Sugano Nobuhiko, Iida Hirokazu, Akiyama Haruhiko, Takatori Yoshio, Nagoya Satoshi, Hasegawa Masahiro, Kabata Tamon, Hachiya Yudo, Yasunaga Yuji
Department of Orthopaedic Medical Engineering, Osaka University Graduate School of Medicine, Yamadaoka 2-2 Suita, Osaka, 565-0871, Japan,
J Orthop Sci. 2014 Jan;19(1):85-9. doi: 10.1007/s00776-013-0490-2. Epub 2013 Dec 12.
Adverse reactions to metal debris (ARMD) after receiving metal-on-metal (MoM) hip implants is a recent concern. However, no epidemiologic study has examined ARMD for MoM hip implants in Japan. The purposes of this study were to research the incidence of ARMD and to identify poorly performing MoM hip implants in Japan.
From 2000 to 2011, 7 companies provided 23,226 MoM implants in Japan. A questionnaire regarding ARMD was sent to 101 hospitals at which 62% of the 23,226 MoM implants had been used.
Replies to the questionnaire were received from 82 hospitals. In these hospitals, surface hip replacement types (SRs) were used in 606 hips and stemmed types were used in 12,961 hips. ARMD were reported in 3 hips (0.5%) with SRs and 160 hips (1.2%) with stemmed types. ARMD in the 3 hips with SRs were asymptomatic and no revisions were performed. Among AMRD with stemmed implants, revision was performed in 83 hips and excision of an ARMD lesion was performed in 3 hips. The remaining 74 hips were asymptomatic and careful follow-up was continued. A significant difference in reoperation rate was evident between SRs (0%) and stemmed types (0.7%). Incidences of ARMD were significantly higher with Ultamet (P = 0.005), Conserve (P < 0.001), and Cormet (P < 0.001) MoM bearing couples than with Metasul bearings.
The incidence of ARMD in large surgical volume hospitals in Japan from 2000 to 2011 was estimated to be 0.5% with SRs and 1.2% with stemmed types. The reoperation rate was significantly higher with stemmed types than with SRs. Three brands of MoM stemmed implants were identified as showing a higher incidence of ARMD.
接受金属对金属（MoM）髋关节植入物后出现金属碎屑不良反应（ARMD）是近期备受关注的问题。然而，日本尚无流行病学研究对MoM髋关节植入物的ARMD进行调查。本研究的目的是调查日本ARMD的发生率，并确定性能不佳的MoM髋关节植入物。
2000年至2011年期间，7家公司在日本提供了23226例MoM植入物。一份关于ARMD的调查问卷被发送至101家医院，这101家医院使用了23226例MoM植入物中的62%。
收到了82家医院对问卷的回复。在这些医院中，606髋使用了表面髋关节置换类型（SRs），12961髋使用了柄型。报告有ARMD的病例中，SRs类型有3髋（0.5%），柄型有160髋（1.2%）。3例SRs类型的ARMD病例无症状，未进行翻修手术。在柄型植入物的ARMD病例中，83髋进行了翻修手术，3髋进行了ARMD病变切除手术。其余74髋无症状，继续进行密切随访。SRs类型（0%）和柄型（0.7%）的再次手术率存在显著差异。与Metasul轴承相比，Ultamet（P = 0.005）、Conserve（P < 0.001）和Cormet（P < 0.001）MoM轴承配对的ARMD发生率显著更高。
据估计，2000年至2011年期间，日本大型手术量医院中，SRs类型的ARMD发生率为0.5%，柄型为1.2%。柄型的再次手术率显著高于SRs类型。已确定三种品牌的MoM柄型植入物显示出较高的ARMD发生率。
