JPRN-UMIN000038925已完成未知
PRESTIGE LP Cervical Disc System (2 levels) Regulated PMS - PRESTIGE LP Cervical Disc System (2 levels) Regulated PMS
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1Not applicable 至 100Not applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients allergic to metals 2) Patients in the process of active infection, or with a serious risk of infection such as an immunodeficiency 3) Patients with a disease that involves severe bone fragility, (or with a cervical vertebra so fragile as to experience difficulty in receiving an implant due to diseases such as severe osteoporosis, osteomalacia, Paget's disease of bone, renal osteodystrophy, Ehlers-Danlos Syndrome, osteogenesis imperfecta, etc.) 4) Patients with notable cervical instability under the lateral images of ante-/retro-flexion 5) Patients with either of the following severe cervical diseases: (1) Bridging osteophyte formation observed at the treated level without maintaining mobility (2) Significantly-narrowing intervertebral height observed at the treated level 6) Patients with a severe facet joint arthrosis at the treated level 7) Patients with a significant lesion or deformity of vertebral body 8) Patients presenting obvious abnormality in cervical alignment (e.g. local kyphosis) 9) Patients presenting an obvious cervical spinal canal stenosis across multiple levels 10) Patients with a trauma involving cervical bone fracture, ligament injury, etc. 11) Patients presenting obvious involuntary movement at the head and neck area
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