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MAGEC X型磁性控制生长棒是否优于早期设计:一项取出物研究。

Is MAGEC X better than earlier designs of magnetically controlled growing rod: an explant study.

作者信息

Joyce Thomas J, Kandemir Goksu, Fender David, Bowey Andrew J, Rushton Paul R P

机构信息

School of Engineering, Newcastle University, Newcastle Upon Tyne, NE1 7RU, UK.

Great North Children's Hospital, Newcastle Upon Tyne, UK.

出版信息

Eur Spine J. 2025 Jan;34(1):244-250. doi: 10.1007/s00586-024-08546-6. Epub 2024 Nov 5.

DOI:10.1007/s00586-024-08546-6
PMID:39499295
Abstract

PURPOSE

Determine the performance of MAGEC X rods through retrieval analysis and comparison with clinical data.

METHODS

A multicentre explant database was searched to identify cases using MAGEC X device. Clinical and surgical data was gathered prospectively. Prior to rod disassembly, rods underwent testing with an external remote controller to measure the force output.

RESULTS

Eleven cases from 6 centres were identified. Implantation occurred at mean age 6.9 years with mean duration of implantation 42 months. Dual rod constructs were used in all but one case, providing 21 MAGEC X rods for explant analysis. Tissue metallosis was identified at revision surgery in 8/11 cases (73%). Of the 21 rods, 13/21 (62%) produced no force while 8/21 (38%) produced the force stated by the manufacturer. Endcap separation was seen in 5/21 (24%) rods. Where full disassembly was possible, 13/14 (93%) rods had an intact locking pin. Average rod growth was 18 mm (range 2-45 mm), equivalent to 5.1 mm per year. Wear debris was found within 20/21 (95%) MAGEC X rods.

CONCLUSION

Despite the substantial design changes with MAGEC X tissue metallosis was seen in most cases; most explanted MAGEC X rods had lengthened only partially and produced no force output. While the previous issue of locking pin fracture appears to have been mitigated with MAGEC X, there are multiple other and new failure modes, such as endcap separation. Overall MAGEC X appears to give little improvement over earlier iterations of the rod.

摘要

目的

通过取出分析并与临床数据比较,确定MAGEC X棒的性能。

方法

检索多中心取出物数据库,以确定使用MAGEC X装置的病例。前瞻性收集临床和手术数据。在拆卸棒之前,使用外部遥控器对棒进行测试以测量力输出。

结果

确定了来自6个中心的11例病例。植入时的平均年龄为6.9岁,平均植入持续时间为42个月。除1例病例外,其余均使用双棒结构,共提供21根MAGEC X棒用于取出分析。在翻修手术中,11例中有8例(73%)发现组织金属沉着症。在21根棒中,13/21(62%)未产生力,而8/21(38%)产生了制造商规定的力。21根棒中有5根(24%)出现端帽分离。在可能进行完全拆卸的情况下,14根棒中有13根(93%)的锁定销完好无损。棒的平均生长长度为18毫米(范围为2 - 45毫米),相当于每年5.1毫米。在21根MAGEC X棒中的20根(95%)内发现了磨损碎屑。

结论

尽管MAGEC X有重大设计变更,但大多数病例仍出现组织金属沉着症;大多数取出的MAGEC X棒仅部分延长且无力输出。虽然MAGEC X似乎缓解了先前锁定销断裂的问题,但存在多种其他新的失效模式,如端帽分离。总体而言,MAGEC X相比该棒的早期版本似乎没有太大改进。

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本文引用的文献

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Complications and Health-Related Quality of Life in Children with Various Etiologies of Early-Onset Scoliosis Treated with Magnetically Controlled Growing Rods-A Multicenter Study.磁控生长棒治疗不同病因早发性脊柱侧凸儿童的并发症及健康相关生活质量——一项多中心研究
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Serum Titanium Levels Remain Elevated But Urine Titanium is Undetectable in Children With Early Onset Scoliosis Undergoing Growth-Friendly Surgical Treatment: A Prospective Study.接受生长友好型手术治疗的早发性脊柱侧弯儿童血清钛水平仍升高但尿液钛无法检测:一项前瞻性研究
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The Evaluation of Serum Metal Ion Levels and Metallosis in Graduated Patients With Magnetically Controlled Growing Rods.
磁控生长棒治疗后毕业患者血清金属离子水平及金属沉着病的评估
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The evolving stall rate of magnetically controlled growing rods beyond 2 years follow-up.磁控生长棒 2 年以上随访时的生长速度变化。
Spine Deform. 2023 Mar;11(2):487-493. doi: 10.1007/s43390-022-00622-5. Epub 2022 Nov 29.
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Metallosis is commonly associated with magnetically controlled growing rods; results from an independent multicentre explant database.金属沉着症通常与磁控生长棒有关; 这是一项独立的多中心植入物数据库研究结果。
Eur Spine J. 2021 Jul;30(7):1905-1911. doi: 10.1007/s00586-021-06750-2. Epub 2021 Feb 5.
7
The NuVasive MAGEC Rod Urgent Field Safety Notice Concerning Locking Pin Fracture: How Does Data From an Independent Explant Center Compare?NuVasive MAGEC 棒紧急现场安全通告:锁定销断裂问题——来自独立取出中心的数据如何比较?
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Spinal Lengthening With Magnetically Controlled Growing Rods: Data From the Largest Series of Explanted Devices.脊柱延长术联合磁控生长棒:最大系列取出装置数据。
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