LIMBER UniLeg Prosthesis for Leg Amputation

Recruiting at 1 trial location

Overseen By Michael Higgins, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LIMBER Prosthetics & Orthotics Inc

Disqualifiers: Diabetes, Pregnancy, Poor sensation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

30 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 6}

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

In good general health as determined by clinical site monitor

Stated willingness to comply with all study procedures and availability for the duration of the study

Weight less than 125kg

Exclusion Criteria

I have diabetes with poor feeling in my limbs.

I am under 75 years old.

I have poor feeling or awareness in my amputated limb.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants are assessed using their normal prosthetic device to establish baseline measurements

4 weeks

1 visit (in-person)

Treatment

Participants use the LIMBER UniLeg prosthetic device and are assessed for functionality and safety

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after using the study device

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LIMBER UniLeg

Trial Overview

The LIMBER UniLeg, a new type of transtibial prosthetic limb made using 3D printing technology, is being tested against traditional passive prosthetics to see if it's just as good but cheaper and faster to make.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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).

LIMBER UniLeg is already approved in United States for the following indications:

Approved in United States as LIMBER UniLeg for:

• Transtibial amputation
• Lower limb amputation

Who Is Running the Clinical Trial?

LIMBER Prosthetics & Orthotics Inc

Lead Sponsor

Trials

1

Recruited

30+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

This study improves a numerical model that connects stump stresses to prosthesis loads for below-knee amputees by incorporating actual stump parameters, enhancing the understanding of how these factors interact.

The research reveals how the resistive moment of the stump balances with the prosthesis's flexion-extension moment, providing insights into the maximum normal stresses experienced during specific phases of walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-order model for the analysis of stump stresses for below-knee amputees. Winarski, DJ., Pearson, JR.[2019]

The pneumatic Airleg prosthetic system allows for early mobilization of patients with lower extremity amputations, serving as a flexible alternative to traditional plaster casts for immediate postoperative fitting and ambulation.

This system offers several advantages, including easy application and removal, the ability to inspect the amputation site, and the facilitation of weight-bearing ambulation with minimal discomfort, as demonstrated in three case reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pneumatic Airleg prosthesis: report of 200 cases. Bonner, FJ., Green, RF.[2004]

Lower extremity amputees have significant potential for lifestyle recovery through the use of adaptive prosthetics, which can greatly enhance their mobility and quality of life.

The initial prosthetic prescription from a physician is crucial, as it determines the type of prosthetics available to the patient, impacting their ability to engage in desired activities and promoting a positive mental attitude during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive prosthetics for the lower extremity. Carroll, K.[2022]

A new lightweight and low-cost alignment coupler for lower limb prostheses was developed, weighing only 166 grams and costing $55, making it accessible for low-income countries.

The coupler allows for significant adjustments in alignment, including 30° of rotation and acceptable ranges of anterior/posterior and medial/lateral translation, demonstrating its potential effectiveness for improving prosthetic fitting and patient mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The reversible adjustable coupling: A lightweight and low-cost alignment component for the lower limb prosthesis. Sasaki, K., Pinitlertsakun, J., Nualnim, P., et al.[2022]

A new cosmetic prosthesis designed for nonambulatory patients with above-knee amputations is cost-effective and easy to create, making it accessible for many users.

This prosthesis not only provides a realistic appearance but also offers durability and flexibility, which are important for patient satisfaction and comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantyhose prosthesis: a cosmetic alternative. Wainapel, SF., Reteguiz, C., Burton, J.[2014]

A study involving 92 participants with lower limb amputations revealed that key issues with prostheses include the fit of the socket, mechanical functioning, and the importance of support for adaptation to life with a prosthesis.

The findings suggest that regular check-ups for prosthesis fit could help identify and resolve issues early, potentially reducing discomfort and improving the quality of life for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues of importance reported by persons with lower limb amputations and prostheses. Legro, MW., Reiber, G., del Aguila, M., et al.[2022]

A systematic study involving 183 below-knee and 100 above-knee amputees found that patients can tolerate a range of alignment variations in their prostheses, with shifts of up to 148 mm and tilts of 17 degrees being acceptable.

The study highlights the significant impact of different prosthetists on alignment outcomes, suggesting that multiple configurations can still provide comfort and function for amputees, challenging the previous belief in a single 'optimum alignment'.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alignment of lower-limb prostheses. Zahedi, MS., Spence, WD., Solomonidis, SE., et al.[2022]

Electromagnetic expandable prostheses can effectively manage limb length discrepancies in adults after treatment for malignant bone tumors, as demonstrated by a case where a patient regained approximately 6 cm of leg length.

This technology, previously successful in pediatric cases, shows promise for adult patients, highlighting the need for further exploration in the management of bone tumors in the adult population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Femoral Expandable Prosthesis In Bone Tumor of an Adult: A Case Report. Fenga, D., Rosa, MA.[2022]

The study reviewed 25 articles involving 253 adults with transtibial amputations to identify variables that assess clinically acceptable prosthetic alignment, highlighting that most studies focused on standing position rather than walking.

Key sensitive outcomes for evaluating prosthetic alignment quality included joint angles and load line locations in standing, while during walking, the forces and timing of gait events were crucial, suggesting that both standing and walking assessments are important for optimal alignment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of variables used to assess clinically acceptable alignment of unilateral transtibial amputees in the literature. Tafti, N., Hemmati, F., Safari, R., et al.[2018]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06648798

Study Details | NCT06648798 | LIMBER UniLeg: Rapid, On ...

This clinical trial will quantify the functionality, clinical efficacy, and quality of care of the LIMBER UniLeg and compare it to traditional passive ...

2.

withpower.com

withpower.com/trial/limber-unileg-prosthesis-for-leg-amputation-ddd35

LIMBER UniLeg Prosthesis for Leg Amputation

Key sensitive outcomes for evaluating prosthetic alignment quality included joint angles and load line locations in standing, while during walking, the forces ...

3.

limberprosthetics.com

limberprosthetics.com/

Limber Prosthetics

The Limber UniLeg is the first transtibial prosthesis that is fully 3D printed to transform both function and freedom. The UniLeg is fully dynamic, ...

4.

wws.inknowvation.com

wws.inknowvation.com/sbir/awards/nih-2023-limber-unileg-digital-and-additive-manufacturing-approach-accessible-prosthetic

NIH 2023 LIMBER UniLeg: a digital and additive ...

The World Health Organization (WHO) estimates that out of the tens of millions of amputees worldwide, only 5% to 15% have access to prosthetics ...

5.

primecareprosthetics.com

primecareprosthetics.com/blog/limber-prosthetics-benefits

Limber Prosthetics: Cutting-Edge Technology

Enhanced comfort: The precise 3D scanning creates prosthetics that better match the unique contours of each residual limb, reducing discomfort ...

6.

limberprosthetics.com

limberprosthetics.com/3d-printed-prosthesis-structural-testing-and-durability/

3D Printed Prosthesis: Structural Testing and Durability

We are pleased to announce that the Limber UniLeg has passed rigorous testing to ensure compliance with ISO 10328:2016 standards.