Developing a Standardized Brim Set with a Scalable Hybrid Design to Streamline Transfemoral Prosthetic Socket Production: A Feasibility Study

ABSTRACT Purpose The aim of the study was to investigate the feasibility of developing a standardized brim set with a scalable design to streamline transfemoral prosthetic socket production. Design A two-phase mixed-methods study comprising: (1) a design based on quantitative analysis and (2) an observational, cross-sectional approach. Methods In phase 1, existing brims were analyzed to develop a standardized brim set. Participants using hybrid transfemoral prosthetic sockets were selected, and the dimensions of the 3D-scanned brims were measured, including circumference, ischial-trochanteric distance, ischial support area, and trimline heights. Statistical analyses were performed to explore potential correlations to inform the scalable brim design. In phase 2, appropriate brims were fitted to participants with transfemoral residual limbs, and each brim section was evaluated using a custom-designed questionnaire. Results Phase 1 resulted in a standardized brim set based on 13 brims, revealing a statistically significant exploratory correlation between brim circumference and ischial-trochanteric distance. In phase 2, involving eight participants, most brim sections achieved satisfactory fitting scores. However, some participants reported discomfort in the groin area and issues with ischial support placement. Conclusions While limited by a small sample size, this study demonstrates the feasibility of developing a scalable brim design for transfemoral sockets. The exploratory findings suggest potential for broader applicability, but further validation with a larger dataset and additional fittings is needed. This approach may improve the consistency, efficiency, and quality of transfemoral prosthetic socket fittings. Clinical Relevance This study contributes to more consistent and anatomically accurate transfemoral prosthetic socket design by introducing a standardized, data-driven hybrid brim set, with the potential to improve clinical efficiency and user outcomes.