Minimally Invasive Isolated Decompression From the Posterior Approach for Degenerative Spinal Stenosis of the Cervical Spine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the cross-sectional area of the dural sac, mm2
研究概览
简要总结
Degenerative stenosis of the cervical spinal canal may be caused by the compression of the posterior part of the dural sac and spinal cord by the hypertrophied ligamentum flavum and facet joints, by the compression of the anterior part of the dural sac and spinal cord by the posterior longitudinal ligament, vertebral osteophytes and protrusion/ herniation.
The choice of surgical treatment in such cases is challenging. Posterior decompression and fixation is often proposed, but it is associated with a traumatic posterior approach, a large wound, and blood loss, a high risk of surgery site infections, and also instability of the metal fixation is possible. Also important is the increase in the surgical procedure cost due to the use of metal implants. An excellent alternative to standard posterior decompression and fixation is a method with isolated decompression of the cervical canal via posterior approach, which does not require any metal fixation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old;
- •Degenerative symptomatic cervical stenosis caused by posterior compression (hypertrophied ligament flavum and/or hypertrophied facet joints etc.) confirmed by MRI;
- •Symptoms persisting for at least 3 months prior to surgery;
- •Planned surgical decompression for one and more cervical level;
- •Given written Informed Consent;
- •Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
排除标准
- •The need for anterior cervical decompression;
- •Prior cervical fusion at any level;
- •Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
- •Neck or non-radicular pain of unknown etiology;
- •History or presence of any other major neurological disease or condition that may interfere with the study assessments;
- •Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
研究组 & 干预措施
Cohort
All patients will undergo minimally invasive isolated decompression via the posterior approach to the cervical spine
干预措施: minimally invasive decompression via the posterior approach (Procedure)
结局指标
主要结局
Change in the cross-sectional area of the dural sac, mm2
时间窗: 3 months after surgery
To observe the change in the cross-sectional area of the dural sac by MRI
次要结局
- Change from baseline in cervical balance parameters(3 months and 12 months postoperatively)
- Change from baseline in Japanese Orthopaedic Association scale(3 months and 12 months postoperatively)
- Change in the cross-sectional area of the dural sac, mm2(12 months postoperatively)
- Change from baseline in Neck Disability Index(2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively)
- Change from baseline in The Health Transition Item from SF-36(2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively)
- Adverse Events(during study, an average of 1 year)
- Change from baseline in Numeric Pain Rating Scale(2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively)