NCT03369288Unknown不适用
Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tracer Uptake
研究概览
简要总结
3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 to 70 years
- •Minimum 3-year follow-up
- •Single-level vertebral kyphoplasty
- •Index surgery at UniversitätsSpital Zürich
- •MRI-scan during initial treatment
- •Informed consent provided
排除标准
- •Combined with other operative procedure on the spine (e.g. dorsal instrumentation)
- •Intraoperative intradiscal cement leakage
- •Previous history of spinal surgery except on the cervical spine
- •Metastatic disease with skeletal involvement
- •Known chronic diseases of the bone metabolism other than osteoporosis
- •Documented pregnancy (see also 6.3)
- •Presence of implants not suited for MRI (pacemaker, neuro-stimulators, pain pumps, insulin pumps, Cochlea implants, metallic foreign bodies like bullet fragments)
结局指标
主要结局
Tracer Uptake
时间窗: at least 3 years after kyphoplasty
Perifokal tracer uptake at the cement-bone border
次要结局
- Intravertebral Discs(at least 3 years after kyphoplasty)
研究者
研究点 (1)
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