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临床试验/NCT04175145
NCT04175145已完成不适用

Impact of Metal Density on Deformity Correction in Posterior Fusions for Adolescent Idiopathic Scoliosis

Ghurki Trust and Teaching Hospital0 个研究点目标入组 96 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
主要终点
Degree of correction achieved

研究概览

简要总结

A retrospective analysis to ascertain the correlation between metal density and deformity correction among individuals with adolescent idiopathic scoliosis.

详细描述

Posterior spinal fusion with pedicle screws has become the "gold standard" for the management of adolescent idiopathic scoliosis (AIS). Pedicle screws provide three column fixation through the strongest part of vertebra thereby enhancing surgeon's ability to do a 3-dimensional deformity correction. The higher pullout strength results in less long-term loss of correction, shorter fusions resulting in preservation of motion segments, lower pseudarthrosis rates and lower implant failures compared with these alternative posterior instrumentation systems. However, studies are contradictoryregarding the effect of metal density on coronaland sagittal curve corrections. Multiple factors including curve flexibility, instrumentation and rod types, reduction strategies and curve types, affect outcomes. Given this, intraoperative decisions regarding the number of anchorage points remain difficult, with considerable inter-surgeon variability.

The rationale for using a high implant density constructs is to obtain more rigid fixation and to limit potential stress concentration at any one screw. Furthermore, health-related quality of life instruments such as the SRS 22, 24, or 30 seem to show little correlation with curve correction. The placement of every additional pedicle screw is associated with increased operative time, risk of neurological deterioration and increased implant cost. If implant density can be lowered without compromising clinical results, reducing the number of screws may improve the efficiency and cost effectiveness of scoliosis surgery. Several authors have demonstrated successful results with low-density instrumentation for the treatment of scoliosis. The purpose of this retrospective review is to describe the demographics of our patient population and to ascertain correlation between metal density and correction achieved.

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
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with adolescent idiopathic scoliosis
  • •Age more than 10 years at time of surgery
  • •Posterior instrumentation consisting of all pedicle screw construct except for bilateral hooks at the uppermost instrumented vertebra
  • •A major curve magnitude between 45 and 80 degrees.

排除标准

  • •Scoliosis patients with a diagnosis other than adolescent idiopathic scoliosis
  • •Previous spine surgery
  • •Use of spinal osteotomies in addition to posterior spinal fusion with pedicle screws
  • •ALenke 5 curve
  • •Patients with less than 2 years' follow-up
  • •Use of hooks or wires below the uppermost instrumented level

结局指标

主要结局

Degree of correction achieved

时间窗: 2 years

(Preop Cobb angle - Postop Cobb angle/ Preop Cobb angle \* 100)

Cobb angle

时间窗: 2 years

Cobb angle is measured as angle sub-tented between the upper and lower end vertebrae (end vertebrae is defined as the vertebra that is most tilted from the horizontal apical vertebra)

次要结局

未报告次要终点

研究者

发起方
Ghurki Trust and Teaching Hospital
申办方类型
Other
责任方
Sponsor

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