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Accuracy of robot-assisted versus conventional freehand pedicle screw placement in spine surgery: a systematic review and meta-analysis of randomized controlled trials.

ABSTRACT: This systematic review and meta-analysis investigated differences in accuracy, operation time, and radiation exposure time between robot-assisted and freehand techniques for pedicle screw insertion. Two investigators independently searched for articles on randomized controlled trials (RCTs) published from 2012 to 2019. The final meta-analysis included seven RCTs. We compared the accuracy of pedicle screw placement, operation time, and radiation exposure time between robot-assisted and conventional freehand groups. Seven RCTs included 540 patients and placement of 2,476 pedicle screws, of which 1,220 were inserted using the robot-assisted technique and 1,256 were inserted using the conventional freehand technique. The pedicle screw positions were classified using the Gertzbein and Robbins classification (grade A-E). The combined results of Grade A [odds ratio (OR) =1.68; 95% confidence intervals (CI): 0.82-3.44; P=0.16), Grade A+B (OR =1.70; 95% CI: 0.47-6.13; P=0.42), and Grade C+D+E (OR =0.59; 95% CI: 0.16-2.12; P=0.42) for the accuracy rate revealed no significant difference between the two groups. Subgroup analysis results revealed that the TiRobot-assisted technique presented a significantly improved pedicle screw insertion accuracy rate compared with that of the conventional freehand technique, based on Grade A, Grade A+B, and Grade C+D+E classifications. The SpineAssist-assisted technique presented an inferior pedicle screw insertion accuracy rate compared with that of the conventional freehand technique, based on Grade A, Grade A+B, and Grade C+D+E classifications. No difference between the Renaissance-assisted and conventional freehand techniques was noted for pedicle screw insertion accuracy rates, based on both Grade A (OR =1.58; 95% CI: 0.85-2.96; P=0.15), Grade A+B (OR =2.20; 95% CI: 0.39-12.43; P=0.37), and Grade C+D+E (OR =0.45; 95% CI: 0.08-2.56; P=0.37) classifications. Regarding operation time, robot-assisted surgery had significantly longer operation time than conventional freehand surgery. The robot-assisted group had significantly shorter radiation exposure time. Regarding the pedicle screw insertion accuracy rate, the TiRobot-assisted technique was superior, the SpineAssist-assisted technique was inferior, and Renaissance was similar to the conventional freehand technique.

SUBMITTER: Peng YN

PROVIDER: S-EPMC7396236 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Accuracy of robot-assisted versus conventional freehand pedicle screw placement in spine surgery: a systematic review and meta-analysis of randomized controlled trials.

Peng Yu-Ning YN Tsai Li-Cheng LC Hsu Horng-Chaung HC Kao Chia-Hung CH

Annals of translational medicine 20200701 13

This systematic review and meta-analysis investigated differences in accuracy, operation time, and radiation exposure time between robot-assisted and freehand techniques for pedicle screw insertion. Two investigators independently searched for articles on randomized controlled trials (RCTs) published from 2012 to 2019. The final meta-analysis included seven RCTs. We compared the accuracy of pedicle screw placement, operation time, and radiation exposure time between robot-assisted and convention ...[more]

PMID: 32793669

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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: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:Sacroiliac (SI) screw fixation is a demanding technique, with a high rate of screw malposition due to the complex pelvic anatomy. TiRobot™ is an orthopedic surgery robot which can be used for SI screw fixation. This study aimed to evaluate the accuracy of robot-assisted placement of SI screws compared with a freehand technique.Thirty patients requiring posterior pelvic ring stabilization were randomized to receive freehand or robot-assisted SI screw fixation, between January 2016 and June 2016 at Beijing Jishuitan Hospital. Forty-five screws were placed at levels S1 and S2. In both methods, the primary end point screw position was assessed and classified using postoperative computed tomography. Fisher's exact probability test was used to analyze the screws' positions. Secondary end points, such as duration of trajectory planning, surgical time after reduction of the pelvis, insertion time for guide wire, number of guide wire attempts, and radiation exposure without pelvic reduction, were also assessed.Twenty-three screws were placed in the robot-assisted group and 22 screws in the freehand group; no postoperative complications or revisions were reported. The excellent and good rate of screw placement was 100% in the robot-assisted group and 95% in the freehand group. The P value (0.009) showed the same superiority in screw distribution. The fluoroscopy time after pelvic reduction in the robot-assisted group was significantly shorter than that in the freehand group (median [Q1, Q3]: 6.0 [6.0, 9.0] s vs. median [Q1, Q3]: 36.0 [21.5, 48.0] s; ?2 = 13.590, respectively, P < 0.001); no difference in operation time after reduction of the pelvis was noted (?2 = 1.990, P = 0.158). Time for guide wire insertion was significantly shorter for the robot-assisted group than that for the freehand group (median [Q1, Q3]: 2.0 [2.0, 2.7] min vs. median [Q1, Q3]: 19.0 [15.5, 45.0] min; ?2 = 20.952, respectively, P < 0.001). The number of guide wire attempts in the robot-assisted group was significantly less than that in the freehand group (median [Q1, Q3]: 1.0 [1.0,1.0] time vs. median [Q1, Q3]: 7.0 [1.0, 9.0] times; ?2 = 15.771, respectively, P < 0.001). The instrumented SI levels did not differ between both groups (from S1 to S2, ?2 = 4.760, P = 0.093).Accuracy of the robot-assisted technique was superior to that of the freehand technique. Robot-assisted navigation is safe for unstable posterior pelvic ring stabilization, especially in S1, but also in S2. SI screw insertion with robot-assisted navigation is clinically feasible.

Project description:Ascertaining the accuracy of the pedicle screw (PS) trajectories is important as PS malpositioning can cause critical complications. We aimed to determine the angle range over which estimation is unreliable; build a low-cost PS placement support system that uses an inertial measurement unit (IMU) to enable the monitoring of surgical tools and PS trajectories, and determine the situations where IMU support would be most beneficial. In PS insertion experiments, we used cadaver samples that included lumbar porcine spines. Computed tomography images obtained before and after PS insertion were viewed. Offsets between the planned and implanted PS trajectories in the freehand and IMU-assisted groups were analyzed. The PS cortical bone breaches were classified according to the Gertzbein and Robbins criteria (GRC). Added head-down tilted sample experiments were repeated wherein we expected a decreased rostro-caudal rotational accuracy of the PS according to the angle estimation ability results. Evaluation of the PS trajectory accuracy revealed no significant advantage of IMU-assisted rostro-caudal rotational accuracy versus freehand accuracy. According to the GRC, IMU assistance significantly increased the rate of clinically acceptable PS positions (RoCA) than the freehand technique. In the head-down tilted sample experiments, IMU assist provided increased accuracies with both rostro-caudal and medial rotational techniques when compared with the freehand technique. In the freehand group, RoCA was significantly decreased in samples with rostral tilting relative to that in the samples without. However, In the IMU-assisted group, no significant difference in RoCA between the samples with and without head-down tilting was observed. Even when the planned PS medial and/or rostro-caudal rotational angle was relatively large and difficult to reproduce manually, IMU-support helped maintain the PS trajectory accuracy and positioning safety. IMU assist in PS placement was more beneficial, especially for larger rostro-caudal and/or medial rotational pedicle angles.

Dataset Information

Accuracy of robot-assisted versus conventional freehand pedicle screw placement in spine surgery: a systematic review and meta-analysis of randomized controlled trials.

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Accuracy of robot-assisted versus conventional freehand pedicle screw placement in spine surgery: a systematic review and meta-analysis of randomized controlled trials.

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