Optimizing Care: The Latest in Lower-limb Prosthetics

When Seth O’Brien, CP, FAAOP(D) , lost his leg to cancer at 24, he went from the height of his physical abilities to the bottom. [caption id="attachment_258507" align="alignright" width="546"] Mart Production/pexels.com[/caption] The man who had once run, cycled, and played baseball couldn’t walk in a traditional socket without his residual limb breaking out into blisters. For a long time, no matter what he tried, he couldn’t get comfortable or live the life he wanted. “I had a rough time getting a prosthesis to fit and was frustrated how things were going,” says O’Brien, chief clinical officer, Wheeler O&P, Arizona. “I just kept thinking there had to be something better than this.” When his prosthetist wasn’t aware of how new technologies might be useful, he started doing his own research. Eventually he discovered vacuum sockets, which changed everything for him. He could finally live pain-free and get back to the activities he loved. “The vacuum socket was something I had to seek out as I became more educated,” he says. “It would have been wonderful if they had seen it as a potential solution earlier.” The experience inspired him so much that he changed careers to work in O&P. Looking back 18 years after losing his leg, he can reflect on the technology available to him then and now. Many developments in recent years existed back then but were unavailable to most patients because they were not covered by insurance. These days, access is improving and technologies that were in their infancy have improved by leaps and bounds. “Things have changed drastically, and yet they are very much the same,” O’Brien says. He and other experts in lower-limb prosthetics are excited about several recent developments and technologies that are helping to optimize care. The developments, including sockets that can be adjusted on the fly, easy-to-use computer-aided design (CAD) software for 3D printers, whole-leg systems designed to work together, and a new insurance-covered patient population for microprocessor knees (MPKs), can help clinicians do their jobs better and improve the lives of their patients. Improving Access to New Socket Technology Adapting to the volume fluctuation of their residual limbs has long been a challenge for lower-limb prosthesis users. The traditional advice of adding or removing socks to add or relieve pressure can be cumbersome and ineffective as it adds padding to all parts of the residual limb when perhaps only a portion needs the support. Experts say that new socket technology that allows users to easily adjust their fit could bring relief to struggling patients and revolutionize how sockets are designed in the future. “Even if you have a device that acts like an anatomical limb, if the user doesn’t have a functional socket, they won’t use it,” says Brian Frasure, CP, senior manager of Clinical Services, Ottobock. With these new sockets, users can adjust their sockets with a turn of a dial when their volume shifts throughout the day. In some cases, they can even target the exact part of the socket they want to adjust. “These can make a world of difference to the end user,” says Frasure. And the good news is that this technology is becoming even more accessible for patients. Effective on April 1, the Centers for Medicare & Medicaid Services (CMS) gave final approval for an L-Code for custom-made adjustable sockets (L-5783). “This will help drive the profession toward adjustability because we will actually get paid for something we do,” says Jason T. Kahle, MSMS, CPO/L, FAAOP, CEO, OP Solutions, Florida. He says one of the leaders in this area is Click Medical, which manufactures the RevoFit kit that is built into the device and allows the user to turn a dial to adjust the socket pressure. Other adjustable sockets include Ottobock’s Varos Socket and LIM Innovation’s Infinite Socket TT-S. In time, adjustable sockets may be even easier to use, says Kahle. A University of Washington team led by bioengineer Joan Sanders, PhD, has a self-adjusting socket in clinical trials called TARPIN (To Auto-release and Relock a Pin). Using undetectable sensors and motion-controlled sensors, Kahle says TARPIN is reported to automatically expand or tighten the socket to keep it at the user’s current residual limb volume, creating an ideal fit. Adjustability is also becoming easier for patients in vacuum sockets, says Kahle. He is an advocate of Anclote Manufacturing’s Elevated Vacuum Pump that allows users to control their vacuum levels manually based on their activities and preferences. “The user can control how much vacuum they get,” Kahle says. “It’s a valuable feature that the user can choose and control their own level of vacuum. It’s a novel device that we’ve fit on many patients.” 3D Printing [caption id="attachment_258508" align="alignleft" width="489"] Mart Production/pexels.com[/caption] Sarah Caragian, CPO, has been in the field since 2018 and has seen huge growth in the way the industry has adopted 3D printing. In her master’s program, it was barely discussed, she says. “You dip your toes in, and maybe they brought in a guest speaker,” she says. “The focus was very much on textbook traditional fabrication.” Now at Macy O&P, Connecticut, she uses the technology daily. They even have a printer running in the waiting room so their patients can see the process in action. “In the past 50 years, things pretty much stayed the same, and then, in the past few years, the quickness of advancements has been unreal,” she says. “While before, companies were shying away because they didn’t know how to use it. Now people realize that this is here and it’s happening, and we have to learn it or take on people who already understand it.” She doesn’t like to say that 3D printing is better than traditional fabrication, but she definitely sees its benefits. For one thing, she doesn’t have to worry about variability in the devices because of the temperature of the ovens or the skill of the technicians who are doing the fabricating. “When you put something in a 3D printer, you know what you are getting out of it,” Caragian says. There are also some things a printer can create that a technician cannot. For example, they’ve added pictures of people’s pets on sockets. However, she is most excited about 3D printing’s capability to create a flexible inner liner that can vary in thickness to better fit the patient’s residual limb. “We can’t tell a technician to make the plastic thinner or thicker in places; that just doesn’t work,” she says. The technology is also improving access to prostheses in less resourced countries, she says. She’s heard of graduate students and clinicians 3D printing prosthetic feet for patients who otherwise would not have access to them. “It’s a great advancement,” she says. “They are functional, durable, will last a long time, and don’t need a lot of replacement parts.” She predicts 3D printing will become more popular as prices come down and as the technology becomes easier for clinicians to use. She’s already seen improvements on both these fronts. “At my old company, it was a crazy price to get a new scanner,” she says. “But I think it has become more accessible lately, kind of like how it was very expensive to get a flat-screen TV ten years ago, and now you can find one for $200.” She says new software has also made big strides in making it easier to 3D print devices. While Macy O&P uses in-house CAD software, their office was introduced to Orten software by Proteor and thought it would be helpful to clinicians new to 3D printing. “It’s easier for people who went to school for O&P and weren’t trained in how to use the technology,” she says. Access to Microprocessor Knees One of the changes the experts are most excited about is the growing availability of MPKs. While the devices themselves are not new technology, they have traditionally been limited to K3 ambulators and above. A proposed CMS policy change would cover K2 ambulators who can prove the devices would assist with fall reduction and help them with daily living. “When it comes to fall retention, reduced mental energy, and the ability to walk on a daily basis, all of the literature shows microprocessor knees have better results,” Frasure says. Jonathan Cook, CPO, clinical education manager, College Park, says that access to MPKs will be beneficial to less active adults who need additional stability and assistance. “Most clinicians will tell you that some of the people we are putting high-end technology on right now could walk on almost anything, whereas these other patients who need the assistance are the ones who could benefit more from the technology,” Cook says. He predicts that as the number of K2 MPK users increases, so will MPKs designed specifically for them. These will be devices that will help with stability and gait but can also be easier to use for patients who might not be as comfortable working with technology. “They will be designing features that might not have as many bells and whistles but are focused more on inherent stability and modes that are geared more toward less active patients,” Cook says. He is already seeing that trend. College Park’s Icon MPK was designed with the ability to be highly customizable if the patient wants but can also be simple to use if they need it to be. He says the device works with an easy-to-use app, but patients can also press a button on the device itself to move between lock and free swing modes or a button for a custom mode. “The whole idea is to make it more simple and straightforward for our patients,” Cook says. Putting It All Together While all this technology is exciting, the individual components are only effective if the whole package works together, the experts say. If the combined components are too heavy, the patient might not use the device as much. The same goes for a patient with a low technology threshold who is given a high-tech device. And if the socket doesn’t feel good, then it won’t matter even if the rest of the system is the best in the world, says Frasure. “It all has to be well thought through when combining it,” he says. To help ensure the whole prosthetic leg system works together optimally, some manufacturers bundle packages of components that have been tested together and validated to work well with one another. This helps both with ease of ordering and ease of use. Some of these systems include Össur Leg Solutions and Ottobock’s lower-leg bundles, which offer a variety of combinations based on the patient’s activity level and other factors. “Every case and every patient is unique,” says Frasure. “Every single component should be thought out so that from soup to nuts every bit works together for the patient.” If they aren’t using a manufacturer’s bundled components, clinicians must ensure they are choosing products that have been proven to succeed with one another. O’Brien says the O&P profession has gotten better at utilizing research. When he first started in O&P, many of the clinicians practiced in the way they had been taught, which may or may not have been the best way. That’s changing, he says. “Where we’re seeing big changes in the industry is how the body of evidence is now guiding our clinical processes, and clinicians are making the most appropriate choices for their patients using the best techniques,” he says. “It used to be a lot more of an apprentice-style, where you practiced the same way you learned.” This type of change is helping to guide research that can then be used to make a case for the technology to insurance payers. The more proof they have, the more likely the technology will eventually be covered, the experts say. “Nobody likes to talk about outcome measures and research, but the reason we’re seeing so much movement is that collectively, as a profession, we’ve seen that our peer review research was lacking or that we didn’t have the data to prove what we are confident we know,” says O’Brien. “As we get better data, we can make a better case to policymakers that these devices are beneficial in the long run.” The proposed policy change of MPKs for K2 ambulators is an example of this, Cook says. As the profession studied the technology more, it was able to prove that serving those patients using it would benefit everyone. “A big part of driving access is our evidence-based practices,” Cook says. “We have to convince payers that these more expensive devices save more money in the long run and create better patient outcomes.” Looking Toward the Future [caption id="attachment_258506" align="alignright" width="435"] Andrej Lisakov/unsplash.com[/caption] While there is so much to be excited about now, the experts say they see upcoming developments and technology that can change the profession even further in the future. Here are some of the topics they see being discussed in the next few decades: Osseointegration As surgeons perfect their methods for anchoring bone to a metal implant, O’Brien sees a spike coming in the number of osseointegration patients. The procedure eliminates socket discomfort—as there is no socket—and has been shown to give patients greater control of their devices since they have a direct connection to them. The challenge is that the procedure creates an open wound and may not be good for patients with vascular issues, such as diabetes, or those who are very active and put a lot of pressure on their bones. O’Brien says more research is being done and improvements are coming. “I think you’ll see somebody cracking the puzzle for osseointegration and managing the challenge of having a stoma and open channel,” he says. “We’ll see it become extremely common and more beneficial than it is today.” In 2023, the American Academy of Orthotists and Prosthetists established the Bone-Anchored Prosthetics Society, which O’Brien predicts will help collect osseointegration data and develop evidence-based practices for clinicians. A Neural Link Between Brain and Prosthesis While it still sounds a little like science fiction, Frasure says research is advancing toward creating a neural link between patients and their prostheses. “It sounds like pie in the sky, but it’s becoming a competitive space, and we’re seeing a broader willingness to collect clinical evidence on the validity of these products,” he says. While the technology is coming, the next hurdle will be convincing patients to trust it, he says. “How do you convince people to have electrodes attached to their brain,” he asks. “When you hear that, it’s scary, and no one wants to be the first to do it.” That said, once it does become a viable solution, it will be a huge leap for the profession, he says. “It’s the next frontier,” Frasure says. Expanded Insurance Coverage for High-tech Devices While some great technology has already been developed, it is still not accessible to many patients because of its cost and payers’ unwillingness to reimburse for it. They predict that as the technology continues to be studied and more widely adopted, insurance carriers will follow suit, the experts say. “I think the capability and technology will 100 percent be there in the future, but it will take much longer for it to be affordable and widely adopted through insurance coverage,” O’Brien says. The hope is that as the O&P community gets better at providing proof of the benefits of technologically advanced devices, insurance carriers will follow suit by acknowledging those benefits in their policies. “My biggest hope for the future is that everyone has access to the technology they need,” says Caragian. “I hope our health insurance system will get better in recognizing that advanced technology is safer because it’s starting to mimic natural, anatomical joints.” Maria St. Louis-Sanchez can be contacted at msantray@yahoo.com.

Optimizing Care: The Latest in Lower-limb Prosthetics

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Editor’s Note–August 2024

Prosthetic Alignment and the Lake Wobegon Effect

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