By Deborah Conn

Assemble a group of orthotists and prosthetists, and sooner or later, someone will lament the sad state of research in the industry. 

The idea that the majority of O&P practitioners are uninterested, ill-equipped, or simply too busy to conduct research is hardly new, but it takes on new urgency in the face of tightening reimbursement and advancing technology. 

“We’re probably at least 10 years behind many other health care fields in understanding how important research is in continuing to get reimbursement,” said Brad Ruhl, president-elect of AOPA and vice president of sales for Otto Bock Health Care, Minneapolis. 

Ruhl is talking about outcomes- or evidence-based research: studies that demonstrate scientifically that a particular product or treatment is successful. But the industry also needs to be aware of research that seeks new and better technology to solve patients’ problems. And much of this research is taking place outside the realm of traditional O&P providers and suppliers. 

“This is a very exciting time for prosthetics,” said Eythor Bender, president of Ossur North America, Aliso Viejo, Calif. He noted that the effects of the war in Iraq has brought benefits to amputees and the industry overall as scientists turn their attention to helping those who have lost limbs in the conflict. 

Progress, with or without you
One example of research that is taking place outside the realm of traditional O&P providers and suppliers is the Open Prosthetics Project, or OPP, an open-source research collaboration among users, designers, and funders. 

The Open Prosthetics Project (OPP) was created after Jonathon Kuniholm had his arm amputated in 2005 as the result of a combat injury in the Iraq War. Kuniholm is a partner in Tackle Design Inc., an industrial design and research and development firm based in Durham, N.C. 

“When I was injured, my partners started looking at upper extremity prostheses even before I did,” he said. “And initially they were really disappointed, even angry, with what was available.” 

Once Kuniholm and his colleagues—Jesse Crossen, Chuck Messer and Kevin Webb—investigated further, they realized the issue was one of economics, not lack of innovation. 

“The reason for the state of development has a lot to do with market size and how quickly a company can recoup research and development costs, if ever,” said Kuniholm. 

“Better devices are hard to find not because no one has thought of a solution, but because there’s no way to get them manufactured and delivered to consumers. It didn’t make sense for us, either, to try to make money developing new prostheses. So we took a different approach.” 

Webb suggested using the open-source model popularized by software developer Linux. “If we publicize what we do—for free—on the Internet, perhaps others will take advantage of it and bring in their own ideas. 

“People ask if we worry that someone will steal our work,” said Kuniholm. “That’s the whole point. We’d like nothing more than to post a design and catch the attention of someone who has the infrastructure to take it the rest of the way and make that product available to the people who need it.” 

Another research effort occurring outside traditional O&P groups was highlighted at the Smart Prosthetics Conference, held in November and sponsored by the National Academies as part of its 15-year Keck Futures Initiative. 

The emphasis was on interdisciplinary brainstorming. Material scientists, neurologists, engineers, medical researchers and others discussed new approaches to developing smart assistive devices. The definition of “prosthetics” was broad, encompassing not only limbs but any replacement in the body, including heart valves and brain tissue.

Three of the attendees at the Smart Prosthetics Conference were Steven Gard, Ph.D., director of the Northwestern University Prosthetics Research Laboratory and Rehabilitation Engineering Research Program in Chicago; Walter Racette, CPO, of the Orthotic and Prosthetic Center at the University of California, San Francisco, immediate past president of AOPA; and Gary Berke, MS, CP, FAAOP, owner of Gary M. Berke Prosthetics and president of the Academy. 

“It was an eye-opening experience,” said Racette. “Gary Berke and I were the only prosthetists there. The idea was to get people who normally don’t talk to each other aware of the issues and have them brainstorm together.”

Join the Open Prosthetics Project (OPP)

The Open Prosthetics Project uses its Web site, www.openprosthetics.org, to post ongoing endeavors and solicit ideas and feedback. Current projects under study include a body-powered hook, body-powered prosthetic bands, an adjustable suspension system, a mechanism for adaptive grasp, and a reissue of the Trautman Hook, a device that is no longer in production. Other areas of interest include finding a lower-cost myoelectric prosthesis and a device to help children learn to use their prostheses more quickly. Kuniholm doesn’t view the project as a threat to traditional practitioners. “I think this can coexist very well with the current model for prosthetic service delivery and existing manufacturers of devices,” he said. In fact, Kuniholm and his partners want to incorporate a forum on the Web site for prosthetic providers to share information about innovative approaches they have achieved. “The industry involves a lot of creativity and custom work on the provider level,” he noted. “We want to help prosthetists be aware of customized solutions that have worked for specific patients and might help others. I know there are other forums out there, but my view is that e-mail lists are an inefficient way to communicate. Either the information is not posted when you need it, or you just don’t have time to keep up with all the messages.” Instead, Kuniholm envisions a well-organized site that prosthetists and patients can search for relevant information.

The call to action
Should the fact that efforts such as the Keck conference and the Open Prosthetics Project are taking place outside the awareness of most O&P practitioners be a concern to the field?

“Not a concern,” said Racette. “A call to action. It’s a bit of a catch-22. For so many years, we’ve flown beneath the radar. Now that we’re finally being recognized as a profession, we have to deal with the responsibility that comes with it.” 

“The Keck Futures Initiative deals with long-range issues,” said AOPA board member Thomas Kirk, Ph.D., president and COO of the Hanger Orthopedic Group in Bethesda, Md. “Breakthroughs in this area have the power to revolutionize the industry. 

“It’s also extraordinarily high risk; it’s much easier to modify something than to do basic science across five or six fields. That risk profile is so great that no company in our little industry would have the resources to undertake it. 

“We should thank them. They’re accepting levels of risk without any guarantee of an outcome. I don’t view it as threatening. This fundamental research will pay dividends on a longer time scale.” 

“I think it is a very positive development,” agreed Ossur North America President Eythor Bender. “We have realized [at Ossur] that even though we have an extremely good R&D team, we can’t do it all ourselves.” 

Ossur collaborates with outside partners, such as the Massachusetts Institute of Technology. Bender said, “We try to follow developments in all kinds of areas of technology to see if they are applicable in this industry. 

“O&P is so small that we can’t always develop things specifically for our field. We’re being pushed to see what’s being used in other applications that can be adapted for O&P.” 

Next Steps For the Keck Smart Prosthetics Conference

To help bridge communication gaps among researchers from different fields, attendees at the Keck Futures Initiative: Smart Prosthetics Conference were asked to view 12 hours of online tutorial lectures in advance. At the conference, 10 task groups were charged with specific problems and given three days to work together. To encourage further investigations, the academies will award a total of $1 million in seed grants—up to $75,000 each—to speed new lines of interdisciplinary research identified by conference participants. Recipients of the competitive grants will be announced in April. “These were long-term research goals, 20 to 30 years at a minimum,” said Gard. “We won’t see any immediate impact on the field.” “We were really brainstorming—we weren’t limited by anything,” said Racette. The diversity of participants was particularly useful. “In [traditional O&P groups], we may not know how something can happen, but it might be possible in other research circles.” Gard agreed. “We need more collaborations—engineers, clinicians, biologists, neurologists—we need to talk with each other. It appears that no profession is going to solve some of these more complex issues on its own. We need a multidisciplinary effort.” For a conference overview, visit www.keckfutures.org/prosthetics.

Fretting about it
While prosthetics research by anyone can be beneficial to the O&P industry, practitioners and manufacturers must stay involved. Kirk, of Hanger, said, “We need to stay awake at night to see how we can capitalize on this research; otherwise, it will pass us by.” 

Kirk advises practitioners to keep up-to-date with what’s going on by reading numerous trade magazines, to conduct the occasional Internet search on a topic that interests them and to read articles and see who contributed.

“It’s always difficult to ask practitioners to spend the time, but they have to do this on their own. It takes some personal effort, like any professional who has to stay current.” 

“Our responsibility is to stay abreast of what’s going on, to see where it might have practical applications,” said Ted Snell, CP, of C.F.I. Prosthetics and Orthotics in Memphis, Tenn. and AOPA’s current president. “The vast majority of us are not aware of the amount of research that’s taking place. With the Internet, the information is available; we just have to look for it.” 

Walt Racette concurred. “The Keck conference stimulated me to say you really need to learn about the research world and how it gets funded. We don’t see that—research seems costly and time-consuming. But we need to find out about grants and make the effort.” 

The payoff for O&P
Development of new technologies and improved devices leads inevitably to the issue of outcomes research, because without it, no one will pay for the innovations. 

“Someone has to pay the toll,” said Kirk. “It’s going to come down to the ability of a technology to generate value. We have to show that if we can get someone up on her feet, we can avoid other costs. If we can demonstrate that, insurance will pay. If we can bring in the soft side, quality of life, that becomes icing on the cake. 

“We have to keep in mind that research for research’s sake is a luxury few companies can afford. But targeted research with clinical trials will find a home. After the fundamental science is done, the burden is on practitioners and manufacturers to demonstrate the benefit. And then we can get reimbursement.” 

In an effort to emphasize the importance of evidence-based research and get practitioners more involved, AOPA and the Academy are assembling a steering committee, headed by Racette, representing AOPA, and Berke, representing the Academy. 

According to Berke, the steering committee has one main objective: to begin to direct the profession as a whole toward outcomes research and evidence-based practice. (See “A Shared Vision for O&P”) 

“The difficult thing about starting research in O&P is that we all come from different levels of experience and understanding,” he said. “Some professionals’ vision is different from others, so it’s hard to create a vision for a broad spectrum. 

“We want to balance different activities in this area. For example, the Academy has a research council with three committees looking at different aspects. AOPA has initiatives underway to look at outcomes- and evidence-based practice. We want to make sure we’re not overlapping, but expanding on our activities.” 

Berke advises patience. “The difficult part of doing appropriate research is that it takes time. Because we didn’t start 50 years ago, we’re behind the eight ball. But we can’t expedite it simply because we’re in a hurry. Quality is more important than just putting out papers.” 

Kirk believes that undertaking a research effort is critical to the field. “How we react and manage this conundrum of being late to the party and the need for quality work will be defining for our profession,” he said. 

“We must challenge ourselves on two fronts: first, we must collectively decide on an agenda of research projects that is aligned with patient needs and proactive with respect to our changing marketplace, and second, we must dedicate the necessary resources to get the program up and moving in a timely fashion.” 

“The lesson from history is that if we do not integrate with the new research efforts and move our projects forward with a sense of urgency, someone else will, and we may not like the outcome.” 

Deborah Conn is a freelance writer based in Falls Church, Va.