Evidence-Generated Sockets for Transtibial Prosthetic Limbs Compared With Conventional Computer-Aided Designs: A...

Area of Science:

• Prosthetics and Orthotics
• Biomedical Engineering
• Rehabilitation Science

Background:

• Personalized prosthetic socket design relies on skilled prosthetists balancing function, comfort, and load transmission.
• Current methods (plaster, CAD/CAM) are iterative, hindering knowledge sharing.
• Evidence-generated (EG) sockets, using past computer-aided socket design (CASD) records, offer a personalized starting point for prosthetic fitting.

Purpose of the Study:

• To assess the comfort of evidence-generated (EG) prosthetic sockets derived from previous CASD records.

Main Methods:

• A crossover trial compared EG sockets with conventional clinician-led CAD/CAM sockets in 17 participants with 19 transtibial amputations across 3 UK NHS clinics.
• Noninferiority of socket comfort score (SCS) was the primary outcome.
• Semistructured interviews were conducted for in-depth user analysis.

Main Results:

• EG sockets showed no statistically significant difference in comfort compared to clinician-led control sockets (median SCS 8.6 vs. 8.8).
• EG sockets exhibited lower variability in SCS across participants.
• Qualitative analysis revealed themes on fitting experiences, socket comparisons, and residual limb factors influencing comfort.

Conclusions:

• EG sockets are noninferior to conventional CASD practice for socket comfort.
• Clinician input remains essential and highly valued by prosthesis users.
• Future work aims to integrate EG sockets into CASD software as a digital starting point for expert clinician modification, optimizing customization and co-design.