Dataset Information

A 3D navigation template for guiding a unilateral lumbar pedicle screw with contralateral translaminar facet screw fixation: a study protocol for multicentre randomised controlled trials.

ABSTRACT:

Introduction

The incidence of lumbar disc degeneration disease has increased in recent years. Lumbar interbody fusion using two unilateral pedicle screws and a translaminar facet screw fixation has advantages of minimal invasiveness and lower costs compared with the traditional methods. Moreover, a method guided by a three-dimensional (3D) navigation template may help us improve the surgical accuracy and the success rate. This is the first randomised study using a 3D navigation template to guide a unilateral lumbar pedicle screw with contralateral translaminar facet screw fixation.

Methods and analysis

Patients who meet the criteria of the surgery will be randomly divided into experimental groups and control groups by a computer-generated randomisation schedule. We will preoperatively design an individual 3D navigation template using CATIA software and MeditoolCreate. The following primary outcomes will be collected: screw angles compared with the optimal screw trajectories in 3D digital images, length of the wound incision, operative time, intraoperative blood loss and complications. The following secondary outcomes will be collected: visual analogue scale (VAS) for back pain, VAS for leg pain and the Oswestry Disability Index. These parameters will be evaluated on day 1 and then 3, 6, 12 and 24 months postoperatively.

Ethics and dissemination

The study has been reviewed and approved by the institutional ethics review board of the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University. The results will be presented at scientific communities and peer-reviewed journals.

Trial registration number

ChiCTR-IDR-17010466.

SUBMITTER: Shao ZX

PROVIDER: S-EPMC5642762 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Publications

A 3D navigation template for guiding a unilateral lumbar pedicle screw with contralateral translaminar facet screw fixation: a study protocol for multicentre randomised controlled trials.

Shao Zhen-Xuan ZX He Wei W He Shao-Qi SQ Lin Sheng-Lei SL Huang Zhe-Yu ZY Tang Hong-Chao HC Ni Wen-Fei WF Wang Xiang-Yang XY Wu Ai-Min AM

BMJ open 20170721 7

<h4>Introduction</h4>The incidence of lumbar disc degeneration disease has increased in recent years. Lumbar interbody fusion using two unilateral pedicle screws and a translaminar facet screw fixation has advantages of minimal invasiveness and lower costs compared with the traditional methods. Moreover, a method guided by a three-dimensional (3D) navigation template may help us improve the surgical accuracy and the success rate. This is the first randomised study using a 3D navigation template ...[more]

PMID: 28733301

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Project description:BackgroundTo analyze the risk factors for pedicle screw invasion of the proximal facet joint after lumbar surgery.MethodsFrom January 2019 to January 2021, 1794 patients with lumbar degenerative disease, such as lumbar disc herniation, lumbar spinal stenosis and lumbar spondylolisthesis, were treated at our hospital. In all, 1221 cases were included. General data (sex, age, BMI), bone mineral density, proximal facet joint angle, degenerative lumbar spondylolisthesis, isthmic lumbar spondylolisthesis and fixed segment in the two groups were recorded. After the operation, vertebral CT of the corresponding surgical segments was performed for three-dimensional reconstruction and evaluation of whether the vertebral arch root screw interfered with the proximal facet joint. The included cases were divided into an invasion group and a noninvasion group. Univariate analysis was used to screen the risk factors for pedicle screw invasion of the proximal facet joint after lumbar surgery, and the selected risk factors were included in the logistic model for multivariate analysis.ResultsThe single-factor analysis showed a significant difference in age, BMI, proximal facet joint angle, degenerative lumbar spondylolisthesis, and fixed segment (P < 0.1). Multifactor analysis of the logistic model showed a significant difference for age ≥ 50 years (P < 0.001, OR = 2.291), BMI > 28 kg/m2 (P < 0.001, OR = 2.548), degenerative lumbar spondylolisthesis (P < 0.001, OR = 2.187), gorge cleft lumbar relaxation (P < 0.001, OR = 2.410), proximal facet joint angle (35 ~ 45°: P < 0.001, OR = 3.151; > 45°: P < 0.001, OR = 3.578), and fixed segment (lower lumbar spine: P < 0.001, OR = 2.912).ConclusionAge (≥ 50 years old), BMI (> 28 kg/m2), proximal facet joint angle (35 ~ 45°, > 45°), degenerative lumbar spondylolisthesis, isthmic lumbar spondylolisthesis and fixed segment (lower lumbar spine) are independent risk factors for pedicle screw invasion of the proximal facet joint after lumbar surgery. Compared with degenerative lumbar spondylolisthesis, facet joint intrusion is more likely in isthmic lumbar spondylolisthesis.

Project description:PurposePedicle screw fixation in the upper cervical spine is a difficult and high-risk procedure. The screw is difficult to place rapidly and accurately, and can lead to serious injury of spinal cord or vertebral artery. The aim of this study was to design an individualized 3D printing navigation template for pedicle screw fixation in the upper cervical spine.MethodsUsing CT thin slices data, we employed computer software to design the navigation template for pedicle screw fixation in the upper cervical spine (atlas and axis). The upper cervical spine models and navigation templates were produced by 3D printer with equal proportion, two sets for each case. In one set (Test group), pedicle screws fixation were guided by the navigation template; in the second set (Control group), the screws were fixed under fluoroscopy. According to the degree of pedicle cortex perforation and whether the screw needed to be refitted, the fixation effects were divided into 3 types: Type I, screw is fully located within the vertebral pedicle; Type II, degree of pedicle cortex perforation is <1 mm, but with good internal fixation stability and no need to renovate; Type III, degree of pedicle cortex perforation is >1 mm or with the poor internal fixation stability and in need of renovation. Type I and Type II were acceptable placements; Type III placements were unacceptable.ResultsA total of 19 upper cervical spine and 19 navigation templates were printed, and 37 pedicle screws were fixed in each group. Type I screw-placements in the test group totaled 32; Type II totaled 3; and Type III totaled 2; with an acceptable rate of 94.60%. Type I screw placements in the control group totaled 23; Type II totaled 3; and Type III totaled 11, with an acceptable rate of 70.27%. The acceptability rate in test group was higher than the rate in control group. The operation time and fluoroscopic frequency for each screw were decreased, compared with control group.ConclusionThe individualized 3D printing navigation template for pedicle screw fixation is easy and safe, with a high success rate in the upper cervical spine surgery.

Project description:BackgroundPedicle screw invasion of the proximal articular process will cause local articular process degeneration and acceleration, which is an important factor affecting adjacent segment degeneration. Although lumbar spondylolisthesis is a risk factor for screw invasion of the proximal joint, there is no clear conclusion regarding the two different types of spondylolisthesis. Therefore, the purpose of this study was to explore the influence of pedicle screw placement on proximal facet invasion in the treatment of degenerative spondylolisthesis and isthmic spondylolisthesis.MethodsIn total, 468 cases of lumbar spondylolisthesis treated by decompression and fusion in our hospital from January 2017 to January 2020 were included in this retrospective study. Among them, 238 cases were degenerative spondylolisthesis (group A), and 230 cases were isthmic spondylolisthesis (group B). Sex, age, body mass index, bone mineral density, preoperative visual analog scale (VAS) and Oswestry Disability Index (ODI) scores, postoperative VAS and ODI scores at 1 month and 3 months, and angle of the proximal facet joint at the last follow-up were recorded and compared between the two groups. The degree of pedicle screw invasion of the proximal facet joint was graded and compared by the SEO grading method.ResultsThere were no significant differences in sex, age, body mass index, bone mineral density, preoperative VAS and ODI scores, or proximal facet joint angle between the two groups (P > 0.05). There was no significant difference in VAS and ODI scores between the two groups at 1 month and 3 months after the operation (P > 0.05). The VAS score of group A at the last follow-up was 1 (1,2). The VAS score of group B at the last follow-up was 3 (1,3). The ODI score of group A at the last follow-up was 6(4,26). The ODI score of group B at the last follow-up was 15(8,36). The VAS and ODI scores of the two groups at the last follow-up were significantly different (P < 0.05). According to the SEO grading method, the invasion of the proximal articular process by pedicle screw placement in group A involved 320 cases in grade 0, 128 cases in grade I and 28 cases in grade II. In group B, there were 116 cases in grade 0, 248 cases in grade I and 96 cases in grade II, with a significant difference (P < 0.01).ConclusionIn summary, a certain number of cases involving screws invading the proximal facet joint occurred in the two different types of lumbar spondylolisthesis, but the number in the isthmic spondylolisthesis group was significantly higher than that in the degenerative spondylolisthesis group, which caused more trauma to the proximal facet joint and significantly affected the patient prognosis.

Dataset Information

A 3D navigation template for guiding a unilateral lumbar pedicle screw with contralateral translaminar facet screw fixation: a study protocol for multicentre randomised controlled trials.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

A 3D navigation template for guiding a unilateral lumbar pedicle screw with contralateral translaminar facet screw fixation: a study protocol for multicentre randomised controlled trials.

Similar Datasets

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