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The Performance of MAGEC X Spine Rods: A Comparative Retrieval Study

Tognini, Martina; Hothi, Harry; Bergiers, Sean; Shafafy, Masood; Tucker, Stewart; Broomfield, Edel; Henckel, Johann; (2022) The Performance of MAGEC X Spine Rods: A Comparative Retrieval Study. Global Spine Journal 10.1177/21925682221096340. (In press). Green open access

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Abstract

Study Design: Multicentre comparative analysis of explanted Spine Magnetically Controlled Growing Rods (MCGRs). Objectives: MAGEC X, the latest commercially available generation, was recalled in 2020 due to the risk of post-implantation separation of an actuator end-cap component. Currently, the supply of all MAGEC rods was temporarily suspended in the UK and the EU. Objective of this study is to compare the performance of the MAGEC X MCGR to the earlier MAGEC 1.3 design iteration, by means of retrieval analysis. Methods: Fifteen of both MAGEC X and MAGEC 1.3 rods were consecutively collected from five different hospitals following removal surgery and matched by time to removal. Clinical and implant data was collected for all MCGRs. Analysis comprised visual assessments of external damage, plain radiograph evaluations, force and elongation testing, MAGEC X end-cap torque testing and disassembly. Mann-Whitney U tests were used to statistically compare groups. Results: Rod distraction reached in vivo was significantly higher in the MAGEC 1.3 (P =.002). There was no statistically significant difference in the total external damage score (P =.870), maximum force produced (P =.695) or distraction reached during force test (P =.880). No pin fracture was detected. Elongation of stroke was mildly higher (P =.051) for the MAGEC X implants. One MAGEC X had evident end cap component loosening. Internal damage scores were mildly lower in the MAGEC X group. Conclusion: MAGEC X showed similar performance results than the previous design iteration MAGEC 1.3. End-cap component loosening was observed, with no major consequences on the internal mechanism.

Type: Article
Title: The Performance of MAGEC X Spine Rods: A Comparative Retrieval Study
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1177/21925682221096340
Publisher version: https://doi.org/10.1177/21925682221096340
Language: English
Additional information: https://creativecommons.org/licenses/by-nc-nd/4.0/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).
Keywords: Science & Technology, Life Sciences & Biomedicine, Clinical Neurology, Orthopedics, Neurosciences & Neurology, magnetically controlled growing rod, MAGEC X, retrieval analysis, CONTROLLED GROWING RODS, COMPLICATIONS
UCL classification: UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Mechanical Engineering
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Surgery and Interventional Sci > Department of Ortho and MSK Science
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Surgery and Interventional Sci
URI: https://discovery.ucl.ac.uk/id/eprint/10149597
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