Biomechanical Design and Validation of a Novel Elliptical Sleeve Pedicle Screw for Enhanced Spinal Fixation Stability

This study aimed to develop a novel modular pedicle screw system incorporating an elliptical sleeve to conform the pedicle’s elliptical cross-section and enhance fixation strength with mechanical stability. The biomechanical evaluation was conducted based on fundamental mechanics principles, followe...

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Main Authors: Ting-Shuo Hsu, Chang-Jung Chiang, Hsuan-Wen Wang, Yu-San Chen, Chun-Li Lin
Format: Article
Language:English
Published: MDPI AG 2025-06-01
Series:Bioengineering
Subjects:
Online Access:https://www.mdpi.com/2306-5354/12/6/668
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author Ting-Shuo Hsu
Chang-Jung Chiang
Hsuan-Wen Wang
Yu-San Chen
Chun-Li Lin
author_facet Ting-Shuo Hsu
Chang-Jung Chiang
Hsuan-Wen Wang
Yu-San Chen
Chun-Li Lin
author_sort Ting-Shuo Hsu
collection DOAJ
description This study aimed to develop a novel modular pedicle screw system incorporating an elliptical sleeve to conform the pedicle’s elliptical cross-section and enhance fixation strength with mechanical stability. The biomechanical evaluation was conducted based on fundamental mechanics principles, followed by a finite element (FE) analysis to assess stress distribution under compressive and torsional loads. Subsequently, mechanical testing was performed to evaluate static and fatigue bending performance and in vitro biomechanical fatigue in porcine vertebrae by pull-out testing after 5000 and 100,000 cycles to assess fixation stability. The FE analysis demonstrated that the elliptical sleeve design improved bending resistance by 1.21× and torsional resistance by 1.91× compared to conventional cylindrical screws. Mechanical testing revealed greater bending/torsion stiffness and fatigue resistance, with the elliptical sleeve screw withstanding 5 million cycles at 235.4 N, compared to 175.46 N for cylindrical screws. Biomechanical pull-out testing further confirmed significantly higher retention strength after 100,000 cycles (1229.75 N vs. 867.83 N, <i>p</i> = 0.0101), whereas cylindrical screws failed prematurely at 10,663 cycles due to excessive displacement (>2 mm). The elliptical sleeve pedicle screw system demonstrated enhanced fixation strength, reduced micromotion, and superior fatigue resistance, making it a promising alternative to conventional pedicle screws for improving long-term spinal fixation stability.
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spelling doaj-art-0a3f44a228c84ab8b59f86f35e32bacf2025-06-25T13:30:08ZengMDPI AGBioengineering2306-53542025-06-0112666810.3390/bioengineering12060668Biomechanical Design and Validation of a Novel Elliptical Sleeve Pedicle Screw for Enhanced Spinal Fixation StabilityTing-Shuo Hsu0Chang-Jung Chiang1Hsuan-Wen Wang2Yu-San Chen3Chun-Li Lin4Department of Biomedical Engineering, National Yang Ming Chiao Tung University, Taipei 112304, TaiwanDepartment of Orthopaedics, Shuang Ho Hospital, Taipei Medical University, New Taipei City 235041, TaiwanDepartment of Biomedical Engineering, National Yang Ming Chiao Tung University, Taipei 112304, TaiwanDepartment of Biomedical Engineering, National Yang Ming Chiao Tung University, Taipei 112304, TaiwanDepartment of Biomedical Engineering, National Yang Ming Chiao Tung University, Taipei 112304, TaiwanThis study aimed to develop a novel modular pedicle screw system incorporating an elliptical sleeve to conform the pedicle’s elliptical cross-section and enhance fixation strength with mechanical stability. The biomechanical evaluation was conducted based on fundamental mechanics principles, followed by a finite element (FE) analysis to assess stress distribution under compressive and torsional loads. Subsequently, mechanical testing was performed to evaluate static and fatigue bending performance and in vitro biomechanical fatigue in porcine vertebrae by pull-out testing after 5000 and 100,000 cycles to assess fixation stability. The FE analysis demonstrated that the elliptical sleeve design improved bending resistance by 1.21× and torsional resistance by 1.91× compared to conventional cylindrical screws. Mechanical testing revealed greater bending/torsion stiffness and fatigue resistance, with the elliptical sleeve screw withstanding 5 million cycles at 235.4 N, compared to 175.46 N for cylindrical screws. Biomechanical pull-out testing further confirmed significantly higher retention strength after 100,000 cycles (1229.75 N vs. 867.83 N, <i>p</i> = 0.0101), whereas cylindrical screws failed prematurely at 10,663 cycles due to excessive displacement (>2 mm). The elliptical sleeve pedicle screw system demonstrated enhanced fixation strength, reduced micromotion, and superior fatigue resistance, making it a promising alternative to conventional pedicle screws for improving long-term spinal fixation stability.https://www.mdpi.com/2306-5354/12/6/668pedicle screwellipsepull-outbiomechanicsfatigue
spellingShingle Ting-Shuo Hsu
Chang-Jung Chiang
Hsuan-Wen Wang
Yu-San Chen
Chun-Li Lin
Biomechanical Design and Validation of a Novel Elliptical Sleeve Pedicle Screw for Enhanced Spinal Fixation Stability
Bioengineering
pedicle screw
ellipse
pull-out
biomechanics
fatigue
title Biomechanical Design and Validation of a Novel Elliptical Sleeve Pedicle Screw for Enhanced Spinal Fixation Stability
title_full Biomechanical Design and Validation of a Novel Elliptical Sleeve Pedicle Screw for Enhanced Spinal Fixation Stability
title_fullStr Biomechanical Design and Validation of a Novel Elliptical Sleeve Pedicle Screw for Enhanced Spinal Fixation Stability
title_full_unstemmed Biomechanical Design and Validation of a Novel Elliptical Sleeve Pedicle Screw for Enhanced Spinal Fixation Stability
title_short Biomechanical Design and Validation of a Novel Elliptical Sleeve Pedicle Screw for Enhanced Spinal Fixation Stability
title_sort biomechanical design and validation of a novel elliptical sleeve pedicle screw for enhanced spinal fixation stability
topic pedicle screw
ellipse
pull-out
biomechanics
fatigue
url https://www.mdpi.com/2306-5354/12/6/668
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AT yusanchen biomechanicaldesignandvalidationofanovelellipticalsleevepediclescrewforenhancedspinalfixationstability
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