October 5, 2015 Fred Hernandez

Osseointegration in the United States

Given the recent Humanitarian approval from the FDA of the Swedish implant, I thought it would be prudent to give an update on where things are today with Osseointegration in the United States. There has also been some misinformation floating around regarding the various teams and their work; which is never a good thing when people are researching their options.

In July we saw the Swedish team under Rickard Branemark receive Humanitarian approval by the FDA for their screw fixation OPRA device. Approval of the device doesn’t mean Osseointegration is now an accepted form of treatment here in the US. It simply means Integrum was given permission to conduct trials under an FDA approved study. Approval is limited to Ak procedures and has a pretty rigid exclusion criteria for patient selection. The procedure is conducted in two stages and can take up to 12 months before a patient begins mobilizing. From what I understand the study has not yet commenced but soon we will be seeing implants being done using this device up in San Francisco under the approved guidelines.

I spoke to the Utah group recently and they were able to confirm a few facts. Their team will be utilizing an implant design made by DJO here in the US. Nothing new there but after several years of clinical studies on animals; they did receive FDA approval to begin their human trials this past July and have been busy preparing for their first round of surgeries. They are still screening prospective patients but have already selected their initial subjects. Their patient base will be made up solely of Veteran Amputees and are on track to perform the first round of surgeries by the end of 2015. The initial FDA approval is for ten subjects and they anticipate having all ten done by June of 2016. The procedure will be done in two stages; six weeks between surgeries, with immediate mobilization thereafter.

The work being done up in Utah has no affiliation with any other center; as their research is exclusive and they are utilizing a device that has been designed solely by their team after extensive animal trials. Long term, the Utah group anticipates being up and running in a commercial capacity for both military and civilian applications in three to five years.

There is also a surgeon in Las Vegas who has done a single implant procedure under what has been reported by some as an FDA study. The surgery was performed by Orthopedic Surgeon Ronald Hillock and the implant was manufactured by Signature Orthopeadics in Australia. There is some conflicting information about what kind of approval he actually has but most likely, the surgeon is performing the procedure under a FDA custom device designation; which limits the amount of procedures to five per year. As the only two teams who possess FDA approval to conduct a study here in the United States are Integrum under Branemark and the Utah group.

From what I understand the surgeon will be conducting his second surgery later this month. The procedure is done in two stages with 8 weeks between surgeries. I’m not clear what the rehabilitation protocol is, as he has only done a single surgery and it takes time; as well as a number of patients in order to develop a proper Rehabilitation protocol when dealing with Osseointegration patients.

The first Osseointegration procedure conducted in the United States was performed in Utah by a surgeon who is not affiliated with the Utah Osseointegration team I previously mentioned. A modified compress device was utilized that is manufactured by Zimmer Biomet here in the United States. Rather than taking an implanted stem approach; the device is coupled near the distal end of the bone and is held in place by a series of screws. The device was initially designed for bone tumor applications. There is not a lot of information about their work being published but from what I understand; when modified for Osseointegration applications, full load bearing is not allowed until three months post Op.

There is also a team in Pittsburgh Pennsylvania who is utilizing this same compress device and has done an unknown number of procedures to date. Their work is being conducted under limited FDA custom device guidelines and they have also been working with Walter Reed to develop an Osseointegration program ultimately seeking to use both the Compress and the Swedish OPRA devices. The two surgeons mentioned above are not interested in being contacted by the general public about Osseointegration. So I chose not to include their names.

The Osseointegration Group of Australia team under Assoc Professor Munjed Al Muderis, is currently seeking FDA approval of their OPL implant. The device is manufactured in Germany by AQ Implants; who recently acquired Orthodynamics (the previous manufacturer of the now discontinued German ILP device). They anticipate receiving approval to begin working in the United States in early 2016.

The OPL device is modeled after modern day hip stems and is offered as a single stage procedure that has patients mobilizing within a week post op; same as with hip replacement procedures being done today. To date, their implant is the most advanced design on the market; offering a single stage procedure and nearly immediate mobilization for both Ak and Bk applications. Knee, hip replacement and limb lengthening procedures with Osseointegrated implants are also being successfully performed by this team. The Sydney team has conducted 170 procedures and is scheduled to reach the 200 mark by years end. Which means they have done more procedures than any other team worldwide.

Even though we are seeing movement in the United States surrounding the use of Osseointegration technology; there remains a lot of work to do before we see it being commonly used as an option to socket based technology. The various teams not only have to finalize their various studies but perceptions surrounding the safety of the technology still needs to change. We are seeing that happen more and more but there also remains a large segment within both the Medical and Amputee communities in general, who don’t fully understand where the technology is today. Osseointegration has been around since 1990 as it relates to amputees and has come a long way since its inception. It has become a safe alternative to socket technology, with proven results and a large number of satisfied patients.

Osseointegration isn’t for everyone but if you are one of those amputees who struggle with socket technology, there is hope; as change is on the horizon. We are certainly in some very exciting times!

Comments (18)

  1. David Dobinson

    How can we move foreward the training of surgeons in Canada?
    It would be amazing if Health Canada and the provincial health care systems could look at Osseointegration as a covered option for amputees that struggle with the current socket designs.

  2. tim stack

    great information. thank you for sharing. hopefully I will get this done sometime soon

  3. Rick Morgan

    Fred, first, thanks for the update on what is going on here in the US!

    I especially like the news regarding Dr Muderis’ plans to begin working in the US early next year. From what I have read about the different processes, I think I like his the best so far.

    How could I get on a list to possibly be one of his patients when he comes to the US? Just contact his team through the website? Honestly I am not sure I would be able to, as I would have to talk my work into paying for it, (and my wife into waiting through yet another surgery), but would like to be considered as an option.

    Thank again,

    Rick Morgan

    • Fred Hernandez

      Hi Rick,

      Yes, the best way to proceed would be to contact the Sydney team through the website.

  4. jill neuvirth

    I’m an AK, mid-40s, prosthesis since 1985. Never smoked. Never have had an infection. How can I get on the trial? I desperately want to get rid of need a socket. I’m looking to the future and hoping the future is soon!

    • Fred Hernandez

      Hi Jill,

      Trials are a bit misleading, as the surgery and implant would still have to be self funded. One is open to only Veterans but they have already selected their study group. The other is being conducted in San Francisco utilizing the Swedish Screw fixation device which takes a minimum of six months before one would be able to load bear.

  5. Selicio Alvarado

    I’m a father of 8, married and struggling as a lbk amputee since 2007. I can’t maintain steady employment because of a socket prosthesis. The fit isn’t always the problem. It’s the amount of sweat. I have used every antiperspirant on the market and nothing works. I work in the construction trades but I can’t advance. Constantly sweating and pistoning in my socket, causes a safety hazard. Please let me know how I can be apart of any trials for below knee amputees. I would greatly greatly appreciate it. I feel as though this is the only option I have left. Thank you!

    • Fred Hernandez

      Hi Selicio,

      Sorry for the delay. The only trials currently in the US unfortunately don’t involve Bk procedures. As they only have approval to conduct Ak procedures. Although, even if they were performing those types of procedures; the surgery and implant would still have to be self funded.

  6. Chi Chi faria

    I had spinal nerve damage from a car accident in 2000 that resulted in the loss of use to my right lower leg from the knee down. I currently use a flexor IFO because of foot drop. My lower right leg has also suffered from muscle withering and non healing fisher wounds on my foot caused by the brace that eventually caused my right toe and foot ball joint to be amputated in 2005. It is only a matter of time before my lower leg will require further amputation. I have been researching this method but have not seen if this will also be suitable for below knee amputees. Also, will this be applied as part of the total amputation process where the limb is removed and the integrated system is inserted at the same time. As a partial amputee with further aggressive amputation in my future, Im very interested to know if this procedure can be done at the time of an amputation rather than after.

    • Fred Hernandez

      The Sydney team has performed a number of successful below knee Osseo procedures. There is actually some video on the home page of a couple of patients you can see walking on the implant. Patients have gone from amputation to implant in the past and do very well.

  7. Pushpa

    Do you know that rate of infection of among the patients who have undergone surgery in Australia? This seems to be the main concern for the procedure. I am exploring with the Sydney group for possible operation. I live in a developing country and have contaminated water for shower, I am wondering what happened in such situation when infection seems to be an issue even in place with uncontaminated water.

  8. Marcus Brisco

    Fred,

    I am curious as to what type of surgeons perform these surgeries. You briefly mentioned an Orthopedic Surgeon did one of the surgeries but if I was interested into possibly going into this field would that be the specialty of surgeon that would give me the best chance to eventually deal with these patients and type of work? Thanks for your time.

    • Fred Hernandez

      Hi Marcus, Sorry for the delay. Orthopaedic surgeons typically perform this procedure. Although Dr Aschoff in Germany is a Hand and plastic surgeon and he has performed just over a 100 Osseo surgeries since 1999. So really depends upon what country you will be working out of and their rules. Although a surgeon trained in joint replacement would be the best option since they are trained specifically for this type of procedure.

  9. Kirk Billingsley

    Fred, I understand that it is a self funded procedure, what may I ask is the total cost? Thanks

  10. jeannie deboer

    Hi Fred. Is there any new updates to this article? Just wondering where we are with civilians being considered for surgery. What about insurance coverage? Is it still considered experimental and not covered? I guess my greatest concern is infection at the site where the metal is sticking out. Do you have any info on long term effects or risk of infection?
    Also, I’ve heard if you want to hike or anything similar that this is too much impact on the leg with osseointegratio…. so higher level of activity amputees aren’t recommended this procedure. Any truth to this?
    Thanks! Jeannie

    • Fred Hernandez

      Hi Jeannie,

      Sure, civilians undergo Osseointegration surgery frequently. A total of 59 have from the US have gone to Sydney to date for the procedure. Out of the two studies underway in the US, one is open to the public who fall within their exclusion criteria but it is for screw fixation Osseointegration. Going that route takes up to a year before walking again after a two stage surgery. In comparison, the Sydney team offers a single stage procedure that has most patients mobilizing in ten to fourteen days post op using a press fit design. So far two of the US patients have received reimbursement through private insurance and a few others under both workmans comp and tricare. There are lots of publications available to read online. Infection does occur but most are no different in severity than on would see with a soft tissue infection from socket use and is treated in the same manner. Although I am four years post op now and have never experienced one. Running and jumping is discouraged, same as with any joint replacement surgery but we do have patients who are very active with light running, sky diving, rock climbing, hiking etc…. With the press fit design they just ask you wait a year before engaging in such activity to allow for full bone integration to occur.

  11. N.T.Cole

    Is there a requisite minimum length of the residual femur necessary in order for osseointegration to be successful? (27 y.o. male who is bilateral amputee.)

    • Fred Hernandez

      The Sydney team has performed implant surgery on stumps as short as 3.5 inches but also has done bone lengthening procedures; as well as many custom setups. Every situation is different but it would be a good idea to get an assessment done to see what can be done for your situation. Submit a patient enquqiry on the following link and someone will contact you in a few days to do a medical screening and discuss your options. http://www.osseointegrationaustralia.com/ogap-opl-patient-information-form

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