Comparison of Socket Geometry, Socket Comfort, and Patient Experience between Manually- and Digitally-Designed Prosthetic Sockets for Lower-Limb Amputees: A Feasibility Study

Abstract

Prosthetic socket manufacturing is experiencing a revolutionary shift towards using digital methods, such as 3D scanning and 3D printing. However, using digital methods requires the clinician to transfer their skills from making sockets by hand to making sockets with a computer. This shift in practice may change the socket geometry and fit; however, to what extent is unknown. Thus, the aim of this study was to explore the feasibility of analyzing geometric and clinical differences between digitally- and manually-designed sockets. Nine adult inpatients with below-knee amputation were recruited. Two sockets were 3D printed for each participant from 3D socket models that were developed from: (1) 3D scanning a manually-modified hand-casted positive mold of the residuum; and (2) a digitally-modified 3D scan of the residuum. Manual and digital procedures were compared for three measures: final socket geometry, the Socket Comfort Score, and a patient experience survey. Feasibility data were collected to measure protocol implementation fidelity to inform a future larger study. These data revealed that 89% of participants followed the intended protocol, no participants dropped out, and only one adverse event was report. As no significant geometric differences were found and participants experienced similar comfort scores between manually- and digitally-designed sockets, study feasibility was determined to be successful. Thus, a randomized control trial study will be conducted to draw statistically relevant conclusions from these outcome measures that may provide meaningful information for improving digital design procedures.