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
About this trial
This is an interventional treatment trial for Vertebral Fracture
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
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
NCT ID
NCT02963571
First Posted
November 10, 2016
Last Updated
November 10, 2016
Sponsor
153rd Hospital of Chinese People's Liberation Army
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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