Posterior Percutaneous Pedicle Screw Fixation for Acute Thoracolumbar Vertebral Fractures
Condition: Vertebral Fracture
MeSH terms: Fractures, Bone; Spinal Fractures
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): posterior percutaneous pedicle screw internal fixation
Intervention type(s): Procedure
Intervention description(s): The patients underwent minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment