Vertebral FractureNCT02963571
Posterior Percutaneous Pedicle Screw Fixation for Acute Thoracolumbar Vertebral Fractures
A study testing posterior percutaneous pedicle screw internal fixation in people with Vertebral Fracture, run by 153rd Hospital of Chinese People's Liberation Army.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 47 years
- Conditions the study is for
- Vertebral Fracture
- What is being tested?
- posterior percutaneous pedicle screw internal fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 47 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Fracture complicated by spinal cord injury
- Fracture complicated by nerve injury
- Refusal to provide informed consent
About this study
Official title: Posterior Percutaneous Pedicle Screw Fixation for Acute Thoracolumbar Vertebral Fractures With Simple Anterior Spinal Column Injury: a Retrospective, Self-controlled Trial
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.
Read the 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.
- Conditions
- Vertebral Fracture
- Being tested
- posterior percutaneous pedicle screw internal fixation
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior percutaneous pedicle screw internal fixationProcedure or surgery
The patients underwent minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.
| Study group | Role | What they receive |
|---|---|---|
| screw fixation | Experimental | The patients underwent minimally invasive posterior percutaneous pedicle screw internal fixation. Receives: Procedure: posterior percutaneous pedicle screw internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before, immediately after, and 3 months after surgery
Secondary outcomes (2)
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.
Measured: before, immediately after, and 3 months after surgery
X-ray
Measured: before, immediately after, and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- 153rd Hospital of Chinese People's Liberation Army
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Liang, 153rd Hospital of Chinese People's Liberation Army
- Investigators
- Lei Liang, Master, Principal investigator, PLA 153 Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963571
- Sponsor's protocol ID
- 153PLA_001
- Status last verified
- Nov 2016
- First submitted
- 10 Nov 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Percutaneous Pedicle Screw Fixation for Acute Thoracolumbar Vertebral Fractures With Simple Anterior Spinal Column Injury: a Retrospective, Self-controlled Trial
- ClinicalTrials.gov ID
- NCT02963571
- Acronym / sponsor ID
- 153PLA_001
- Conditions
- Vertebral Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- 153rd Hospital of Chinese People's Liberation ArmyUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| screw fixation | Experimental | Procedure: posterior percutaneous pedicle screw internal fixationThe patients underwent minimally invasive posterior percutaneous pedicle screw internal fixation. |
Who may qualify
- Ages
- 25 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Fracture complicated by spinal cord injury
- Fracture complicated by nerve injury
- Refusal to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posterior percutaneous pedicle screw internal fixationThe patients underwent minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury. | Procedure or surgery | screw fixation |
Primary outcome
The Cobb angle of the injured vertebral body
Time frame: 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.
2 secondary outcomes
Anterior height of the injured vertebral body
Time frame: before, immediately after, and 3 months after surgery
X-ray
Time frame: before, immediately after, and 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Liang, Master principal investigator
PLA 153 Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing posterior percutaneous pedicle screw internal fixation in people with Vertebral Fracture, run by 153rd Hospital of Chinese People's Liberation Army.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Cobb angle of the injured vertebral body (time frame: before, immediately after, and 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.