The Compress® transcutaneous implant for rehabilitation following limb amputation
The Compress® transcutaneous implant for rehabilitation following limb amputation
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DOI：
10.1007/s00113-017-0339-9
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发表时间：
2017-04-01
期刊：
影响因子：
--
通讯作者：
Lindsey, B.
中科院分区：
文献类型：
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作者：
McGough, R. L.;Goodman, M. A.;Lindsey, B.
截肢是各种骨科疾病的不幸结果。许多截肢者可以在功能上安装传统的悬挂插座。然而，一个重要的子集，这种传统的治疗失败，不能发挥作用。在欧洲，替代接受腔假体的方法已经存在了25年。在那里，无法使用功能性窝修复体的患者可以进行经皮骨整合。通过这项技术，假肢可以牢固地连接到残骨上，并且消除了承窝，在许多情况下可以改善功能和患者满意度。在美国，监管障碍极大地限制了经皮骨整合的采用和接受。CompressA（R）器械是作为大块内假体（如股骨远端置换）的替代固定方法而开发的。设计独特的假体牢固地固定在皮质骨的末端，然后承受较大的轴向应力。然后，骨贪婪地生长到装置中，提供永久的骨整合。我们最近将该器械用于经皮使用。这些程序已在美国根据海关监管进行。结果令人鼓舞，我们正计划在不久的将来开始一项监管试验。
Amputation is an unfortunate outcome of a variety of orthopedic conditions. Many amputees can be functionally fitted with conventional suspension sockets. A substantial subset, however, fails this conventional treatment and is unable to function. In Europe, an alternative to socket-based prostheses has been available for 25 years. Patients there who are unable to functionally use socket-based prostheses have been offered the possibility for transcutaneous osseointegration. With this technology, the prosthetic limb can be rigidly attached to the residual bone, and the socket is eliminated, in many cases enabling improved function and patient satisfaction. In the United States, regulatory barriers have greatly limited the adoption and acceptance of transdermal osseointegration. The CompressA (R) device was developed as an alternate means of fixation for massive endoprostheses, such as distal femoral replacements. A uniquely designed prosthesis is rigidly anchored to the end of the cortical bone and is then subjected to a large axial stress. The bone then grows avidly into the device, providing permanent osseointegration. We have recently adopted this device for transcutaneous use. These procedures have been performed in the United States on a custom regulatory basis. Results of this have been encouraging, and we are planning to begin a regulatory trial in the near future.