Adverse events involving hallux metatarsophalangeal joint implants: Analysis of the United States Food and Drug Administration data from 2010 to 2018

BackgroundThe prevalence of osteoarthritis of the hallux metatarsophalangeal joint (MTPJ) is 1 in 40 people over the age of 50. Surgical treatment options for MTPJ arthritis include joint preservation, joint resurfacing, and arthrodesis. Hallux MTPJ implants have evolved over the past several decades, but are associated with various complications. The aim of this study was to examine the MAUDE database to determine reported adverse events for hallux MTPJ implants.Materials and methodsThe US Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2010 to 2018 to review voluntary reported adverse event reports for approved implants within the United States. We recorded the type of adverse event and excluded duplicate reports and those extracted from already published literature.ResultsAmong 64 reported hallux MTPJ implant adverse events, the most common modes of adverse events were component loosening (34%), infection (14.1%), component fracture (9.4%), inflammation (9.4%), and allergic reaction (7.8%). Regarding implant type, Cartiva SCI had the highest percentage of adverse events (23.4%), followed by Arthrosurface ToeMotion (20.3%), Ascension MGT (12.5%), Arthrosurface HemiCAP® (10.9%), Futura primus (9.4%), and Osteomed Reflexion (6.3%). There was an increase in reported adverse events after 2016. The MAUDE database does not report the total incidence of implant insertion.ConclusionOur study of the MAUDE database demonstrated that component loosening and infection are the most common modes of adverse events for hallux MTPJ implants. Cartiva accounted for one-fourth of the implant-related adverse events during our study period, followed by ToeMotion, and Ascension MGT implants. Continued reporting of adverse events will improve our understanding on short and long-term complications of various hallux MTPJ implants.Level of evidenceLevel IV; Case Series from Large Database Analysis; Treatment Study.     

膝屈曲状态胫股关节压应力光弹性分析

以胫股关节光弹材料模型模拟膝关节在屈曲０°、１０°、２０°和３０°状态下加载。结果显示胫股间接触面积内髁大于外髁，应力分布外髁大于内髁，最大应力分布于接触部位中心点附近。随着膝关节屈曲角度增加，（１）中心点后移，３０°以内胫股间打滑率内侧为４０．２３％，外侧为４５．９２％；（２）胫骨平台两中心点内移，中心点间距增加；（３）胫股间接触面积减少；（４）应力峰值增加，其增加率远大于面积减少率。实验结果提示膝关节畸形矫正时，要注意恢复胫股间的正常对合与应力分布。     

膝骨关节病的关节镜诊断治疗

目的 通过对79例84膝骨关节病的关节镜诊断治疗回顾性总结,探讨高效率、创伤小、疗效佳的方法。方法 采用关节镜微创技术,结合术前检查对膝骨关节病分为：软骨破坏型,滑膜类型,游离体型及半月板型,依此施行有针对性,局限化手术治疗。结果 69膝得到6mo-3a的随访,按膝关节综合评分表评分,优20％,良59％,可和差21％。结论 该方法具有创伤小、康复快、并发症少等优点,在病损严重的病例,全膝置换或截骨术是进一步提高总体疗效的适宜选择。     

CT scanning and arthroscopic evaluation of patellofemoral malalignment

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双极人工股骨头置换术治疗高龄股骨颈骨折

目的 通过对６６例７０岁以上老年人股骨颈骨折临床分析,探讨其手术可行性、术式选择。方法 回顾分析患者的术前并存症、术前准备、术式选择、麻醉方式、术中情况、术后处理及随诊情况。结果 本组无术中死亡病例,平均住院２８天,平均随访２６个月。良好率６３．６％。结论 ７０岁以上老人股骨颈骨折行双极股骨头置换术治疗是可行的。