The Establishment of the Integration of Posterior Approach Surgical Treatment and Postoperative Intensive Recovery Management of Patients With Degenerative Cervical Spine Myelopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Cervical spine mechanical analysis
研究概览
简要总结
This study aims to establish the specialist consensus of the integration of posterior approach surgical treatment and postoperative intensive recovery management for CSM or OPLL patients, and verify its safety, practicability and reliability.
详细描述
In order to establish the specialist consensus of the integration of posterior approach surgical treatment and postoperative intensive recovery management, and verify its safety, practicability and reliability, this study enrolled 130 patients with CSM or OPLL undergoing C3-7 open-door laminoplasty. Patients are divided in two groups randomly. The study group has 80 patients, treated with postoperative intensive recovery management, and the control group has 50 patients. The data is collected preoperatively, at 3-month follow-up and 1-year follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age: 18~70 years. (2) Diagnosed as CSM or OPLL. (3) Going to receive C3-C7 open-door laminoplasty. (4) Agree to join this study and sign the informed consent.
排除标准
- •(1) Anterior and posterior combined surgery. (2) Posterior laminoplasty combined fusion. (3) Severe osteoporosis. (4) Morbid obesity. (5) patients with mental disorder. (6) patients with previous history of cervical spine surgery. (7) Abnormal laboratory report of liver function, kidney function and hematologic system.(8) Poor compliance. (9) Patients with other surgical contraindications. (10) Patients with intemperance or taking drugs. (11) Patients who joined other study within the last 3 months.
结局指标
主要结局
Cervical spine mechanical analysis
时间窗: Preoperation to 1 year after surgery.
The ROM and multi-dimensional mechanical analysis of cervical spine before surgery, at 3-month postoperative follow-up and 1-year follow
Cervical spine functions
时间窗: Preoperation to 1 year after surgery.
NDI score and JOACMEQ score before surgery, at 3-month postoperative follow-up and 1-year follow
次要结局
- Outcome of quality of life(Preoperation to 1 year after surgery.)
- Outcome of pain(Preoperation to 1 year after surgery.)
- Neurological outcome(Preoperation to 1 year after surgery.)