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).
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Persons, aged 18 to 75
In good general health as determined by clinical site monitor
Not currently using a prosthetic device
Prosthetic device with active motors, sensors, etc.
Pregnancy (due to fall risk)
Diabetic (due to poor limb sensation), self reported
LIMBER Prosthetics & Orthotics Inc
Lead sponsor
University of California, San Diego
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator