Baylor Partnership Develops New Model to Aid Sri Lankan Amputees

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Disaster relief efforts typically require arriving on-scene with emergency solutions as quickly as possible. This is not the priority with rendering O&P aid in Sri Lanka, a country whose 26-year civil war ended eight years ago.

In fact, the carefully strategized approach Baylor College of Medicine's Center for Global Initiatives is pursuing, in partnership with the Sri Lanka Ministry of Health, Nutrition and Indigenous Medicine, began as collaborative research addressing kidney disease and esophageal cancer, says Jared Howell, MS, CPO, FAAOP, director, Orthotics and Prosthetics Program, Baylor College of Medicine.

In addition to civil war injuries and lingering trauma, "Sri Lanka, like many other developing countries, has increasing prevalence of the diseases that have plagued the U.S. population for a long time," Howell explains. "We're seeing a significant rise globally in heart disease, diabetes, cancers, and other diseases. During a recent visit to Houston, the Ministry of Health had expressed interest in furthering research and development of new prosthetic technologies, and specifically 3D printing technologies, to address this significant need in the Sri Lankan population right now."

Howell and his team recognize that while O&P professionals have taken the 3D printing process to Haiti and Guatemala to fit devices on patients following natural disasters, studies of the long-term effectiveness of such responses are lacking. "There's really been no research to validate this effort, or to test the safety and feasibility of 3D-printed sockets," he points out.

So, Howell took the unusual step of backing up to take a closer look. From the perspective of an institution known for research, the Baylor team devised a blueprint for O&P response to Sri Lanka's need. "We realized that if we're going to do this right, we needed to do two or three things simultaneously," he says. "First, to test the feasibility and safety of the 3D-printed designs [we must test] them on the local population here in the United States. Once we validate that technology and process, simultaneously we will also develop educational resources and be able to train Sri Lankan O&P clinicians and others to fit patients in-country."

The program's goal, he says, is not simply to provide service, but also to change lives. "The more effective way of doing that is to develop the training and protocols that allow people in-country to provide this care and follow-up themselves. We'll provide the training, the expertise, the technology, and the management and oversight of the research and science side of things in order to empower the country's O&P professionals to take charge."

Why 3D Printing?

Howell cites several factors for investigating 3D printing for this project. "First, it takes about 13 individual and distinct steps to make a current prosthetic socket. With a 3D printer, we can cut those steps from 13 to three steps. So, there's a significant reduction in the hands-on time required, and also a significant reduction in the specific materials that need to be used."

Above and below: Plaster casting in a fabrication area. Photographs courtesy of Sharmila Anandasabapathy.

The plastic used for 3D printing will need to be acquired outside of Sri Lanka, but in less-resourced countries, plaster and plaster bandage materials are also hard to come by-and sometimes present inconsistent quality issues, as well. Howell points to past experiences in South and Central America, where plaster is mixed half-and- half with sand to stretch the supply, which compromises quality. Thus, assuming they will have access to plastic, fabricating 3D-printed prostheses presents an efficient and economical solution for O&P care in Sri Lanka.

In the process of providing that solution, Howell also expects to make and validate discoveries of significance to the O&P community in the United States, pushing the envelope for 3D-printed sockets worldwide.

A new component that can be added to contemporary 3D printers, which he believes will revolutionize the process and reduce costs, is being introduced at the Rapid 3D Printing Conference in Pittsburgh, May 9-11, and will be validated in use.

The concept of testing and evaluating socket performance in use rather than via computer simulation is being pioneered by the Baylor team, which, Howell notes, will develop standards that may serve the industry in the future. "We had wanted to plug into a current standard to validate- but we realized that no such standard existed."

New standards will apply to the socket designs, he explains. "That opens up all kinds of possibilities for different elements, different designs; we're going to be doing all of that through computer simulation and developing physical models to validate those computer simulations."

Why Sri Lanka?

Although much of the country has been deemed relatively safe since its civil war ended in 2009, there is still a risk of unexploded landmines in some of the more rural areas-mines that have been largely responsible for the 160,000 war-related amputations. How many of those 160,000 people with amputations remain in need of care?

"I wish we had an answer for you," Howell admits. "But I believe the number that still needs care is quite significant. We do know that the landmine victims tend to be fairly young."

A 2004 article published by UNICEF ("Landmines Pose Gravest Risk for Children") notes that at least one in five victims of landmines are children, according to the International Campaign to Ban Landmines. "Children are at particular risk of injury and death from landmines and other explosive remnants of war because [the explosives'] small size, unfamiliar shape, and colours can make them look like toys."

Sri Lanka's lower-limb prosthetic response to date has taken the form of the Jaipur Foot, a solid rubber prosthetic foot that was developed in India, Howell notes. "I think it's a question of resources, cost, and probably of training. It's what they know how to do. Unfortunately, these urethane prostheses can be especially challenging for the pediatric population due to their weight, bulk, and limited motion."

The need for pediatric prostheses is unquestionable; Caroline Soyars, BASc, BS, a global health fellow at Baylor, identifies only one O&P clinic within the northernmost region of Sri Lanka. "While O&P clinics are scattered throughout the country, there are certainly not enough to support the high demand for prosthetic care, especially for those residing in rural and remote regions," she notes.

The Jaipur Foot currently in use is made primarily of rubber and is relatively heavy for pediatric users.

She describes a longer-term solution that would implement prosthetic care side-by-side with oncology care for children who need access to both specialties, instead of sending them to separate facilities.

Although politics can sometimes be a stumbling block to diplomacy and can delay or prevent the development of productive rehabilitative relationships in low- and middleincome countries, Soyars says Baylor is fortunate to have a conduit to Sri Lanka through an existing friendship between Sharmila Anandasabapathy, MD, professor of medicine in gastroenterology and director of Baylor Global Initiatives, and Bandula Wijay, PhD, ambassador for science, technology, and innovation for Sri Lanka, who is based in the Houston area.

"The relationship budded into the opportunity for a visit last fall from the minister of health and a delegation of ten other individuals focused on improving healthcare in Sri Lanka through collaboration on clinical research projects to benefit their country," Soyars says.

It Takes More Than a Village

Since then, "a significant amount of external funding" and effort from Baylor have been committed to the pediatric prosthetic care project. The project depends on strong partnerships and sponsor support.

"We have been very fortunate to have multiple partners that have helped us with some of the 3D printing, some of the technology development, as well as some of the software needs to be able to make 3D printing simpler," Howell says. "They're experts in material science and they have some really unique proprietary methods for fusing those materials together. They get much better strength out of the prostheses than if we were to print them on the standard 3D printer."

Blake Teipel, CEO, TriFusion Devices, College Station, Texas, initially met with Howell to explore technology's role in streamlining O&P care. "One of the messages that we took away is that the O&P industry is under increased pressure from regulatory compliance and is experiencing increasing numbers of patients, with not enough clinicians to see those patients," Teipel says.

TriFusion is currently commercializing some world firsts in materials technology, especially for O&P-which may lead to answers to that dilemma. "We're using an electrically conductive polymer that heats up much more evenly and much more deeply when we 3D print with it, so the heat-affected zone is about ten times larger than the heat-affected zone for normal 3D-printed parts," he explains. "This superheating allows us to make stronger 3D-printed parts than were previously available. That now makes 3D printing a viable technology for definitive sockets, for example."

Their new FlashFuse filament material, launching this year, is primarily targeted for North American and European markets; but for Baylor's Sri Lanka project, TriFusion is using strong, but lower-cost materials that are environmentally sustainable and designed to be composted when the prosthesis' life cycle is ended.

Workers handcraft prostheses at the Jaffna Jaipur Clinic in Sri Lanka.

"The overseas market and developing economies are already struggling with a Styrofoam problem. We felt it was important to have a material that had a really good end-of-life solution," Teipel says.

TriFusion's role may also include retraining foreign clinicians, who can leapfrog technologies by using 3D printing, thereby enjoying greater freedom in the design. According to TriFusion's research, it typically takes a prosthetist or technician about three hours to make a conventional socket, and only about 25 minutes to scan the patient's residual limb and design a 3D socket. Thus, clinicians will potentially be able to see six times as many patients if fabrication is outsourced. If it's not, as in Sri Lanka, clinicians will learn how well the in-clinic manufacturing model will work to increase productivity.

TriFusion will be putting together the overseas kit, including the printer, the materials and training, and the scanning and modification solution- the latter will be provided by another partner, Standard Cyborg, San Francisco.

Garrett Spiegel, cofounder of Standard Cyborg, is responsible for building the software program that enables the 3D scanning and modeling, and digitizes the plaster and modification processes. With the program, practitioners can scan in the patient's limb and make all modifications digitally-then design and print the final socket device.

The program is the stage upon which the project's performance is founded. Why is it the best choice for an economical overseas venture like this one? "When we started Standard Cyborg, a lot of my experience was in prosthetics in the developing world-including with the clinic in India that produced the Jaipur Foot," Spiegel says. "Specifically, we worked with them to design a prosthetic knee for resource-limited clinics, the ReMotion Knee" (www.d-rev.org/projects/mobility).

By increasing the efficiency of the small number of O&P practitioners in resource-limited settings, Standard Cyborg's software allows the practitioners to see more patients, thus increasing the amount of care they can provide. "Our system is unique in that it's all browser-based; it's all online, so you can access it from anywhere in the world that has internet access," Spiegel explains. "We designed our system with 3D printing in mind from the getgo, instead of designing it for carving. We made it really simple and easy to use; it takes less than an hour and a half to train new customers. Jared [Howell] teaches students at Baylor how to use our system as part of their curriculum."

The logo for the Jaffna Jaipur Centre for Disability Rehabilitation.

The design does not require extensive update downloads-each time the user logs onto the Standard Cyborg website, changes and new features are already in place and immediately accessible. Also, if a Sri Lankan practitioner requests assistance with a patient's socket, a Baylor collaborator in the United States can help with modifications because all the files are online. Additionally, a chat window built into the software allows instant messaging with Standard Cyborg engineers, if they are needed to provide customer support.

Quality is also more consistent because everything is quantitative and documented, Spiegel points out. "What we're good at is software," says Spiegel. "We're excited that we can use our skills to equip practitioners with tools that make them drastically more efficient so that they can provide even more care to more patients."

Putting Experience to Work

Baylor's experience in previous international research projects has prepared Howell, Soyars, and the rest of the team well; they know what to look for, and how to approach a project like this one for Sri Lanka, Soyars notes. "For me, personally, it's just having a mindfulness of local capacity to be able to translate this new technology, and the awareness that it's not something that can't be comprehended or learned or understood, if culturally appropriate training methods are utilized."

Soyars has learned the importance of having all the pieces in one place, "making sure that when we're trying to provide a comprehensive process we're asking the right questions to provide that process."

Since Baylor's efforts are focused on a long-term solution, she stresses another preparedness issue: "Another big piece of it when you're thinking about the 3D printers and servers is how they're going to be maintained and repaired if something were to go wrong-and establishing the supply chain to get replacement components to the end facilities. We're not just training individuals how to provide the care, or even just [how to] use the printer to print. How do you have capacity on the ground to be able to actually maintain all the technical components outside of the clinical care?"

Fortunately, she says, "Established institutions in Sri Lanka have wide and far-reaching expertise when it comes to the engineering side of things. They're providing a very important piece/set of knowledge and expertise on the ground that we could not provide to do this work effectively. It's definitely a give-and-take relationship; the skill and knowledge is there to be able to maintain it locally. I think that's one of the reasons why Sri Lanka was so appealing to us."

Status Report

As of this writing in early March, Howell was recruiting five pediatric patients for the pilot study that will be the first phase of the project. The second phase, a much larger study to validate claims and findings from the pilot work, will follow immediately. Howell anticipates the in-country phase will begin in Sri Lanka in September, mirroring a similar effort launching in June in Tanzania in collaboration with Rotary International, where the population faces a similar crisis.

There are a lot of people trying to solve some of these problems, which are challenges even for patients in the United States. Our goal is to put the infrastructure in place so that we have the research, the validation, and are starting to develop the tools to actually make an impact in Sri Lanka," Howell concludes. "I think that we're going to learn a lot as we work through the research process and as we have more opportunities to test feasibility incountry. I think, actually, the exciting parts are yet to come."

Judith Philipps Otto is a freelance writer who has assisted with marketing and public relations for various clients in the O&P profession. She has been a newspaper writer and editor and has won national and international awards as a broadcast writer-producer.