Posterior Percutaneous Pedicle Screw Fixation for Acute Thoracolumbar Vertebral Fractures

NCT ID: NCT02963571

Last Updated: 2016-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-06-30

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.

Conditions

Vertebral Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

screw fixation

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

Group Type: EXPERIMENTAL

posterior percutaneous pedicle screw internal fixation

Intervention Type: PROCEDURE

The patients underwent minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.

Interventions

posterior percutaneous pedicle screw internal fixation

The patients underwent minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 47 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

153rd Hospital of Chinese People's Liberation Army

OTHER

Sponsor Role: lead

Responsible Party

Lei Liang

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lei Liang, Master

Role: PRINCIPAL_INVESTIGATOR

PLA 153 Central Hospital

Other Identifiers

153PLA_001

Identifier Type: -

Identifier Source: org_study_id