Multicenter Post Market Clinical Follow-Up (PMCF) Study on the Safety and Performance of Ennovate® Complex - A Prospective Study on Scoliosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Change of Pain
研究概览
简要总结
Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in selected centers (not interventional, multicentric)
详细描述
This clinical study is one of the Post-Market Clinical Follow-Up (PMCF) measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Complex system.
The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in deformity disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent in the documentation of clinical and radiological results of patients who are minimum 18 years old
- •Informed consent in the documentation of clinical and radiological results of patients AND legal representative (parent) for patients who are younger than 18
- •Patient's indication according to IFU
- •Patient is not pregnant
排除标准
- •Patient's clear unability or unwillingness to participate in follow-up examinations
研究组 & 干预措施
Ennovate® Complex
All patients who are treated with the Ennovate® Complex system in accordance with indications given in the instructions for use (IFU)
干预措施: posterior stabilization for the cervical spine (Device)
结局指标
主要结局
Change of Pain
时间窗: preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively
ain will be assessed by the patient using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal / worst pain".
次要结局
- Change of Quality of Life(preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively)
- Bone Fusion(at final follow-up approximately 24 months after surgery)
- Cumulative number of Side effects(throughout the follow-up up to 24 months postoperatively)
- Change of Every day life(preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively)