Satellite™ PEEK Nucleus Replacement Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Health-related Quality of Life Using the Visual Analogue Scale for Back Pain
研究概览
简要总结
The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.
The purpose of this study is to evaluate number of adverse device effects (ADEs), serious adverse device effects (SADEs) and serious adverse event (SAEs) and early clinical effectiveness for the Satellite™ Nucleus Replacement in a standard clinical practice. Data collection will include information on health related quality of life (QoL), physical functioning and adverse event after nucleus replacement surgery. Radiographic measures will also be assessed to evaluate changes in disc height at the operated level and changes in segmental range of motion.
All patients who were implanted with a Satellite™ Nucleus Replacement Prosthesis in the participating sites are eligible for participation in the Satellite ™ Retrospective Analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 must have signed a Patient Data Release Form
- •Age of at least 18 years and skeletally mature at the time of surgery
- •Exclusion Criterion:
- •Patient has not reached the age of legal consent according to local laws
排除标准
- 未提供
结局指标
主要结局
Health-related Quality of Life Using the Visual Analogue Scale for Back Pain
时间窗: Up to 12 months follow up visit
The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.
Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain
时间窗: Up to 12 months follow up visit
The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.
Physical Functioning Using the Oswestry Disability Index (ODI)
时间窗: Up to 12 months follow up visit
The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 50; 0 meaning 'no disability' and 50 meaning 'maximum disability'.
Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs)
时间窗: Patients were followed up according to the local practice, up to 1 year
次要结局
- Range of Motion (ROM) at Implanted Level(Up to 12 months follow up visit)
- Device Subsidence Measured as Interbody Height Ratio (IBHR)(Up to 12 months follow up visit)
- Intervertebral Disc Space (IVD) at Implanted Level(Up to 12 months follow up visit)
- Changes in Device Placement(Up to 12 months follow up visit)