Preclinical testing of total shoulder replacements

在金属对金属髋关节崩溃之后，对植入式器械的临床前测试的审查正在加强，以更好地复制体内条件。注意力集中在髋关节和膝关节器械及其已建立的（尽管有限）ISO/ASTM方案上。TSR是自然关节退化或创伤患者的一种新兴治疗选择（英国：50，255 2012-2020）。然而，磨损/降解的临床前测试标准不存在或无法复制临床观察到的失效模式。目的：将我们对器械失效模式的理解转化为TSR。根据外科医生、行业和学术界的意见，将提供一种考虑失效模式和退化的植入物测试新理念（超越基准）。

Following the metal-on-metal hip debacle scrutiny is intensifying on preclinical testing of implantable devices to better replicate the in-vivo condition. Attention has focussed on hip and knee devices and their established, albeit limited, ISO/ASTM protocols. TSR is an emerging treatment option for patients with natural joint degradation or trauma (UK:50,255 2012-2020). Yet, preclinical testing standards for wear/degradation do not exist or fail to replicate clinically-observed failure modes. Aim: To translate our understanding of device failure modes to TSR. Taking input from surgeons, industry and academics, a new philosophy to implant testing (beyond-benchmarking) considering failure modes and degradation will be delivered.