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临床试验/NCT04688437
NCT04688437Unknown不适用

Correlation Among Standing-sitting Sagittal Spinal Alignment, Paravertebral Muscle and Postoperative Clinical Outcomes in Patients With Adult Degenerative Scoliosis

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
The sagittal spinal parameters in millimeters

研究概览

简要总结

This is a prospective single-center study. Patients with adult degenerative scoliosis are prospectively enrolled and followed. All patients will take standard standing and sitting posteroanterior and lateral whole spine X-ray and lumbar MRI examination before and after surgery. Functional evaluation and radiographs were assessed preoperatively and postoperatively.This study will focus on the correlation among standing-sitting sagittal spinal alignment, paravertebral muscle and postoperative clinical outcomes in patients with adult degenerative scoliosis.

详细描述

The sagittal alignment of the spine, or sagittal balance, describe the ideal and normal sagittal spinal curvature distribution. With the deepening of the research on spinal morphology, function and pathology, more and more researchers pay attention to the role of sagittal alignment in the diagnosis and treatment of spinal deformity diseases. Some studies have shown that the restoration of patients with appropriate sagittal alignment can significantly improve their quality of life. Besides, paravertebral muscle can also influence the retaining of sagittal alignment. However, how to define the ideal sagittal alignment is still controversial for different patients with adult degenerative scoliosis(ADS) .

It was proved that the differences in sagittal parameters of the standing and sitting positions positions were influenced by age, gender and pelvic incidence(PI). In addition, patients with high PI are more prone to sagittal decompensation after long segment fixation (fixation of three or more segments) .Therefore, We speculate that the sagittal curvature of patients with large PI changes greatly from standing position to sitting position. So after long segment fixation, the spine in the state of standing position is more difficult to adapt to the changes of curvature and stress in sitting position, which is the possible reason that patients with high PI are more prone to sagittal decompensation. At present, how to design the proper corrective goals for patients according to both sagittal alignment and paravertebral muscle needs further research.

Thus, this study is aim to explore these three points about ADS patients: the characteristics of the sagittal spinal alignment changes from standing to sitting ; the adaption of the spine curvature in the standing and sitting position after long segment fixation surgery and the relationship among standing-sitting sagittal spinal alignment, paravertebral muscle and postoperative clinical outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Clinical diagnosis of adult degenerative scoliosis
  • Cobb angle ≥10°

排除标准

  • Neuromuscular diseases
  • Arthritis
  • A previous history of lumbar fusion surgery

结局指标

主要结局

The sagittal spinal parameters in millimeters

时间窗: 12 months after surgery

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

The sagittal spinal parameters in degrees

时间窗: 12 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) Cobb angle of the curves

parameters of paraspinal muscles

时间窗: 12 months after surgery

fatty infiltration rate of paraspinal muscles

functional outcomes of paraspinal muscles

时间窗: 12 months after surgery

the time of paraspinal muscle strength test

次要结局

  • Back pain assessed by the VAS(3 months after surgery; 6 months after surgery; 12 months after surgery;)
  • Disability assessed by the Japanese Orthopaedic Association (JOA)(3 months after surgery; 6 months after surgery; 12 months after surgery;)
  • Disability assessed by the Oswestry Disability Index (ODI)(3 months after surgery; 6 months after surgery; 12 months after surgery;)
  • Leg pain assessed by the VAS(3 months after surgery; 6 months after surgery; 12 months after surgery;)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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