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临床试验/NCT04559672
NCT04559672Unknown不适用

Cervical Laminoplasty Versus Laminectomy and Fusion: the Long-term Results Comparison

Shanghai Changzheng Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005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
60
试验地点
1
主要终点
Change of Sagittal Lordosis Angle

研究概览

简要总结

The objective of this study is to retrospectively analyze and compare the long-term clinical and radiographic results of multi-level laminoplasty to multi-level laminectomy and fusion for the treatment of patients with cervical myelopathy or myeloradiculopathy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Patients aged at least 18 years
  • The patient has the diagnosis of degenerative cervical myelopathy
  • The myelopathy or myeloradiculopathy requires a posterior cervical decompression of the spinal canal involving two or more contiguous intervertebral levels including and between C3 and C7
  • More than five years of follow-up time

排除标准

  • Presence of primary focal anterior compression of the cervical spinal cord
  • Previous surgery of the cervical spine
  • Tumor, infection, or trauma of the cervical spine or cord
  • Patients with ankylosing spondylitis
  • Patients with neurodegenerative diseases, or any neuropathies

结局指标

主要结局

Change of Sagittal Lordosis Angle

时间窗: baseline, 12 months post-treatment and through study completion, an average of 10 year

Measured by lateral X-Ray image. The change of lordosis was calculated and compared.

Reoperation rate

时间窗: through study completion, an average of 10 year

Any reoperation involving the same segments or adjacent segments will be calculated.

Change of Neck Disability Index (NDI)

时间窗: baseline, 12 months post-treatment and through study completion, an average of 10 year

Ranging from 0%-100%. A higher score indicates more patient-rated disability.

Change of Japanese Orthopaedic Association Score (JOA)

时间窗: baseline, 12 months post-treatment and through study completion, an average of 10 year

Total score 0-17. The lower the score the more severe the deficits.

次要结局

  • Change of Range of Motion(baseline, 12 months post-treatment and through study completion, an average of 10 year)
  • Change of Pain Scores on the Visual Analog Scale (VAS)(baseline, 12 months post-treatment and through study completion, an average of 10 year)
  • Complication rate(through study completion, an average of 10 year)

研究者

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

Xuhua Lu

Director of Traumatic Orthopaedic Department

Shanghai Changzheng Hospital

研究点 (1)

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