Objective: Personalised prosthetic socket design depends upon skilled prosthetists who aim to balance functional human-prosthesis coupling with safe, comfortable load transmission to skin and soft tissues. This study's objective was to assess the comfort of sockets generated from past computer aided socket design records. Design: A crossover non-inferiority trial with embedded qualitative interview study. Setting: Three United Kingdom National Health Service clinics. Participants: Seventeen people with nineteen transtibial amputations. Intervention: Evidence-Generated sockets and conventional clinician-led computer aided (Control) designs Main Measures: Socket Comfort Score and semi-structured interview. Results: Evidence-Generated sockets had no statistically-significant difference in comfort compared to clinician-led Control sockets (p=0.38, effect size=0.08), but a lower socket comfort score variability across the group. Analysis of interviews revealed themes around fitting session experiences, similarities and differences between the Evidence-Generated and Control sockets, and residual limb factors impacting perceptions of socket comfort. These provided insights into the participants' experience of the study and the value of expert prosthetist input in socket design. Conclusions: Evidence-Generated sockets demonstrated noninferiority to conventional clinical computer aided design practice in terms of socket comfort. Both quantitative and qualitative results indicated how clinician input remains essential and is valued by prosthesis users. Work is underway to incorporate the evidence-generated sockets into computer aided design software such that they can act as a digital starting point for modification by expert clinicians at fitting, potentially reducing time spent on basic design, enabling prosthetists to focus on more highly-skilled customisation and co-design with their patients.

Authors FM, MDH, CO, CM, SG, HH, VK have no conflict of interest to declare. Authors JS, JB, CR, AD & PW declare employment and/or shareholding in Radii Devices Ltd. Authors DH, CW, JK, SS, KM, DHS declare employment at Opcare Ltd.

NCT06597266

https://clinicaltrials.gov/study/NCT06597266

This research was funded by the Royal Academy of Engineering (RAEng), grant numbers RF/130 and EF1819\8\24, Innovate UK, grant 10014827, the Higher Education Innovation Fund (HEIF), and The Alan Turing Institute, grant EP/N510129/1. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

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Ethics committee of University of Southampton (ERGO 76033.A3) and UK national review boards (IRAS 313408 / HRA REC 22/YH/0215) gave ethical approval for this work.

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