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临床试验/NCT00109213
NCT00109213已完成3 期

Greenwich Lumbar Stenosis SLIP Study: A Multi-center, Randomized, Prospective Clinical Trial Comparing Spinal Laminectomy to Laminectomy With Instrumented Pedicle Screw Fusion for Lumbar Stenosis With Grade I Spondylolisthesis

Greenwich Hospital5 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2002年5月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
66
试验地点
5
主要终点
SF-36 (physical component summary score)

研究概览

简要总结

The purpose of the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). There are two types of operations that surgeons perform for this problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves (decompression with instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes.

详细描述

There is considerable debate among spinal surgeons regarding the optimal surgical procedure for lumbar spinal stenosis with a grade I spondylolisthesis. The major question is whether or not instrumented pedicle screw fusion should be undertaken when a decompressive laminectomy is performed to relieve neural compression. This multi-center, randomized, prospective clinical study aims to address this question by testing the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long-term patient outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Symptomatic lumbar spinal stenosis and single level grade I spondylolisthesis (3-14 mm)

排除标准

  • •History of previous lumbar spinal surgery in region of stenosis
  • •Gross spinal instability (defined as greater than 3 mm motion on flexion/extension studies)
  • •Serious medical illness (ASA Class III or higher)
  • •Spondylolisthesis greater than 14 mm or associated with spondylolysis

研究组 & 干预措施

1

Active Comparator

Lumbar Laminectomy without Fusion

干预措施: Lumbar Laminectomy (Procedure)

2

Active Comparator

Lumbar Laminectomy with Pedicle Screw Instrumented Fusion

干预措施: Lumbar Laminectomy with Instrumented Pedicle Screw Fusion (Procedure)

结局指标

主要结局

SF-36 (physical component summary score)

时间窗: 2 year

次要结局

  • Oswestry Disability Index(2 year, 3 year, 4 year)
  • Major Complication rate(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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