Toward a Digitally Informed Knitted Prosthetic Interface With Graded Stiffness to Enhance Comfort in Transtibial Amputees: Proof-of-Concept Case Study.

Background: Despite considerable advancements in prosthetic technology, a substantial proportion of lower limb amputees reduce or discontinue prosthesis use, with reported nonuse rates ranging from 12% to 53%. This reflects the multifactorial challenges associated with long-term prosthetic use, among which comfort and skin health are consistently identified as key determinants. More specifically, studies point toward nonbreathable silicone liners trapping heat and sweat, leading to skin and hygiene problems. These persistent limitations underscore the need for alternative interface materials that offer improved breathability, moisture management, and tunable mechanical properties. Objective: This study aimed to introduce Flexoknit, a transtibial prosthetic liner that integrates user-specific digital skin strain analysis with computer numerical control multimaterial knitting to create a mechanically tuned, breathable, and anatomically customized interface. Using digital biomechanical data as the primary design driver-rather than clinician heuristics alone-Flexoknit aims to determine the feasibility and performance of a skin strain-guided, computer numerical control-knitted prosthetic interface in terms of material function, clinical performance, and user experience. Methods: Flexoknit uses programmable multimaterial knitting, incorporating thermal-reactive yarns that stiffen when heated to create structural support zones, alongside spandex yarns that provide elastic compression and breathable zones. Uniaxial tensile tests showed that yarn and stitch combinations can generate distinct stiffness grades, with nearly order-of-magnitude differences. The spatial layout of these graded zones aligns high-stiffness regions with the lines of nonextension, and low-stiffness regions with areas of greater skin strain. With the new prosthetic interface, a series of controlled tests was conducted to compare performance against the participant's existing prosthesis with a conventional silicone liner. User testing was organized into 3 domains (ie, mobility, suspension, and comfort) using standardized quantitative assessments and structured qualitative data collection. Results: User testing demonstrated a 22.5% improvement in total range of motion, a 37.5% reduction in interface mass, and improved thermal regulation in hot, humid environments compared to that of a conventional silicone liner. The user walked unaided and performed sit-to-stand movements, reporting positive comfort and usability feedback. Conclusions: This work establishes Flexoknit as a promising direction for future prosthetic development-one that integrates principles of biomechanics, textile engineering, and digital fabrication to create user-centered interface solutions. The findings suggest that digitally engineered knitted interfaces can provide a highly customizable, breathable, and compliant alternative to conventional silicone liners, particularly for lower-activity amputees or individuals prioritizing comfort and ease of use.