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STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 4  |  Page : 152-157

Posterior percutaneous pedicle screw fixation for acute thoracolumbar vertebral fractures with simple anterior spinal column injury: study protocol for a retrospective, self-controlled trial


Department of Spine Surgery, Orthopedic Trauma Center, PLA 153 Central Hospital, Zhengzhou, Henan Province, China

Correspondence Address:
Wen-de Liu
Department of Spine Surgery, Orthopedic Trauma Center, PLA 153 Central Hospital, Zhengzhou, Henan Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-4157.194807

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Background: Posterior pedicle screw fixation is commonly used for thoracolumbar fracture. However, associated disadvantages include severe trauma, extensive bleeding, long rehabilitation time, and long postoperative duration of intractable lumbar stiffness and low back pain. Percutaneous pedicle screw external fixation can reduce injury caused by screw insertion into the paraspinal muscles; particularly in acute thoracolumbar vertebral compression fracture with simple anterior spinal column injury. We hypothesized that minimally invasive posterior percutaneous pedicle screw fixation for acute thoracolumbar vertebral fractures with simple anterior spinal column injury would exhibit good curative effects. Methods/Design: This retrospective, single-center, self-controlled trial was performed in the PLA 153 Central Hospital, Zhengzhou, Henan Province, China. Thirty-two patients with acute thoracolumbar vertebral fracture with simple anterior spinal column injury (22 males and 10 females, average age 24.7 years, range 25-47 years) were included. All patients underwent minimally invasive posterior percutaneous pedicle screw internal fixation and were followed up for 3 months. The primary outcome measure was the Cobb angle of the injured vertebral body before, immediately after, and 3 months after internal fixation, which was used to investigate the change in the thoracolumbar spine curvature. The secondary outcome measures included: the anterior height of the injured vertebral body and radiographic findings before and immediately after internal fixation and at the last follow-up (to evaluate the recovery of thoracolumbar vertebral fracture), operation time, intraoperative blood loss, and duration of hospitalization. Other outcome measure was the incidence of adverse events 3 months after internal fixation. Discussion: This study aims to validate the curative effects of minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury, and provide objective long-term follow-up data for future studies. Trial registration: ClinicalTrials.gov identifier: NCT02963571. Ethics: The study protocol had been approved by the Ethics Committee of PLA 153 Central Hospital, China and was performed in strict accordance with the Declaration of Helsinki developed by the World Medical Association. Informed consent: Written informed consent regarding study protocol and treatments had been obtained from each patient.


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