Replies - Silicone AFO's

Replies - Silicone AFO's

mkshop

5/10/2005

Below are the replies to my previous question regarding silicone AFO's.

Original question:

I had a podiatrist ask me to look into a new AFO design out of Britain. It
is called a Silicone AFO. I went to their website and found it to be an
interesting design and patients seem to be having good success with it. It
is intended primarily for use with patients with foot drop. I was able to
find more information at different websites and found the responses weren't
all positive. People seemed to like the feel, flexibility, and fit in the
shoe. Some problems were with weight, incidences of cracking and tearing,
inability of material to breathe and the need for use of an arch support in
situations of pes planus or pes plano-valgus in conjunction with their foot
drop.

My question to the list is this:

Have any of you had a chance to work with this orthosis.
What was your experience?
Positive or negative feedback from patients?
How durable is it?

Also, how can you laminate with silicone and incorporate strength with
flexibility? I haven't in my 23 years as an orthotist ever custom
fabricated a silicone type device.

How difficult to work with is it? Is there a high failure rate? Is cost
prohibitive?

I appreciate your time and hope to hear your opinions. I will try to post
responses anonymously in a few days.

Kevin Matthews, CO/LO
MK P&O Services
210-614-9222

I researched this myself and found it to be a very interesting design. I found both positive and negative feedback. At $1000.00 each for central fab and not knowing whether or not the patient will benefit I could not recommend this to anyone. If they want to pay to try them I won't chase them off, but will explain the possibility of a negative outcome.

There is and interesting article written by an italian physician with CMT that was given a pair to try. Anyone that would like it just e-mail me and I'll forward a copy.

The jury is still out on this one. I called my podiatrist and explained what I found and she dropped the idea like a hot potato. Replies follow:

#1
I have not worked with it but have seen one patient who came into my office with one. She did not care for it and was fitted with a plastic AFO.
It is very tough material and I suspect that it would prove extremely durable so long as the zipper did not break.
It is very tough material and I suspect that it would prove extremely durable so long as the zipper did not break.
I have no idea as to failure rate etc. but can say that making a fit adjustment was next to impossible. You cannot effectively glue pads to silicone and you cannot grind the material well either.


#2
I have fitted a large number of these devices with good outcomes.

#3
Kevin, I have worked with 3 patients with these. Yes, they are
expensive and tricky to modify if there are pressure spots. They are
warranted for 6 months and I am told that the expected life is about 2
years. I can discuss this more if you would like to call me.
#4
Kevin, I have worked with 3 patients with these. Yes, they are
expensive and tricky to modify if there are pressure spots. They are
warranted for 6 months and I am told that the expected life is about 2
years. I can discuss this more if you would like to call me.

#5
As a prosthetist-orthotist I have been curious about attempting to fabricate an orthosil dorsi-assist AFO. Orthosil is Otto Bock's silicone laminating resin. It is very tough and used with their elastic tricot tube stocking could provide a fairly thin lower profile type AFO for those special cases of flail peroneal nerve palsy. It probably would not be flexible enough to don without an incorporated zipper or strap closure. It wouldn't breath, but maybe a thin sock underneath could provide comfort for those sensitive to the encasement of silicone. The SAFO website displays something along the lines of what I had been thinking about. It would seem to me that some type of fabric structure would be necessary for longevity. Laminating with orthosil is not difficult, but takes practice. Especially for someone not versed in laminations. The learning curve would cost some money and time. If you have the vacuum system for laminations most of the cost is already covered. Spend several hundred dollars for resin and elastic tricot stockinette and give it a whirl. I would suggest spending some time with a prosthetist or prosthetic technician experienced with these laminations prior to trying it yourself. I am curious about their (SAFO's) reinforcement for toe lift? Metal, plastic or other L? Bock's orthosil can be blended for softer or stiffer durometers. It cannot be pigmented.

#6
i saw this item this past year--its very nice--their central fab fee is 1000.00 us dollars--i tried to introduce it but no one wanted to pay for it --including third party payors---its patented----

#7
the central fab fee from england is 1000.00 per unit---other than a private pay patient good luck---your third party payors are not about to spend that kind of money on an iten that last about 2 years-depending in activity

#8
Kevin,

     Just a few of my thoughts. It has been my finding that at first blush new products and concepts like this often show great promise due to marketing dazzle. As is often the case though, they require tremendous personal and financial sacrifice while you are on the low end of the learning curve. This is due in part to the highly complex nature of reducing the variables involved to produce an affordable low cost streamlined marketplace product.

     Experience has shown laminating silicone with nylon or similar type interfaces using traditional PVA vacuum bag techniques is a difficult procedure and rarely produces the desired long term results one is looking for. Contact anyone who has fabricated and delivered the classic Fillauer 3-S socket system. Almost everyone in the field who has tried it, has abandoned this technique. PVA vacuum bag laminated silicone liners manifest two fundamental problems when utilizing traditional laminating processes.

     First the liners will stretch over time causing an increase of circumference and loss of intimate suction fit and suspension. Second the cloth interface material is invariably exposed to contact with the skin, (because of frictional wear and the inherently limited material interface saturation capabilities). The exposed cloth material eventually becomes a fertile and perpetual incubator for foul smelling bacterial propagation.

     Because of these two downsides, most everyone I know has switched to prefabricated liners or custom mold fabricated liners, which eliminate almost completely the previous two problems.

     Prefabricated products as well as custom products have a unique feature that is lacking in a PVA vacuum bag technique. They maintain consistent wall thickness throughout the mold during the lamination (extrusion) process. This is the necessary and key feature for prevention of the two previous mentioned problems utilizing a Fillauer 3-S vacuum bag technique.

     Both prefab and custom products have their limitations however. Prefab products fail to address the full spectrum of anatomical diversity, while custom products are often cost prohibitive in many instances.

     Not having familiarity with the product you describe, it would be hard to determine whether or not this is a PVA vacuum bag lamination, custom mold or prefabed mold product. Regardless, if Dorset is not utilizing molds with fixed wall thickness, I doubt the product in its present state will have a lasting place or life span in the field of P & O.

     One last thing to consider is the products price and reimbursement possibilities. Our current Medicare system (insurance included) has become adversarial on a number of issues. Medicare is hostile to the introduction on new technology, creating entrance barriers to unique and new treatment protocols. It is not necessarily that these products and procedures aren't efficacious, but that the powers that be perceive their implementation as a further impediment and threat to achieving the Balanced Budget Act (which they are under orders by congress to implement).

     What a tragedy that these short-sighted bureaucrats can't see these things in their proper perspective, possible elimination of additional patient treatment procedural costs, and more importantly a decrease in the amount of patient suffering and physical burdens. Increasing patient satisfaction almost universally results in a direct lowering of Medicare system service utilization and thus lowers costs and promotes a balanced budget.

     I hope this email lends some unique perspective and provides some profitable food for thought.