Department of Industrial Engineering, University of Padua, Padua (PD), Italy.
INAIL Prosthetic Center, Vigorso di Budrio (BO), Italy.
Prosthet Orthot Int. 2023 Feb 1;47(1):3-12. doi: 10.1097/PXR.0000000000000222. Epub 2023 Feb 9.
BACKGROUND: The advent of novel manufacturing technologies, materials, and socket design concepts could introduce risks to prosthetic limb users, as the existing knowledge base for safe fabrication may not apply. Moreover, although structural test standards exist for mass-produced prosthetic components, they are not applicable to prosthetic sockets. METHODS: The "AOPA Socket Guidance Workgroup" was formed in 2020 to provide the prosthetic community with evidence-based clinical best practices and methods in the field of prosthetic socket structural analysis. This multidisciplinary expert workgroup undertook a critical analysis of the knowledge gaps regarding the requirements for mechanical testing of lower limb prosthetic sockets. RESULTS: The Workgroup identified knowledge gaps in 4 domains. Domain 1 describes the shape and composition of a mock residual limb, required to support and generate in vivo representative loading within the socket. Domain 2 concerns prosthetic socket coordinate systems and alignment. Domain 3 regards the components and requirements of test specimens. Finally, Domain 4 considers test conditions, loading parameters, and acceptance criteria. CONCLUSIONS: This paper describes these knowledge gaps in detail and recommends potential solution approaches based on literature review, group consensus around existing knowledge, or the formation of new study groups to fill each knowledge gap. Our intent is for the recommendations arising from this paper to support the community (e.g., researchers in the clinic, academia, industry, and funders) in addressing these knowledge gaps.
背景:新型制造技术、材料和插座设计理念的出现可能会给假肢使用者带来风险,因为现有的安全制造知识库可能并不适用。此外,尽管存在大量生产的假肢部件的结构测试标准,但它们不适用于假肢插座。
方法:2020 年成立了“AOPA 插座指导工作组”,为假肢社区提供假肢插座结构分析领域的循证临床最佳实践和方法。这个多学科专家工作组对下肢假肢插座机械测试要求的知识空白进行了批判性分析。
结果:工作组在 4 个领域确定了知识空白。第 1 个领域描述了模拟残肢的形状和组成,这是在插座内支撑和产生体内代表性负载所必需的。第 2 个领域涉及假肢插座坐标系和对准。第 3 个领域涉及测试标本的组成部分和要求。最后,第 4 个领域考虑了测试条件、加载参数和验收标准。
结论:本文详细描述了这些知识空白,并根据文献综述、围绕现有知识的小组共识,或形成新的研究小组来填补每个知识空白,推荐了潜在的解决方案方法。我们的目的是希望本文提出的建议能够支持社区(例如,临床、学术界、行业和资助者中的研究人员)解决这些知识空白。
Clin Orthop Relat Res. 2025-1-24
Med Eng Phys. 2022-1
Health Technol Assess. 2001
Clin Orthop Relat Res. 2025-2-19
Prosthet Orthot Int. 2024-4-1
Can Prosthet Orthot J. 2023-12-22
Med Eng Phys. 2022-1
Materials (Basel). 2020-9-7
Prosthet Orthot Int. 2012-6