Here
I am in Berlin at my 5th SAS. It's great to come
here again and see how the industry has changed.
(Perhaps it's just my perception that has changed.)
The good trip to Berlin started at 4am Monday
morning in California. Lousy routing had me changing
planes in Chicago and again in Frankfurt. I'm
looking forward to a wonderful congress. I attend
3-4 meetings a year, but SAS is the best. Check
out the program, posted HERE.
Please
note that my opinons expressed here are just
that... my opinons.
iSpine
Lending Library - check it out!!! I have two copies
of the program and abstract book available
for the lending library.
Technology
Disclaimer
The
devices, procedures, etc... discussed on this
site are in various stages of development.
While some have been proven safe and efficacious,
are FDA approved and widely available; others
may be in a wide range of developmental stages.
Some are proven and are just waiting for FDA
approval of the manufacturing process, which
is expected very soon. Some are exciting ideas
that may prove to be very bad ideas; possibly
even harmful disasters. Some represent brilliant
ideas that may ultimately become life-saving
products while others will never make it to
the marketplace. Even for the great products,
development / testing / approval process may
take years or even decades. There is no guarantee
that any information presented here is correct.
Items discussed here may never be available
to the patient community. Medical decisions
should not be made based on information found
here.
iSpine
Lending Library - check it out!!!
(I
have 2 copies of the program and abstract
book for the library.)
Day
1 - Tuesday, May 1, 2007
Private Lessons:
The
layover in Frankfurt turned out great. As I
waited
to board the plane to Berlin, I bumped into Dr.
Joshua Auerbach. He's working at U Penn and has
been doing significant ADR-related research.
I had met him last June in Straubing as he was
training and setting up a study on vertebroplasty
(using Cortoss). On Thursday, he's presenting
a paper titled: "Effect of implant
size or subfailure vertebral endplate compression
mechanics in lumbar total disc replacement"
He
also is presenting the following four posters
Segmental
Contribution towards Total Lumbar Range
of Motion in Disc Replacement and Fusions:
A Comparison of Operative and Adjacent
Levels
Augmentation
with Cortoss Improves Vertebral Body
Compression Biomechanics for Lumbar Disc
Arthroplasty
Effects
of ProDisc Positioning on Lumbar Kinematics
as Determined using Specimin-Specific
Finite Element Model
Total
Disc Replacement Changes Facet Contact
Stresses in Extension, Lateral Bending,
and Axial Rotation.
We
had about an hour and a half together. Instead
of sitting in on a 15 minute talk, to hear the
data, we got to spend a full 1.5 hours reviewing
his data. Being able to ask questions 1 on1 with
the author was a great bonus. This is incredibly
interesting stuff. Vertebroplasty, facet loading,
positioning issues and adjacent level motion/stresses
are all topics near and dear to all of us.
Exhibit hall open early:
I was not planning on attending the "pre-course" sessions today.
After the 22 hour travel ordeal, I found that I was unable to get an early
check-in. I left my bags at the hotel and went to the conference venue to
check in. I was surprised to learn that the exhibit hall was open as the
vendors were setting up. Although I was way underdressed in jeans, tennis
shoes, and a sport shirt that I'd come from California in... I made my way
around the exhibit hall. 5 years ago and for 2 years after that, SAS, NASS
and the other spine meetings were dominated by Charite' and ProDisc. A couple
of years ago, we started to see more new technology, and a whole bunch of "ME
TOO" devices that were basically knock-offs of the current designs.
This year, there is some wonderful new technology.
Globus'
new lateral and posterior approach lumbar
discs look like quantum leap improvements
over the MISS approach total discs that we
were seeing last year. There is a new cervical
disc by SpinalKinetics that is bringing back
some great ideas that hadn't worked in the
past... but with the problems solved. They
have a cervical disc with a compressable
poly core that will be held in place with
a mesh 'chinese finger trap' that holds the
core in place, holds the 2 endplates together,
yet still allows normal range of motion in
all dimentions (including axial rotation),
while providing dampening or shock absorption
in a unique way.
Pre
Course Instructional sessions open....
After
cruising the exhibit hall, I discovered that
I could get into the Pre-Course Instructional
sessions. Zeegers and Büttner-Janz were there...
it was nice to see them again. The session that
I came in on was "What have we learned from
Total Joint Surgery - And How It Relates To Total
Disc Replacement"
The
last paper was presented by Dr. Steve Kurtz.
He was discussing wear debris, explant retrieval
analysis, device failures, etc. He presented
xrays of 2-explanted
Charite's,
both implanted same day, both explanted the same
day. One core was pretty throughly destrouyed
and one intact. The oxidation of the UHMWPE on
the destroyed device was substantially higher.
The implication seemed to be that oxidation of
the device lead to catastrophic failure of one
core, while the other core was fine. I had a
little exchange with Dr. Kurtz about whether
the oxidation caused the failure, or the failure
caused the oxidation. We met a little later and
continued the discussion. I hope to see films
of the pre-expant configuration as well as the
pre-core-failure config. That will answer a lot
of questions for me.
Maverick
Explantation: Read
on iSpine about Dr. Zeegers explanting a
GPN client's Maverick at L5-S1 last week.
More
to come about the day's sessions.
Day
2 - Wednesday, May 2, 2007
More
to come about the day's sessions.
Day
3 - Thursday, May 3, 2007
More
to come about the day's sessions.
20
years of Lumbar Arthroplasty:
A celebration of the CHARITE' Artificial
Disc
J&J
/ DePuy Spine hosted an evening event to
celebrate more than 2
decades of spine arthroplasty. Appropriately,
co-inventor, Karin Büttner-Janz was honored
with the presence of several thankful patients
including Mr. Wolfgang Lehmann, the first
artificial disc patient. His ground-breaking
surgery
was done on September 19, 1984... yes, almost
23 years ago. Also present was Dr. G Pietschmann
who was one of the first SB Charite III patients.
His Charite' disc was implanted on his birthday
in 1988. I found it amusing that his surgery
was on his birthday, because I consider September
19, 2002 to be my re-birthday!
Mr. Lehmann is 15 years
older than I am. I wish that I was in as
good a shape as he is... he sill plays tennis
two times a week! Dr. Pietschmann also works
out regularly.. I feel so pale and out of
shape next to them!
During
the session, I had an epiphany that I shared
with the group.
I have been attending the surgeons conferences
for almost 5 years now. I always sought out
Dr. Büttner-Janz to thank her for her part
in saving my life. I always felt as if I
was thanking her on behalf of Charite' patients
everywhere. As I sat and watched the incredible
panel and audience that included some of
the most experienced ADR surgeons in the
world, I was taken by the gravity of where
I was (Berlin) and who I was with. It was
amazing to meet the patients that were done
2 decades ago. I realized that I should not
be thanking her on behalf of Charite' patients... really,
every patient that has benefitted from any
spine arthroplasty device owes a debt of
gratitude
to Dr. Büttner-Janz
and so many of of the other pioneers who
made it happen. ProDisc, Flexicore, Maverick,
Kineflex, MobiDisc, etc.... all of them! Willem
Zeegers, Thierry David, Luiz Pimenta, Matthew
Scott-Young,
Louis Nel, Scott Blumenthal, John Regan and
others... all pioneers in their own right.
This
was an excellent technical session as well.
The history was discussed
and hearing Büttner-Janz' description
of how critical decisions (like using a mobile
core) were made was very interesting. I was
surprised to hear her discussing use of discography
back in the 1980's. About 1/2 of the spine
surgeons I know (the ones not at SAS), still
don't believe in discography. Unfortunately,
Dr. Büttner-Janz had to leave before
I could ask her about that. I was able to
discuss
it at length with doctors Zeegers and David
and all talk to Büttner-Janz about
it tomorrow.
After the revision discussion,
I asked if anyone had ever revised a Charite',
only replacing the core. I was shocked that
that had been done only once. Zeegers replaced
a core when a wire marker broke. The prosthesis
was nicely sized and positioned and functioning
properly, so only the core was replaced.
Thierry David remarked that the reason there
are no other core replacements is because
revision surgeries are done because of problems
that result in incongruent placement of the
plates, subsidence, migration, etc.... By
definition, most revisions must include explantation
of the plates.
I truly enjoyed this event
and felt honored to participate. When I deal
with Zeegers, Büttner-Janz and Regan (also
did surgery on me), I really feel like these
are the people who
were instrumental in my recovery... personally
involved.
THANK YOU DOCTORS!
Mark
Day 4 - Friday, May
4, 2007
More
to come about the day's sessions.
SAS-7, The Day
After - (Saturday,
May 5, 2007)
Breakfast
with Hiram Chee,
Executive Vice President,
SpinalKinetics
Update
5/5/07, 7pm Berlin
Like
most industry exec's at a trade show, I imagine
that Mr. Chee was up until the wee hours
of the
morning, wining and dining potential customers.
That didn't keep him from responding to an early
morning SMS message asking if he could meet
me for breakfast. He gladly obliged and seemed
to be thankful for an excuse to get an early
start as he had only one free day in Berlin
and he was ready to see some sites!
Spinal
dynamics has a new cervical total disc replacement
(M6°) that
is very interesting. I hope to write much more
about
it later. Mr.
Chee had just
spent a most greuling week representing his
company at SAS.
I do not envy the people who work the shows...
it's endless hours; zero rest; non-stop work
work work. He must have been exhausted. Even
so, as we got into almost 3 hours of non-stop
spine, it was clear that we could have gone
on all day. He's excited about what he does
and has so much interesting information and
insight to share. Being so many years into
this, I should not be suprised by this phenomenon,
but I still am. I too am excited about what
I do and want to soak up the information like
a sponge. I
think and hope that he finds my unique perspective
as a patient and patient advocate interesting
and useful as well! .
Our
conversation covered so much ground. He's a
design engineer that's been involved in new
medical
devices for 25 years. As EVP of SpinalKinetics,
he oversees and/or is involved in many aspects
of development, manufacturing, operations and
marketing. His insights into the difficulties of
bringing new product to market were eye-opening.
We discussed many of the new technologies being
presented at SAS; what is going to work... what's
not; patent infringement lawsuits; ethical issues
surrounding clinical trials; marketing spin vs.
useful information, constrained vs. unconstrained
prostheses, keel vs. cleats... and on and on
and on. One of the more interesting topics we discussed
was why some centers get such different results
than others. For me, I could not have had a
more interesting breakfast.
I hope
it
was
more
than
just another
morning at the office for him. After our 3 hour
breakfast... so much for an early start on his
sightseeing. Maybe with the 40 cups of coffee
that we each had, he can tour them at high speed.
Coffee with the researcher
Update
5/5/07, 9pm Berlin
As
Mr. Chee and I were saying goodbye in the hotel
lobby, we bumped into Jenni
Buckley. I'd
been meaning to talk to her throughout the conference,
but never caught up with her. (You have to understand
how fast these conferences move. If you blink
or stop to chat with someone, you miss something
important. You get to the end of the conference
and realize how much you wanted to do that you
never got to.) "Jenni, you get the
Mark Mintzer award for best questions asked throughout
the
conference." No joke, she really asked
some provocative questions that spawned some great
discussions
during many of the panels. (I don't know how prized
the Mark Mintzer award will be. It's probably not
worth much, but she seemed to appreciate the compliment.)
I asked if she had a few minutes to chat? "Sure,
I'm going for coffee, why don't you join me." I
really needed another cup, so we walked over to
Potsdamer Platz for more caffeine.
I
wanted to talk to her about an interesting
issue that I perceive regarding spine researchers.
Ms. Buckley is a postdoctoral scholar working in
Orthopaedic Surgery and Bioengeneering Laboratory
run by Jeff Lotz. At SAS-3 in Phoenix, AZ, I wrote
about "My lunch with the researchers".
I had gone out to lunch with a neurosurgeon and
several prominent
researchers. My friend, Neil Crawford, runs the
spinal mechanics research lab a the Barrow Neurological
Institute in Phoenix. His colleagues at the lunch
run prestigious labs all over the continent. During
lunch, I said, "OK, I have a captive
audience here. I want to know... imagine for a
minute that:
you've
been suffering from unrelenting, severe low
back pain for 2 years.
you've failed all types
of
conservative treatment
your doctors
are telling you that you need ADR or a 2-level
360 fusion.
You are so bad-off that you have
no quality of life. You are desperate.
What
do you do?"
I
was shocked by the answer. I was honestly
expecting gentlemen to give me some insight into
the ProDisc vs. Charite' dilemma that many potential
ADR patients were struggling with. That's the choice
that I thought they were making. To a man... every
one of them said that they'd most likely do nothing,
or a 2-level global fusion. Remember that this
was 4 years ago. At SAS-7, I was hoping to
recreate that
event. Unfortunately, there was not time, but I
hope that Neil will help me recreate my informal
poll of top researchers via email. 4-years later,
I'm expecting that they've learned the error of
their ways and will all embrace motion preservation
technology. However, the buzz that I'm getting
from the researchers I spoke to this year is something
like: "If I'm a lumbar patient, I still think
I'd still choose
fusion. Cervical ADR is looking pretty
good, so I'd take a closer look
at it before
deciding
what to do."
What
I wanted to talk to Ms. Buckley about is my
theory about what I've heard from all these
brilliant PhD's who study spinal mechanics, all
day, every day. Some may think that the take-home
message is, "Wow... these people really know
what they are talking about... I'd better be
worried about ADR." I don't think so. IMHO,
the take home message may something more on the
order
of:
They
do not understand the premise of the question.
They do not understand what a chronic
pain patient faces. When you are so bad that
you'd happily undergo a surgery even if the
stands only a 50% chance of success... do nothing
is not an option.
They
do not understand the consequences of
a failed fusion. They live in a world
of pull-out-strength, compression characteristics,
coupled motion,
particle size, oxidation rates, wear
debris, etc...
When they
worry about the
advisibility of using new technology,
they may not realize that the 'gold standard'
may not be golden? In my
early days of being a spine patient,
I thought
that
you go
to the doc, do what he says and you get
better. I
had no idea how common failed back surgery
is, or how severe the consequences could
be. Do they know?
We
had a wonderful walk and a great discussion.
I got to have another latte' as I was feeling
the need for some more
caffeine. Jenni seemed to be intrigued by my "patient's
perspective" of the industry that she lives
in. Her experience is very interesting to me. Her
publications include:
Non-Invasive Strength Assessment of Human
Thoracolumbar Vertebrae,
UC Berkeley, Copyright
2006
Sensitivity of Vertebral
Compressive Strength to Endplate Loading
Condition,
Journal for Biomechanical Engineering,
October 2006
Quantitative computed tomography-based predictions
of vertebral strength in anterior bending
Comparison of quantitative computed tomography-based
measures in predicting vertebral compressive
strength
Influence of disc arthroplasty placement
on motion segment kinematics
Poke around on her website, me.berkeley.edu/~jbuckley/.
Look at her CV and research. She's been studing
bone quality, vertebroplasty, spinal kinematics
re: disc arthroplasty, and more for many years.
Getting a private lesson from her on the difference
between DEXA and QCT bone density measurements
was very, very informative and really helped
me to understand why so many doctors prefer QCT.
She's invited me to participate in a panel discussion
at a conference for biomedical researchers, or
a she discribed it, "a geekfest". As with the
Ethics conference I've participated in for a
few years now, having the patient's perspecitve
represented is still a unique and refreshing
idea.
Unfortunately, I had to
cut our discussion short... we only an hour or
so before
I had to run. But the day's next event was amazing!
Charite',
31.975 years of experience, or
Update
5/6/07, 1:00 am Berlin
Charite',
22.7005 year follow-up, or
"How
long will a poly core last?
What
should this post be titled? Here is the math:
5-May-2007 minus 19-September-1984, that's 8,263
days, or 22.7005 years that Wolfgang Lehmann
has had his SB-Charite' ADR in his spine.
5-May-2007
minus 20-September-2002, that's 1,688 days,
or 4.637 years. Multiply 4.637 times 2 discs,
to get my total experience with 2 SB-Charite-III
ADR's.
So, on a tennis court in Berlin today, we had
31.975 years worth of Charite' ADR experience
playing. I had been hoping to make this happen
for some time and I have to give my thanks to
Karin Büttner-Janz for making it so. I can't
tell you how much fun this was or how emotional
it was for the both of us. I ran from my morning
meetings to my hotel to change and just barely
make it on-time to SportClub Mitte in what in
1984 was East Berlin.
I
had hoped to have someone to video for us,
but that didn't happen. We started warming
up
and I was wondering how I'd get the video...
what pictures should I take? After a nice warm-up,
we decided to play a set. Keep in mind that I
have settled into a lifestyle working, and working
more, and then working some more. (My clients
that have me call them at all hours will attest
to that.) I am waaaay out of shape, but hopefully,
I'll correct that soon. In any case, just a few
minutes into our match, I was suprised how the
need to create a photo opportunity was 100% replaced
with the joy of running and sweating, and hitting
a tennis ball and competing again. I rediscovered
why I probably don't participate in athletics
much anymore. I don't have a medium switch. I
want to run every ball down... I think I can
reach every passing shot. The extreme lunging,
sprinting, rapid direction changes, etc... are
a little extreme for an out of shape 50 year
old grandfather with 3 spine surgeries
and 2 artificial disc. I don't understand
what
none
of that
is in any
way limiting for the 64 year-old grandfather
across the net who's running my legs off. ("Me,
a grandfather...
that still sounds wierd!)
Just
a couple of games into the set, I really went
for an impossible ball and pulled up a little
lame with a minor groin pull. OK... work it off...
run it off... I'll be OK. There was no way that
I'd stop playing now... this is way too cool.
I wondered if I got hurt, how would I get the
video of us
playing tennis that I wanted. Oh well... if it
happened, I'd have Wolfgang video them putting
me into the ambulance... that would make a better
story anyway. (Maybe it would teach me a lesson
that I need to learn!)
Wolfgang's
English is much better than my German, but
my German isn't very good. It was often difficult,
but we communicated OK and some of our court-change
conversations were quite interesting. In 1988,
I played tennis 6 days a week. A minor fall skiing
injured my rotator cuff. A few weeks later, I
still could not lift my arm above shoulder height,
but I was getting very antsy not playing tennis.
So, I signed up for the tennis leagues at my
club and played left handed. I was a 5.0 player,
but joined the 3.0 league as a lefty. I came
in second and moved up to 3.5 where I won about
1/2 of my matches. I've never met anyone else
who'd done that... until today. Wolfgang had
exactly the same experience. We are so different,
yet have so much in common.
Later
in the match, I was ahead, so I 'gifted' him
a point by electing to volley a ball that
was clearly going to be way out. It was going
to be so far out that I was embarrassed by having
done that. He was clearly unhappy by my choice
but politely accepted the point. A few seconds
later, he gifted a point back to me in a similar
fashion.... just like I would have done. Nobody
is going to give me a point that I didn't earn...
I don't care what the score is. We are so different,
yet have so much in common.
After
our set, we did try to capture some video.
I'll put it up as soon as I can. We sat down
for a beer and talked a bit about our spine ordeals.
Remember that we have a significant language
barrier. I was interested in his recovery, so
I drew him a graph of mine. Starting at a constant
pain of 8/10, I drew a blip to 9 for the first
week post-op, back to 8 for the second, then
a steady march downwards till week 7 where my
pain levels were down in the 2,3,4 range. I was
surprised to hear that his graph started at a
constant pain level of 9, then at 24
hours post-op it was less than 1. He was classic
discogenic pain... remove the disc and your pain
goes away. He was in it for 1.5 years and I believe
that he was as severely disabled, or more than
I was.
I talked about the impact on my family... my
wife being a stay-at-home mom for 18 years, suddenly
needing to support the family financially and
still clean and shop and... We talked about the
depression that comes along with endless months
or years of chronic, severe pain. I think that
our ordeals were very much the same. Again, we
are so different, yet have so much in common.
I have to discuss the disc. Wolfgang's Charite
is nothing like mine. They call it the 'bottle
cap'. This surgery was done before placement
and implant sizing issues were understood. This
surgery was done before potential complications
for total disc replacement were understood. Today,
when I'm dealing with someone who's going for
a single-level ADR of any type, I worry for them...
23 years after Wolfgang's surgery, we are still
dealing with many of the same issues that were
discovered in the early patients through the
80's and 90's. The fact that Wolfgang is playing
tennis 23 years later is a testament to the genious
of Kurt Shellnack and Karin Büttner-Janz - the
'S' and 'B' in SB Charite'. The fact that they
got it right the first time... with no roadmap
to guide them... I find remarkable.
While
we were playing I kept thinking how amazing this
is... East Berlin, 23 years with the very
first disc, and now at age 64, still playing
tennis twice a week.. When we were done
and
enjoying a beer it was
great
to get
to know him a little better. Knowing that
we had been through the same experience
with
almost
the same device, 18 years and 1
day apart... this was just too much fun.
Looking at my new friend's natural smile
instead of that grimace of pain made this
one of the
most
incredible
experiences I've ever had. We both had
to come to Germany to get it done, but his
trip
was
a little shorter than mine.