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临床试验/NCT02963571
NCT02963571已完成不适用

Posterior Percutaneous Pedicle Screw Fixation for Acute Thoracolumbar Vertebral Fractures With Simple Anterior Spinal Column Injury: a Retrospective, Self-controlled Trial

153rd Hospital of Chinese People's Liberation Army0 个研究点目标入组 32 人开始时间: 2010年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
主要终点
The Cobb angle of the injured vertebral body

研究概览

简要总结

To validate the safety and effectiveness of minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.

详细描述

History and current related studies Thoracolumbar spinal fractures are frequently seen after trauma because of the biomechanical transitional junction of this structure. The primary treatment method used for traumatic thoracolumbar spinal fracture is posterior pedicle screw fixation, but this method has some disadvantages including severe trauma, extensive bleeding, long rehabilitation time, and long postoperative duration of intractable lumbar stiffness and low back pain. These complications occur mainly because of wide stripping and injury of the paraspinal muscles and peri-articular denervation. Percutaneous pedicle screw external fixation of spine fracture can reduce injury caused by screw insertion into the paraspinal muscles, particularly in the treatment of acute thoracolumbar vertebral compression fracture with simple anterior spinal column injury.

Adverse events We recorded possible adverse events, including wound pain, infection, back muscle pain, spinal cord/nerve injury, screw pull-out, or screw loosening. If severe adverse events occurred, details including the data of occurrence and measures taken to treat the adverse events were reported to the principle investigator and the institutional review board within 24 hours.

Possible biases and management measures Possible biases

  • Diagnosis bias
  • Admission rate bias (hospitalized patients were preferred to reduce loss to follow-up and to increase compliance)
  • No response bias (subjects not responding to the questionnaire or not responding truthfully)
  • Mixed bias (sex and age) Measures taken to control possible biases
  • Formulation of strict inclusion and exclusion criteria
  • Ensuring sample independence
  • Discussion of the mixed factors that may potentially influence the curative effects, such as pathological factors, course of disease, and sex

Statistical analysis Statistical analysis was performed by a statistician using SPSS 19.0 software (IBM, Amrok, USA), and was conducted following the intention-to-treat principle. Normally distributed measurement data were expressed as the mean ± SD, and minimums and maximums. Non-normally distributed measurement data were expressed as lower quartile (q1), and median and upper quartile (q3). The Wilcoxon matched-pairs signed-ranks test was performed for comparison of the Cobb angle before surgery with the Cobb angle 3 years after surgery, and the McNemar's chi-squared test was used to compare the incidence of adverse reactions. The significance level was α = 0.05.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 47 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Meet the diagnostic criteria of acute thoracolumbar vertebral fracture with simple anterior spinal column injury as confirmed by radiography, CT and MRI
  • AO classification type A
  • Thoracolumbar injury severity score of 4-5 (Park et al., 2016)
  • Traumatic fracture
  • Age 25-47 years

排除标准

  • Fracture complicated by spinal cord injury
  • Fracture complicated by nerve injury
  • Refusal to provide informed consent

结局指标

主要结局

The Cobb angle of the injured vertebral body

时间窗: before, immediately after, and 3 months after surgery

To investigate the change in the thoracolumbar spine curvature. A greater Cobb angle indicates more severe kyphosis.

次要结局

  • X-ray(before, immediately after, and 3 months after surgery)
  • Anterior height of the injured vertebral body(before, immediately after, and 3 months after surgery)

研究者

发起方
153rd Hospital of Chinese People's Liberation Army
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lei Liang

Attending Physician

153rd Hospital of Chinese People's Liberation Army

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