Joyce Thomas J, Kandemir Goksu, Fender David, Bowey Andrew J, Rushton Paul R P
School of Engineering, Newcastle University, Newcastle Upon Tyne, NE1 7RU, UK.
Great North Children's Hospital, Newcastle Upon Tyne, UK.
Eur Spine J. 2025 Jan;34(1):244-250. doi: 10.1007/s00586-024-08546-6. Epub 2024 Nov 5.
Determine the performance of MAGEC X rods through retrieval analysis and comparison with clinical data.
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.
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.
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.
通过取出分析并与临床数据比较,确定MAGEC X棒的性能。
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。
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。
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。