osseointegration

[Mark Lesek]

I am currently in the USA to promote OI.The support we received in LA at the ACA conference was overwhelming. Thank You. Most amputees had never heard of OI or believed the smoke screen of infection by vested interests in the prosthetics industry who feel threated as their money is made by socket revisions approximately every 2 years. OI gives amputees more independence because it makes prosthetics more of a pure engineering solution.It also increases function especially for proximal amputees like myself.

[Jon Kuniholm]

All -

I just got back from a trip to California, and do not always have time to respond instantly to anything. The beauty of this community is exactly that--it is a community, and as such I hope that most of the time it can function without my direction.

My position on this is no different than it has been before. While Open Prosthetics is meant to be about prosthetics, it has evolved to encompass just about all issues surrounding amputation, and while OI is but one method of suspension, and is an experimental one that it not available in most places and nowhere at an affordable price, it is certainly a valid subject of discussion.

HOWEVER. There are a few posters on this site who happen to be OI patients who seem to keep posting about OI with absolutely no regard to providing new info or a balanced view on the topic. As the surgeons and researchers who are proponents of OI themselves acknowledge, infection is a significant issue that must be resolved before the procedure can become commonplace. In the interim, the experimental procedure is still a viable option for those amputees of high level who are not currently prosthesis users who can afford the very real possibility of losing more of their limb to infection.

There is no conspiracy against OI, here or anywhere. This issue has been examined thoroughly and fairly, and we have some biased proponents, and some correspondingly reactionary opponents. I think that it is very important to note that staph was found on the recent test of an OI patient's site of which some of us are aware, and that while there is currently no deep bone infection, that staph is the number one cause of Osteomyelitis, and that the bolt heads straight for the interior of a bone, where such a problem could proceed.

Please be respectful of each other, be mindful of the fact that this site was not created to be a bully pulpit for single issues, post things when they are new and relevant, and PLEASE stop saying that there's a freaking conspiracy about anything. I'm beginning to believe that if there's a conspiracy about anything, it's illegal marketing of a non-FDA-approved surgical procedure.

I have to run, but hopefully that makes some things a little more clear.

Be nice to each other, or dad will have to pull over and spank everyone.

[Wolf Schweitzer]

1) The immune system usually is different in the mouth, face, on
fingers and toes than on other body parts. So infectious risk really
is different depending on the body part. Often this is an issue for
open wounds that require surgical sutures: fingers or toes and facial
wounds really have a lower infection risk than arms, legs or back /
belly / chest regions. Amputation stumps are a particularly bad body
region generally to deal with open wounds and with infectious risks.
They are often poorly circulated. I am an otherwise healthy person,
and my stump also took 5-6 weeks or more to heal, wounds now heal only
slowly there, and the stump gets very cold and blue if I don't pay
attention. So, we humans and particularly amputees are not homogenous
little gummi bears ready to get drilled holes in anywhere in a similar
way - but our bodies are regionally / locally rather different.

2) If I was in charge of the process to regulate limb prosthetics, I'd
argue that there are *goals* to be reached with a patient. These goals
can be *measured* and they are associated with *costs*. There is no
way that you can successfully drill bolts into a lot of poorly
circulated, poorly skin grafted, diabetic or post infectious stumps -
and those just are the majority. Skin rashes under the prostheses are
an issue that are related to a number of factors - but one is the
willingness and ability of the patient to maintain a clean
environment. If I hear that someone is unable to avoid any of these
rashes, I am not sure I'd credit that person with being able to
keeping a bolt skin hole clean enough either - and that's just me. -
So in absence of any really striking and shining demo videos of
unsurpassed perfection of ADL (activities of daily living), I see
*absolutely* no need to make osseointegration an insurance covered
treatment. - However, osseointegration is not at all forbidden. They
could forbid that - and that is certainly not the case. So just like
plastic surgery you can go get osseointegrated if you pay for it
yourself. I see absolutely no reason - as someone to contribute to my
health insurance - that other insured members spend our collective
money on hugely overpriced technology that restricts their lives
further particularly if there are other options. And for only 1-2
patients per 10 million inhabitants a year that REALLY need
osseointegration, there needs to be no new law. Those can always be
solved on basis of exceptions, using application forms and getting
insurance experts to talk with your doctor. That can be changed,
however, if really striking and convincing evidence is presented of
just HOW MUCH BETTER life is with these bolts. Massively improved
walking patterns. Hugely better manual prosthetic function. Stuff like
that. So if someone has an osseointegration and the degree of
functionality is not better than for the same disability without
osseointegration, I'd call the outcome a failure that does not suggest
it is necessary. That's why I am continuously interested in seeing ADL
being completed in a strikingly better way *due* to osseointegration
(and *not* due to other prosthetic components, terminal devices, ..).
Prove that - and I am convinced you'd get wide approval.

~ 1 ~

[Bob Owens]

The time has come, for Jon Kuniholm, to weigh in.

[Wolf Schweitzer]

It is laudable to see that your military will spend millions towards OI. However, they cannot run away from reality nor can anybody else. A friend of mine here is working for a newly defined task and what she is doing is following up patients with implant issues such as prosthetic hip joints, and what the task is about is registering issues ranging from low grade infection, biofilm characterization to implant loosening or failure. These problems are not new, but registering them is. From these problems, new issues as to correctly informing patients arise - because what risks are they being told? With different risks come different requirements.

You have to understand that such medical implants are a tee-totally different thing than prosthetic appendages. This site here is about prosthetics just as a car fan website is about repainting cars or using different light bulbs. We can do whatever we like to our prosthetic appendage - but it does not concern anybody else in terms of cost or responsibility. But medical implants are a subject quite unlike prosthetic appendages.

First of all, the patient will risk a lot more regarding their body, their health. If I use a different hook today than I did yesterday, risk is near zero, and if anything happens it will be with almost 100% certainty damage to some object that I tried to grip and either squeezed, dropped or scratched. As I see that happening, I can reduce the risk further. If you as a patient decide to become osseointegrated, you risk a lot more. First of all, you agree to undergoing operative risks of the usual kind - hemorrhage, infection, damage to nerves, anesthesia, et cetera - and already that is considerable given that osseointegration is a process that may require several operations. Secondly, you from then on carry risks of implant losening and infection that are a significant addition to the operative necessities already mentioned; taking antibiotics over and over again and fighting resistant bacteria over and over again may cause serious damage such as loss of hearing or other problems. The overall health status of people that suffered low grade infections with acute exacerbations over a few years may not be as good as you think. Thirdly you risk to live in a less understood situation - prosthetic sockets have been around for decades and with all their disadvantages and advantages, we know a lot about them - dermatologic issues, problems of fitting, et cetera. Conversely, amputee osseointegration is new and with new technologies come risks that test pilots have - sudden failure, unexpected failure, .. . Last but not the least, medical problems with your implant may become understandable to your doctor - but not to you, and as doctors that are operating as test pilots themselves may have a tendency to downplay complications you risk to become misinformed. All in all, the direct health risks that go with Open Prosthetics inasmuch as it restricts itself to the design and build of externally added limb replacements is not in the slightest way comparable to the health risks that one undergoes when becoming osseointegrated.

Secondly, cost is vastly different. Vastly. If I decide to start tinkering on a new gripper, I may up spending anywhere between 400 to 3000 bucks over the next 1-2 years and then may have a product that requires little or no further spending for the time after that. If that becomes too much for me, I am absolutely able to drop tinkering right now and here. That is not the case for osseointegration. Once osseointegrated, I cannot just "opt out" of wearing an implant. Osseointegration is a procedure with commercially vested interests. Branemark may charge amounts such as 80'000$ for one operation. If you require fixes and follow up, and as much as we like to believe "things to be open for improvement" - once you are wearing a Branemark implant you must follow his orders for insurance reasons and these are purely risk and finance oriented, products are patented. In other words, the amount of loss of financial freedom for osseointegrated patients - either for them personally or for their insurance companies - and the practical loss of freedom (as you do have to follow strict behavioral orders) is huge. In no way is it comparable to tinkering with prosthetic limb replacement appendages which is what Open Prosthetics deals with. As a further example to this take the car industry - you may tinker with your car as much as you like but as soon as other people are affected by it - that is, if you want to drive it on a public road - you have to get it approved to be roadworthy by a technical authority. And as damages of osseointegration may well run up to financial amounts similar to small car accidents it should be clear that responsible governance would mean that these are processed in the respective offices rather than in a virtual backyard garage - which is what Open Prosthetics is. As finances to significantly control, widen or restrict our personal freedom, osseointegration per se is not at all a free pass to freedom. Much rather, personal freedom can be extremely reduced and to decide and discuss this openly, a degree of independence is required that so far I see nowhere.

Thirdly, people live with dreams and hopes. If risk and finances are at stake, talking about dreams and hopes is important. You do build dreams and hopes on information that you are given. And if people are desperate and depressed - and many amputees are desperate and depressed - they are even more prone to falling victim to dreams and hopes even if these are unrealistic than so-called healthy people. That then opens up the subject of proper versus mis-information. As far as I oversee the information that I have obtained regarding implant, financing it, getting it to heal well, getting set up with proper prosthetics, permanent and chronic ooze, Staphylococcus aureus bacteria growing in that permanent ooze, I cannot say that Robert or Mark were "tee totally frank" with us here on Open Prosthetics. Systematically, dire realities are not posted here. Obviously not, as their goal is to raise hopes and fly dreams. For being credible, they like to stand before the label "Open Prosthetics" - not before the label "my own personal opinion". That is why them being here for that purpose is such a controversial subject. A responsible information however will respect factual accuracies. As things need to be kept in perspective it is probably irrelevant if I exaggerate the advantages of a certain cheap little plastic piece that I might have developed for my prosthetic hand - if it fails, a few cents are lost. But if dreams and hopes are misguided for osseointegration - medical implant devices - a lot more can be lost, and I mean *a whole lot more*. If I lose more of my already shortened arm, this would not be acceptable to me unless the reasons for that are really grave and understandable - and to weigh such properly, proper information is absolutely essential. That means that the rather meager (in my view) advantages of osseointegration compared to a well built (not a sloppy work) and well fitting socket need to be compared by people that are not affected by the unstable nature of subjective ups and downs. As even doctors that operate patients have a tendency to down play complications an independent registry is required to keep track of government spending here.

So the spirit of "independent thought" could well support osseointegration. Osseointegration is a medical procedure that falls under medical care, responsibility and data protection. The scope is far too wide and serious for a little blog site such as here. I have already put out a call to registering prosthetic device failures - but that is serious stuff with serious data processing, NOT a blog site aspect. If independent thought does support osseointegration it will send the evangelizers away from rising hypes here and make them part of a strict monitoring system.

As no bolt implant development is done by amateurs - surface coating, surface structuring, testing all are far too complex and require professional equipment and staff - bolt implant development is not a suitable subject for Open Prosthetics. It would be theoretically, but forget about it in any practical aspect. - This leaves us with the question whether we want to discuss bolt implant wearer's subjective experiences on Open Prosthetics. As I see that positive information is boasted and very significant negative information is not placed here, I will place my finger on that and call the reporting I see here "quite biased" and in aforementioned context I see that as irresponsible to others and technically uninformative. As I knew that being a discrepancy of significant amount from early on, I have opposed the "osseointegration advertising" performed by Robert and Mark here from early on.

With that, I do not oppose osseointegration. But boasting subjective likings belong on a private / personal blog. Americans that protect freedom and talk about being nonsensical could potentially understand that - but I have no idea what typ of hysteria limb loss creates in the USA at this moment. If the army now invests millions into OI they either have too much money, are totally desperate or both. Systematic implant monitoring is and systematic research is definitely relevant for osseointegration but naming these obviously is the latest taboo to be broken (otherwise we'd know it from Mark and Robert I guess), and it requires real sophisticated setups far beyond the scope of Open Prosthetics. And I am definitely interested whether the USA can do better than this in terms of osseointegration information.

I would like to see this remain a virtual backyard where we tinker with grip issues, control issues and any other parts easy to take off and replace. Where risk of failure is relatively cheap. But osseointegration and information about it, here and with the current players, is technically unsound and irresponsible.

[Bob Owens]

Our military is spending millions of dollars towards OI interface solutions for our soldiers who did not make it back home in one piece. Check out the Neuro-prosthetics 2010 symposium just held here in the states at WPI, exclusively about moving forward with OI in America.

Why wouldn't I consult Jon Kuniholm's position? Jon also spoke at Walter Reed with us specifically about OI and I believe the DoD is partially funding this site along with Advanced Arm Dynamics? Besides, Jon invited me to add OI content to this site. Would be a shame if Jon and the DoD gave up it's voice. Appears Jon has already given up administrative powers. I've also met plenty of veterans while at the ACA in LA who want OI.

Well, Jon Kuniholm, what is your current position regarding OI discussed on your site? I'm cool either way, but I want to read it from you.

[Wolf Schweitzer]

While it certainly is mentally cheaper to just sit here and call for the "supervisor" to sort things out for you rather than starting your own blog where your OI phantasies all belong it certainly *is* exactly that - mentally cheap :) ... 2 ...

[Bob Owens]

"Jon Kuniholm could you weigh in here and let us know if this discussion is appropriate on this site? Wolf seems to have elected himself ad-hoc administrator here and his admonishments are a bit heavy handed. Please advise."

Jon, what is your position regarding OI discussed on your site?

[Bob Owens]

Really, I want to help you.

[Wolf Schweitzer]

Whatever. 3.

[Bob Owens]

And you've also stated that you can produce and offer an OI interface for about $2,000. Cool, do it. I'll even freely offer my help to you.