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临床试验/NCT02881580
NCT02881580已完成不适用

Risk Factors for Proximal Junctional Kyphosis Assessment After Spinal Instrumentation

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2015年6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
314
试验地点
1
主要终点
Number of proximal junctional kyphosis

研究概览

简要总结

The surgical management of spinal deformities especially in adults is complex. The conventional surgical treatment of these deformations is a scope arthrodesis of the spine. The quality of the result depends on many variables such as the choice of the vertebrae to fuse, location and the number of implants, the type of material used or the type of correction maneuver used.

All these variables affect the surgical outcome and may be involved as a modifiable risk factor for possible postoperative complications. The study proposes to focus on the junctional kyphosis postoperative proximal (CJP or Proximal Junctional Kyphosis: PJK). Their prevalence in adults ranges from 20% to 43% depending on the series.

The radiographic definition of CJP's kyphosis with an angle> 10 ° measured from the lower plate of the proximal instrumented vertebra to the upper plate of the adjacent vertebra proximal not instrumented; this measure is being compared to the pre operative data.

Either the CJP are asymptomatic and do not require revision surgery either they are and thereby generate a revision surgery.

Several factors may potentially influence the development of the CJP. Among them, age, preoperative comorbidities, obesity, osteoporosis, lesions of the posterior elements, hybrid instrumentation, correction forces applied during surgery, sagittal balance pre and post operative degeneration joint capsules, etc. There are few studies on the identification and analysis of these risk factors; literature gives only single-center studies on small samples with a single surgical procedure. Review articles describe the incidence and risk factors of the CJP. However, the pathophysiological mechanisms of the CJP are still controversial to this day.

The aim of this study is to determine the incidence of occurrence of postoperative kyphosis proximal junctional and identify risk factors for developing this major complication of a multicenter population of scoliosis operated an extensive fusion.

详细描述

objectives:

Determine on a homogenous population of scoliosis operated for an extended fusion of 4 or more vertebrae:

  • the incidence of proximal junctional kyphosis
  • Modifiable risk factors and non modifiable of occurrence of CJP.
  • the rate of CJP leading to revision surgery and the surgical recovery factors.

Methodology :

This is a multicenter retrospective cohort enrolling in Chapter X of the Data Protection Act and provides, as part of this research, the collection of individual data for evaluation of care and prevention practices with authorization request to the CNIL; the opinion of CCTIRS is not required in this case.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 40 years
  • Decline minimum 6 months
  • Scoliosis degenerative etiology, neurological and idiopathic.
  • segmental instrumentation over 3 levels (4 vertebrae) in the lumbar area.
  • Patients operated on for the 1st time.

排除标准

  • Lumbar spinal surgery or history of chest instrumented
  • Etiology post traumatic tumor
  • non-segmental instrumentation (Harrington type)
  • segmental instrumentation on less than 3 levels.
  • Pre and unreadable or missing postoperative radiograph
  • Decline <6 months

结局指标

主要结局

Number of proximal junctional kyphosis

时间窗: Day 1

次要结局

  • Number of proximal junctional kyphosis leading to revision surgery and the surgical recovery factors.(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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