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Modified pedicle screw placement at the fracture level for treatment of thoracolumbar burst fractures: a study protocol of a randomised controlled trial.

ABSTRACT: INTRODUCTION:The optimal treatment for burst fractures of the thoracolumbar spine is controversial. The addition of screws in the fractured segment has been shown to improve construct stiffness, but can aggravate the trauma to the fractured vertebra. Therefore, optimised placement of two pedicle screws at the fracture level is required for the treatment of thoracolumbar burst fractures. This randomised controlled study is the first to examine the efficacy of diverse orders of pedicle screw placement and will provide recommendations for the treatment of patients with thoracolumbar burst fractures. METHODS AND ANALYSIS:A randomised controlled trial with blinding of patients and the statistician, but not the clinicians and researchers, will be conducted. A total of 70 patients with single AO type A3 or A4 thoracolumbar fractures who are candidates for application of short-segment pedicle screws at the fractured vertebral level will be allocated randomly to the distraction-screw and screw-distraction groups at a ratio of 1:1. The primary clinical outcome measures will be the percentage loss of vertebral body height, screw depth in the injured vertebrae and kyphosis (Cobb angle). Secondary clinical outcome measures will be complications, Visual Analogue Scale scores for back and leg pain, neurological function, operation time, intraoperative blood loss, Japanese Orthopaedic Association score and Oswestry Disability Index. These parameters will be evaluated preoperatively, intraoperatively, on postoperative day 3, and at 1, 3, 6, 12 and 24 months postoperatively. ETHICS AND DISSEMINATION:The Institutional Review Board of the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University have reviewed and approved this study (batch: LCKY2018-05). The results will be presented in peer-reviewed journals and at an international spine-related meeting after completion of the study. TRIAL REGISTRATION NUMBER:NCT03384368; Pre-results.

SUBMITTER: Hu ZC

PROVIDER: S-EPMC6352792 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Modified pedicle screw placement at the fracture level for treatment of thoracolumbar burst fractures: a study protocol of a randomised controlled trial.

Hu Zhi-Chao ZC Li Xiao-Bin XB Feng Zhen-Hua ZH Wang Ji-Qi JQ Gong Lan-Fang LF Xuan Jiang-Wei JW Fu Xin X Jiang Bing-Jie BJ Wu Long L Ni Wen-Fei WF

BMJ open 20190128 1

<h4>Introduction</h4>The optimal treatment for burst fractures of the thoracolumbar spine is controversial. The addition of screws in the fractured segment has been shown to improve construct stiffness, but can aggravate the trauma to the fractured vertebra. Therefore, optimised placement of two pedicle screws at the fracture level is required for the treatment of thoracolumbar burst fractures. This randomised controlled study is the first to examine the efficacy of diverse orders of pedicle scr ...[more]

PMID: 30696677

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Project description:IntroductionA number of imaging technologies have been developed to reduce the risk of pedicle screw (PS) misplacement. For example, preoperative three-dimensional (3D) planning can reportedly enhance implant placement accuracy in some orthopedic surgeries. However, no study has investigated the effect of preoperative 3D planning on PS placement without intraoperative 3D navigation. Thus, in this study, we aim to examine the accuracy of PS placement and identify the risk factors for PS misplacement in thoracolumbar surgeries performed using preoperative 3D planning software with intraoperative fluoroscopic guidance in a retrospective study.MethodsIn total, 25 consecutive patients (197 PSs) underwent thoracic or lumbar spinal fusion surgeries using preoperative 3D planning with intraoperative fluoroscopic guidance. PS misplacement was graded based on the degree of perforation (Grade 0, no perforation; Grade 1, <2 mm; Grade 2, 2-4 mm; Grade 3, >4 mm) observed in postoperative computed tomography (CT). Deviations between planned and actual PSs were evaluated by matching preoperative and postoperative CT volume images for each vertebra.ResultsThe overall PS misplacement rate was 6.6% (Grade 1: 4.0%, Grade 2: 1.5%, Grade 3: 1.0%). The median linear deviations of PS entry points between planned and actual locations were determined to be 3.3 mm and 3.3 mm for the horizontal and vertical axes, respectively. The median angular deviations of the PS axis were 6.2° and 4.5° for the transverse and sagittal planes, respectively. Multivariate analysis revealed that horizontal deviation of the PS entry point was the sole factor associated with Grade ≥1 PS misplacement (odds ratio=2.47, p<0.001).ConclusionsPreoperative 3D planning software without intraoperative 3D navigation was able to achieve a relatively low PS misplacement ratio among the reported ratio of conventional techniques without navigation. Surgeons should carefully ensure that the entry point is consistent with preoperative planning, especially in the mediolateral direction to avoid misplacement in this method.

Dataset Information

Modified pedicle screw placement at the fracture level for treatment of thoracolumbar burst fractures: a study protocol of a randomised controlled trial.

Publications

Modified pedicle screw placement at the fracture level for treatment of thoracolumbar burst fractures: a study protocol of a randomised controlled trial.

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