LIMBER UniLeg Prosthesis for Leg Amputation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new 3D-printed prosthetic leg, the LIMBER UniLeg, to determine if it matches the performance of traditional prosthetic legs. The goal is to make prosthetics more affordable and quicker to produce, increasing global accessibility. Participants will use their usual prosthetic for one month and the LIMBER UniLeg for another month to compare performance. The trial seeks participants in Southern California who have had a below-knee amputation for over a year and currently use a basic prosthetic without motors or sensors. As an unphased trial, this study offers a unique opportunity to contribute to innovative prosthetic development and improve accessibility for others.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the study focuses on prosthetic devices, it seems unlikely that medication changes are required.
What prior data suggests that the LIMBER UniLeg prosthesis is safe for use?
Research has shown that the LIMBER UniLeg has undergone several important tests. It has passed strict checks to meet international safety and durability standards, ensuring the prosthetic limb can be used daily without breaking.
In early studies with individuals who have lost a lower limb, no serious safety problems emerged. The LIMBER UniLeg is lighter and less expensive than traditional options, potentially making it easier and more comfortable to use.
While this specific trial doesn't mention any negative effects, the prior testing for safety and durability is reassuring. Prospective participants might find this information helpful in feeling more confident about the safety of the LIMBER UniLeg.12345Why are researchers excited about this trial?
The LIMBER UniLeg is unique because it offers a potentially more adaptable and comfortable option compared to traditional prosthetic legs. Unlike standard prosthetics, which often require multiple fittings and adjustments, the UniLeg aims to provide a customizable fit through innovative design features, possibly enhancing mobility and user satisfaction. Researchers are excited about its potential to improve the quality of life for amputees by offering a prosthesis that better mimics natural leg movement, reducing discomfort and increasing ease of use.
What evidence suggests that the LIMBER UniLeg is effective for leg amputation?
Research shows that the LIMBER UniLeg is a promising option for people with leg amputations. This 3D-printed artificial leg is designed to perform as well as traditional prosthetics. The trial will assess the LIMBER UniLeg by comparing its performance to participants' normal devices over a two-month period. Studies have examined important factors such as leg movement and weight distribution when standing and walking, which are crucial for proper prosthetic function. The UniLeg offers more comfort by fitting the unique shape of each person's remaining limb, reducing discomfort. Additionally, 3D printing may lower costs and increase accessibility to prosthetics, marking significant progress for those currently unable to access these solutions.12346
Who Is on the Research Team?
Herb Barrack, CPO
Principal Investigator
LIMBER Prosthetics & Orthotics Inc
Are You a Good Fit for This Trial?
This trial is for individuals with below-the-knee amputations who currently use a passive prosthetic leg. Participants will be involved in the study for two months and must be willing to switch between their normal device and the study device.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants are assessed using their normal prosthetic device to establish baseline measurements
Treatment
Participants use the LIMBER UniLeg prosthetic device and are assessed for functionality and safety
Follow-up
Participants are monitored for safety and effectiveness after using the study device
What Are the Treatments Tested in This Trial?
Interventions
- LIMBER UniLeg
LIMBER UniLeg is already approved in United States for the following indications:
- Transtibial amputation
- Lower limb amputation
Find a Clinic Near You
Who Is Running the Clinical Trial?
LIMBER Prosthetics & Orthotics Inc
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of California, San Diego
Collaborator