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Radiographic and Clinical Outcomes of Robot-Assisted Posterior Pedicle Screw Fixation: Two-Year Results from a Randomized Controlled Trial.

ABSTRACT: PURPOSE:We prospectively assessed the early radiographic and clinical outcomes (minimum follow-up of 2 years) of robot-assisted pedicle screw fixation (Robot-PSF) and conventional freehand pedicle screw fixation (Conv-PSF). MATERIALS AND METHODS:Patients were randomly assigned to Robot-PSF (37 patients) or Conv-PSF (41 patients) for posterior interbody fusion surgery. The Robot-PSF group underwent minimally invasive pedicle screw fixation using a pre-planned robot-guided screw trajectory. The Conv-PSF underwent screw fixation using the freehand technique. Radiographic adjacent segment degeneration (ASD) was measured on plain radiographs, and clinical outcomes were measured using visual analogue scale (VAS) and Oswestry disability index (ODI) scores regularly after surgery. RESULTS:The two groups had similar values for radiographic ASD, including University California at Los Angeles grade, vertebral translation, angular motion, and loss of disc height (p=0.320). At final follow-up, both groups had experienced significant improvements in back VAS, leg VAS, and ODI scores after surgery (p<0.001), although inter-group differences were not significant for back VAS (p=0.876), leg VAS (p=0.429), and ODI scores (p=0.952). In the Conv-PSF group, revision surgery was required for two of the 25 patients (8%), compared to no patients in the Robot-PSF group. CONCLUSION:There were no significant differences in radiographic ASD and clinical outcomes between Robot-PSF and Conv-PSF. Thus, the advantages of robot-assisted surgery (accurate pedicle screw insertion and minimal facet joint violation) do not appear to be clinically significant.

SUBMITTER: Park SM

PROVIDER: S-EPMC5889997 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Radiographic and Clinical Outcomes of Robot-Assisted Posterior Pedicle Screw Fixation: Two-Year Results from a Randomized Controlled Trial.

Park Sang Min SM Kim Ho Joong HJ Lee Se Yeon SY Chang Bong Soon BS Lee Choon Ki CK Yeom Jin S JS

Yonsei medical journal 20180501 3

<h4>Purpose</h4>We prospectively assessed the early radiographic and clinical outcomes (minimum follow-up of 2 years) of robot-assisted pedicle screw fixation (Robot-PSF) and conventional freehand pedicle screw fixation (Conv-PSF).<h4>Materials and methods</h4>Patients were randomly assigned to Robot-PSF (37 patients) or Conv-PSF (41 patients) for posterior interbody fusion surgery. The Robot-PSF group underwent minimally invasive pedicle screw fixation using a pre-planned robot-guided screw tra ...[more]

PMID: 29611407

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Project description:BackgroundThe anterior pedicle screw (APS) technique for L5 and S1 is crucial for proper anterior lumbar interbody fusion (ALIF). This study aimed to determine the projection, screw trajectory angle, and bone screw passageway length (BSPL), as well as the screw insertion regularity and the operating area within which it is safe to perform insertion.MethodsForty patients with low back pain, all of whom had lumbar computed tomography scans available, was included in this retrospective analysis. Radiographic parameters were measured, including: the distances from the projection to the upper endplate, lower endplate, and midline; the transverse and sagittal screw angles; and the BSPL. In addition, 10 fresh adult cadaveric lumbosacral spine segments were selected to determine the safe anatomic area in which to operate. Finally, APSs were inserted in L5 and S1 to determine the regularity of APS insertion.ResultsWe measured the anterior projection parameters, including: the distances to the upper endplate (L5: 12.5±1.3 mm; S1: 4.54±0.87 mm), lower endplate (L5: 17.3±1.6 mm), and midline (L5: 6.6±0.7 mm; S1: 6.6±0.6 mm); the screw trajectory angle, including the transverse screw angle (L5: 25.3±2.8°; S1: 25.7±2.6°), sagittal screw angle (L5: 17.1±1.7°; S1: 22.4±1.1°); and the BSPL (L5: 48.6±3.5 mm; S1: 48.0±3.5 mm). The regularity of APS insertion in L5 and S1 was determined. Upon the needle reaching a point in the lateral view, it reached the corresponding point in the anteroposterior (AP) view. The anatomic parameters of the safe operating area were as follows: the distance from the abdominal aortic bifurcation to the L5 lower edge (40.50±9.40 mm); the distance from the common iliac vein confluence to the L5 lower edge (27.80±8.60 mm); and the horizontal distance from the inner edge of the common iliac vein to the L5 lower edge (37.50±1.30 mm). We also determined the distance between S1 holes (29.30±1.30 mm), the L5/S1 intervertebral height (17.20±1.50 mm), and the safe operating area (2,058.20±84.30 mm2).ConclusionsThis study has determined the projection, screw trajectory angle, and BSPL of APSs in L5 and S1, their insertion regularity, and the area in which the operation can be safely performed.

Project description:ObjectiveTo determine the rates and risk factors of pedicle screw placement accuracy and the proximal facet joint violation (FJV) using TINAVI robot-assisted technique.MethodsPatients with thoracolumbar fractures or degenerative diseases were retrospectively recruited from June 2018 and June 2020. The pedicle penetration and proximal FJV were compared in different instrumental levels to identify the safe and risk segments during insertion. Moreover, the factors were also assessed using univariate and multivariate analyses.ResultsA total of 72 patients with 332 pedicle screws were included in the current study. The optimal and clinically acceptable screw positions were 85.8% and 93.4%. Of the 332 screws concerning the intra-pedicular accuracy, 285 screws (85.8%) were evaluated as Grade A according to the Gertzbein and Robbins scale, with the remaining 25 (7.6%), 10 (3.0%), 6 (1.8%), and 6 screws (1.8%) as Grades B, C, D, and E. Moreover, in terms of the proximal FJV, 255 screws (76.8%) screws were assessed as Grade 0 according to the Babu scale, with the remaining 34 (10.3%), 22 (6.6%), and 21 screws (6.3%) as Grades 1, 2, and 3. Furthermore, the univariate analysis showed significantly higher rate of penetration for patients with age < 61 years old, sex of female, thoracolumbar insertion, shorter distance from skin to insertion point, and smaller facet angle. Meanwhile, the patients with the sex of female, BMI < 25.9, grade I spondylolisthesis, lumbosacral insertion, longer distance from skin to insertion point, and larger facet angle had a significantly higher rate of proximal FJV. The outcomes of multivariate analyses showed that sex of male (adjusted OR 0.320, 95% CI 0.140-0.732; p = 0.007), facet angle ≥ 45° (adjusted OR 0.266, 95% CI 0.090-0.786; p = 0.017), distance from skin to insertion point ≥ 4.5 cm (adjusted OR 0.342, 95% CI 0.134-0.868; p = 0.024), and lumbosacral instrumentation (adjusted OR 0.227, 95% CI 0.091-0.566; p = 0.001) were independently associated with intra-pedicular accuracy; the L5 insertion (adjusted OR 2.020, 95% CI 1.084-3.766; p = 0.027) and facet angle ≥ 45° (adjusted OR 1.839, 95% CI 1.026-3.298; p = 0.041) were independently associated with the proximal FJV.ConclusionTINAVI robot-assisted technique was associated with a high rate of pedicle screw placement and a low rate of proximal FJV. This new technique showed a safe and precise performance for pedicle screw placement in spinal surgery. Facet angle ≥ 45° is independently associated with both the intra-pedicular accuracy and proximal FJV.

Project description:BackgroundTraditional paired meta-analyses have yielded inconsistent results for the safety and effectiveness of robotic-assisted pedicle screw placement due to the high heterogeneity within studies. This study evaluated the clinical effectiveness and safety of robotic-assisted pedicle screw placement.MethodsThe Embase, PubMed, and Cochrane Library databases were searched with no language limitations from inception to Jan 4, 2022. Odds ratio (OR), mean difference (MD), and 95% confidence interval (CI) were used to report results. The main outcomes were accuracy of pedicle screw placement, proximal facet joint violation, and complications. The study protocol was published in PROSPERO (CRD42022301417).Findings26 trials including 2046 participants evaluating robotic-assisted pedicle screw placement were included in this study. Our pooled results showed that Renaissance (OR 2.86; [95% CI 1.79 to 4.57]) and TiRobot (OR 3.10; [95% CI 2.19 to 4.40]) yielded higher rates of perfect pedicle screw insertion (Grades A) than the conventional freehand technique. Renaissance (OR 2.82; [95% CI 1.51 to 5.25]) and TiRobot (OR 4.58; [95% CI 2.65 to 7.89]) yielded higher rates of clinically acceptable pedicle screw insertion (Grades A+B). However, ROSA, SpineAssist, and Orthobot were not associated with higher perfect pedicle screw insertion and clinically acceptable pedicle screw insertion rates. Robot-assisted techniques were associated with low rates of proximal facet joint violation (OR 0.18; [95% CI 0.10 to 0.32]; I2:9.55%) and overall complications (OR 0.38; [95% CI 0.23 to 0.63]; I2:27.05%). Moreover, robot-assisted techniques were associated with lower radiation doses (MD -14.38; [95% CI -25.62 to -3.13]; I2:100.00%).InterpretationOur findings suggest that only Renaissance and TiRobot systems are associated with high accuracy rates of pedicle screw placement. Robotic-assisted techniques hold great promise in spinal surgery due to their safety and effectiveness.FundingThis work was supported by grants from the National Natural Science Foundation of China (No. 81871818), Tangdu Hospital Seed Talent Program (Fei-Long Wei) and Natural Science Basic Research Plan in Shaanxi Province of China (No.2019JM-265).

Project description:ObjectiveThe purpose of this study was to analyse the biomechanical characteristics of pedicle screws with different placement methods and diameters in the treatment of Tile C1 pelvic fractures by finite element simulation technology and to compare them with the plate fixation model to verify the effectiveness of pedicle screw fixation.MethodsA three-dimensional digital model of a normal pelvis was obtained using computed tomography images. A finite element model of a normal pelvis containing major ligaments was built and validated (Model 1). Based on the verified normal pelvis finite element model, a Tile C1 pelvic fracture model was established (Model 2), and then a plate fixation model (Model 3) and a pedicle screw fixation model with different screw placement methods and diameters were established (Models 4-15). For all pelvic fracture fixation models, a vertical load of 500 N was applied on the upper surface of the sacrum to test the displacement and stress distribution of the pelvis in the standing state with both legs.ResultsThe finite element simulation results showed the maximum displacement of Model 1 and Models 3-15 to be less than 1 mm. The overall maximum displacement of Models 4-15 was slightly larger than that of Model 3 (the maximum difference was 177.91×10-3 mm), but the maximum displacement of iliac bone and internal fixation in Models 4-15 was smaller than that of Model 3. The overall maximum stress (maximum stress of the ilium) and maximum stress of internal fixation in Models 4-15 were less than those in Model 3. The maximum displacement difference and maximum stress difference at the fracture of the pubic ramus between each fixed model were less than 0.01 mm and 1 MPa, respectively. The greater the diameter and number of pedicle screws were, the smaller the maximum displacement and stress of the pelvic fracture models were.The maximum displacement and stress of the pelvic fracture models of the screws placed on the injured side of the pubic region were smaller than the screws on the healthy side.ConclusionBoth the anterior and posterior pelvic rings are fixed with a pedicle screw rod system for treatment of Tile C1 pelvic fractures, which can obtain sufficient biomechanical stability and can be used as a suitable alternative to other implants.The greater the diameter and number of pedicle screws were, the greater the pelvic stability was, and the greater was the stability of the screws placed on the injured side of the pubic region than the screws on the healthy side.

Dataset Information

Radiographic and Clinical Outcomes of Robot-Assisted Posterior Pedicle Screw Fixation: Two-Year Results from a Randomized Controlled Trial.

Publications

Radiographic and Clinical Outcomes of Robot-Assisted Posterior Pedicle Screw Fixation: Two-Year Results from a Randomized Controlled Trial.

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