OHSU, UCF launch first US clinical trial of 3D-printed prosthetics for children

May 16, 2018 by Erik Robinson, Oregon Health & Science University
A new U.S. clinical trial will test bionic arms for children produced on 3D printers. The trial is a partnership between OHSU and a nonprofit based at the University of Central Florida in Orlando, Limbitless Solutions. Credit: OHSU/Kristyna Wentz-Graff

The first U.S. clinical trial of bionic arms for children produced on 3-D printers is launching today thanks to researchers at OHSU in Portland, Oregon, and a nonprofit based at the University of Central Florida in Orlando.

Albert Chi, M.D., associate professor of surgery in the OHSU School of Medicine, will be the lead clinical investigator in collaboration with Albert Manero, Ph.D, the CEO and a co-founder of Limbitless Solutions, which creates bionic arms for .

"Where this goes from here is going to be huge," said Chi, a national leader in advanced prosthetic technology. "It's my personal aspiration to provide advanced prosthetics to all those in need. Making it affordable and accessible is the goal, and I really do believe 3-D printing technology is the solution."

Thousands of children are born without arms each year. There are few good options for them. Between therapy and material, the combined cost of traditional prosthetics can easily exceed $100,000—prohibitively expensive for children who will quickly outgrow the devices.

"But our bionic arms can change all that," Manero said. "We hope our work will ultimately allow us to provide prosthetic arms to children at little or no cost. 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."

Limbitless' myoelectric arms operate using a pair of leads placed on the skin which activate when children flex their muscles. These devices can be produced at a hardware cost of less than $1,000 each in the lab at UCF. The latest version of the arm includes multiple motors and smart phone technology to improve a child's ability to grip objects and use it for various gestures.

The clinical trial (link to site) will recruit 20 children, primarily from the Southeast and the Pacific Northwest, to be fitted with Limbitless' advanced custom-designed arms. The children will be trained to use them over the course of one year. Occupational therapy will be provided in Orlando and Portland as part of the study. The trial will test the functionality of the arms in children aged 6 to 17, gauge the effect on their quality of life, and determine how children are using the arm for specialized tasks.

The clinical trial will help to determine whether the Food & Drug Administration would approve the arm for market clearance, which would enable them to be covered by insurance. The Limbitless collaborators, which include surgeon and UCF College of Medicine professor Juan Cendán, degree, hope that this is the first of several trials across the nation and could establish a nonprofit model in which 3-D printing technology brings custom-designed prosthetics for children who need them.

"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," Manero said.

For UCF, this step is a good example of the power of higher education and partnerships.

"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," said UCF President John C. Hitt. "As America's Leading Partnership University, we engage others of common cause to achieve what no one entity can accomplish alone. Limitless has taken these lessons to heart and is changing the lives of many."

OHSU is eager to see how the expertise of both partners impacts the lives of children everywhere.

"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," said OHSU President Joe Robertson, M.D., M.B.A. "Advancements in 3-D 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."

The bionic arm project began in 2014 when Manero, then a UCF college graduate student, and a group of his friends gathered around a kitchen table after a parent asked Manero to build her son an arm. Manero and his team built the first prototype that summer. The student group went on to establish a nonprofit at UCF that brings together elements of engineering, design, art, and even video game development to train children to use the devices. The team produced and distributed several prototypes. Actor Robert Downey Jr. helped deliver one arm to a 6-year-old Iron Man. In 2016, Limbitless and professors at UCF's School of Visual Art and Design teamed up and created fun video games to train children's muscles in anticipation of receiving bionic arms.

Chi has directed the Targeted Muscle Reinnervation program at OHSU since he arrived from Johns Hopkins University in 2016. Using cutting-edge technology funded in large part by the Department of Defense, Chi surgically reassigns nerve endings in such a way that patients control their prosthetics simply by thinking about the action they want their prosthetic hand or arm to perform.

The clinical trial is open to children nationwide, but proximity to the two trial sites is key to completing the year-long process. Families interested in participating should visit 3DHope.com and sign up for more information.

Explore further: Robotics startup launches first medically approved 3-D printed bionic arms

Related Stories

Robotics startup launches first medically approved 3-D printed bionic arms

April 25, 2018
A robotics company which began as a startup at Bristol Robotics Laboratory (BRL) has launched the world's first medically certified 3-D printed artificial arms for amputees.

3-D surprise: Girl missing part of arm gifted a prosthetic

June 4, 2015
When 10-year-old Annika Emmert patted Winter the dolphin's smooth back at the Clearwater Marine Aquarium on Thursday, she thought that was the best part of her morning.

Use of MS drug expanded to include children

May 14, 2018
(HealthDay)—The U.S. Food and Drug Administration has expanded its approval of the multiple sclerosis drug Gilenya (fingolimod) to include children aged 10 and older.

Prosthetic arms can provide controlled sensory feedback, study finds

April 27, 2018
Losing an arm doesn't have to mean losing all sense of touch, thanks to prosthetic arms that stimulate nerves with mild electrical feedback.

Most parents willing to enroll child in food allergen trials

April 4, 2018
(HealthDay)—The majority of caregivers of children with food allergy are willing to consider participation in clinical trials for food allergy immunotherapy, according to a research letter published in the March issue of ...

Recommended for you

Urban and rural rates of childhood cancer survival the same, study finds

October 23, 2018
Childhood and adolescent cancer survival in the United States does not vary by rural/urban residence at the time of diagnosis, finds a new study from the Brown School at Washington University in St. Louis.

Breastfeeding protects infants from antibiotic-resistant bacteria

October 18, 2018
A recent study completed at the University of Helsinki investigated the amount and quality of antibiotic-resistant bacteria in breast milk and gut of mother-infant pairs. The findings have been published in the journal Nature ...

Inflammation in the womb may explain why some babies are more prone to sepsis after birth

October 9, 2018
Each year 15 million infants are born preterm and face high risks of short- and long-term complications, including sepsis, severe inflammation of the gut, and neurodevelopmental disorders. A new report in the American Journal ...

Dummies not to blame for common speech disorder in kids

October 9, 2018
New University of Sydney research shows bottles, dummies, and thumb sucking in the early years of life do not cause or worsen phonological impairment, the most common type of speech disorder in children.

'Genes are not destiny' when it comes to weight

October 9, 2018
A healthy home environment could help offset children's genetic susceptibilities to obesity, according to new research led by UCL.

Old drug could have new use helping sick premature babies

October 8, 2018
Researchers from The University of Western Australia, King Edward Memorial Hospital and Curtin University are investigating whether an old drug could be used to help very sick premature babies.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.