U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Applied Mechanics.
U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Clinical Evidence and Analysis, Division of Clinical Evidence and Analysis 2.
Med Eng Phys. 2020 Oct;84:103-114. doi: 10.1016/j.medengphy.2020.08.005. Epub 2020 Aug 18.
Establishing normative and outlying loads on transfemoral osseointegrated devices will assist development of preclinical mechanical testing strategies to inform manufacturers and government regulators. Therefore, force and moment data from osseointegrated transfemoral transcutaneous implants were collated to better understand baseline load levels. Load data were also collected from other devices including transfemoral socket prostheses, instrumented hip stems, instrumented knee devices, instrumented limb salvage femoral endoprostheses, as well as estimated loads on transfemoral prostheses using data from able-bodied subjects. These additional data were assessed for their ability to bolster the limited osseointegrated device data. Several activities of daily living were investigated to characterize normative loading. Falling events were investigated to characterize outlying loads. Results revealed that limited loading data exist for osseointegrated devices. The most often reported activity was level walking. While these normative data may inform fatigue testing, they may not fully characterize fatigue loads during all activities of daily living. Socket prosthetics and able-bodied individuals may provide supplementary data, but significance is limited by sample sizes. Falling data are sparse, and insufficient data exist for characterizing adverse loads on osseointegrated devices. Future data collection should include more activities of daily living and adverse events to better define osseointegrated device loading profiles.
建立股骨骨整合式穿皮植入物的规范和异常负荷将有助于制定临床前机械测试策略，为制造商和政府监管机构提供信息。因此，对股骨骨整合式穿皮植入物的力和力矩数据进行了整理，以更好地了解基线负荷水平。还从其他设备收集了负荷数据，包括股骨 socket 假肢、带仪器的髋部假体、带仪器的膝关节假体、带仪器的肢体保肢股骨假体，以及使用健全受试者的数据估计股骨假体的负荷。评估了这些额外的数据，以确定它们是否能增强有限的骨整合式设备数据。进行了多项日常活动以确定正常负荷，研究了跌倒事件以确定异常负荷。结果表明，骨整合式设备的负荷数据有限。最常报告的活动是水平行走。虽然这些正常数据可以为疲劳测试提供信息，但它们可能无法完全描述所有日常活动中的疲劳负荷。socket 假肢和健全人可能提供补充数据，但由于样本量有限，其意义有限。跌倒数据稀缺，用于描述骨整合式设备不良负荷的数据不足。未来的数据收集应包括更多的日常活动和不良事件，以更好地定义骨整合式设备的负荷曲线。
