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Data Debut

The new Limb Loss and Preservation Registry provides a framework for O&P data analysis and evidence-based patient care

By MICHAEL COLEMAN

Join the Registry

O&P facilities are called to participate in the newly launched Limb Loss and Preservation Registry. Learn more and join at

www.llpregistry.org.

OWNERS AND PRACTITIONERS at O&P facilities seeking big-picture information about the health outcomes of individuals with limb loss and limb difference are about to get some longawaited help.

The first U.S. Limb Loss and Preservation Registry quietly launched in March but will soon get a big promotional push. The registry will help close a gaping hole in the O&P profession’s collective wisdom, which previously limited practitioners’ ability to review and assess current research in their quest to provide patients with the best evidence-based care. Before now, many of the available statistics were more than two decades old, and longitudinal data had never been collected.

That’s all about to change. The new registry, created and managed by the Mayo Clinic with $5 million in seed money from the National Institutes of Health (NIH) and the Department of Defense (DOD), offers O&P practitioners the first quality registry of data on those who have lost limbs, or struggled to preserve limbs, and their health outcomes with or without prostheses. The registry, which already contains data on 37,000 patients, compiles vital information about advances that make a difference in the care of people with limb loss and limb difference. If prosthetists and orthotists embrace this new opportunity and provide the data necessary for the registry to flourish, its founders expect the amount of available data to grow by leaps and bounds in the coming years. Studies have shown that at least 1.7 million people—or one out of 190 Americans—are living with limb loss. That number is predicted to double by 2050.

Building the Registry

Kenton Kaufman, PhD, PE, a Mayo Clinic professor of biomedical engineering, professor of orthopedics, and the W. Hall Wendel Jr.

Musculoskeletal Research Professor, was the driving force behind the new registry. He will join a panel of experts to discuss this major industry breakthrough at the 2022 AOPA National Assembly in San Antonio. Kaufman describes the new registry as a “lightning strike” for the industry.

“We’ve been talking about evidencebased care for well over a decade, and this registry is the best way to get evidence to support the care that’s provided because we can now aggregate large volumes of data,” Kaufman says. “With large volumes of data, you can see trends. We have [information about] components that are used, but there’s very little evidence to support what’s being used or the plans used to provide care, or even the amputations that are performed.

“This is an opportunity for the individuals involved in caring for amputees to be united in a common goal that will benefit everyone,” Kaufman adds. “It’ll benefit the patients; it’ll benefit the providers; it’ll benefit the manufacturers; and it’ll benefit payors. Everybody benefits—we just need to participate.”

The impetus for participation is clear. The registry will include hospital amputation data from U.S. adults and children, updates from O&P providers about the care patients receive, and information from patients about their outcomes. Within five years, the data will help patients and their providers better decide what choices to make based on a specific set of circumstances, with data analytics helping to predict each patient’s functional status. The hope is that the data will lead to breakthroughs not only in patient care, but prosthesis innovation. The registry will contain data about lower- and upper-extremity amputees, according to Kaufman: “Upper extremity is small in terms of volume, but large in terms of impact.”

The registry also may provide information that will lead to payors approving devices that might otherwise be rejected because of a lack of information about their necessity and effectiveness. In addition, researchers studying diseases and conditions that contribute to limb loss, such as vascular disease and diabetes, will have access to the registry.

How It Works

Danielle Melton, MD, a physiatrist at the Texas Health Science Center McGovern Medical School in Houston and a member of the panel that will unveil the registry at the National Assembly, has been pushing for its creation for years. “I have several amputee clinics, and I have a pretty large patient population, and a lot of what I have to do is justify medical necessity for prosthetic devices,” Melton says. “We think we know that we’re getting [patients] the right therapy and the right prosthetic device, and they’ll ultimately have better outcomes. But quite frankly, we don’t have the information to back that up. When we have peer-to-peer evaluations with medical directors of insurance companies, they’ll always ask for that information, and we can’t give it to them.”

The NIH and DOD are funding the registry’s creation and its first five years of operation, and there is no per-patient cost to enroll patients. Kaufman, Melton, and other registry advocates encourage O&P care providers to enroll all of their relevant patients. After five years, O&P providers will need to pay for a subscription to cover the registry’s costs. “The more participants we have, the more information we have, and the more valuable the data,” Kaufman explains, adding that, ultimately, the cost to O&P providers will depend on the number of participants in the registry. “Obviously, if we can spread it over a large number, the costs will be low.”

Jeffrey Brandt, CPO, founder of Ability Prosthetics and Orthotics, says the registry, if widely adopted by O&P clinics around the country, can help transform the industry.

“My belief is that this will start to provide, once we translate the information in the registry, a framework for true evidence-based care in clinical practice,” says Brandt, who also is on the panel at the Assembly. “It’ll give a clearer understanding of our impact as providers and give us an opportunity to really show that what we do for patients has a valuable impact.”

Michael Coleman is a contributing writer to O&P Almanac.