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      Assessment of Surgical Procedural Time, Pedicle Screw Accuracy, and Clinician Radiation Exposure of a Novel Robotic Navigation System Compared With Conventional Open and Percutaneous Freehand Techniques: A Cadaveric Investigation

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          Abstract

          Study Design:

          Cadaveric study.

          Objective:

          To evaluate accuracy, radiation exposure, and surgical time of a new robotic-assisted navigation (RAN) platform compared with freehand techniques in conventional open and percutaneous procedures.

          Methods:

          Ten board-certified surgeons inserted 16 pedicle screws at T10–L5 (n = 40 per technique) in 10 human cadaveric torsos. Pedicle screws were inserted with (1) conventional MIS technique (L2–L5, patient left pedicles), (2) MIS RAN (L2–L5, patient right pedicles), (3) conventional open technique (T10–L1, patient left pedicles), and (4) open RAN (T10–L1, patient right pedicles). Output included (1) operative time, (2) number of fluoroscopic images, and (3) screw accuracy.

          Results:

          In the MIS group, compared with the freehand technique, RAN allowed for use of larger screws (diameter: 6.6 ± 0.6 mm vs 6.3 ± 0.5 mm; length: 50.3 ± 4.1 mm vs 46.9 ± 3.5 mm), decreased the number of breaches >2 mm (0 vs 7), fewer fluoroscopic images (0 ± 0 vs 108.3 ± 30.9), and surgical procedure time per screw (3.6 ± 0.4 minutes vs 7.6 ± 2.0 minutes) (all P < .05). Similarly, in the open group, RAN allowed for use of longer screws (46.1 ± 4.1 mm vs 44.0 ± 3.8 mm), decreased the number of breaches >2 mm (0 vs 13), fewer fluoroscopic images (0 ± 0 vs 24.1 ± 25.8) (all P < .05), but increased total surgical procedure time (41.4 ± 8.8 minutes vs 24.7 ± 7.0 minutes, P = .000) while maintaining screw insertion time (3.31.4 minutes vs 3.1 ± 1.0 minutes, P = .650).

          Conclusion:

          RAN significantly improved accuracy and decreased radiation exposure in comparison to freehand techniques in both conventional open and percutaneous surgical procedures in cadavers. RAN significantly increased setup time compared with both conventional procedures.

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          Most cited references35

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          Accuracy of pedicle screw placement: a systematic review of prospective in vivo studies comparing free hand, fluoroscopy guidance and navigation techniques.

          With the advances and improvement of computer-assisted surgery devices, computer-guided pedicle screws insertion has been applied to the lumbar, thoracic and cervical spine. The purpose of the present study was to perform a systematic review of all available prospective evidence regarding pedicle screw insertion techniques in the thoracic and lumbar human spine. We considered all prospective in vivo clinical studies in the English literature that assessed the results of different pedicle screw placement techniques (free-hand technique, fluoroscopy guided, computed tomography (CT)-based navigation, fluoro-based navigation). MEDLINE, OVID, and Springer databases were used for the literature search covering the period from January 1950 until May 2010. 26 prospective clinical studies were eventually included in the analysis. These studies included in total 1,105 patients in which 6,617 screws were inserted. In the studies using free-hand technique, the percentage of the screws fully contained in the pedicle ranged from 69 to 94%, with the aid of fluoroscopy from 28 to 85%, using CT navigation from 89 to 100% and using fluoroscopy-based navigation from 81 to 92%. The screws positioned with free-hand technique tended to perforate the cortex medially, whereas the screws placed with CT navigation guidance seemed to perforate more often laterally. In conclusion, navigation does indeed exhibit higher accuracy and increased safety in pedicle screw placement than free-hand technique and use of fluoroscopy.
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            Free hand pedicle screw placement in the thoracic spine: is it safe?

            A retrospective study. To evaluate the safety of a free hand technique of pedicle screw placement in the thoracic spine at a single institution over a 10-year experience. Thoracic pedicle screw fixation techniques are still controversial for thoracic deformities because of possible complications including neurologic. Three hundred ninety-four consecutive patients who underwent posterior stabilization utilizing 3204 transpedicular thoracic screws by 2 surgeons from 1992 to 2002 were analyzed. The mean age was 27 + 10 years (range 5 + 3-87 + 0 years) at the time of surgery. Etiologic diagnoses were: scoliosis in 273, kyphosis in 53, other spinal disease in 68. Pedicle screws were inserted using a free hand technique similar to that used in the lumbar spine in which anatomic landmarks and specific entry sites were used to guide the surgeon. A 2-mm tip pedicle probe was carefully advanced free hand down the pedicle into the body. Careful palpation of all bony borders (floor and four pedicle walls) was performed before and after tapping. Next, the screw was placed, followed by neurophysiologic (screw stimulation with rectus abdominus muscle recording) and radiographic (anteroposterior and lateral) confirmation. An independent spine surgeon using medical records and roentgenograms taken during treatment and follow-up reviewed all the patients. The number of the screws inserted at each level were as follows (total n = 3204): T1, n = 13; T2, n = 60; T3, n = 192; T4, n = 275; T5, n = 279; T6, n = 240; T7, n = 230; T8, n = 253; T9, n = 259; T10, n = 341; T11, n = 488; T12, n = 572. Five hundred seventy-seven screws inserted into the deformed thoracic spine were randomly evaluated by thoracic computed tomography scan to assess for screw position. Thirty-six screws (6.2%) were inserted with moderate cortical perforation, which meant the central line of the pedicle screw was out of the outer cortex of the pedicle wall and included 10 screws (1.7%) that violated the medial wall. There were no screws (out of the entire study group of 3204) with any neurologic, vascular, or visceral complications with up to 10 years follow-up. The free hand technique of thoracic pedicle screw placement performed in a step-wise, consistent, and compulsive manner is an accurate, reliable, and safe method of insertion to treat a variety of spinal disorders, including spinal deformity.
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              Accuracy of pedicular screw placement in vivo.

              The accuracy of pedicular screw placement was assessed in 40 consecutive patients treated with the AO "Fixateur Interne." Postoperative CT scans were used to measure canal encroachment from the medial border of the pedicle, the angle of insertion and the point of entry. Eighty-one percent of the screws were placed within 2 mm of the medial border of the pedicle and 6% had 4-8 mm of canal encroachment with two patients developing minor neurological complications that spontaneously resolved. Four percent were inserted lateral to the pedicle. The parameters linked to satisfactory screw placement include entry point, angle of insertion and pedicular isthmus widths. Improvement in accuracy was noted in the latter 25% of screw insertions, reflecting the learning curve associated with this technique.
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                Author and article information

                Journal
                Global Spine J
                Global Spine J
                GSJ
                spgsj
                Global Spine Journal
                SAGE Publications (Sage CA: Los Angeles, CA )
                2192-5682
                2192-5690
                24 September 2019
                October 2020
                : 10
                : 7
                : 814-825
                Affiliations
                [1 ]Rothman Institute, Ringgold 6559, universityThomas Jefferson University Hospital; , Philadelphia, PA, USA
                [2 ]Musculoskeletal Education and Research Center, A Division of Ringgold 110044, Globus Medical, Inc; , Audubon, PA, USA
                [3 ]Ringgold 21771, UCSF Medical Center; , University of California, San Francisco, CA, USA
                [4 ]Ringgold 2971, Henry Ford Health System; , Detroit, MI, USA
                [5 ]Tabor Orthopedics, Division of MSK Group PC, Memphis, TN, USA
                [6 ]Nationwide Children’s Hospital, Columbus, OH, USA
                [7 ]Hospital for Joint Diseases, NYU Langone Medical Center, New York, NY, USA
                [8 ]Ringgold 1259, universityUniversity of Michigan; , Ann Arbor, MI, USA
                [9 ]Ringgold 21772, universityUniversity of California, Davis Medical Center; , Sacramento, CA, USA
                [10 ]Ringgold 2345, universityMedical University of South Carolina; , Charleston, SC, USA
                [11 ]Inland Neurosurgery and Spine Associates, Spokane, WA, USA
                Author notes
                [*]Jonathan A. Harris, Globus Medical, Inc, 2560 General Armistead Avenue, Audubon, PA 19403, USA. Email: jharris@ 123456globusmedical.com
                Author information
                https://orcid.org/0000-0002-8073-0796
                https://orcid.org/0000-0002-7077-5480
                https://orcid.org/0000-0002-8580-0706
                Article
                10.1177_2192568219879083
                10.1177/2192568219879083
                7485081
                32905729
                b74f7396-c496-4c92-bb1b-223e28bd4c57
                © The Author(s) 2019

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 License ( https://creativecommons.org/licenses/by-nc-nd/4.0/) which permits non-commercial use, reproduction and distribution of the work as published without adaptation or alteration, without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

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                cadaveric,computer-assisted navigation,surgical robotics,pedicle screws,screw accuracy

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