Hidden Dangers of Orthotic Technology

Asking questions would be dull work for both writer and reader if the answers were always the ones we expected. When we raised the topic of the latest in orthotic technology, however, we heard more from orthotic professionals than the anticipated paeans of praise for the brightest and best new custom-fabricated and/or -fitted devices. Across the board, their enthusiasm was leavened with concern for the hidden dangers to both patients and practitioners utilizing this new technology. The same words of warning kept popping up repeatedly throughout our discussions and research: The need for education. Certainly we are seeing some exciting advances in the fieldnot only with regard to the technology used to create and customize orthoses, but also in the newer materials available to craft them. For instance, carbon fiber prepreg materialsa carbon fiber weave pre-impregnated with thermosetting resinshave entered the arena and are now more widely available for use in practitioner labs. The material provides superior strength with significantly reduced weight and thickness. Stance control knee joints and ankle joints offer superior material choices, and ankle joints are becoming more durable with better designs for variable motion control. The application of CAD/CAM technology to orthotics is also making a huge difference to many. The technology simplifies cranial measurement and fitting and enables faster, more economical methods of circumferential measurement for spinal orthosis candidatesmethods such as the Charleston Brace. [ Editor's note: For more information on some recent orthotic innovations, see related story, " Some New Developments in Orthotics "] Why Education Is Critical With new technology and all its attractions come problemsproblems that must be addressed and hopefully solved by education. Mark Taylor, CO, University of Michigan, appreciates the hard work that has gone into creating the variety of knee joints now available. "We are slowly starting to introduce these knee joints into our patient loadas soon as we understand the right patient to put them on. One of our biggest concerns is putting the wrong type of knee joint on the wrong patient and introducing them to risk. "There's no 'page 58' to tell us what knee joint is the right knee joint for what patient pathology," Taylor continues. "All we have are a few small brochures identifying the characteristics of the individual joints. We must evaluate each patient on the patient's own meritsgait, muscle, strength, and so forth. We must evaluate each joint and its capabilities, and then we must correlate the two together." Taylor fears that this technology will fall into the hands of those less qualified, and consequently may be fitted to a noncandidate. Used on the wrong patients, such devices could cause greater harm, putting the patients at greater risk. Taylor is developing a reference guideline that will help prevent such errors of judgment. The objective is to develop literature that explains not necessarily how each joint works, but what patients would be appropriate candidates for the joint. It's a very slow, tedious process which may take several years to complete, although Taylor plans to present preliminary data at the 2005 National Assembly of the American Orthotic & Prosthetic Association (AOPA) meeting September 25-28 in Las Vegas, Nevada. Taylor and his colleagues are currently gathering data from polio patients and stroke patients in order to measure outcomes, determining what has worked best, what doesn't work, why it doesn't work, and in what environments it works and doesn't work. The compiled directory of information will be available for sharing with orthotic practitioners across the nation. More Options: More Complexity With more and better choices available to orthotists, the practitioner's job has become more difficult. "You used to be able to put a locking knee joint on a patient with weak or absent quadriceps, and that was the end of it," says Taylor. "They unlocked it when they sat down. Now you have to consider the environment, the available knee joint options, and the two have to match, so orthotic practitioners have to think a little bit harder than they used towhich is good for the patients, because it gives them more options. "The biggest problem is that we have to give the patients more options, but at the same time keep them safe." Taylor and his colleague, Ammanath Peethambaran, CO, also of the University of Michigan, have seen patients from other facilities or clinics that have been fitted with inappropriate knee joints which are causing patients to be at risk. "It's very difficult to explain to the patient that there's just not enough information out there yet," says Taylor. "We can't go to a manual that tells you exactly what patient to use the orthosis on. I don't want my colleagues to start using this new technology on a trial-and-error basis. Eventually the error will catch up to them when patients face potentially detrimental repercussions." The risk is increased with elderly patients. When the new technology is fit on patients with osteoporosis, their weaker bones are more likely to sustain damage if they fall. Hanger's Approach Kaia Halvorson, CPO, vice president of orthotics for Hanger Prosthetics & Orthotics Inc., Bethesda, Maryland, also emphasizes the importance of educating practitioners, patients, and referral sources concerning the benefits, indications, and contraindications of new orthotic technology. "It requires an in-depth evaluation process to determine if the patient is indeed a candidate for this technology and will be able to use it safely and effectively," she notes. Hanger has been markedly successful in implementing not only specified training for stance control, but in building bridges between potential competitors. By hosting two-day training seminars with each of the manufacturers, Hanger ensures that its practitioners are well-informed regarding indications and contraindications and are equipped to make the best choice for their patients. Physical therapists, occupational therapists, and allied health professionals are also invited to orthotic symposiums concerning the new technologywhich are offered across the country, at a rate of four or five per month. "I think that we have been successful in reaching the referral sources and the allied health professionals with the message that it is advantageous for them to refer patients to certified orthotists or licensed orthotists," says Halvorson. "We've really tried to educate them on the better continuum of care for their patients that an orthotist can provide, as opposed to a manufacturer representative who may be in and out in one day." That message stresses that a certified orthotic practitioner can maintain all the follow-up and manage all the adjustments in case of swelling or edema, volumetric changes, or anatomical changes, something that physical and occupational therapists may not be able to provide. Since the symposiums educate attendees not only on sports and functional knee orthoses, but orthotics in general, it makes a clear point in a non-confrontational manner: "There are a lot of different pieces to the big picture," Halvorson points out. "And as orthotists, with an education in biomechanics and with fabrication capabilities, we have the ability to do more for the patient at that end of the spectrum. Allowing us to fit the orthosis, and allowing them to continue monitoring their other patients, frees up some of their time so they can spend it doing gait training and other activities and therapy modalities. This also encourages a team effort, rather than an 'us-versus-them' attitude." It's working. Halvorson reports a written response from a physical therapist, offered on a symposium evaluation form. "Wow! There's a lot that I don't know!" "That was exactly the comment that we were looking for," says Halvorson, "as we portray to them that there are a lot of different parts of orthotic treatment beyond just putting on an off-the-shelf AFO or putting on a knee brace. If they are made aware of the different variations and modifications orthotists can accomplish, hopefully they will also recognize that we can have a better outcome than they might in an office or facility that doesn't have those options." Since pre-preg materialsfor example, carbon fiber which is pre-impregnated with resinsare now becoming an option for practitioners to work with in their own labs, education also becomes a very real part of the orthotist's advancement. "It's difficult for orthotists to embrace a new technology if it means they're going to have to basically relinquish the actual manufacturing to someone else," believes Don Katz, CO, LO, FAAOP, Texas Scottish Rite Hospital, Dallas. The alternative, of course, is educating and equipping oneself to handle the CAD/CAM process in-house. "There are real challenges," Katz points out, especially with pre-preg. "The lamination process for orthotic applications has a high learning curve, and is very time-consuming. The ability to consider pre-preg materials for stronger, lighterweight fabrication, albeit a very slow heating process, to my understanding, should have some advantages over laminating." Katz also believes that expanding our knowledge is a vital adjunct of embracing new technology. "We have a gap of understanding," he observes. "We, as a field, need to do more in quantifying what advantages these new technologies really offer our patients. That's a huge assignment, because despite all the wonderfully innovative new ankle joints, knee joints, materials, and techniques, unless we're really, truly able to demonstrate in an unbiased fashion what advantages those technologies or new techniques offer our patients, we're basically spinning our wheels. "This is where we have to become much more critically minded as a profession. The future of our profession relies on it," he declares. Like Taylor, Katz notes that we still need to quantify what an AFO might offer a patient, as well as what differences the material or joint choice might make. He has also seen a number of improperly fitted patients. "There's nothing that can do more harm to new technology than its inappropriate use for a patient population. If you put an ankle joint on a patient that is frankly contraindicated to benefit from an articulated ankle in an AFO, then you're not going to be helping that patient. That in turn could also make the future use of that ankle joint suspect." The Academy's Project Quantum Leap is currently addressing this issue. Future Trends Within the last year or two, the technology pendulum has swung backward and is bringing useful traditional knowledge back into vogue, in combination with newer methods. Those who haven't touched plaster or fiberglass in years because of their commitment to CAD are now taking a hard look at partnering the two. "There is a very real advantage in some cases to taking a direct cast or mold from the patient, and then digitizing that negative mold and using CAD/CAM technology from that point forward," Katz observes. "It appears that we're starting to get a little more of a melding of the twoold and new techniquesto hopefully realize advantages to both the practitioner and the patient." Taylor, who has 20 years of clinical experience in private practice, is hoping to see design engineers working more closely in the future with practitioners who have a significant amount of clinical experience since "what works in the lab or in a controlled environment doesn't necessarily work on the farm. Researchers and practitioners need to team up and work together. " Liquid metal (magnetorheologic fluid) is another future orthotic development Taylor looks forward to. Prosthetic advances have been made with Ossur's Rheo Knee TM , which relies on liquid metal that solidifies instantly when introduced into a magnetic fieldand then liquefies just as quickly when the magnetic charge is interrupted. The material could be used in a tubular-type design, Taylor speculates, that could dramatically improve the performance of knee orthoses. We can also look forward to continuing advancements in stance control technology as well as different variations of carbon fiber systems, according to Halvorson. "The more stance control devices we see, the more money manufacturers will invest in further research and development to refine their current models. My hope is that we will see pediatric versions of stance control within the next year; this is a population that would greatly benefit from the reduction in energy costs and gait deviations caused by the locked-knee alternative. She continues, "I believe that we're also going to see an increase of carbon fiber implementation, and not just with regard to creating rigid orthoses, but with the introduction of more carbon fiber AFOs from Ossur and Otto Bock, we're going to continue to see more adaptations, as well. I'd like to see an opportunity to customize those different designs, because currently they're off-the-shelf designs." What Are We Lacking? "The inability or limited ability to adjust the orthosis for growth has been a deterrent to embracing some of the newer technology and materials in our practice here," Katz says. "If it's not going to be adjustable for growth, then we're not really going to be providing that much of an advantage to our pediatric and adolescent patients, let alone to ourselves. If you can't make the necessary adjustments to reflect sixth months' worth of growth and have to start over with a new orthosis, you're not really doing them much of a favor." And insurance would be unlikely to reimburse for frequent replacements. Since patient acceptance is key to compliance and success, Taylor and his colleagues are paying special attention to things that annoy patients. "If you're a young teenage student or in college, and you wear one of the new knee joints, and it clicks and clacks all the way up to the front of the class when you give your report, you're probably not going to use it," Taylor points out. "Some of these joints cause a lot of noise or have a tremendous amount of upkeep or maintenance to them; we're finding out the patients are rejecting that. They don't want to have to come back in every two or three days to have something adjusted." So the formula for future orthoses is: "Can't be noisy, can't be heavy, has to work 100 percent of the time." Says Taylor, "Basically, they are looking for miracles from a device that is reliable more than 80 percent of the time." He reminds us, "The world was not made flat. There are inclines, declines, steps, uneven ground, etc. Patients need to be stable and feel secure in all environments." "The same thing applies to spinal orthoses," Peethambaran added. "Putting on a TLSO restricts their overall performance, so the younger scoliosis patients12 to 16 years oldwill not be happy with an orthosis that restricts them from extracurricular and school activities. So we are also working on certain user-friendly, ergonomic, and functional TLSO designs." Ankle joints need to be more durable, Taylor points out, since they have to stand up to a tremendous amount of repetitive stress and load. "We're finding out that sometimes the newer orthoses don't hold up as well as the older conventional designs. The challenge is interfacing the joint with some of the new materials we're using. The interface area is where we have breakdownwe need to improve that area." Earlier orthotic intervention is also needed in the case of stroke patients who are being sent home without any support. Once again, perhaps this is not a lack of technology but of education through using outcomes to demonstrate that orthotic support is beneficial and produces worthwhile results for the patient. "We know that, but unfortunately our colleagues in the medical field don't seem to," Taylor notes. "At the University of Michigan O&P Center, we ask our consumers not only to help educate others, but also to serve as our voice to our regional and local leaders about reimbursement issues. We're actually getting some progress on that. Congressmen and women are starting to listen to their constituents, who carry much more voting weight than we do."

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