LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
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).
Description
Globally, 35-40 million people need prosthetics or other assistive devices, and this number is expected to double by 2050 due to factors including an aging population and the rise in diabetes. However, only 5-15% of people in need have access to prosthetics or other assistive devices, in both underserved and developed countries. The result is that millions of people are denied basic quality of life because they can't walk, take care of themselves, or participate in society. The lack of availability stems from several factors including poor access to clinics and high cost. Prosthetic devices ar…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Persons, aged 18 to 75 4. In good general health as determined by clinical site monitor 5. Weight \< 125kg 6. Are not diabetic (self reported) 7. Be a unilateral transtibial amputee of more than 1 year since amputation 8. Have an existing prosthetic device(s) that does not use sensors or motors (is passive) 9. Live in the Southern California region (within 50 miles of UCSD) 10. Has sufficient sensation in resid…
Interventions
- DeviceLimber 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 DiegoLa Jolla, California
- Limber Prosthetics & Orthotics IncSan Diego, California