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Osseointegration Part One

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Am glad this part is almost over for you Paul.

Keep us informed

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Paul,

I'm glad to hear that you came through with no infections... I'll keep you in my prayers and I hope that your pain level will subside dramatically soon.....

Higgy

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Thak you sue, mmarie, cat and Higgy. There may be a slight reduction in the pain but no major reduction yet. Mind you the tablets were only just working before and now they seem to be dealing with the pain easily.

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Thank you for sharing this amazing journey with us. Hope your days get better quickly.

Ally

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Paul,

I think that you are so brave, to have this done. I hope that the pain lessens, and you can get up and about again. Please let us know how you are getting on.

Take care of yourself.

Sue

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Thanks Ally and Sue, I will keep you posted about my progress.

I have had to look on the internet because none of the nurses can remember how to do a stump bandage. The stitch line still looks clean and dry and I am managing to have baths now with the help of my wife and a polythene bag taped to my leg. It is wonderful to feel clean again even if it is very awkward to bathe at the moment.

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Guest bearlover

I know what you mean Insane about feeling clean again. To feel human again. Iam happy the worst is over and done with..Hang in trere! You sound like your doing fantastic...And a wonderful loving wife..Kudo to her too! ;)

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Well, I was supposed to be having the stitches taken out today but they changed the appointment and I have to go this Thursday instead. some of the stitches are very itchy but fortunately there is a dressing over them so I can't do damage and scratch the itch. I still haven't been able to reduce the pain killer tablets but they adequately cope with the pain now.

I can't wait until Thursday when the stitches will be taken out and maybe then I will be told that I can move around using my crutches and also be allowed to drive the car again.

I have noticed that I have lost some of the range of movement in my leg. It is ok to the left, right and back but lifting it up is where I can only raise it to 90 degrees. that means I can only just sit upright and if I lean forward the leg won't allow me go go any further than 90 degrees. I remember breaking my leg many years ago and a similar thing happened. It was difficult and painful to get the full range of movement back in the knee joint but I managed it after a while.

I didn't expect to end up with the range of movement restricted and nobody warned me about it but I was told that the position where the muscles were attached was moved during the operation. So, I will have that to work on once the stitches are out.

I'll let you know more after Thursday.

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Good luck to you Paul, keep us posted

Thanks Paul. Here is my next update:

I had the stitches out yesterday after they had been in for 3 weeks and one day! Four of them were particularly painful coming out and on the most painful one I let out an expliteve and quickly apologised. I am really pleased they are out but I have to leave a dressing on for two days, so on Saturday evening I will be languishing in a lovely deep bath. :D

As far as the pain goes I was taking 100mg of Tramadol tablets 4 times a day and I have now been able to reduce them to three times a day. I am also taking a nerve blocker called Gabapentin 300mg 3 times a day and once I get the hang of the reduction to the other tablets I may knock that one down to two times a day.

I have been fortunate enough to have no need for tablets in the past and I want to get it back to that way but it looks like it is going to take longer than I initially thought.

I am now officially allowed to move around again and also I am allowed to drive once more. :D

More updates as they happen.

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Good stuff cheers Paul, keep it coming, it's great getting an up front and personal story as it happens...

I'll second that. I've been asked to contemplate the same procedure and your feed back is very useful.

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thanks for your comments Oneblue and Sparky. I intend to continue with the updates. I was advised both for and against this proceedure and was not pressurised in any way, I was given all the facts both for and against then left to make my own mind up. This to me seems to be the only way I can continue to keep my mobility.

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Today has been better than usual, I have been out for a little drive which was very nice and I had a nice soak in the bath and that was even better. I have no dressing on at all now and I am managing without a support bandage too. It seems that my muscles are strong enough now to cope without the support bandage. My next goal is to sleep as I used to do instead of having to sleep on my back.

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January 1, 2007

Recent Advances in Osseointegration

Experts in osseointegration discuss the benefits, risks and latest progress in bone-anchored prostheses.

By Rachel Kelley

Throughout history, some of the most significant inventions have been discovered purely by accident. Such is the case with osseointegration or bone-anchored implants. In the early 1950s, Prof. Per-Ingvar Brånemark, of Gothenburg, Sweden, implanted titanium optical chambers into rabbits to study microcirculation in bone marrow. The scientist found that the bone had completely integrated with the implant and was virtually impossible to remove without fracturing the bone. He coined the term osseointegration and postulated correctly that titanium implants could eventually be used as a type of bone anchorage in humans.

Since 1965, osseointegrated dental fixtures have been implanted in more than 1 million people worldwide. Other applications include facial prostheses, hearing aids, finger joints, thumbs and more recently, orthopedic or upper and lower extremity applications, particularly treatment of transfemoral amputees.

First patient

The first patient to be implanted with a lower extremity osseointegrated prosthesis was a bilateral transfemoral female amputee in Gothenburg, Sweden. Since that time, about 100 patients, mostly in Europe, have had successful lower extremity osseointegration procedures, mostly transfemoral. More than 30 patients have undergone osseointegration treatment for transhumeral and transradial amputations.

In the United States, the procedure is not yet approved by the Food and Drug Administration (FDA).

Advantages

For carefully selected patients, osseointegrated bone-anchored prostheses have proven to have distinct advantages over traditional socket prostheses. For instance, patients do not encounter pain or pressure as they can with a conventional prosthesis. The prosthesis is quick and easy to don and doff using an Allen wrench. There is improved function and patients experience osseoperception, the increased perception of the environment through the osseointegrated prosthesis.

“The most significant advantage of the osseointegrated prosthesis is elimination of the socket,” said Rickard Brånemark, MD, MSc, PhD, an orthopedic surgeon in the department of orthopedics at Sahlgren University Hospital in Gothenburg, Sweden. “We have many patients say it was a bigger change in their lives to go from a socket to a titanium implant than it was from having a leg and losing it. In other words, they tell us it cannot be compared because it is so much better.”

According to Brånemark, his patients can do whatever they like and the bone-anchored prosthesis will always fit. There are no skin problems, it will fit in cars and while sitting on the floor, and they can walk as much as the muscles allow them to.

“And the next day, they can walk the same amount of time because they do not have any skin break down,” he said.

David J. Reisberg, DDS, medical director of the cranial facial center at the University of Illinois Medical Center, Chicago, and a specialist in maxillofacial prostheses and prosthodontics, would like to see FDA approval of osseointegrated devices for orthopedic use because often, the residual limb in the conventional prosthesis bears on the soft tissue causing discomfort.

“The osseointegrated device, on the other hand, bears on the implant rather than the soft tissue,” he said.

According to Evan Herold, marketing manager of bone anchored solutions for Cochlear Americas, a company in Denver that provides people with aesthetic facial prosthetic devices anchored by titanium implants, there has not been any documented case of someone rejecting an implant.

“There has not been one documented case in the history of medicine,” he said. “It is that much of a solid procedure.”

Patient with an osseointegrated prosthesis (left) and standing (bottom right). A close-up photo of the titanium bolt (bottom left).

Images reprinted with permission of Rickard Brånemark, MD, MSc, PhD.

Facial prostheses

Facial prostheses can make a remarkable difference in the quality of patients’ lives and Reisberg assists in this process. He treats many types of patients, e.g., trauma and cancer patients or those missing part of their face due to a congenital condition. These patients may be rehabilitated in the orbital, nasal, midface or ear areas. An example of the latter would be a patient who has hemifacial microsomia, a congenital malformation where all or part of an ear is missing.

“This is when half of the face is usually smaller than the other half and it can relate to the occlusion of the teeth, the appearance of the jaw bone, and the existence of the ear and the ear canal,” Reisberg said.

Treatment of these and any facial prosthesis patients requires a team approach. The prosthetic and surgical specialists must work closely from the outset to achieve an optimal result. After determining that the patient is a candidate for an implant-retained prosthesis, Reisberg and his colleagues fabricate a template of the planned prosthesis to use as a guide during surgery. This helps to determine the number of implants to be placed, as well as their ideal locations, Reisberg said. The implants are threaded into sites in the bone that have been prepared by a series of drills and countersinks. They may be covered over by skin or immediately exposed through the skin by means of a connecting abutment. Following 3 to 6 months of healing to allow for osseointegration, fabrication of the prosthesis begins. It is first sculpted in wax and then cast in a medical grade silicone rubber that is custom colored to blend with the patient’s own skin.

“If a patient is getting a prosthetic ear, for example, the surgeon would put three little implants, about 3 mm to 4 mm in length each, in the side of the head,” added Herold. “The implants would sit there for 3 months so they could osseointegrate with the bone, becoming incredibly sturdy anchors for the ear to be attached to.”

At the end of 3 months the surgeon will take back the skin flap and attach an abutment on top of the implant and screw it in. The ear would simply snap on.

According to Reisberg, several centuries ago, patients used metal prostheses that they kept on with a wire or an early version of a rubber band or strap. Since the middle 20th century, skin adhesives have been commonly used to retain facial prostheses. Implants came to the United States by FDA approval in 1990.

“If a patient is getting a prosthetic ear, for example, the surgeon would put three little implants in the side of the head,” said Herold. “The implants would sit there for 3 months so they could osseointegrate with the bone, becoming incredibly sturdy anchors for the ear to be attached.”

Surgical candidates

To maximize success for both facial and dental applications, a good quality and quantity of bone is needed, as well as a healthy blood supply to the area to be implanted, Reisberg said. Radiation therapy can decrease the success rate, but there are certain things that can be done to increase the blood supply to an area and improve success such as hyperbaric oxygen treatments. Any surgical site, whether a leg, orbit ear or mouth, needs an adequate blood supply for healing, Reisberg said.

In general, individuals with uncontrolled diabetes, autoimmune diseases, smokers or anyone with any medical condition that would prevent healing, are generally not good candidates for any osseointegration procedure, including lower extremity amputees. However, there are no hard and fast rules, Reisberg said.

For lower extremity patients, the best candidates are young, traumatic, unilateral transfemoral amputees who are psychologically stable, Brånemark added.

“Dysvascular amputees or elderly patients with poor circulation are not good candidates,” he said.

Surgical procedures

After osseointegration with a titanium implant, a synthetic ear matches the surrounding skin coloration.

Image reprinted with permission of Evan Harold, Cochlear Americas.

The surgical procedure for titanium implants is generally the same whether it be dental, facial or orthopedic. Low-speed drilling is used to maintain the integrity of the bone tissue. It is a two-stage process. The first stage involves a fixture that is threaded into the bone and the wound is closed for 6 months to allow bone healing to occur around the implant. In the case of a transfemoral amputee, the fixture is threaded into the medullary cavity. It is important that during this stage the implant is not loaded so the bone can grow into the threads. Movement of the implant during this time may cause loosening.

At 6 months or stage 2, the implanted fixture is exposed again and an abutment or titanium elongation of the skeleton is attached to the fixture. This abutment is a sort of safety component so if the implant is overloaded, it will break instead of the implant. The wound is closed with the abutment penetrating the skin. The prosthesis is attached to the abutment in various ways, depending on the application. During the second stage for a lower extremity amputee, the implant is gradually loaded which may take up to 6 months to achieve full weight bearing. The whole osseointegration process takes 12 months and with some patients who have poor quality bone, 18 months.

Risks and complications

Almost all surgical procedures have risks or drawbacks. Osseointegration takes more time in terms of rehabilitation. The implant needs to be loaded carefully. In the transfemoral patient, there is the potential risk of loosening or the patient falling and possibly fracturing the bone while it is healing. There could also be some mechanical problems of the implant such as bending or fracture of the abutment or fixture. The fitting of the abutment in the fixture might wear out by excessive use or the abutment might need a change to a somewhat bigger abutment. This can be accomplished as an outpatient procedure since the implant system is modular to allow easy change of the abutment.

According to Brånemark, during the beginning years of the procedure, there were some great success and also some problems with mainly loosening of the implant.

“During the onset of loosening, you have micromotion and micromotion makes it easier for bacteria to enter into the body and that created infection,” Brånemark told O&P Business News. “We now have few loosenings, less than 5%, and we have almost no severe infections.”

Some patients have irritation now and then, but that is not considered a severe complication by either the patient or the physician. Reisberg said that the only problem with infection is the one risk that would be present in any normal surgical procedure.

Brånemark currently has 18 patients who have been followed for more than 2 years in a prospective study. Of the 18 patients, there is one failure and all the others experienced great improvements in function and quality of life. Brånemark said that he has had only had one reamputation, which occurred in 1995,

Why titanium?

“When my father was a young researcher, he asked other researchers what kind of material he should use for this optical experimental implant,” Brånemark said. “Someone told him, ‘There is new material called titanium and it is supposed to be good with bone. So he sort of by accident found that it was good in bone tissue. So far, I do not think there is another material that has proven to be better.”

Titanium has an inert oxide on its surface. This oxide is like a ceramic material on the outside. No one understands in detail why it works so well in the body.

“Some laboratory results indicate that the oxide has slight anti-inflammatory properties,” Brånemark said.

Reisberg added that titanium is probably one of the most inert if not the most inert material for the body.

“The body does not reject it as a foreign material,” he said.

What the future holds

Will sockets be obsolete in the future? Brånemark believes that they will be an alternative for the elderly, but for others, titanium implants will be a much better option.

“With time, this will become a primary procedure in selective patients, Brånemark said. “I also hope that the improved anchorage to the body will force the development of better prosthetic components.”

Herold added that from the perspective of the facial implant business, it has been a bit slow for people to move away from the old fashioned adhesive retained prosthesis.

“The bone anchored implants show so much more viability,” he said. “People can go out and live without fear of their ear, eye or nose being dislodged.”

Brånemark thinks the procedure for orthopedic use will be approved by the FDA for use in the United States within 5 years.

“I think it will be faster if the Veterans Administration or military would be interested in bringing in this technology,” he said.

Neuroprosthetics is the development of artificial devices to replace or improve the function of an impaired nervous system. Essentially, a neuroprosthetic is a surrogate for any component of the central nervous system or a device which enhances the function of any component of the central nervous system. Neuroprosthetics is a type of brain-machine interface.

Presently, the neuroprosthesis used most extensively is the cochlear implant which is used by about 100,000 people worldwide. Research is ongoing in several areas including retinal implants and seizure-preventing implanted electrode arrays. Scientists are also studying microchips that can be implanted in the brain that interface with osseointegrated prostheses. It may be possible in the near future to control artificial prosthetics by thought patterns.

“Brain waves or electroencephalograms can be used by some patients with paraplegia to control computers,” said Brånemark. “The patients cannot do complex things yet, but they can learn to do simple things like controlling an on/off switch, for instance. This means that today there are ways of directing simple prosthetic devices. For the prosthetic devices to be effective, more complex controlling mechanisms are needed, but this is an important first step.”

Understanding the versatility of titanium

The desirable qualities and varied applications of titanium and its alloys have resulted in their implementation in a number of strategic industries. The fourth most abundant structural metallic element in the earth’s crust and the ninth industrial metal, titanium’s commercial forms are titanium dioxide and titanium-iron oxide. It is a chemical element in the periodic table with the symbol Ti and atomic number 22.

In 1791, William Gregor, a priest who also had an intense interest in chemistry, discovered titanium while experimenting with the mineral menachanite. In 1795, Martin Heinrich Klaproth, a German chemist, coined the term titanium. First isolated in the late 19th century in its impure form and then in a purer form in the early 20th century, metallic titanium came into use in the 1950s, predominantly in the aircraft industry.

Titanium and its alloys are used in many areas. A few of them include architecture, cryogenic equipment, petrochemical refineries, military hardware, sporting equipment, automotive, and marine. It is a key material in spacecrafts, space launchers and the space station.

Characteristics

Positive characteristics of titanium include:

Superior strength yet half the weight of steel

Biocompatible, tissue compatible and nontoxic

Possible anti-inflammatory properties

Outstanding resistance to corrosion (including seawater and chlorine)

Fire and shock resistant

Cost effective

Favorable cryogenic properties

Easily weldable and machinable

Vital and elastic

Withstands extreme temperatures.

Medical applications

More than 2.2 million pounds of titanium devices are implanted into patients around the world annually. In medicine, titanium materials are used in joint replacement parts, surgical instruments, dental and orthopedic implants, pacemaker cases, centrifuges, artificial heart valves and orthopedic materials such as nails, nuts, plates and screws. Due to more active baby boomers and people living longer overall, joint replacements have increased significantly.

Fit and forget

Titanium is more biocompatible that stainless steel or cobalt chrome. “Fit and forget” is a term that is crucial when discussing implantation in humans. The efficacy and dependability of devices is mandatory in medical implantations and titanium is unprecedented in its strength to weight ratios, biocompatibility and economics. Titanium is non magnetic so there is no danger to implanted electronic devices. In dental implants, titanium has no taste and is highly resistant to corrosion from body fluids. Titanium is also highly resistant to cracking or fractures.

Lightweight titanium surgical instruments are helpful in decreasing surgeons’ fatigue while operating. The instruments can be sterilized repeatedly without compromising quality and they are nonreflective.

More applications

Other uses include:

Eyeglasses

Cookware

Sunscreen

Fireworks

Bicycle frames

Artificial gemstones

Body piercing

House and artists paint.

Titanium is as strong as steel but 45% lighter and 60% heavier than aluminum but twice as strong. It has the potential for use in desalination of sea water into fresh water. Titanium is found in meteorites and on the moon and sun. It is also present in the human body.

For more information:

http://periodic.lanl.gov/elements/22.html

http://www.azom.com/details.asp?ArticleID=1794

http://www.deutschetitan.de/eng/profi/kb1-neu.html

http://www.titanium.com

http://www.titaniuminfogroup.co.uk/titanium.htm

http://www.titaniumllc.com/history_of_titanium.htm

For more information:

Neuroprosthetics, Brain Emulation and Mind Uploading: The Ultimate VR Concepts. Available at: http://www.virtualworldlets.net/Resources/...sBrainEmulation. Accessed Dec. 4, 2006.

Orthopaedic Osseointegration. PowerPoint Presentation. Available at: http://sdnp3.ucsd.edu/osseointegration.htm. Accessed Nov. 9, 2006.

Rachel Kelley is a staff writer for O&P Business News.

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I hope you all had a good Christmas and that you have a happy New Year. I think it is time I updated the post once more with my thoughts.

I still have to take the pain tablets but I am now taking the Tramadol 50mg one tablet only three times a day and the Gabapentin 300mg (nerve blocker) twice a day. The stump still looks bigger than it did but after a word with my prosthetist he said it could take as much as 3 months for the swelling to go down fully. I am not able to stop the Tramadol as I tried going without the other day and I don't fancy trying that for a while again. I seem to be able to stand for longer than I did and was able to do the dusting and the polishing in the house yesterday. After New Years Day I intend to get back into my garage and check the underside of my car and attend to any chipped paintwork.

I have more or less regained all of the movement in the leg but the last bit still pulls and hurts a little and the best way I have found to do this involves the toilet! :lol: Whilst sat on the toilet I lean forward until the flat of my hands are touching the floor. The toilet seems to be a secure seat and it holds the leg in position well. When I do the toilet exercise the leg is as far as it will go and only my stomach prevents it from going further.

I drink lots of coffee so I do the stretching exercise regularly.

I have been a little tearful due to the lack of mobility and the pain going on for as long as it is doing and there are things I have had to put on hold due to not being able to do them at the moment. I look back to how I was the week before and that is the only way I can see that I am making progress. Looking back and also looking forward is what is getting me through along with the support of my wife and mother.

I will update again soon and once again I hope you all have a happy New Year.

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Hi Paul, thanks for the update, sounds like you are progressing slowly but surely in the right direction. I can relate to the tears of frustration due to lack of mobility one-step forward and two backward or so it seems. Checking the underside of your car can also cause a severe pain in the wallet.

Wishing you and your family all the best for the New Year.

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It is good to hear that you are coming along quite well. Keep your spirits up and don't try to come off your pain meds to fast.

JudyH

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Paul, even slow progress IS progress! I can feel your frustration in your post, but it does sound like things are still moving in the right direction. Very clever, using the toilet as a base for your stretches... my rehab folks showed me a bunch of stuff I could do using my kitchen cabinets... I think it DOES help to know that you're working with something that's securely bolted to the house!

Try to remember how slow progress seemed the first time around... and look at the "big picture." You're charting new ground for ALL of us, and that's quite a courageous accomplishment!

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I have been a little tearful due to the lack of mobility and the pain going on for as long as it is doing and there are things I have had to put on hold due to not being able to do them at the moment. I look back to how I was the week before and that is the only way I can see that I am making progress. Looking back and also looking forward is what is getting me through along with the support of my wife and mother.

That sounds just like me about 3 years ago, Paul - it's not much fun, is it? :(

You're doing everything right...just give it time...and plenty of ice packs. ;)

Take care

Lizzie :)

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Thank you Sparky, JudyH, cherylm and Lizzie for your kind words or encouragement. I have managed to get myself down to the garage today and spent 3 hours working on my car. I have come back in for a cup of coffee and will be going out again for another hour later. I managed to remove a wheel and a plastic guard and in there is as good as new again now. I will leave the paint to harden and return the guard and wheel tomorrow.

Don't worry about my wallet Sparky, this is a job I do on the car every three years. Sometimes I even give it a polish underneath :o

So, although I am working sat on my butt I am now back in the garage and being productive again. :D I did have to hop a little dragging the trolley jack and also to get some paint and a brush but don't tell anyone :rolleyes:

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