Hidden Dangers of Orthotic Technology
By Judith Philipps Otto 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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