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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the LIMBER UniLeg Prosthesis treatment for leg amputation?

The research highlights the importance of a well-fitting and properly aligned prosthesis for comfort and mobility, which are key factors in the effectiveness of prosthetic treatments like the LIMBER UniLeg. Adaptive prosthetics, which include features like lightweight and flexible designs, can significantly improve the quality of life for amputees by allowing them to engage in activities they enjoy. ^{1 2 3 4 5}

How does the LIMBER UniLeg Prosthesis differ from other treatments for leg amputation?

The LIMBER UniLeg Prosthesis is unique because it is designed to provide a more natural and comfortable fit for individuals with leg amputations, potentially improving mobility and quality of life. Unlike other prostheses, it may incorporate advanced materials or design features that enhance its functionality and adaptability to the user's needs. ^{1 6 7 8 9}

Research Team

Herb Barrack, CPO

Principal Investigator

LIMBER Prosthetics & Orthotics Inc

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Issues of importance reported by persons with lower limb amputations and prostheses. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A systematic review of variables used to assess clinically acceptable alignment of unilateral transtibial amputees in the literature. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Adaptive prosthetics for the lower extremity. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Alignment of lower-limb prostheses. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The reversible adjustable coupling: A lightweight and low-cost alignment component for the lower limb prosthesis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pneumatic Airleg prosthesis: report of 200 cases. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Pantyhose prosthesis: a cosmetic alternative. [2014]

8. Bulgaria pubmed.ncbi.nlm.nih.gov

Femoral Expandable Prosthesis In Bone Tumor of an Adult: A Case Report. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

First-order model for the analysis of stump stresses for below-knee amputees. [2019]