3D Printed Prosthetics for Congenital Limb Deformities

Overseen By Albert Manero, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Orlando Health, Inc.

Disqualifiers: Non-English-speaking, Shoulder disarticulation, Wrist disarticulation

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

Compensation: Varies

Number of Visits: Unknown

Duration: 14 months

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This will be a prospective study over a 14-month duration with clinical evaluations throughout. Limitless Solutions will provide prosthetics and training system for study subjects that qualify for enrollment.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the 3D Myoelectric Prosthetic Device treatment for congenital limb deformities?

Research shows that 3D-printed prostheses are cost-effective and customizable, making them a good option for children with congenital limb differences. Studies also indicate that myoelectric prostheses can improve manual dexterity and user satisfaction, although some challenges remain with certain functions. ^{1 2 3 4 5}

Is 3D printed prosthetics generally safe for humans?

3D printed prosthetics, including myoelectric devices, have been used safely in children and adults with limb differences, though they may require more frequent repairs compared to traditional devices. These prosthetics are lightweight, customizable, and affordable, making them a practical option for growing children. ^{1 4 5 6 7}

How does the 3D Myoelectric Prosthetic Device treatment differ from other treatments for congenital limb deformities?

The 3D Myoelectric Prosthetic Device is unique because it uses 3D printing to create affordable, customizable prosthetics that can be easily repaired and upgraded as children grow. Unlike traditional prosthetics, which can be expensive and less adaptable, these devices offer advanced functionality and are tailored to the specific needs of each child, making them a cost-effective and practical option for growing children with limb differences. ^{1 2 4 7 8}

Research Team

Albert Manero, PhD

Principal Investigator

Limbitless Solutions

Eligibility Criteria

This trial is for children aged 7 to 17 with congenital upper limb deficiencies, specifically missing parts of the arm above or below the elbow. Participants must speak English. Children with shoulder or wrist disarticulation are not eligible.

Inclusion Criteria

I am between 7 and 17 years old.

Congenital/infant upper limb deficiency specifically transhumeral and transradial limb deficiency as identified by Limbitless Solutions.

Exclusion Criteria

I/My family does not speak English.

I have had a shoulder or wrist disarticulation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the 3D myoelectric prosthetic device and undergo training with the device

14 months

Regular visits for clinical evaluations

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 3D Myoelectric Prosthetic Device

Trial Overview The study tests a new type of prosthetic arm that's made using 3D printing and can be controlled by muscle signals (myoelectric). It will last for over a year, and kids will get these arms along with training on how to use them.

Participant Groups

Group I: Prosthetic device Experimental Treatment 1 Intervention

All subjects will receive the 3D myoelectric prosthetic device

Who Is Running the Clinical Trial?

Orlando Health, Inc.

Lead Sponsor

Trials

32

Recruited

15,100+

University of Central Florida

Collaborator

Trials

101

Recruited

1,191,000+

Limbitless Solutions

Collaborator

Trials

2

Recruited

40+

Findings from Research

3D printing technology can significantly reduce the cost and improve the accessibility of prosthetic devices for children with limb differences, making it easier for them to obtain customized solutions.

Children with upper limb differences benefit particularly from 3D-printed prostheses due to their rapid growth and tendency to damage devices, allowing for more affordable repairs and upgrades.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in 3D-Printed Pediatric Prostheses for Upper Extremity Differences. Tanaka, KS., Lightdale-Miric, N.[2022]

In a study involving seven participants aged 9 to 62 with unilateral congenital upper limb amputation, all successfully controlled a myoelectric prosthesis with multiple degrees of freedom using pattern recognition technology, achieving proficiency comparable to their sound limb.

The results indicate that both children and adults can effectively use myoelectric prostheses with pattern recognition control, suggesting significant potential benefits for this population in enhancing their functional capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Ability of Congenital Upper Extremity Amputees to Control a Multi-Degree of Freedom Myoelectric Prosthesis. Kaluf, B., Gart, MS., Loeffler, BJ., et al.[2022]

Current prostheses for individuals with upper limb amputation or congenital limb difference are inadequate, leading to issues like rejection and pain, highlighting the need for improved solutions.

Emerging technologies such as robotic limbs and osseointegrated prostheses show promise in meeting user needs, but they also introduce new risks that must be carefully evaluated through user perspectives and feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper extremity prosthesis user perspectives on unmet needs and innovative technology. Benz, HL., Jia Yao, ., Rose, L., et al.[2022]

A 3D-printed prosthetic hand was successfully created for an 8-year-old boy with a traumatic wrist amputation, costing less than $20 and taking under 8 hours to print, demonstrating a cost-effective solution for prosthetics in developing countries.

The prosthesis showed significantly improved function during follow-up assessments, indicating that 3D printing can provide effective and personalized rehabilitation options for children with amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional-printed upper limb prosthesis for a child with traumatic amputation of right wrist: A case report. Xu, G., Gao, L., Tao, K., et al.[2022]

References

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

Advances in 3D-Printed Pediatric Prostheses for Upper Extremity Differences. [2022]

2. Singapore pubmed.ncbi.nlm.nih.gov

Functional Assessment of 3D Printed Prosthesis in Children with Congenital Hand Differences-A Prospective Observational Study. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Clinical results of an investigation of paediatric upper limb myoelectric prosthesis fitting at the Quebec Rehabilitation Institute. [2017]

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

Evaluating the Ability of Congenital Upper Extremity Amputees to Control a Multi-Degree of Freedom Myoelectric Prosthesis. [2022]

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

Upper extremity prosthesis user perspectives on unmet needs and innovative technology. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Myoelectric prostheses for kindergarten age children. Analysis of first reactions and experiences]. [2009]

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

Three-dimensional-printed upper limb prosthesis for a child with traumatic amputation of right wrist: A case report. [2022]

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

Prosthetic restoration in congenital lower limb deficiency. A case study. [2022]