RecruitingNot ApplicableNCT06648798

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

Sponsor

LIMBER Prosthetics & Orthotics Inc

Enrollment

30 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

amputation of lower limb Prosthesis Non-inferiority Trial of Prothesis

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria11

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
Weight < 125kg
Are not diabetic (self reported)
Be a unilateral transtibial amputee of more than 1 year since amputation
Have an existing prosthetic device(s) that does not use sensors or motors (is passive)
Live in the Southern California region (within 50 miles of UCSD)
Has sufficient sensation in residual limb as tested by the clinical site monitor
Agreement to adhere to Lifestyle Considerations throughout study duration 11a. Use the testing device (EPD or UniLeg) only during the testing periods. 11b. Walk at least 14,000 steps per week (average of 1 mile per day). 11c. Maintain a similar diet and activity level throughout study duration (no abrupt changes of weight, activity, etc.)

Exclusion Criteria7

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
No under 18 (due to inability to consent)
No over 75 (due to fall risk)
Poor proprioception or sensation at the residual limb

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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).