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

Florence Mbithi1, Maggie Donovan-Hall1, Jennifer Bramley2

  • 1Mechanical Engineering Department, University of Southampton, Mailpoint M7, University Road, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 2380595394.

JMIR Rehabilitation and Assistive Technologies
|August 21, 2025
PubMed
Summary
This summary is machine-generated.

Evidence-generated prosthetic sockets offer comparable comfort to traditional methods, reducing design time and enhancing prosthetist customization. This innovation supports better patient outcomes in prosthetic limb fitting.

Keywords:
CAD/CAMcomputer aided design and manufacturingevidence-based practiceprosthetic socket designqualitative researchtranstibial

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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.