - A Prospective Study on Total Indications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Change of Spinal Disability measured by Oswestry Disability Index (ODI)
研究概览
简要总结
Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter
详细描述
The study collects a data set for each patient receiving a PROSPACE 3D, PROSPACE 3D Oblique, or TSPACE 3D implant. It is intended to collect data preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively containing
- Basic medical history
- Type of surgical procedure
- Treated segments
- Implant characteristics (including additional implants for anterior/posterior stabilization)
- Scores: ODI, Pain (VAS), EQ-5D
- Patient satisfaction
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change of Spinal Disability measured by Oswestry Disability Index (ODI)
时间窗: preoperatively, at 3 months postoperatively and at 12 months postoperatively
The Oswestry Disability Index (ODI) is designed to measure back-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including pain, personal care, lifting, Walking, sitting, standing, sleeping, sex life, social life and travelling. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
次要结局
- Side effects(up to 12 months postoperatively)
- Change of Quality of Life (EQ-5D)(preoperatively, at 3 months postoperatively and at 12 months postoperatively)
- Change of Pain (VAS)(preoperatively, at 3 months postoperatively and at 12 months postoperatively)
- Bone fusion(12 Months postoperatively)