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The design and fitting of prosthetic sockets can significantly affect the acceptance of an artificial limb by persons with lower limb amputations. Clinical fitting is typically an iterative process, which requires patients’ feedback and professional assessment. When feedback is unreliable due to the patient’s physical or psychological conditions, quantitative measures can support decision-making. Specifically, monitoring the skin temperature of the residual limb can provide valuable information regarding unwanted mechanical stresses and reduced vascularization, which can lead to inflammation, skin sores and ulcerations. Multiple 2D images to examine a real-life 3D limb can be cumbersome and might only offer a partial assessment of critical areas. To overcome these issues, we developed a workflow for integrating thermographic information on the 3D scan of a residual limb, with intrinsic reconstruction quality measures. Specifically, workflow allows us to calculate a 3D thermal map of the skin of the stump at rest and after walking, and summarize this information with a single 3D differential map. The workflow was tested on a person with transtibial amputation, with a reconstruction accuracy lower than 3 mm, which is adequate for socket adaptation. We expect the workflow to improve socket acceptance and patients’ quality of life.

DisclaimerThe opinions expressed in the article are the authors' and do not reflect the views of the Department of Veterans Affairs or the US Government. AcknowledgmentsThe AOPA Socket Guidance Workgroup kindly acknowledges the ISO/TC 168 (Prosthetics and Orthotics) WG3 (Testing) for their comments during the preparation of this manuscript. The Workgroup also acknowledges Susannah Engdahl for her commitment as Workgroup Manager, Jeffrey Erenstone for leading the Workgroup activities as Chair, and Joe McTernan for the support to the Workgroup.

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.