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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests 3D-printed prosthetics for children with certain congenital limb differences. The goal is to evaluate how well these new myoelectric prosthetic devices, which use muscle signals for movement, function for children with upper arm limb deficiencies. Participants will receive the prosthetic and training on its use. Children aged 7 to 17 with specific arm differences, such as missing parts above or below the elbow, may qualify for this study. As an unphased trial, this study provides a unique opportunity for children to access innovative prosthetic technology and contribute to advancements in pediatric prosthetic care.

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 prior data suggests that this 3D myoelectric prosthetic device is safe for congenital limb deformities?

Research has shown that 3D-printed myoelectric prosthetic devices are safe for both children and adults with limb differences. These devices enable users to move artificial limbs using muscle signals and are generally well-received. Studies have found that these prosthetics enhance users' ability to grasp and perform tasks, with most users expressing satisfaction with their functionality.

Although considered safe, these prosthetics might require adjustments for a perfect fit. The available data reports no major safety concerns, suggesting that 3D myoelectric prosthetic devices are a promising and safe option for potential users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 3D myoelectric prosthetic device for congenital limb deformities because it offers a customized and potentially more functional alternative to traditional prosthetics. Unlike standard prosthetics, which are often mass-produced and require extensive manual adjustments, these 3D printed devices are tailored to fit the unique anatomy of each individual. This approach allows for a better fit and increased comfort, while the myoelectric technology offers users more intuitive control over limb movements by using electrical signals from their muscles. This could lead to improved dexterity and ease of use compared to conventional options.

What evidence suggests that this 3D myoelectric prosthetic device is effective for congenital limb deformities?

Research has shown that 3D-printed myoelectric prosthetic devices work well for people born with limb differences. These devices are affordable and can be tailored to fit individual needs. Studies have found that they greatly enhance task performance, especially in children. Users report better control and comfort compared to traditional prosthetics. Overall, these devices offer a promising way to improve quality of life and independence. Participants in this trial will receive the 3D myoelectric prosthetic device to further evaluate its effectiveness. ^{2 3 4 6 7}

Who Is on the Research Team?

Albert Manero, PhD

Principal Investigator

Limbitless Solutions

Are You a Good Fit for This Trial?

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 have had a shoulder or wrist disarticulation.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05547308?term=AREA%5BConditionSearch%5D(%22Congenital%20Abnormalities%22)&rank=7

Evaluation of 3D Printed Myoelectric Prosthetic Devices in ...

A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group or subgroup ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12565071/

The Current State of 3D-Printed Prostheses Clinical ...

The included studies assessed different 3D-printed prosthetic types and upper and lower limb prostheses. The main clinical outcomes analyzed were functional ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05547308

Evaluation of 3D Printed Myoelectric Prosthetic Devices in ...

Evaluation of 3D Printed Myoelectric Prosthetic Devices ... Limb Deformities, Congenital. Upper Extremity Deformities, Congenital. Congenital Abnormalities ...

4.

withpower.com

withpower.com/trial/3d-printed-prosthetics-for-congenital-limb-deformities-5143c

3D Printed Prosthetics 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 ...

5.

mdpi.com

mdpi.com/2079-4983/16/10/370/pdf

The Current State of 3D-Printed Prostheses Clinical ...

Results: A total of 1420 studies were identi- fied, with 11 meeting the inclusion criteria. The included studies assessed different 3D- printed ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04059107

Prosthetic Device in Children With Upper Congenital Limb ...

This is a study being performed to evaluate the safety and effectiveness of 3D printed myoelectric prosthetic devices in children with a congenital upper limb ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5940585/

Functional changes through the usage of 3D-printed ...

The purpose of this study was to identify functional and strength changes after usage of 3 D-printed transitional prostheses for multiple weeks for children ...