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临床试验/NCT02904681
NCT02904681已完成不适用

Multicenter Retrospective Evaluation of the Surgical Management of Spinal Growth Dystrophy

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Surgery complication type

研究概览

简要总结

Spinal growth dystrophy (CRD), also called Scheuermann's disease, corresponding to impaired vertebral structure occurring in children and adolescents with involvement of the growth cartilage causing impaired growth and kyphosis.

There are forms thoracolumbar and thoracic conventional forms of DRC with variable clinical expressions; the most important being kyphosis with spinal stiffness associated with painful elements.

The radiographic definition according Sorenson is uniformisation 5 ° affecting at least three adjacent vertebrae.

Scheuermann's disease and three problems. First, the thoracic kyphosis generates back pain which may be thoracic or lumbar indirectly attributed to compensatory lordosis. Moreover disruption sagittal balance frequently causes a significant aesthetic discomfort. Finally, scalability because the curvature may increase the likelihood of degenerative lesions disc degeneration or lumbar spinal stenosis for example.

When the disease is diagnosed early, treatment is most often associated with orthopedic physiotherapy. However, for patients with active deformation, despite an orthopedic brace treatment with chronic pain, neurological deficit or for aesthetic reasons, surgical decision can be taken.

The goal of surgical treatment of DRC is a correction of the thoracic kyphosis. It goes through a spinal fusion must be released from his column stiffness in a bad position, changing the equilibrium profile and ensure that it remains in a good position.

This surgery usually requires a prior operative time (thoracic surgery to remove the intervertebral discs) and a posterior surgical time (blockage of the vertebrae together with a bone graft and osteosynthesis). Currently different surgical strategies are practiced there is no real consensus between the teams.

详细描述

objectives:

  1. Evaluation of the rate and type of complications in different age categories and surgical strategies.
  2. Evaluation of clinical results based on surgical strategies.
  3. Evaluation of sagittal balance and correction obtained based surgical strategies

Methodology and duration of the research

This is a multicenter retrospective cohort on the assessment of surgical practices cited objectives. Also, this research is in Chapter X of the Data Protection Act and allows the collection of personal data for the purpose of evaluation of care and prevention practices with authorization request to the CNIL; the opinion of CCTIRS therefore not required in this case.

This study concerns the data of patients operated with the techniques mentioned in addition with a decline of more than 20 years.

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

入选标准

  • patients operated on for an arthrodesis Dystrophy Spinal Growth (DRC)
  • Age> 10 years
  • monitoring of minimum one year

排除标准

  • deformation in the frontal plane
  • kyphosis malformation
  • osteoporotic or degenerative kyphosis
  • post laminectomy kyphosis
  • constitutional bone disease
  • connective Tissue Disease

结局指标

主要结局

Surgery complication type

时间窗: Day 30

Statement from the database keops

次要结局

  • Assessment od the clinical results based on surgical strategies(Day 30)
  • Assessment of correction Score obtained(Day 30)
  • Assessment of sagittal balance and correction Score obtained(Day 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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