May 17, 2018 | By Thomas

The team at Limbitless Solutions, a University of Central Florida-based nonprofit company that makes 3D-printed bionic arms for children, is partnering with researchers at Oregon Health & Science University (OHSU) on a clinical trial that will determine whether the devices will be covered by insurance.

Credit: OHSU/Kristyna Wentz-Graff

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 children.

"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 3D 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. Limbitless' myoelectric arms operate using a pair of leads placed on the skin which activate when children flex their muscles. According to the company, 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.

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.

The clinical trial 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.

"We hope our work will ultimately allow us to provide prosthetic arms to children at little or no cost," Manero said. "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."

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.

Credit: OHSU/Kristyna Wentz-Graff

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.

Partners participating in the trial said they hope it is the first of several trials across the nation and could establish a nonprofit model for 3D printed 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.

The clinical trial is open to children across the United States, but proximity to the two trial sites in Orlando and Portland, Oregon is needed to complete the year-long process. Families interested in participating should visit 3DHope.com.

 

 

Posted in 3D Printing Application

 

 

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