LIMBER UniLeg Fast and Custom 3D-Printed Transtibial Prosthetic Legs A Study Comparing the New Device to Traditional Passive Prosthetics for Adults with Lower Limb Amputation

What this Trial Is About

Researchers are evaluating the LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, designed to be comparable to traditional passive prosthetic limbs but at a lower cost and faster production time. This trial aims to address the global prosthetic accessibility crisis by using digital technology to provide an affordable and quickly manufactured prosthesis. The study focuses on adults aged 18 to 75 who have undergone unilateral transtibial amputation and typically use passive prosthetic devices without motors or sensors. The study involves one group of 30 participants who will use their usual prosthetic device for one month and then the LIMBER UniLeg for another month. This non-inferiority design compares the new devices performance against the participants existing passive prosthesis. The LIMBER UniLeg is fully 3D printed as a single piece, aiming to simplify manufacturing and provide a better fit through digital scanning and design. Participants will be assessed at baseline, four weeks, and eight weeks on mobility tests like the 6-minute walk, Timed-Up-and-Go, and 25-foot walk. Quality of care will also be evaluated through gait symmetry, perceived balance confidence, and activity levels measured at home. The study collects both quantitative and qualitative data to compare the functional performance and safety of the LIMBER UniLeg to traditional devices during the two-month study period.

LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees