Multicenter, Not Randomised, Non-interventional, Postmarket Clinical Follow-Up (PMCF) Study on the Performance / Safety of Arcadius XP L® Interbody Fusion Device
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Aesculap AG
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Functional outcome after minimum 1 year postoperatively
研究概览
简要总结
The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients who received a Arcadius XP L® interbody fusion device between 2016 until approx. January 2021 (minimum Follow-up is one year) in the study center
- •all indications as given by the instructions for use: degenerative disc disease (DDD), Instability, Spondylolisthesis up to grade 1, Post-discectomy syndrome, Post-traumatic instability
- •Written informed consent for the documentation of clinical and radiological results
排除标准
- •Patient is not willing or able to participate at the follow-up examination
- •Patients living outside a radius of 100 km around the study center
- •all contraindications as given by the instructions for use:
结局指标
主要结局
Functional outcome after minimum 1 year postoperatively
时间窗: at follow-up approximately 1 year postoperatively
The Oswestry Disability Index (ODI) is designed to measure back-specific disability. The questionnaire is self-administered and has 10 items concerning pain and activities of daily living including personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. It is a self-administered questionnaire Each section is scored on a 0-5 scale, 5 is for maximum disability. The index is calculated by dividing the total score by the total possible score, which is multiplied by 100 and expressed as a percentage. 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
- Radiological Outcome: Bone fusion(at follow-up approximately 1 year postoperatively)
- Rate of (Serious) adverse events(at follow-up approximately 1 year postoperatively)
- Pain assessment(at follow-up approximately 1 year postoperatively)
- Development Quality of life (EQ-5D-5L)(at follow-up approximately 1 year postoperatively)