跳至主要内容
临床试验/NCT01011569
NCT01011569已完成不适用

Randomized Controlled Trial of Cage Versus Plate in One Level Cervical Disc Disease

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2004年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Disc height ratio, cervical lordosis, bone fusion and segmental lordosis at the index level

研究概览

简要总结

There are largely 2 surgical methods for one-level cervical disc disease; cage only and plate/graft. Even there are many reports about the efficacy of either cage only or plate/graft, prospective comparative study is few. The object of the present study is to present design of prospective study and to demonstrate preliminary result.

详细描述

Prospective study was started from April 2004 after permission by our Institutional Review Board. Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy. We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history. Operation method was randomized using the table of random sampling numbers. All operations were performed with standard anterior-medial approach. Two types of cages and 2 types of plates were used: cage, MC+ cage (LDR, Austin, Tx, USA) or Solis cage (Stryker, Kalamazoo, Michigan, USA); plate, Black stone (Orthofix, McKinney, Tx, USA) or Atlantis (Medtronic, Minneapolis, MN, USA). We checked neck disability index (NDI), neck visual analogue scale (VAS) and limb VAS before operation and 1/3/6/12/24/36 months after operation. Disc height ratio, cervical lordosis, bone fusion status and segmental lordosis at the index level were measured from X-rays and follow-up X-rays were obtained at before operation and 1/3/6/12/24/36 months after operation. The present prospective study was planned until 80 patients (cage n = 40, plate/graft n = 40) were enrolled.

研究设计

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

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy.

排除标准

  • We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history.

结局指标

主要结局

Disc height ratio, cervical lordosis, bone fusion and segmental lordosis at the index level

时间窗: 1/3/6/12/24/36 months after operation

次要结局

未报告次要终点

研究者

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

Chun Kee Chung

Professor

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验

Comparison of Cage Versus Plate in One Level... | 临床试验