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Submission For The Record of Orthotic and Prosthetic Alliance

Mr. Chairman, thank you for the opportunity to submit this testimony on behalf of the Orthotic and Prosthetic Alliance (“O&P Alliance”).  The O&P Alliance is a coalition of four of the primary organizations representing the field of orthotics (orthopedic braces) and prosthetics (artificial limbs).  The four organizations include the American Academy of Orthotists and Prosthetists (“AAOP”), the National Association for the Advancement of Orthotics and Prosthetics (“NAAOP”), the American Orthotic & Prosthetic Association (“AOPA”), and the American Board for Certification in Orthotics, Prosthetics, and Pedorthics (“ABC”).  The O&P Alliance represents the professional, scientific, research, business, and quality improvement aspects within the fields of orthotics and prosthetics.

Professional orthotic and prosthetic care combined with appropriate medical, surgical, and rehabilitative management provides the Veteran with limb loss and/or limb dysfunction the opportunity to live a highly functional life.  The O&P Alliance would like to stress the importance of funding prosthetic and orthotic research and development.  The past thirty years has seen great clinical and technological advancements in the orthotic and prosthetic fields.  We have amputees and others with limb impairments to achieve unprecedented levels of function with the assistance of artificial limbs and orthopedic braces.  The orthotic and prosthetic field must continue to advance in several areas to more accurately replicate human function and develop better measurement tools to assess quality and compare the relative effectiveness of orthotic and prosthetic interventions.

Historically, the Department of Veterans Affairs (“VA”) has realized considerable success in conducting orthotic and prosthetic research.  For example, the VA developed a method of fabricating a transparent plastic to assess the quality of prosthetic socket fit in lower-limb amputees; the VA was among the first to design an energy-storing and releasing prosthetic foot that spawned a new generation of far more responsive prosthetic feet for application to lower limb amputees with extensive mobility needs.  The functional benefit of prosthetic feet of this design has been shown to reduce the walking fatigue and create a more fluid gait.  The VA has also supported the adaptation of Computer Aided Design/Computer Aided Manufacture (CAD-CAM) to the field of prosthetics and orthotics, yielding significant new advancements and efficiencies in measurement, fitting, and fabrication of orthotics and prosthetics. 

Within the private sector of the organized field of orthotics and prosthetics we have seen many technological advancements that have become the standard of care for amputees and those with orthopedic impairments.  The 1980’s and 1990’s were a time of significant industry investment in orthotic and prosthetic development that yielded many new advances achieving greater comfort, lighter weight, improved durability, and especially, increased function.  It should be noted that the VA Prosthetic and Sensory Aids Service has adopted many of these advancements in O&P technology and routinely cover these technologies for veterans with orthotic and prosthetic needs.

While technology has come a long way since the days of wooden legs and heavy metal braces, much remains to be done.  To help plot a research agenda, the American Academy of Orthotists and Prosthetists has recently conducted a series of consensus conferences designed to prioritize such research.  In addition, significant efforts have been undertaken in this area by the National Center for Medical Rehabilitation Research at the NIH.  O&P technology research has also been supported by at least three other federal agencies, including the National Institute on Disability and Rehabilitation Research within the Department of Education, the National Science Foundation, and the Department of Defense. 

The pace of technological research and development has not been matched by the pace of outcomes research in the O&P field.  The VA amputee population alone is widely disparate.  It includes both aging and geriatric veterans who have become accustomed to more traditional technology, and newer, younger amputees returning from conflict abroad whose expectations for prosthetic rehabilitation are extremely high.  In order to build on the successes the VA and the O&P field has had to date, it is necessary that the VA take into consideration that the patient population they serve is both growing and changing.  We believe that these factors will make it vital for the VA to work more closely with the private sector to help lead the way for all users of orthotics and prosthetics, veterans and non-veterans, to benefit from continued research and quality care in this field. 

The demand for orthotic and prosthetic services continues to increase, not only from the influx of amputees and those with musculoskeletal injuries returning from combat abroad, but also from chronic disease at home.  There are nearly 200,000 members of the armed forces now in war zones who will be eligible for VA services as they leave the military.  Young men and women returning from Iraq and Afghanistan may need VA services for the rest of their life.  Diabetes, and the precursor to this chronic illness, obesity, are on the rise and are major contributors to amputation rates and other orthopedic conditions in this country.  As the “baby boom” generation continues to age, the incidence and prevalence rates of orthopedic conditions will continue to increase significantly.

For these reasons, there is a national need to improve the evidence base of prosthetic and orthotic care.  Research is needed to develop better measurement instruments that will assist an orthotist or prosthetist with clinical decision-making and verify whether an orthotic or prosthetic intervention achieves a particular clinical goal.  The ability to quantify functional outcomes will result in more accurate and clinically relevant cost-benefit analyses.  These analyses, in turn, will enable more reliable quality of life studies as related to the application of new technologies currently being marketed directly to the public.

Furthermore, research is needed to provide measurement tools for the practitioner to be able to assess performance of the orthosis and/or prosthesis and measure outcomes in environments outside the traditional clinic setting.  It is difficult to utilize multi-center studies for orthotics and prosthetics due to the problems inherent in the inter-laboratory reliability of measurements involving gait laboratories.  Research is needed to improve multi-center measurement reliability.  In order to be statistically significant, this research should involve studies of sufficient size.

The practice of orthotics and prosthetics is a very personal relationship between the patient and the practitioner.  It is highly clinical and technical, and is for the remainder of the person’s life.  The process of creating a complex treatment plan, coordinating treatment with the various medical and ancillary disciplines necessary for successful outcome is necessarily protracted.  There are many steps in the process requiring many appointments to achieve comfort, stability, and function.  The end result is a melding of human flesh and man-made/designed hardware that is uniquely fit to meet the medical and functional needs of the patient, affording the Veteran the maximum degree of independence.  The entire process is purely customized to the particular individual.  As such, the practice of quality orthotics and prosthetics demands practitioner expertise and skilled technique which can vary considerably from practitioner to practitioner.  There is a need for systems which can capture scientifically the subjective decision-making skills of practitioners recognized for their high level of expertise so that these skills can be shared more widely.  When fully realized, the development of these tools and measurements will improve patient care across a broad spectrum of the public at a lower cost.

To conduct effective evidence-based research, we believe it is imperative that there be a strong partnering between the VA and private sector O&P professionals who have potentially more current experience with such patients.  Currently, many of the O&P services provided by the VA are performed under contract though private O&P practitioners.  By teaming with the private sector on a comprehensive research agenda, the VA will be able to conduct more reliable research and serve all orthotic and prosthetic patients more effectively in the future.  Considering the interests of the Department of Defense in providing quality orthotic and prosthetic care to wounded service men and woman, it stands to reason that DoD would also be a logical partner in this joint enterprise.

We therefore propose that the VA and DoD fund a joint initiative with active involvement from the private sector to create a Prosthetic and Orthotic Outcomes Research and Treatment Center.  Such a center would enable the military and VA health care systems to work with and alongside the civilian O&P profession to further develop the evidence base in the field.  Such a center or network of centers could work cooperatively to further define common terms, refine functional measurement tools, conduct comparative studies of various technologies, and measure outcomes of prosthetic and orthotic interventions to clearly identify which treatment protocols are most effective. 

In this manner, patients would benefit from improved, evidence-based approaches to maximize their functional capacity.  Health care payers (both military and civilian) would have additional data in which to base their coverage decisions and maximize their investment in prosthetic and orthotic services and the prosthetic and orthotic research community would be spurred into developments that are still on the horizon and improve education and training or O&P clinicians.

Conclusion:

The O&P Alliance appreciates the opportunity to testify on this very important issue.  We urge the members of the Committee to continue to fund and conduct research in the areas of orthotics and prosthetics, and to work with the private sector to ensure that this research investment is optimized.  We stand ready to work with this Committee to address these critical issues. Thank you for your consideration of our views.  If you wish to discuss these issues further, please contact Peter W. Thomas, counsel to the O&P Alliance, at 202-466-6550.