3D Printed Prosthetics for Congenital Limb Deformities

AM
Overseen ByAlbert Manero, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Orlando Health, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.23467

Who Is on the Research Team?

AM

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?
1Treatment groups
Experimental Treatment
Group I: Prosthetic deviceExperimental Treatment1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

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 ...
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 ...
Evaluation of 3D Printed Myoelectric Prosthetic Devices in ...Evaluation of 3D Printed Myoelectric Prosthetic Devices ... Limb Deformities, Congenital. Upper Extremity Deformities, Congenital. Congenital Abnormalities ...
3D Printed Prosthetics for Congenital Limb DeformitiesResearch shows that 3D-printed prostheses are cost-effective and customizable, making them a good option for children with congenital limb differences. Studies ...
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 ...
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 ...
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 ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security