NCT05262478已完成不适用
Medium-Term Radiological And Clinical Follow-Up of Alpha-D Cervical Disk Prosthesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Heterotropic ossification
研究概览
简要总结
Prostheses use subsequently became prevalent and a number of studies were conducted. However, prosthesis-associated heterotropic ossification (HO) in the segments with prostheses was reported in 2005, which disrupted mobility and caused fusion.
In the present study, we aimed to investigate the clinical outcomes, HO incidence, and prosthesis mobility in the patients following the operative use of Alpha-D disc prosthesis as developed and used by the authors to treat cervical disk diseases.
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
- 27 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cervical disc hernia
- •underwent cervical discectomy and received cervical disc prostheses
排除标准
- •history of cervical surgery,
- •kyphotic deformity,
- •rheumatological or other systemic diseases,
- •severe osteophytes caused by advanced degenerative disc disease
- •severe spinal stenosis
结局指标
主要结局
Heterotropic ossification
时间窗: Postoperative 18-78.months
McAfee-Mehren classification
次要结局
- visual analog scale(4 and 12 months after surgery)
- neck disability index(4 and 12 months after surgery)
研究者
Mehmet Kursat Karadag
Principal Investigator
Ataturk University
研究点 (1)
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