A team of researchers and surgeons from the University of Utah and the George E. Wahlen Department of Veterans Affairs Medical Center in Salt Lake City are working hard to address the needs of the thousands of wartime veterans returning home with limb amputations unable to support traditional prosthetics. Often these veterans have skin issues or lack ample remaining limb length to qualify for the standard socket-type attachment system.
The researchers have spent the last six years developing an alternate solution that involves osseointegrated direct skeletal attachment of prosthetic limbs. The device is implanted directly into the remaining bone, then passes through the skin so that a prosthetic limb cam be attached without the need for a socket. Nothing like this has been attempted before in the United States, and only 250 procedures have been attempted world wide, with mixed results.
“We are trying desperately to provide relief to the many veterans who have lost a limb,” says Roy Bloebaum, professor of orthopaedics at the University of Utah and the director of the VA Bone and Joint Research Lab. “Most of these people are very young and have many years to live. Our goal is to give them back all of the abilities they had before they were injured.”
Recently, the researchers, which include Kent Bachus, an engineer, professor, and director of the Orthopaedic Research Lab at the University of Utah, and Peter Beck, an orthopaedic surgeon and adjunct professor of orthopaedics, partnered with DJO Surgical. DJO Surgical is a global developer and manufacturer of medical devices that has licensed the implant technology and is playing an active role in the remaining research and development.
The Food and Drug Administration accepted the device into a program that permits designing a human early feasibility study. DJO Surgical applied for the FDA study and will be responsible for managing the implementation of the study, which will last up to three years. During the three years, ten patients will have the device implanted. The team can develop and refine the device between each operation, which supporters hope will streamline the refinement process and compress the development cycle.
The three problems that must be overcome include getting the bone to grow into the device, preventing infection, and addressing the skin interface. The team of researchers believes they have overcome these problems by coating the titanium device with a porous titanium material called P2 (P squared), which allows skin and bone to grow into the material to form a secure bond.
“We are excited to sign this partnership agreement with the University of Utah and Dr. Bloebaum,” says Bryan Monroe, DJO’s senior vice president and general manager of DJO Surgical. “With the combination of our proprietary titanium P2 porous coating and Dr. Bloebaum’s unique approach for percutaneous osseointegrated prosthesis, we believe that we have developed a winning solution that will have a monumental impact on the lives of amputees.”
The three researchers have quite a way to go before hospitals will consider offering their implant prosthesis. They are working on securing $5 million in grants and other partnerships similar to the partnership with DJO Surgical, so they may fine tune and perfect the process and device.