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临床试验/NCT04958590
NCT04958590已完成不适用

The Standing and Sitting Spino-pelvic Sagittal Alignment in Chinese Population

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2019年2月20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
216
试验地点
1
主要终点
Group 2 The sagittal spinal parameters in degrees

研究概览

简要总结

This study is aimed to demonstrate the standing and sitting spino-pelvic sagittal alignment in Chinese population, then to explore the influence of spinal fusion on the changes when moving from standing to sitting positon.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
42 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Group 1 90 Healthy Volunteers - age >40 years, no history of neck pain, back pain, or radicular pain in the previous six months, no history of chronic neck or back pain lasting more than three months, no history of spinal disease or surgery, no spinal deformity or lumbar spondylolisthesis, no history of hip or knee arthroplasty or other realignment surgery of the lower extremities, and no history of neuromuscular disorders.
  • Group 2 126 patients Clinical diagnosis of Lumbar degenerative disease

排除标准

  • Group 1 90 Healthy Volunteers
  • Group 2 126 patients
  • Neuromuscular diseases
  • Arthritis
  • A previous history of lumbar fusion surgery

结局指标

主要结局

Group 2 The sagittal spinal parameters in degrees

时间窗: 3 months after surgery

The parameters included TPA (T1 pelvic angle,the angle between the line from the axis of the femoral head to the center of T1 and the line from the axis of the femoral head to the midpoint of the S1 endplate), lumbar lordosis (LL,the angle between the upper endplate of L1 and S1), thoracic kyphosis (TK,The angle between the upper endplate of T4 and the lower endplate of T12), pelvic incidence (PI,The angle between the line perpendicular to the midpoint of the sacral plate and the line connecting this to the midpoint of the hip axis), pelvic tilt (PT,The angle between the line from the middle of the sacral plate to the middle of the hip axis and the vertical line), sacral slope (SS,The angle between the sacral endplate and the horizontal line)

Group 1 The sagittal spinal parameters in millimeter

时间窗: 6 months after study started

SVA (sagittal vertical axis, The offset between the center of C7 and the plumb line drawn from posterosuperior corner of S1)

Group 1 The sagittal spinal parameters in degrees

时间窗: 6 months after study started

The parameters included TPA (T1 pelvic angle,the angle between the line from the axis of the femoral head to the center of T1 and the line from the axis of the femoral head to the midpoint of the S1 endplate), lumbar lordosis (LL,the angle between the upper endplate of L1 and S1), thoracic kyphosis (TK,The angle between the upper endplate of T4 and the lower endplate of T12), pelvic incidence (PI,The angle between the line perpendicular to the midpoint of the sacral plate and the line connecting this to the midpoint of the hip axis), pelvic tilt (PT,The angle between the line from the middle of the sacral plate to the middle of the hip axis and the vertical line), sacral slope (SS,The angle between the sacral endplate and the horizontal line)

次要结局

  • Group 2 Back pain assessed by the VAS(3 months after surgery)
  • Group 2 Leg pain assessed by the VAS(3 months after surgery)
  • Group 2 Disability assessed by the Oswestry Disability Index (ODI)(3 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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