In the 16th century, conventional wisdom for treating patients with bullet wounds abided by the Galenic system, which was dedicated to theory rather than empirical knowledge. The lack of clinical evidence led to painful treatment of bullet wounds as gunpowder was assumed to be poisonous to the body. To nullify the poison, boiling oil was poured into the wound.
In 1537, a young military surgeon, Ambroise Paré, broke from this tradition by using soothing balms made from egg yolks, rose oil, and turpentine. The next morning, he discovered his battlefield patients fared much better than patients treated with boiling oil.
Paré would later father many innovations, and he would publish his findings in vernacular French rather than the academic writing of Latin, which allowed others to follow in his footsteps and build on his evidence.
Paré’s contributions are a perfect encapsulation of what it means to be innovative, but what about modern innovations? What has been a groundbreaking innovation of the past ten, 20, or 30 years? We posed this question to veteran O&P professionals and burgeoning O&P master’s students to explore the nature of innovation and where it will take us in the future.
The Evolution of Liners
To learn how liners are taking on new and exciting forms, we had a chat with two SPS Sales Managers, Pierre Masson, CPO, and Christina Cox.
Masson, who practiced as a CPO from 2005 until 2018 when he joined SPS, explains, “The biggest changes I’ve seen is the PeLite liner to silicone TPE or urethane liners.” TPE liners feature a combination of thermoplastic elastomer, mineral oil, and vitamin E, which protects the skin from abrasion and offers a high level of comfort. Liners made from urethane are stiffer and allow for a more balanced distribution of pressure.
Masson continues, “Back in the day, the PeLite liner and supracondylar weight were essential because it acted as a pendulum swinging off the patient’s leg. Once we got better traction with TPE or any type of liner interface, it created a tighter connection and was more secure for the patient.”
Christina Cox, who has been an SPS Sales Manager for seven years, agrees that liners have come a long way. “When I started about 21 years ago,” Cox adds, “a lot of patients were still pulling themselves into a direct skin-fit socket. The sockets came with a parachute-like donning sleeve that would wrap around their leg so the patient could pull it through the hole in the bottom of the socket. They would push and pull themselves into the skin-fit. Now the seal-in liner has advanced to the point that patients can now use a liner instead of a direct skin-fit type system.”
Seal-in liners made it dramatically easier to don and doff a socket, but some patients prefer the classic direct skin-fit interface. Whatever their preference, liners have evolved leaps and bounds with variations in material, size, and suction ability so any patient can find a liner that works for them.
Upgrading Sockets
Liners now come in a kaleidoscope of variety, but what about the humble socket? Currently, sockets are crafted to the individual patient, with many factors that can cause a socket design to go south.
Ottobock’s Senior Clinical Specialist Gerald Stark, PhD, MSEM, CPO/L, FAAOP(D), provides insight into how sockets can become a burden when they don’t fit well. “There is a window of time that [prosthetists] can fit the patient. A lot of times, if they don’t adjust for the hip flexion contracture, they can’t fit the prosthesis better. [At Ottobock], we have pattern recognition that helps sockets fit accurately. For a pattern of the whole limb, they need to go through the fitting process so there are no gaps. If there are any gaps, then the whole math breaks down,” he says.
Fitting a socket to have the correct load transmission, stability, and distribution of weight can be tricky. Unfortunately, ill-fitting sockets are a common concern among patients, with many reports of skin irritation, blistering, and discomfort. Because of these issues, O&P professionals have looked to direct skeletal attachment (DSA) as a socket option.
Through osseointegration (OI), DSA is implanted into an amputee’s residuum bone and protrudes out of the skin to attach directly to a prosthesis.
Shane Coltrain, CPO, is the founder of Orthotics & Prosthetics East, Greenville, North Carolina, and a limb loss patient. He believes skeletal attachment procedures will become more common as concerns regarding ill-fitting sockets grow. “I have several patients that have OI and the skeletal attachment systems has undoubtedly been more functional and beneficial in the long term, when risk of infection is controlled,” he notes.
OI emerged from the dental field with the first successful implant in 1965, but it was not used in O&P until 1994. Benefits of the procedure for patients include an unrestricted range of motion around the hip joint, better sitting comfort, improved sensory feedback, improved limb control, and reduced soft tissue problems.
However, the rehabilitation period can be lengthy, and there is a risk of infection. “As someone who struggled with ill-fitting sockets, creating dynamic versus hard, rigid sockets is a priority. More than likely, 3D printing will increase the options of more flexible, dynamic sockets. In the future, I imagine 3D printing will transition to direct skeletal attachment and possibly limb replacement,” Coltrain says.
Computer-aided design (CAD) is a technology-based innovation for O&P that captures the shape of residual limbs to manufacture a custom-fit orthosis or prosthesis. With an accurate image, the clinician can change and correct the form electronically and send the picture to the technical staff for fabrication.
“I’ve been using CAD and scanning technology for 20 years,” says Coltrain. “We still use plaster and fiberglass casting tape occasionally, but about 98 percent of prosthetic patients are scanned.”
Clinicians who use CAD techniques are finding they have more time for patient care and clinical assessment. It will be interesting to see whether sockets are transformed by clinician adoption of CAD or by patients opting for DSA. Innovation creates many crossroads that can drastically alter the future for the classic socket.
MPKs Transform Patients and Policy
"It’s hard to talk about innovation without mentioning microprocessor knees (MPKs). According to Cox, MPKs had a big impact on patients when they arrived on the market. “A patient would come in with a bit of a limp. The microprocessor’s powered feature would literally erase the limp within 25 to 30 steps to create a more symmetrical gait.” MPKs were a boon for patient confidence.
Cox continued, “They also improved patient fatigue—not to mention mental fatigue.” Traversing different terrains no longer took as much focus for patients because the MPK adapted and conformed to the ground better than other prosthetic devices.
Stark provides a different perspective about the impact of the C-Leg, the original microprocessor knee that launched in 1997. “It was really earthshaking, but what was really earthshaking about the C-Leg wasn’t the device, it was the impact it had on process.”
When the C-Leg launched, justifying the costs to insurers was a hurdle because O&P outcomes were not widely documented. Stark continues, “More outcome studies were implemented and much more focus was put into research. Meetings changed from ‘how to do things’ to ‘how do we justify them?’”
This innovation changed the profession by magnifying the need to prove why new technology was beneficial to the patient. Today, the C-Leg is one of the most scientifically researched prosthetic devices.
Imagining the Future of O&P
What will the future of O&P look like? We posed this question to MSOP students.
Sophia Mancini, one of SPS’ 2021 O&P Master's Scholarship recipients and an O&P student at Eastern Michigan University, is excited to see how gait analysis transforms. “I believe we will see a lot of progress regarding clinical gait analysis. I’m interested in how we can provide better feedback to patients regarding gait and outcome measures,” Mancini says. “Optimizing gait efficiency is incredibly important for patient comfort and energy conservation.”
“I wrote a paper about the advantages of implementing technology for clinical gait analysis. It could be any technology, but I suggested radar because it’s cheap and mobile,” Mancini says. “Few clinics are equipped with motion capture sensing technology. A simple solution like radar would provide more availability for clinicians to collect valuable data. Having a device that can provide feedback regarding a patient’s gait and their progress would be invaluable in the future.”
Jason Kercher, an O&P student at the International Institute of Orthotics and Prosthetics, describes how virtual reality (VR) is helping shape the way amputee patients are overcoming the mental aspect of losing a limb. “In our field, VR helps with gait analysis and assists new amputees working on building muscle strength.” VR is shown to help ease phantom limb pain by tricking the patient’s brain into thinking it is still in control of the missing limb.
“This technology could also assist patients who need orthotic devices because it could help improve muscular imbalance,” Kercher adds. VR’s many applications are sure to expand in the coming years.
Our second SPS O&P Master's Scholarship recipient, Jaime Purdie, also an Eastern Michigan University student, believes 3D printing will one day become an everyday tool. “I believe that in the next ten to 20 years, 3D printing will become well incorporated into clinical care for specific patients and used on a regular basis.” As costs are driven down and regulations are created to support new advancements, 3D printing will have a powerful role in shaping the future of O&P.
Emma Northrup, an O&P master’s student at the University of Hartford, explains how she was able to find new and compassionate ways to administer patient care despite the pandemic. “There is definitely innovation happening on the patient interface side. And I see that improvement, especially after COVID. We were tested as a country in many ways.” O&P was always a very hands-on industry, but the pandemic nudged the industry to adopt more digital technology.
Northrup continues, “The pandemic taught our industry a whole new way to provide assistance and guidance. I’m very excited to see how we will continue to advance this innovation of assisting patients on a virtual, but still hands-on level.
Final Thoughts
”Innovation revolves around facilitating patient comfort and improving mobility. From Paré’s bullet wound treatment to modern-day socket alternatives, improving patient care has always been central to advancing technology and processes. Listening and learning from multigenerational clinicians can be a catalyst for change. Let’s continue to uphold Paré’s ideals of sharing knowledge, relying on clinical outcomes, and upholding patient comfort as we work towards providing a better future for patients.
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