ISRCTN42774128已完成未知
Prospective International multicentre Evaluation of Radiological and Clinical Effects of stand-alone polyetheretherketone (PEEK) intervertebral spacers for anterior cervical discectomy and fusion (ACDF): a prospective single-arm observational surgical implant trial
Deutsche Arthrose Hilfe e.V. (Germany)0 个研究点目标入组 356 人开始时间: 2009年4月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 356
研究概览
简要总结
2017 results in https://pubmed.ncbi.nlm.nih.gov/28465721/ (added 30/12/2020)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Age greater than or equal to 18 years, either sex
- •2. Cervical degenerative disc disease at a single level, C3/C4 - C7/Th1
- •3. Clinical signs of myelopathy or radiculopathy
- •4. Presence of neck/arm pain (cervicobrachialgia) and/or radicular deficits, which are refractory to conservative therapy
排除标准
- •1. Unable to provide informed consent to surgery
- •2. Osteoporosis, fractures, or concomitant tumours of the cervical vertebrae
- •3. Previous surgery in the affected level
- •4. Fusion of either immediately adjacent level (due either to a previous operation or natural history)
- •5. Kyphosis or instability/hypermobility in functional x-rays (because this was taken as an indication for ventral plating)
- •6. Systemic, spinal, or local infection (acute or chronic)
- •7. Known allergies or intolerance to the implant material PEEK
研究者
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