Recently I had the opportunity to visit the College Park facilities in Michigan. A Russian friend of mine is a distributor of their products and asked if I would come along as a patient model. He brought sixteen of his colleagues over from various parts of Russia to learn more about the company and products he sells to them. There was a mix of Prosthetists, Surgeons and Rehabilitation Physicisans in attendance. He also wanted to show them Osseointegration technology being used on an actual patient; which is the main reason why I was asked to be there. Prior to this opportunity, their only exposure had been to the Swedish device; of which they were not supportive of, primarily due to the use of screw fixation as a way of interfacing with the bone.
My amputation is certainly a part of who I am, although I can honestly say that it has never defined me. Am I disabled? Sure I am but that has never stopped me from doing anything I wanted to do in life. As a matter of fact, up until I got involved with Osseo a few years back; I never even considered myself an amputee. It just wasn’t something I focused on or even had any dealings with unless it involved an occasional appointment with a prosthetist over the years.
I know there are a lot of amputees out there that don’t consider themselves disabled but the fact is we are. We have a physical impairment and that simple fact defines us as disabled. Although that certainly doesn’t mean we are some sort of invalids. It simply means we have to find different ways of doing the things we want to engage in; as there are a lot of amputees who enjoy a variety of activities.
Personally, you would never find me engaging in any type of activity that involved running or jumping, even if I could. I left that in my teenage years and I am fine with that; as I can’t stand sports unless it involves boxing or mma. Sports in general, simply bores the hell out of me and I can care less who the players are. These days I’m content simply chilling with a Cuban in one hand and a Jack on ice in the other but to each his or her own. In the end it’s whatever makes one happy.
Anyone that cares to read my blogs knows I am no fan of microprocessor prosthetic components. Although, I do think it is a good idea to at least try various components in order to see what they may or may not have to offer.
Yesterday I had the opportunity to trial the Biom T2 foot. I have been seeking a trial of the foot for about a year now but the company had some reservations fitting an Osseo patient. They had some concerns given the fact the foot is powered. Ossur had the same concerns when we first discussed the possibility of trialing their Power Knee; although my surgeon cleared the use of such a device after a year post op. The fact that an Osseo patient in the Netherlands recently trialed the foot, gave BIONX a level of reassurance things would be fine. My buddy Jason who is a sales rep for the company arranged for the trial here in Vegas and brought along two prosthetists who also work for the company in order to set things up and film the trial.
The BiOM T2 was designed by Hugh Herr of MIT, who is a bilateral Bk. I find it a bit ironic how Dr Herr has developed the most advanced foot on the market today, yet still utilizes 500 year old socket technology. Although not everyone who wears a socket experiences significant issues, so Osseo wouldn’t make any sense for someone like him. The foot was designed to emulate missing muscles and tendons, allowing an amputee to be propelled forward at toe off. They call it Bionic Propulsion and report patients will be able to do the following.
• Walk with the Gait of a non Amputee
• Walk with the same energy as a non Amputee
• Walk with a natural self-selected walking speed
• Navigate uneven terrain with less effort and greater speed
• Reduce Musculoskeletal stress
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.
On Friday August 7th I drove down from Vegas to meet with my prosthetist Mark Schall over at Quality Care Prosthetics. We had been looking for a torsion device to use with the Kinterra by Freedom Innovations and Mark had ordered a Torsion Adapter from Centri for me to try. Fillauer distributes the device and it is the only one we found short enough to fit between my VGK and the Kinterra since the foot lacks any height adjustment. The adapter offers three stiffness options and is rated up to 275lbs. It has a build height of 2.28 inches with a maintenance free titanium core that offers 45 degrees of rotation in either direction. It comes in three colors that correlate to the level of stiffness one desires. Given my weight, Mark ordered the black one which offers the greatest stiffness level. Although I find the rotation force to be a bit light.
The initial impression was good. I regained the rotation in the ankle that I like, as it took pressure off the implant giving me more of a natural gait movement. You may recall during my last visit to Marks office we had tried another rotator but it was too tall. I met Adam O from Game Changer that day and I ended up leaving on the Game Changer foot to trial. Even though the Game Changer is a really nice foot that has great movement, it is missing the ankle rotation I enjoy walking with (Although Adam does have plans to add a built in torsion adapter in the future). One thing I noticed when going off the Reflex Rotate by Ossur, was that as I rolled over the new foot on slippery surfaces (like tile); the foot would rotate inward in a kind of sliding motion. The lack of rotation transfers torque directly to the bottom of my foot instead. One thing to remember is the fact that I no longer have a socket and thus rotational forces are no longer transferred to the interface between the socket and the soft tissue of my stump. I have to rely on the small amount of movement within my hip, unless I use a torsion device. A normal leg gives one movement in the hip, knee and ankle as one walks; yet in comparison the use of prosthetic components typically don’t accommodate this type of natural movement. Imagine walking with your good leg as simply a hinged knee and ankle with no rotational movement. It feels like I am walking with a stiff gait when coupled with the implant. By using a torsion adapter my gait to feels more freeing and natural.
So I have been on the Game Changer foot for the past three weeks. My normal every day foot is the Relfex Rotate by Ossur, which is one of my favorites but lately the rotator has become a bit spongy and has me dipping when coming through a step. It has gotten to the point that I can no longer adjust the height to get that sweet spot and the foot is either too high or too low. With the implant, I can literally feel even the slightest change; so even a quarter turn either way is noticeable and affects my gait.
The Game Changer was designed by the founder of Ability Dynamics and inventor of the Rush foot; although he sold Ability Dynamics in 2011 and is no longer affiliated with the company. His current design takes his Rush concept to the next level. From what I understand, the foot is comprised of the same material that is utilized in Apache Helicopter blades and is extremely flexible, yet durable. It can handle loads up to 1500 lbs and is 8 times more flexible and ground compliant than comparable carbon fiber feet. The designer showed me some video where he had the foot shot twice clean through with a .40 caliber and afterwards it was put on a patient who walked away on it; pretty impressive actually.
Although that really doesn’t mean much if the foot doesn’t walk properly. The first time I saw the foot, I actually thought to myself; what a strange looking design but I’ll give it a go. Initially it felt a bit soft in the heel (similar to what I experienced with my Rush trial) but the foot has a quick and easy user adjustment called VSC heel shock. The foot also has a Tibial Advancement feature; the company claims that it has an effect on knee swing in Ak applications. All one has to do is reach down and twist a dial that has a small wheel attached to it. It looks like a miniature rollerblade wheel but by adjusting it, you can increase or decrease the amount of heel stiffness and knee swing. The user can also easily adjust the height since the foot has a Rotatable Pyramid Adapter; making it a completely user friendly device.
I have to admit, I am a bit behind on a few blogs and my time on the Kinterra is one of them. The Kinterra is a foot by Freedom Innovations and offers users with 12 degrees of ankle articulation via the use of non microprocessor hydraulic technology. The foot is comprised of carbon fiber and is intended for low to moderate impact K3 walkers. It’s rated at 275lbs and weighs a mere 1.75lbs, with an overall build height of 4.3 inches. Both the heel and toe are split and provide one with a nice amount of Pronation and supination movement.
The weight of a particular component has never been an issue for me unless the product is too light but the weight of this foot felt good. I have said it before but I don’t care for components that don’t make me feel as if I have an equal weight distribution on both sides. Components that tend to be too light feel like I am wearing something foreign and fake. Which is funny because that’s exactly what it is, fake. Legs built like this just tend to flop around too much for my preference. I simply prefer something that comes close to the weight of a real leg.
Day 4 Post Op. Sunday March 23.
Today is a bitter sweet day. On one side, all of my shackles come off and I get to put some serious time into my loading. On the other, I have to say Good bye to Best Friend. My Heart. My Soul. Rebecca is heading home today to look after our lives back home. Our dogs need her and our store needs her.
I try not to think about having to say goodbye. I will be staying here to complete my rehab for an estimated 3 weeks. This will be the single longest stretch of time we have been apart since we met. Its not something either of us are looking forward to. And quite frankly, it sucks. I already miss her and she hasn’t even left my room yet. This is probably the biggest sacrifice we have had to make in order for me to get this far.
The day is going to be simple and straight forward enough. There will be 4 sessions of 15 minutes each, loading 15kgs. Oh, and one strategically timed shower… and by the way my face feels, a shave is going to feel incredible too. You might be wondering, “4 days without a shower? Ripe!” I did have a few good ole fashioned sponge baths to keep the odor away.
Day 3 Post Op. Saturday March 22nd.
Before I get started I need to make a statement.
It occurred to me today as thought about this story that I am narrating. I feel something needs to be set straight. I have made reference to my implant procedure in a number of crude ways. Hammering, Slamming, Drilled, Pounded, and Shoved to name just the ones I remember. The truth is, it’s extremely far from any of that. To minimize Dr Munjed’s work to the point where it would be referenced like a Blacksmith, is completely wrong. I only do it for the literary prose. Its with incredible skill, precision, and care that he and his team undertake to make sure that he can stand there at the end of your surgery and say to your face, “Perfect.” It didn’t feel right to not address this.
I awake after, what was a good night sleep, relatively speaking. Its hard not to sleep when 2 to 4 nurses come into your room and tell the evenings tale and what to expect for the upcoming day. Shift change wasn’t always a pain in the ass. Today, I welcomed it.
And i was excited. This morning I was to begin being unshackled, as I liked to put it. Because of my progress, it was decided that today, they would begin to remove all that binds me to this bed. Im down to 6 “shackles” if you’ve been keeping count. Part of the program is to start weaning off of the Ketamine drip, remove the mini epidural, and remove the vacuum pack. Right on cue, I was thinking. Throughout my slumber I didn’t search out the Green Button and I felt remarkably good this morning. Pain was near zero and I was hoping this was a good sign of things to come.
Don, my nurse, returns with the epidural dressing. I let him in on my discovery.
“Hmmm,” as he bends down closer to look. “Ummmm,” he continues, “Well….”
“Is it out?”
“Yea. I am pretty sure its out,” as he fidgets with the dressing.
“What does that mean?”
“Not sure. I don’t think I’ve ever had one come out.”
A chill runs up my stoned spine as my brain calculates the inevitable. One loose epidural plus no narcotic in spine equals one level of pain killing gone. Im still on my side, and thankfully I am facing to the left where the “Christmas tree” of machines is stacked next to my bed a mere foot away. Along with the machine that goes PING, there is my nemesis… the one thing my pride has been trying to avoid. The Hero in me was high above it until now but the Pain Wielding Phantoms have knocked down one layer of my pain killing defense. My pride gives way…. I reach for the Button at the end of the black cord hanging on the machine that goes PING. It feels small in my hand, not like the one you see on TV where it could be used in a game show to chime in with the right answer before the other contestants. Nope… much smaller, yet it carries a big punch.
I push the Green Light and the machine goes BEEP. The green light goes out.
“That’s probably a good idea Paul. Get ahead of it,” Don advises. “When the green light comes back on, that means you can hit it again.”
He didn’t have to tell me twice. I already could feel the effects the fentanyl slipping in and my pride slipping away. Ive only had opiate based drugs in my life twice before. Once when I was amputated, and once when I suffered 1st/2nd degree burns thanks to a moronic move with a hot car radiator. Remember kids, don’t open a hot radiator cap. Anyway, it doesn’t seem to matter if its Morphine, Demerol, or Fentanyl, the feeling as it washes over you is about the same. Along with my pride, my sense of worrying about the epidural coming out went away as well.