Tognini Martina, Hothi Harry, Bergiers Sean, Shafafy Masood, Tucker Stewart, Broomfield Edel, Henckel Johann, Hart Alister
The Royal National Orthopaedic Hospital and Institute of Orthopaedics and Musculoskeletal Science, University College London, Stanmore, UK.
Department of Trauma and Orthopaedics, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Global Spine J. 2024 Jan;14(1):122-129. doi: 10.1177/21925682221096340. Epub 2022 Apr 21.
Multicentre comparative analysis of explanted Spine Magnetically Controlled Growing Rods (MCGRs).
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.
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.
Rod distraction reached in vivo was significantly higher in the MAGEC 1.3 ( = .002). There was no statistically significant difference in the total external damage score ( = .870), maximum force produced ( = .695) or distraction reached during force test ( = .880). No pin fracture was detected. Elongation of stroke was mildly higher ( = .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.
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.
对取出的脊柱磁控生长棒（MCGRs）进行多中心比较分析。
MAGEC X是最新的商用型号，由于植入后致动器端盖部件分离的风险，于2020年被召回。目前，英国和欧盟已暂时停止所有MAGEC棒的供应。本研究的目的是通过取出分析比较MAGEC X MCGR与早期MAGEC 1.3设计迭代产品的性能。
在取出手术后，从五家不同医院连续收集15根MAGEC X和15根MAGEC 1.3棒，并按取出时间进行匹配。收集所有MCGR的临床和植入数据。分析包括对外部损伤的视觉评估、X线平片评估、力和伸长测试、MAGEC X端盖扭矩测试及拆解。采用曼-惠特尼U检验进行组间统计学比较。
MAGEC 1.3在体内达到的棒撑开程度显著更高（P = .002）。在总外部损伤评分（P = .870）、产生的最大力（P = .695）或力测试期间达到的撑开程度（P = .880）方面，无统计学显著差异。未检测到销钉骨折。MAGEC X植入物的行程伸长略高（P = .051）。一根MAGEC X有明显的端盖部件松动。MAGEC X组的内部损伤评分略低。
MAGEC X的性能结果与先前的设计迭代产品MAGEC 1.3相似。观察到端盖部件松动，但对内部机制无重大影响。
