17 May 2018. A clinical trial is recruiting participants to evaluate low-cost prosthetic arms custom-designed for children and produced with three-dimensional printing. The study is conducted by Oregon Health & Science University in Portland and University of Central Florida in Orlando, assessing the 3-D printed prosthetics made by Limbitless Solutions, a not-for-profit organization in Orlando.
The 3-D printed bionic arms, as they’re called by Limbitless Solutions, are designed to provide children born without arms, a condition known as congenital limb loss. In 2006, a study estimated congenital limb loss occurs in 0.3 for every 1,000 births in the U.S., affecting between 1,500 and 4,500 children per year. More than half (59%) of these cases involve the upper limbs. Specific causes for the condition are often difficult to determine, but genetics and environmental factors are believed to play key roles.
Limbitless Solutions says most prosthetic limbs for children today are expensive, often costing as much as $100,000, and because children grow quickly, they can be used for only brief periods. Albert Manero, CEO and co-founder of Limbitless while a graduate engineering student at UCF, says the group’s approach could change all that. The devices have leads placed on the skin that read electrical signals generated when the person flexes muscles in the remaining part of the arm. The organization says its latest version of the prosthetic limb has multiple motors to improve gripping ability and uses smartphone technology to recognize gestures, with hardware costs in UCF labs under $1,000.
The clinical trial is expected to enroll 20 children with congenital limb loss, age 6 to 17, who will be fitted with custom-designed prosthetic arms. Participants will receive training in the use of the devices in Orlando and Portland, then monitored for a year. The study team will look primarily for the functionality of the devices, as well as effects on participants’ ability to perform specialized tasks and overall quality of life. The lead investigators are Albert Chi, professor of surgery at OHSU and a specialist in upper extremity electric-powered prosthetics, and Juan Cendán, a founding faculty member at UCF’s medical school and also a surgeon.
The Limbitless web site has a page to sign up for the trial, but most participants are expected to reside in the Northwest or Southeast parts of the U.S. “We hope our work will ultimately allow us to provide prosthetic arms to children at little or no cost,” says Manero in a joint statement. “There is a real psychological-social aspect of having an arm they can customize and which reflects their personality.”
“Where this goes from here is going to be huge,” adds Chi. “Making it affordable and accessible is the goal, and I really do believe 3-D printing technology is the solution.” Manero, Chi, and Zachary Pamboukas, a 9 year-old user of a 3-D printed prosthetic arm, tell more about the device and clinical trial in the following video.
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