For the first time ever in the United States, University of Utah and VA researchers will test implanted devices to anchor prosthetics worn by fighters who have lost limbs in war.
The U.S. Food and Drug Administration has approved a feasibility study for what's called osseointegrated direct skeletal attachment of prosthetics.
At present, it's difficult to attach prosthetics when the amputee has a short limb, and skin abrasions and blisters are common, said Roy Bloebaum, one of the three researchers. He is professor of orthopaedics at the U. and the director of the Veterans Affairs Bone and Joint Research Lab.
In the clinical trial that will begin within a year at the George E. Wahlen Veterans Affairs Medical Center in Salt Lake City, 10 veterans or active members of the armed forces will have devices implanted in their remaining bone.
The device will pass through the skin so a prosthetic limb can be attached without the need for a socket, as is typically used to attach lower-body prosthetics.
It has never been used in humans in the United States, and with mixed results in about 250 patients in Sweden, Germany and Australia.
If the implants are successful, the trial will be broadened to the Brooke Army Medical Center, Walter Reed Army Medical Center and the VA hospital in Virginia, Bloebaum said.
"It could even get bigger quicker, and we would take it out to the civilian population," said Bloebaum. "But right now, the major need is for our extremely traumatized war fighters."
Because of medical and military technological advances, many more warriors are surviving the loss of arms, legs, hands and feet.
"Now kids [fighters] have two, three or four limbs blown off who would have not lived in previous wars, and some of them have very short limbs," said Bloebaum, who was a para-rescuer during the Vietnam War.
As of January, there were 2,100 veterans of the wars in Iraq and Afghanistan who had lost at least one limb, Bloebaum said Thursday.
In the civilian world, some 185,000 Americans have amputations every year, 54 percent because of vascular diseases like diabetes and 45 percent because of trauma like auto accidents, according to The Amputee Coalition.
Bloebaum's research partners are Kent Bachus, an engineer and a professor of orthopaedics and director of the Orthopaedic Research Lab at the university, and Peter Beck, an orthopaedic surgeon and adjunct professor of orthopaedics.
The company DJO Surgical has licensed the implant technology and will manage the feasibility study.
DJO is a global developer, manufacturer and distributor of medical devices.
The U. team has been developing the device for six years and has successfully implanted it in 86 sheep, Bloebaum said.
Those results gave the researchers confidence that the device made of titanium and coated with a porous titanium material a proprietary coating DJO owns will work in a way that previous devices have not.
Such implants typically have three main problems: getting the bone to grow into the device, preventing infection and creating a good bond to the skin where the device protrudes from the body.
Research so far indicates the bonding material works like Velcro, Bloebaum said. "It creates a natural bacteria barrier."
The FDA study will allow the researchers to implant three patients, assess the results and modify the device before more implants, if needed, he said. "You get two or three chances to tweak the design."
Bryan Monroe, DJO's senior vice president and general manager of DJO Surgical, said that his company's proprietary titanium coating and Bloebaum's approach should be "a winning solution that will have a monumental impact on the lives of amputees," according to a U. news release.
The Department of Defense, VA and private donors have all contributed to the project, but the researchers are still looking for $5 million in funding.
Bloebaum said the feasibility study may take three years, and the amputees may be veterans or those still serving in the military.
"We're passionate about wanting to help the current generation of Iraq and Afghanistan amputees."