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LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
Sponsor: LIMBER Prosthetics & Orthotics Inc
Summary
The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling global reach through the use of digital technologies to solve the worldwide prosthetic accessibility crisis. This is a single-site, Phase I, Clinical Research Study to test the effectiveness and safety of the LIMBER UniLeg. One study group of 30 participants involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-12-20
Completion Date
2026-10-31
Last Updated
2024-11-26
Healthy Volunteers
No
Interventions
Limber Limb
Participants will be involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).
Locations (2)
University of California San Diego
La Jolla, California, United States
Limber Prosthetics & Orthotics Inc
San Diego, California, United States