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Posterior Percutaneous Pedicle Screw Fixation for Acute Thoracolumbar Vertebral Fractures

Primary Purpose

Vertebral Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
posterior percutaneous pedicle screw internal fixation
Sponsored by
153rd Hospital of Chinese People's Liberation Army
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertebral Fracture

Eligibility Criteria

25 Years - 47 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    screw fixation

    Arm Description

    The patients underwent minimally invasive posterior percutaneous pedicle screw internal fixation.

    Outcomes

    Primary Outcome Measures

    The Cobb angle of the injured vertebral body
    To investigate the change in the thoracolumbar spine curvature. A greater Cobb angle indicates more severe kyphosis.

    Secondary Outcome Measures

    Anterior height of the injured vertebral body
    To evaluate the morphological recovery of the thoracolumbar spine. A smaller anterior height of the injured vertebral body indicates less severe injury to the vertebral body.
    X-ray

    Full Information

    First Posted
    November 10, 2016
    Last Updated
    November 10, 2016
    Sponsor
    153rd Hospital of Chinese People's Liberation Army
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02963571
    Brief Title
    Posterior Percutaneous Pedicle Screw Fixation for Acute Thoracolumbar Vertebral Fractures
    Official Title
    Posterior Percutaneous Pedicle Screw Fixation for Acute Thoracolumbar Vertebral Fractures With Simple Anterior Spinal Column Injury: a Retrospective, Self-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    153rd Hospital of Chinese People's Liberation Army

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vertebral Fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    screw fixation
    Arm Type
    Experimental
    Arm Description
    The patients underwent minimally invasive posterior percutaneous pedicle screw internal fixation.
    Intervention Type
    Procedure
    Intervention Name(s)
    posterior percutaneous pedicle screw internal fixation
    Intervention Description
    The patients underwent minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.
    Primary Outcome Measure Information:
    Title
    The Cobb angle of the injured vertebral body
    Description
    To investigate the change in the thoracolumbar spine curvature. A greater Cobb angle indicates more severe kyphosis.
    Time Frame
    before, immediately after, and 3 months after surgery
    Secondary Outcome Measure Information:
    Title
    Anterior height of the injured vertebral body
    Description
    To evaluate the morphological recovery of the thoracolumbar spine. A smaller anterior height of the injured vertebral body indicates less severe injury to the vertebral body.
    Time Frame
    before, immediately after, and 3 months after surgery
    Title
    X-ray
    Time Frame
    before, immediately after, and 3 months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    47 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Fracture complicated by spinal cord injury Fracture complicated by nerve injury Refusal to provide informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lei Liang, Master
    Organizational Affiliation
    PLA 153 Central Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Posterior Percutaneous Pedicle Screw Fixation for Acute Thoracolumbar Vertebral Fractures

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