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      Construction and Accuracy Assessment of Patient-Specific Biocompatible Drill Template for Cervical Anterior Transpedicular Screw (ATPS) Insertion: An In Vitro Study

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          Abstract

          Background

          With the properties of three-column fixation and anterior-approach-only procedure, anterior transpedicular screw (ATPS) is ideal for severe multilevel traumatic cervical instabilities. However, the accurate insertion of ATPS remains challenging. Here we constructed a patient-specific biocompatible drill template and evaluated its accuracy in assisting ATPS insertion.

          Methods

          After ethical approval, 24 formalin-preserved cervical vertebrae (C2–C7) were CT scanned. 3D reconstruction models of cervical vertebra were obtained with 2-mm-diameter virtual pin tracts at the central pedicles. The 3D models were used for rapid prototyping (RP) printing. A 2-mm-diameter Kirschner wire was then inserted into the pin tract of the RP model before polymethylmethacrylate was used to construct the patient-specific biocompatible drill template. After removal of the anterior soft tissue, a 2-mm-diameter Kirschner wire was inserted into the cervical pedicle with the assistance of drill template. Cadaveric cervical spines with pin tracts were subsequently scanned using the same CT scanner. A 3D reconstruction was performed of the scanned spines to get 3D models of the vertebrae containing the actual pin tracts. The deviations were calculated between 3D models with virtual and actual pin tracts at the middle point of the cervical pedicle. 3D models of 3.5 mm-diameter screws were used in simulated insertion to grade the screw positions.

          Findings

          The patient-specific biocompatible drill template was constructed to assist ATPS insertion successfully. There were no significant differences between medial/lateral deviations ( P = 0.797) or between superior/inferior deviations ( P = 0.741). The absolute deviation values were 0.82±0.75 mm and 1.10±0.96 mm in axial and sagittal planes, respectively. In the simulated insertion, the screws in non-critical position were 44/48 (91.7%).

          Conclusions

          The patient-specific drill template is biocompatible, easy-to-apply and accurate in assisting ATPS insertion. Its clinical applications should be further researched.

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          Most cited references30

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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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            Cervical pedicle screws versus lateral mass screws. Anatomic feasibility and biomechanical comparison.

            Biomechanical comparison of the pull-out strengths of lateral mass and pedicle screws in the human cervical spine. Measurements of pedicle dimensions and orientation were compiled. To determine if transpedicular screws provide greater pull-out resistance than lateral mass screws and to investigate the anatomic feasibility of pedicle screw insertion. Cervical pedicle screws have been reported in limited clinical and biomechanical studies, and some quantitative cervical pedicle anatomy has been reported. No direct biomechanical comparisons have been made between lateral mass and pedicle screws. Fifty-six fresh disarticulated human vertebrae (C2-C7) were evaluated with computed tomography to determine morphometry and vertebral body bone density. Lateral mass and pedicle screws were randomized to left versus right. A 3.5-mm cortical screw was used for both techniques, unless a pedicle was narrower than 5.0 mm; then a 2.7-mm cortical screw was used instead. Pedicle wall violations were recorded. Screws were subjected to a uniaxial load to failure. Mean pedicle height, width, and angle with respect to the vertebral midline were tabulated for each level. The mean load-to-failure was 677 N for the cervical pedicle screws and 355 N for the lateral mass screws. No significant correlations for either screw type were found between pull-out strength and bone density, screw length, or vertebral level. Pedicle and lateral mass dimensions were highly variable and not predictive of pull-out strength. Seven (13%) minor pedicle wall violations were observed. Cervical pedicle screws demonstrated a significantly higher resistance to pull-out forces than did lateral mass screws. The variability in pedicle morphometry and orientation requires careful preoperative assessment to determine the suitability of pedicle screw insertion.
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              A novel patient-specific navigational template for cervical pedicle screw placement.

              STUDY DESIGN.: Prospective trial. OBJECTIVE.: To develop and validate a novel, patient-specific navigational template for cervical pedicle placement. SUMMARY OF BACKGROUND DATA.: Owing to the narrow bony anatomy and the proximity to the vertebral artery and the spinal cord, cervical instrumentation procedures demand the need for a precise technique for screw placement. PATIENT.: Specific drill template with preplanned trajectory has been thought as a promising solution for cervical pedicle screw placement. METHODS.: Patients with cervical spinal pathology (n = 25) requiring instrumentation were recruited. Volumetric CT scan was performed on each desired cervical vertebra and a 3-dimensional reconstruction model was generated from the scan data. Using reverse engineering technique, the optimal screw size and orientation were determined and a drill template was designed with a surface that is the inverse of the posterior vertebral surface. The drill template and its corresponding vertebra were manufactured using rapid prototyping technique and tested for violations. The navigational template was sterilized and used intraoperatively to assist with the placement of cervical screws. In total, 88 screws were inserted into levels C2-C7 with 2 to 6 screw in each patient. After surgery, the positions of the pedicle screws were evaluated using CT scan and graded for validation. RESULTS.: This method showed its ability to customize the placement and the size of each screw based on the unique morphology of the cervical vertebra. In all the cases, it was relatively very easy to manually place the drill template on the lamina of the vertebral body during the surgery. The required time between fixation of the template to the lamina and insertion of the pedicle screws was about 80 seconds. Of the 88 screws, 71 screws had no deviation and 14 screws had deviation <2 mm, 1 screw had a deviation between 2 to 4 mm and there were no misplacements. Fluoroscopy was used only once for every patient after the insertion of all the pedicle screws. CONCLUSION.: The authors have developed a novel patient-specific navigational template for cervical pedicle screw placement with good applicability and high accuracy. This method significantly reduces the operation time and radiation exposure for the members of the surgical team. The potential use of such a navigational template to insert cervical pedicle screws is promising. This technique has been clinically validated to provide an accurate trajectory for pedicle screw placement in the cervical spine.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2013
                10 January 2013
                : 8
                : 1
                : e53580
                Affiliations
                [1 ]Department of Anatomy, Guangdong Provincial Key laboratory of Medical Biomechanics, School of Basic Medicine Science, Southern Medical University, Guangzhou, Guangdong, China
                [2 ]Department of Orthopedics, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China
                Southern Medical University, China
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: JL MF JO. Performed the experiments: MF LL XK. Analyzed the data: JL MF. Contributed reagents/materials/analysis tools: LL WZ LT JO. Wrote the paper: JL MF.

                Article
                PONE-D-12-28004
                10.1371/journal.pone.0053580
                3542371
                23326461
                7fe9f5ee-8c5a-4a08-a27f-c97bf2e16889
                Copyright @ 2013

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 13 September 2012
                : 3 December 2012
                Page count
                Pages: 8
                Funding
                Projects 6110920, 6110922 and 6110923 were supported by National Natural Science Foundation of China ( http://www.nsfc.gov.cn). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Biology
                Anatomy and Physiology
                Musculoskeletal System
                Bone
                Engineering
                Bioengineering
                Biomedical Engineering
                Medical Devices
                Medicine
                Anatomy and Physiology
                Musculoskeletal System
                Bone
                Drugs and Devices
                Medical Devices
                Surgery
                General Surgery
                Orthopedic Surgery

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