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

The study was not formally randomized; prosthetists chose which socket to fit first, which introduces potential carryover effects. Recruitment was via convenience sampling, resulting in a cohort that was predominantly male (16 of 17) and older than the general amputee population, limiting generalizability. The assessment was at a single timepoint (initial fitting), so it does not reflect how comfort and function might change over weeks or months of wear. The automated designs were based on data from a single center, which may not represent the diversity of clinical practices or patient populations elsewhere.

Several authors are employed by or hold shares in Radii Devices Ltd, the company developing the evidence-generated socket technology. Others are employed by Opcare Ltd, the service provider that supplied the clinical data and expert design insight.

Do not interpret the lack of significant difference in comfort scores as evidence that automated design can replace prosthetist involvement. The study found that while average comfort was similar, the automated method failed to address specific individual pain points that human experts successfully managed.