Evidence-Generated Sockets for Transtibial Prosthetic Limbs Compared With Conventional Computer-Aided Designs: A Multiple-Methods Study From the Patient's Perspective.

Background: 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.

Objective: This study aimed to assess the comfort of EG sockets, generated from past CASD records.

Methods: 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.

Results: 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.

Conclusions: 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.