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临床试验/NCT03358225
NCT03358225Unknown不适用

A Muti-Center Study Comparing 3 Procedures for Bi-level Cervical Spondylosis

Peking University People's Hospital0 个研究点目标入组 198 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
198
主要终点
range of the motion of operative segments and adjacent segments

研究概览

简要总结

A muti-center study to compare the safety and efficacy of anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery for bi-level cervical spondylosis.

详细描述

Patients with bi-level cervical spondylosis undergoing anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery in the muti-center hospital were retrospectively reviewed.The safety and efficacy were evaluated based on scores of the Neck Disability Index (NDI), visual analog scale (VAS), and Japanese Orthopedic Association (JOA) and the range of motion of both operative segments and adjacent segments,not only in the preoperative,but also in the 5 days,6 months,12 months and the 5 years after surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) Cervical degenerative pathology with symptomatic radiculopathy or myelopathy at two consecutive segments from C3 to C7 which not responding to conservative treatment for 6 weeks. (2) Preoperative magnetic resonance imaging (MRI), complete cervical spine radiography and computed tomography (CT) showed anterior compressive pathology. (3) None or slight osteophyte at the posterior edge of vertebrae. (4) None significant spinal stenosis or posterior compression.

排除标准

  • ossification of the posterior longitudinal ligament (OPLL), tumor, fracture, infection, history of cervical spine surgery, narrowing of the spinal canal, and any serious general illness. Cases with one or more than two segments requiring treatment were also excluded.

结局指标

主要结局

range of the motion of operative segments and adjacent segments

时间窗: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

Standard dynamic flexion and extension lateral cervical radiographs were obtained to evaluate range of motion of C2-C7 and operative segments and superior and inferior adjacent segments, cervical lordosis, and radiographic changes in adjacent segments.

次要结局

  • scores of the Neck Disability Index(preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively)
  • scores of the visual analog scale(preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively)
  • scores of the Japanese Orthopedic Association(preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liu Haiying

department of spinal surgery

Peking University People's Hospital

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