Editor's Note: This article has been updated to reflect a change in collaborators that occurred after publication.
Kenton Kaufman, Ph.D., departments of Orthopedic Surgery and Physiology and Biomedical Engineering at Mayo Clinic in Rochester, is a veteran investigator of limb amputation and prostheses with more than 25 years of experience. He’s on the Medical Advisory Board of Prosthetics 2020, an initiative of the American Orthotic Prosthetic Association. His research is funded by the National Institutes of Health (NIH), Department of Veterans Affairs, Department of Defense (DOD) and National Science Foundation, among others. He has a large DOD grant to teach wounded members of the armed services how to use prostheses and reduce falls. He recently completed the largest study to date on microprocessor-controlled prosthetic knees.
Last fall, Dr. Kaufman was awarded a $5 million five-year contract by the National Center of Medical Rehabilitation Research in the National Institute of Child Health and Human Development to develop and launch the national Limb Loss and Preservation Registry. It will be the first national registry of people who have lost limbs, and will include the electronic health records of U.S. adults and children. The registry’s goal is to establish the number of Americans who have limb loss and preservation procedures and then improve prevention, treatment and rehabilitation activities for this population. The research award is supported by the NIH and DOD.
“Interest in and research about limb loss and prostheses are cyclical with major conflicts or wars,” says Dr. Kaufman. “The general public becomes aware of limb loss when they see a story about a wounded soldier or an amputee running in the Olympics. We’d like to help keep interest more consistent because limb loss has a huge impact on mobility and socialization. Your world can become small quickly when you have an amputation and experience a loss of mobility. The data in the registry and research as a result of it will help the NIH and DOD make the best decisions about research gaps in limb loss and areas that need funding to improve the quality of life for all people coping with limb loss.”
Dr. Kaufman planted the seed for the registry when he submitted a project for funding to the DOD in 2015. He didn’t receive the funding, but his proposal prompted the DOD and NIH to discuss collaboration, which led to a federal solicitation for the registry.
“Receiving the grant is an honor and a large responsibility,” says Dr. Kaufman, the W. Hall Wendel, Jr. Musculoskeletal Research Professor and director of Mayo Clinic’s Motion Analysis Laboratory. “This will be a collaborative effort, drawing on the expertise of several subcontractors and Mayo Clinic alumni.”
Dr. Kaufman’s team will include the American Academy of Orthopedic Surgeons (AAOS); the Thought Leadership and Innovation Foundation; and Prometheus Research LLC, a Connecticut-based health care informatics company that develops clinical research registries that accelerate discovery.
Dr. Kaufman’s Mayo Clinic colleague, Daniel Berry, M.D., the L.Z. Gund Professor of Orthopedics, has been in charge of registries for the AAOS; and colleague David Lewallen, M.D., is medical director of the American Joint Replacement Registry — part of the AAOS.
“Drs. Lewallen and Berry have been very helpful in sharing the lessons they have learned from the American Joint Replacement Registry, which started in 2010,” says Dr. Kaufman. “Their advice has helped guide the design of the Limb Loss and Preservation Registry.”
Dr. Kaufman’s team will design and build the registry between now and 2020. That involves determining the data elements, number of potential participants, security requirements, data entry and storage, data access and permissions, reporting requirements and analytics.
“It’s up to us to develop a business model that will sustain the registry,” says Dr. Kaufman. “Our goal is to create a platform that can be used to standardize, measure and report patient outcomes data, support evidence-based decision-making, enhance health care delivery, and establish and disseminate best clinical practices.”
Dr. Kaufman says current data indicates that 2 million people in the U.S. have limb loss, but the data is outdated. The Amputee Coalition of America estimates there are 185,000 new lower-extremity amputations each year in the U.S. alone. Registry data will come from three sources: ∙
Data will include cause of amputation, rehabilitative therapies, prosthesis use, mobility, barriers to care, quality of life, and other outcomes. Researchers will use data from the limb loss registry to determine regional and cultural variations in care, the best standards of care, prevention strategies, health policy changes to offer better support, and technology advances needed to provide better devices.
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