Mbithi Florence, Donovan-Hall Maggie, Bramley Jennifer, Steer Joshua, Rossides Charalambos, Worsley Peter, Ostler Chantel, Metcalf Cheryl, Hannett Dominic, Ward Caroline, Kitchen Jack, Steventon Sioned, McIntosh Katy, Guo Shigong, Harvey Helen, Henderson Slater David, Kolli Vijay, Dickinson Alex
Mechanical Engineering Department, University of Southampton, Mailpoint M7, University Road, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 2380595394.
Radii Devices Ltd, Bristol, United Kingdom.
JMIR Rehabil Assist Technol. 2025 Aug 21;12:e69962. doi: 10.2196/69962.
Personalized prosthetic socket design depends upon highly skilled prosthetists. They aim to balance functional human-prosthesis coupling with safe, comfortable load transmission from the prosthesis to the skeleton, through vulnerable skin and soft tissues. Both traditional plaster and computer-aided design and manufacturing (CAD/CAM) methods are iterative, and sharing knowledge is difficult. Evidence-generated (EG) sockets derived from past computer-aided socket design (CASD) records could provide a personalized starting point for limb fitting, potentially reducing time spent on basic design and enabling prosthetists to focus on more highly-skilled customization.
This study aimed to assess the comfort of EG sockets, generated from past CASD records.
A crossover trial compared EG sockets, derived from 163 previous transtibial devices, with conventional clinician-led CAD/CAM sockets. Noninferiority was assessed for the socket comfort score (SCS) outcome measure, and semistructured interviews provided in-depth user analysis. The setting was 3 UK National Health Service clinics, with 17 participants with 19 transtibial amputations.
EG sockets had no statistically significant difference in comfort compared with clinician-led control sockets (median SCS 8.6 for EG sockets and 8.8 for CAD/CAM controls; P=.43, effect size=0.05), but a lower variability in SCS across the group (95% CIs 8.0-9.0 for EG and 7.5-9.5 for CAD/CAM devices, respectively). Analysis of interviews revealed themes around fitting session experiences, similarities, and differences between the EG and CAD/CAM 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.
EG sockets demonstrated noninferiority to conventional clinical CASD 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 EG sockets into CASD 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 customization and co-design with their patients.
个性化假肢接受腔设计依赖于高技能的假肢矫形师。他们旨在平衡人体与假肢的功能性耦合，以及通过易受损的皮肤和软组织，实现从假肢到骨骼的安全、舒适的负荷传递。传统的石膏模型法和计算机辅助设计与制造（CAD/CAM）方法都是迭代式的，且知识共享困难。从过去的计算机辅助接受腔设计（CASD）记录中生成的循证（EG）接受腔可为肢体适配提供个性化的起点，有可能减少在基础设计上花费的时间，并使假肢矫形师能够专注于更高技能要求的定制工作。
本研究旨在评估从过去的CASD记录中生成的EG接受腔的舒适度。
一项交叉试验将源自163个先前经胫骨装置的EG接受腔与传统的临床医生主导的CAD/CAM接受腔进行了比较。对接受腔舒适度评分（SCS）这一结果指标进行了非劣效性评估，并且通过半结构化访谈提供了深入的用户分析。研究地点为英国3家国民医疗服务体系诊所，17名参与者共进行了19例经胫骨截肢手术。
与临床医生主导的对照接受腔相比，EG接受腔在舒适度方面无统计学显著差异（EG接受腔的SCS中位数为8.6，CAD/CAM对照接受腔为8.8；P = 0.43，效应量 = 0.05），但该组中SCS的变异性更低（EG接受腔的95%置信区间分别为8.0 - 9.0，CAD/CAM装置为7.5 - 9.5）。访谈分析揭示了围绕适配过程体验、EG接受腔与CAD/CAM对照接受腔之间的异同，以及影响接受腔舒适度认知的残肢因素等主题。这些为了解参与者的研究体验以及专家假肢矫形师在接受腔设计中的投入价值提供了见解。
在接受腔舒适度方面，EG接受腔表现出不劣于传统临床CASD实践。定量和定性结果均表明临床医生的投入仍然至关重要且受到假肢使用者的重视。目前正在开展工作，将EG接受腔纳入CASD软件，使其能够作为数字起点，供专家临床医生在适配时进行修改，这有可能减少在基础设计上花费的时间，使假肢矫形师能够专注于更高技能要求的定制工作以及与患者的共同设计。
