Preclinical testing of total shoulder replacements

在金属对金属髋关节崩溃之后，对可植入设备的临床前测试正在加紧审查，以更好地复制体内情况。人们的注意力集中在髋关节和膝部设备及其已建立的、尽管有限的ISO/ASTM协议上。TSR是一种新兴的关节自然退化或创伤患者的治疗选择(英国：50,255 2012-2020)。然而，磨损/退化的临床前测试标准并不存在，或者无法复制临床观察到的故障模式。目的：将我们对设备故障模式的理解转化为TSR。从外科医生、工业界和学术界获得意见，将提出一种考虑故障模式和退化的植入测试(超越基准)的新理念。

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.