NMRC Hosts First DoD Osseointegration Program Meeting
Story by Doris Ryan, Naval Medical Research Center Public Affairs
The Naval Medical Research Center (NMRC) hosted the first Department of Defense Osseointegration Program steering committee meeting to plan the next step in implementing osseointegration (OI) prosthesis research and clinical trials for wounded service members with upper or lower extremity amputations, December 1. OI refers to a surgical procedure to implant a device directly into a bone that will exit the skin and attach to a unique functional prosthesis. In essence, OI enables one to attach an external prosthesis directly to the skeleton, and is useful for patients who cannot tolerate a traditional, socket-based prosthesis.
The steering committee met at the National Intrepid Center of Excellence, located on the campus of Naval Support Activity Bethesda, Maryland, home of the Walter Reed National Military Medical Center.
U.S. Army Col. Michael S. Heimall, Interim Director, Walter Reed National Military Medical Center (WRNMMC), welcomed the attendees saying, “This group coming together at this particular time is very important for where we have to go for advanced amputee care and rehab programs. You have a unique opportunity with the group you have assembled and with the intellectual capital you have available. We are the world’s leaders, unfortunately, in blast injury and traumatic amputee services because of what we have experienced over the last 14 years.”
OI is a technology that can improve the lives of service members living with major limb amputations. By attaching prosthesis directly to the skeleton, orthopaedic surgeons can mitigate problems associated with skin grafts and heterotopic ossification that are common after blast and other traumatic injury.
U.S. Navy Cmdr. Jonathan A. Forsberg, head of the Regenerative Medicine at NMRC, and U.S. Army Lt. Col. Benjamin Kyle Potter, Deputy Chief of Orthopaedic Surgery at WRNMMC facilitated the day-long meeting.
Forsberg laid out the broad agenda for the meeting, “Osseointegration is uniquely suited for wounded service members with upper and lower amputations, but the technique is complex and requires a coordinated effort. This steering committee will bring together all aspects of the technology to deliver state of the art care to the wounded warfighter. First, we need to establish the priorities to guide complimentary research, establish ways to work together, and make OI a reality for our patients.”
He added, “Because OI is an emerging technology, we have a responsibility to introduce it to DoD beneficiaries in the most conscientious manner possible. By aligning ourselves with existing DoD research and development programs, we have the unique opportunity to develop the complementary technologies that will ultimately make OI safer and therefore more widely applicable in the future.”
Potter provided an overview of the care provided for wounded warfighters from point of injury in combat to care in a major Military Treatment Facility in the U.S. and the prolonged critical care and rehab needed to overcome their injuries.
“It is important, as we are thinking of this as a DoD OI program, to recognize that military patients really are unique, different from civilian trauma patients. They have unique sets of problems and a prolonged critical care period. The ultimate goal is maximize return to duty and to maximize function and quality of life for patients who realistically won’t be returning to duty,” said Potter.
He pointed out that service members who sustain extensive blast related soft tissue trauma to their residual limbs often experience challenges with traditional prosthetic socket fitting and wear.
World experts in OI attended the meeting including Professor Rickard Brånemark, who recently relocated from Göteborg Sweden, to San Francisco. Brånemark developed the OPRA device, has been performing OI procedures in Sweden and other countries for over two decades, and only recently obtained FDA approval for the OPRA device in patients with transfemoral (above-the-knee) amputations.
Seeing an opportunity to expand the indication to patients with upper extremity amputations, Brånemark, Forsberg and Potter obtained FDA approval to begin an Early Feasibility Study in military patients, this winter.
Attendees also included military and academic experts in the field along with industry product developers and they discussed all aspects of the technology to deliver future care to service members and veterans, including the clinical trials scheduled to begin in early 2016 at WRNMMC. The clinical trials will include orthopaedic surgeons, rehabilitation physicians, prosthetists and therapists because the post-operative rehabilitation takes between 12 and 15 months.
“There are four clinical trials planned, the first will begin enrolling patients in early 2016 at Walter Reed,” said Forsberg.
He added, “Having these world leaders in OI as stakeholders is critically important, and it has taken several years for us to develop this level of participation. The goal is to advance the science and technology of OI by fostering an environment of discussion and collaboration; and, from that comes innovation. DoD has provided a forum, funding and administrative support to conduct four multi-center clinical trials and several projects evaluating complementary technology.”