Limbitless Solutions Launches First Clinical Trial in the US of 3D Printed Bionic Prosthetic Arms for Children | 3DPrint.com







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Nonprofit organization Limbitless Solutions is on a mission to empower kids through its creative and fun, but still functional, 3D printed bionic arm prosthetics. Now the organization, which got its start at the University of Central Florida (UCF), is one step closer to its goal – the first US clinical trial of 3D printed bionic arms for children just launched today, thanks in large part to Limbitless Solutions and researchers at the Oregon Health & Science University (OHSU) in Portland.

Albert Manero, PhD, the CEO and Co-Founder of Limbitless Solutions, said, “It’s been a long journey, and we are so excited to see the trials start because we believe it will make a difference in children’s lives.”

Albert Manero, Co-Founder and CEO of Limbitless Solutions, and Albert Chi discuss the clinical trial at OSHU’s campus in Portland. [Image: UCF]

Manero, together with Albert Chi, MD, an associate professor of surgery in the OHSU School of Medicine, will be the lead clinical investigators for the trial, which will help to determine if the FDA will approve the 3D printed prosthetics for market clearance – this means they would be eligible for insurance coverage, which is a big deal.

“Where this goes from here is going to be huge. It’s my personal aspiration to provide advanced prosthetics to all those in need,” explained Chi. “Making it affordable and accessible is the goal, and I really do believe 3D printing technology is the solution.”

It’s amazing just how far this 3D printed bionic arm project, which got its start around a kitchen table, has come. Back in 2014, Manero, a UCF doctoral student at the time, heard about a 6-year-old boy named Alex who was in need of an arm. He gathered his friends together to create a 3D printed, myoelectric prosthetic for less than $350.

Limbitless Solutions designed new arms for the first clinical trial of its kind in the US. [Image: Nick Leyva, UCF ’15]

After delivering the first prototype to Alex, who participated in the organization’s Guinness Record attempt and later received a Marvel-ous 3D printed upgrade to the arm, the group established a nonprofit for 3D printed bionic prosthetics that combines elements of art, engineering, design, and even video game development, which helps train kids, and their muscles, on how to use their new devices.

Every year, thousands of children are born without arms, and the combined cost of traditional prosthetics can reach over $100,000. This is not usually covered by insurance, as children quickly outgrow their devices.

“But our bionic arms can change all that. We hope our work will ultimately allow us to provide prosthetic arms to children at little or no cost,” said Manero. “There is a real psychological-social aspect of having an arm they can customize and which reflects their personality. It allows kids to be kids and understand their opportunities are limitless.”

[Image: Kristyna Wentz-Graff, OHSU]

The organization’s myoelectric arms use two leads, which are placed on the skin and activate when muscles are flexed. The arms cost UCF less than $1,000 in hardware costs to make, and the newest version uses smartphone technology and motors to improve a child’s ability to grip objects. But, as Chi directs the Targeted Muscle Reinnervation program at OHSU, he uses technology funded mainly by the Department of Defense to surgically reassign nerve endings, so patients can control their prosthetics simply by thinking about the action they want to complete. So who knows what the next version will do?

OHSU President Joe Robertson, MD, MBA, said, “Dr. Chi brings a rare combination of expertise as a surgeon and as a biomedical engineer, and OHSU is proud of his innovative work to improve the lives of patients affected by limb loss. Advancements in 3D printing technology make it possible to greatly expand the number of people who can benefit from advanced prosthetics, especially children. We’re eager to see the results of this clinical trial, which could lay the groundwork for improving the lives of thousands of children in Oregon and across the country.”

Albert Chi (center), associate professor of surgery in the OHSU School of Medicine, works with John Sparkman, director of research and development for Limbitless Solutions, and Dominique Courbin, director of production.

This clinical trial will recruit 20 children, mainly from the Pacific Northwest and the Southeast, to receive custom-designed, 3D printed prosthetic arms. Over the course of a year, they will be trained on how to use them, and the study will also provide occupational therapy in Portland and Orlando. The functionality of the arms in children ages 6-17 will be tested in the trial, to see how the arms are used for specialized tasks and gauge their effect on the participants’ quality of life.

Zachary Pamboukas, 9, looks over a new myoelectric arm. Zachary has been using a previous model, which will be used in the clinical trial. [Image: Kristyna Wentz-Graff, OHSU]

Limbitless collaborators, including surgeon and UCF College of Medicine Professor Juan Cendán, hope that this trial will only be the first of several across the nation that can help set up a working nonprofit model in order to provide children with 3D printed, custom-designed prosthetics.

“At UCF, we use the power of scale and the pursuit of excellence to impact tomorrow’s greatest challenges and to make a better future for our students and society. As America’s Leading Partnership University, we engage others of common cause to achieve what no one entity can accomplish alone,” said UCF President John C. Hitt. “Limbitless has taken these lessons to heart and is changing the lives of many.”

While the trial is open to children across the country, proximity to the two sites is very important. Interested families can sign up for more information. Funding for the clinical trial and 3D printing the arms will be raised by community and corporate partners identified by Limbitless Solutions. To learn more, watch this short video on the OHSU site.

Last summer, Open Bionics launched its clinical trial for 3D printed bionic arms for children in the UK, the first such trial in the world.

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[Source: UCF]

 





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