Pedicle screw insertion with patient-specific 3D-printed guides based on low-dose CT scan is more accurate than free-hand technique in spine deformity patients: a prospective, randomized clinical trial

Cecchinato, Riccardo; Berjano, Pedro; Zerbi, Alberto; Damilano, Marco; Redaelli, Andrea; Lamartina, Claudio

doi:10.1007/s00586-019-05978-3

Cited by 79 publications

(82 citation statements)

References 19 publications

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“…Then, 4 animal studies and 4 cadaver specimen studies were excluded from the 21 studies that met the inclusion criteria. Finally, 13 eligible trials [14,[17][18][19][20][21][22][23][24][25][26][27][28] were included in this meta-analysis. The flow diagram for the literature selection is shown in Fig.…”

Section: Literature Search Resultsmentioning

confidence: 99%

“…Six of the seven randomized controlled trials [14,17,18,[22][23][24] had a low risk of performance bias due to the random sequence generation method, and only one study [27] had a high risk due to selection bias. Five studies [18,[22][23][24]27] had a high risk of performance bias with due to the method of blinding the participants and personnel, and the other studies had an unclear risk [14,17]. One study [24] had a high risk of detection bias, and another study [22] had a high risk of attrition bias.…”

Section: Literature Search Resultsmentioning

confidence: 99%

“…Begg's test indicated some evidence of publication bias (Begg's test, P = 0.044 < 0.05; Egger's test, P = 0.032 < 0.05). A reanalysis of the log-transformed data excluding the data of one study [17] showed a summary OR of 3.34 (95% CI, 2.68-4.17, I 2 = 0.00%, P for heterogeneity = 0.469) and no evidence of publication bias among the studies (Begg, p = 0.086; Egger, p = 0.105), indicating that methodological differences in data processing may partly explain the asymmetry of the funnel plot.…”

Section: Publication Biasmentioning

confidence: 99%

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Pedicle screw placement in spinal neurosurgery using a 3D-printed drill guide template: a systematic review and meta-analysis

Xie

et al. 2020

J Orthop Surg Res

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Background: Many surgeons believe that the use of a 3D-printed drill guide template shortens operative time and reduces intraoperative blood loss compared with those of the free-hand technique. In this study, we investigated the effects of a drill guide template on the accuracy of pedicle screw placement (the screw placed completely in the pedicle), operative time, and intraoperative blood loss. Materials/Methods: We systematically searched the major databases, such as Medline via PubMed, EMBASE, Ovid, Cochrane Library, and Google Scholar, regarding the accuracy of pedicle screw placement, operative time, and intraoperative blood loss. The χ 2 test and I 2 statistic were used to examine heterogeneity. Odds ratios (ORs) with 95% confidence intervals (CIs) were used to calculate the accuracy rate of pedicle screw placement, and weighted mean differences (WMDs) with 95% CIs were utilized to express operative time and intraoperative blood loss. Results: This meta-analysis included 13 studies (seven randomized controlled trials and six prospective cohort studies) involving 446 patients and 3375 screws. The risk of research bias was considered moderate. Operative time (WMD = − 20.75, 95% CI − 33.20~− 8.29, P = 0.001) and intraoperative blood loss (WMD = − 106.16, 95% CI − 185.35 − 26.97, P = 0.009) in the thoracolumbar vertebrae, evaluated by a subgroup analysis, were significantly different between groups. The 3D-printed drill guide template has advantages over the free-hand technique and improves the accuracy of pedicle screw placement (OR = 2.88; 95% CI, 2.39~3.47; P = 0.000). Conclusion: The 3D-printed drill guide template can improve the accuracy rate of pedicle screw placement, shorten operative time, and reduce intraoperative blood loss.

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Section: Literature Search Resultsmentioning

confidence: 99%

Section: Literature Search Resultsmentioning

confidence: 99%

Section: Publication Biasmentioning

confidence: 99%

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Pedicle screw placement in spinal neurosurgery using a 3D-printed drill guide template: a systematic review and meta-analysis

Xie

et al. 2020

J Orthop Surg Res

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“…Cecchinato et al [16] [17] использовали систему опорных цилиндров, отметив, что полые цилиндры-направители не должны соприкасаться с костью, поскольку полное удаление тканей в точке ввода при имплантации в поясничном отделе может быть затруднительно. Остальные цилиндры служат в качестве опорного каркаса.…”

Section: Discussionunclassified

“…Результаты исследования демонстрируют высокую степень безопасности и точности имплантации при использовании навигационных направителей, что в целом соответ-ствует ранее опубликованным работам [10][11][12][13][14][15][16][17]. Стоит отметить, что в некоторых исследованиях продемонстрировано успешное использование матриц для установки винтов в С 1 [6], тогда как мы отметили недостаточную стабильность матрицы на данном уровне за счет малой площади поверхности.…”

Section: Discussionunclassified

Determination of optimal design of navigation templates for transpedicular implantation in the cervical and thoracic spine: results of cadaveric studies

et al. 2019

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Generating patient‐matched 3D‐printed pedicle screw and laminectomy drill guides from Cone Beam CT images: Studies in ovine and porcine cadavers

et al. 2022

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Background The emergence of robotic Cone Beam Computed Tomography (CBCT) imaging systems in trauma departments has enabled 3D anatomical assessment of musculoskeletal injuries, supplementing conventional 2D fluoroscopic imaging for examination, diagnosis, and treatment planning. To date, the primary focus has been on trauma sites in the extremities. Purpose To determine if CBCT images can be used during the treatment planning process in spinal instrumentation and laminectomy procedures, allowing accurate 3D‐printed pedicle screw and laminectomy drill guides to be generated for the cervical and thoracic spine. Methods The accuracy of drill guides generated from CBCT images was assessed using animal cadavers (ovine and porcine). Preoperative scans were acquired using a robotic CBCT C‐arm system, the Siemens ARTIS pheno (Siemens Healthcare, GmbH, Germany). The CBCT images were imported into 3D‐Slicer version 4.10.2 (http://www.slicer.org) where vertebral models and specific guides were developed and subsequently 3D‐printed. In the ovine cadaver, 11 pedicle screw guides from the T1–T5 and T7–T12 vertebra and six laminectomy guides from the C2–C7 vertebra were planned and printed. In the porcine cadaver, nine pedicle screw guides from the C3–T4 vertebra were planned and printed. For the pedicle screw guides, accuracy was assessed by three observers according to pedicle breach via the Gertzbein–Robbins grading system as well as measured mean axial and sagittal screw error via postoperative CBCT and CT scans. For the laminectomies, the guides were designed to leave 1 mm of lamina. The average thickness of the lamina at the mid‐point was used to assess the accuracy of the guides, measured via postoperative CBCT and CT scans from three observers. For all measurements, the intraclass correlation coefficient (ICC) was calculated to determine observer reliability. Results Compared with the planned screw angles for both the ovine and porcine procedures (n = 32), the mean axial and sagittal screw error measured on the postoperative CBCT scans from three observers were 3.9 ± 1.9° and 1.8 ± 0.8°, respectively. The ICC among the observes was 0.855 and 0.849 for the axial and sagittal measurements, respectively, indicating good reliability. In the ovine cadaver, directly comparing the measured axial and sagittal screw angle of the visible screws (n = 14) in the postoperative CBCT and conventional CT scans from three observers revealed an average difference 1.9 ± 1.0° in axial angle and 1.8 ± 1.0° in the sagittal angle. The average thickness of the lamina at the middle of each vertebra, as measured on‐screen in the postoperative CBCT scans by three observes was 1.6 ± 0.2 mm. The ICC among observers was 0.693, indicating moderate reliability. No lamina breaches were observed in the postoperative images. Conclusion Here, CBCT images have been used to generate accurate 3D‐printed pedicle screw and laminectomy drill guides for use in the cervical and thoracic spine. The results demonstrate sufficient precision compared with th...

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Pedicle screw insertion with patient-specific 3D-printed guides based on low-dose CT scan is more accurate than free-hand technique in spine deformity patients: a prospective, randomized clinical trial

Cited by 79 publications

References 19 publications

Pedicle screw placement in spinal neurosurgery using a 3D-printed drill guide template: a systematic review and meta-analysis

Pedicle screw placement in spinal neurosurgery using a 3D-printed drill guide template: a systematic review and meta-analysis

Determination of optimal design of navigation templates for transpedicular implantation in the cervical and thoracic spine: results of cadaveric studies

Generating patient‐matched 3D‐printed pedicle screw and laminectomy drill guides from Cone Beam CT images: Studies in ovine and porcine cadavers

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