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临床试验/NCT00768313
NCT00768313撤回4 期

A Multi-Centre Randomized Phase IV Clinical Trial Comparing Rods of Varying Yield Strengths and Their Ability to Hold Correction of Adolescent Idiopathic Scoliosis.

Queen's University2 个研究点 分布在 1 个国家开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
试验地点
2
主要终点
percent correction in both frontal and sagittal planes for idiopathic scoliosis

研究概览

简要总结

There has been a growing trend amongst surgeons to use a construct for correction of scoliosis which involves segmental instrumentation with pedicle screws. Pedicle screw proponents cite greater curve control in all planes, which results in improved spinal curve correction. Some surgeons have noted due to the increased strength of the all screw construction that the rod is now the weak part of the spinal fixation. Although no evidence has been raised in regards to hardware failure there is a perception that a loss of balance in the sagittal plane is the result of flex in the titanium rod. A novel solution to the issue of rod flexibility is raised with the expedium super steel instrumentation which allows for greater stiffness than a 5.5 mm titanium rod with the same lower profile. This study aims to compare the new super steel technology with other established instrumentations used to correct spinal stenosis.

详细描述

screw purchase was to be recorded but study has been withdrawn.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • aged 10-20;
  • presenting with a progressive lenke type 1A, N; or
  • type idiopathic adolescent scoliosis measuring greater than 45 degree cobb angle

排除标准

  • rigid scoliosis requiring a three column release or osteotomy;
  • patients that can not have pedicle screw instrumentation due to technical concerns

结局指标

主要结局

percent correction in both frontal and sagittal planes for idiopathic scoliosis

时间窗: pre-op, 3, 6, 12, 24 months

次要结局

  • screw purchase(intraoperative)

研究者

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

Dr. Daniel Borschneck

Principal Investigator

Queen's University

研究点 (2)

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