Prospective Controlled Clinical Study of Individualized, Precise and Standardized Posterior Cervical Open-door Surgery for Cervical Spinal Stenosis
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
- JOA score change
研究概览
简要总结
To evaluate the safety and effectiveness of individualized, precise and standardized open-door posterior cervical surgery through a single-center, exploratory clinical study, so as to provide a more reliable basis for the treatment of cervical spinal stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of 28-85 years old; Through systematic clinical and imaging examination, patients diagnosed with C3-7 multilevel cervical spondylitis myelopathy or cervical spinal stenosis who need to undergo posterior cervical open-door surgery.
- •No contraindications in preoperative routine tests and examinations.
- •Informed consent of patients.
排除标准
- •Cervical radiculopathy
- •Cervical kyphosis or instability
- •Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases
- •Revision surgery or combined anterior-posterior surgery is required
- •Serious neurological diseases affect the postoperative effect evaluation
- •Mental illness cannot cooperate with follow-up
- •Contraindications for MRI examination
- •Patients themselves or their families do not agree to participate in the study
- •Other situations that are not suitable for study participation.
研究组 & 干预措施
Centerpiece titanium plate
All surgical operations were performed by the same group of senior spine surgeons. The range of open door decompression involved C3 ~ C7. For convenient operation and more accurate statistics, the right side of the door axis and the left side of the door seam were selected for all operations. Centerpiece titanium plates were used for intraoperative fixation.
干预措施: Centerpiece titanium plate (Procedure)
3D printed arch titanium plate
Before surgery, according to the imaging results, according to the effective imaging indicators screened in the early stage and the calculated door opening Angle formula, the door opening Angle of the patient's posterior cervical vertebra and the size of the fitted arch titanium plate were designed by mimics 10.0 software, and the titanium plate was printed using 3D printing technology. During the operation, the developed laminae opener was used to accurately control the door opening Angle and appropriate size titanium plate was installed for internal fixation. The standardized laminae door opening guide was used to complete the preparation of the door shaft side and door opening side of the lamina
干预措施: Centerpiece titanium plate (Procedure)
结局指标
主要结局
JOA score change
时间窗: pre-operation,3 months after surgery, 6 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%.
NDI score change
时间窗: pre-operation,3 months after surgery, 6 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 program 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
时间窗: pre-operation,3 months after surgery, 6 months after surgery, 1 year 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.
次要结局
- Maximum spinal cord compression change(pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery)
- Compression ratio change(pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery)
- Transverse area change(pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery)