Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery: a Multicenter Retrospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- NDI score change
研究概览
简要总结
The aim of study was evaluated the relationship between the relevant evaluation indexes of cervical spine open-door surgery, prognosis and complication rate, and provided theoretical basis for personalized surgical program through multi-center retrospective clinical study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms and signs of the patients were typical. MRI showed single or multiple central herniation of C3-C7 intervertebral discs or spinal stenosis at corresponding levels, which confirmed cervical myeloid cervical spondylosis or cervical spinal stenosis.
- •Conservative treatment for more than 3 months before surgery was ineffective.
- •The patients underwent cervical single open-door surgery.
- •Informed consent was obtained from the patient and his family, informed consent was signed, and a complete follow-up was completed after surgery
排除标准
- •Cervical spondylotic radiculopathy.
- •Cervical kyphosis or instability.
- •Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases.
- •Revision surgery or combined anterior-posterior surgery is required.
- •The patients had severe neurological diseases affecting the evaluation of postoperative results.
- •Psychopath.
- •MRI or CT for contraindications.
研究组 & 干预措施
Preoperative
postoperative (3 months)
干预措施: cervical single open-door surgery (Procedure)
postoperative (6 months)
干预措施: cervical single open-door surgery (Procedure)
postoperative (1 year)
干预措施: cervical single open-door surgery (Procedure)
结局指标
主要结局
NDI score change
时间窗: pre-operation,3 months after surgery, 1 year after surgery
Neck Disability Index (NDI) score is used to assess the disorder of spinal cord which is in the form of questionnaires. Postoperative improvement rate = (total score)/ (numbers of programme X5) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: the improvement rate when 60%-80% means extremely severe dysfunction, when 40%-60% means severe dysfunction, when 20-40% means moderate dysfunction, and when less than 20% means mild dysfunction.
VAS score change
时间窗: pre-operation,3 months after surgery
A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
lamina open angle
时间窗: 3 months after surgery
The Angle of opening of the cervical unilateral lamina while cervical single open-door surgery
JOA score change
时间窗: pre-operation,3 months after surgery, 1 year after surgery
Japanese Orthopedic Association (JOA) score is used to assess the function of spinal cord which is in the form of questionnaires. Postoperative improvement rate = ((postoperative score - preoperative score)/ (17- preoperative score)) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: cure when the improvement rate is 100%, effective when the improvement rate is greater than 60%, effective when 25-60%, and ineffective when less than 25%.
次要结局
- Compression ratio change(pre-operation,3 months after surgery, 1 year after surgery)
- transverse area change(pre-operation,3 months after surgery, 1 year after surgery)
- Maximum spinal cord compression change(pre-operation,3 months after surgery, 1 year after surgery)
- Sagittal Canal Diameter change(pre-operation,3 months after surgery, 1 year after surgery)