Limb Loss and Preservation Registry

More than 2 million people in the United States have lost a limb, either through trauma, disease or other medical condition. That number grows by about 185,000 each year. While many are combat veterans, just over half are amputees who have lost a limb due to vascular disease.

Mayo Clinic is undertaking a five-year program to develop, establish, and populate a national limb loss and preservation registry. The project is part of a competitive contract from the National Institutes of Health and Department of Defense. The goal is to collect data so this growing field of research and treatment can be based on reliable evidence.

Data will be collected on amputations and hospitalizations; details on prosthetic fittings and the providers of those prosthetics; and patient-reported outcomes. Eventually, objective data will be collected on how well patients are functioning. This is considered quality improvement data that will help improve practice standards across the country. Full informed consent protocols will be in place on any resulting research studies.

Information will be collected, stored and analyzed under the highest security. Data will be in a well-protected repository that meets or exceeds federal requirements. Mayo will develop analytical tools to provide data dashboards and statistical reports.

Mayo Clinic will be working with the American Joint Replacement Registry and the Thought Leadership & Innovation Foundation, which will develop and host a process to encourage volunteer participation in the registry. The Amputee Coalition of America will help convey the importance of patients participating in the registry. Health care and prosthetics providers and facilities will also help recruit patients and provide information.

The deidentified data will be used by physicians and researchers working in surgery, wound care, physical and rehabilitation medicine, biomechanics, physical therapy, occupational therapy, prosthetics, orthotics, podiatry, and psychiatry. It also will be used by engineers, industrial scientists and manufacturers who are working to create improved prosthetic devices. In the long term, the data will also help health care providers, patients and families, all of whom need up-to-date, reliable information and resources. Health economists, public regulatory agencies, policy makers, advocacy groups and payer organizations will also benefit from the data.

The goal is to bring together validated, detailed medical information so it can be analyzed and applied to make a better future for patients.

The effort will be overseen by a committee with members from the National institutes of Health, the Department of Defense, the Veterans Administration, the Center for Medicare and Medicaid Services, and the Food and Drug Administration. Mayo will also receive guidance from an independent panel of specialists with diverse expertise, ranging from medicine and science to manufacturers and the military.