7 1/2 weeks later - My Progress and Some Pics

[Bionic]

I've read that another contributor to femoral neck fracture (FNF) is reduced bloodflow to the femur after surgery.  From what I've read, the posterior approach is muscle sparing and helps patients get back on their feet quickly, but it also cuts some important blood vessels, which can cause the femur to weaken temporarily.  The effect of impaired femoral circulation generally peaks at about 3 months post-op, which means the bone may be weakest just when the patient is starting to feel really good.  Circulation is slowly restored, and by 6 months bone strength is back to normal, or nearly so.

There are some interesting studies out there.  One showed that, contrary to everyone's expectations, blood flow to the femur was a much stronger predictor of FNF than notching or other mechanical errors during surgery.

Dr. Gross has said he thinks uncemented femoral components ought to have a lower risk of FNF than cemented ones, since they don't use cement, which gives off heat when curing and could possibly kill some of the bone.

So far the data don't bear that out, however, and uncemented femurs are just as likely to fracture as cemented ones (but no more likely).

[stevel]

I know Dr. Su uses the NCP (neck capsule preservation) with the posterior approach and I believe Dr. Gross does the same.  This helps preserve bloodflow to the femoral neck and helps stabilize the hip for post-op activity.

[obxpelican]

From what I've read about Dr. Gross his incidence of femoral neck fracture is the same as when he did cemented, bear in mind the top doctors like Gross, Mont, Su and many others take on more difficult surgeries than other doctors and for the most part they have really good results.  To me that speaks volumes on all of their abilities. 

I read somewhere where the fracture that Dr. Gross had in his first series of uncemented was a case of poor bone quality on a woman.

In the end Bionic, you're going to be in the same study that I'm in and we've chosen something that makes sense to us but in the end "could" end up not working out, although the early numbers are very good which tend to be VERY promising--- I've yet to have anything fall out yet.  ;D  so that makes me feel good so far.


Chuck

[Bionic]

I view "not work out" in a statistical sense.  Uncemented femurs will work in the majority of cases (consider the earlier study from Dr. Gross's paper).  But they won't be a success unless they work nearly 100% of the time, since they're being compared to cemented fixation, which always works.

Uncemented femurs will only be worth the initially higher risk (assuming the initial risk is higher) if they can be shown to have greater longevity than cemented ones.  That's what Dr. Gross is banking on, that uncemented femurs will still be plugging along 20 or 30 years after surgery, whereas the cemented ones will be failing.

[stevel]

Chuck and Bionic,

I believe you guys are part of the group that is undergoing clinical trials of the biomet uncemented total hip resurfacing device.  Only Dr. Gross is doing the surgery in the US.  FDA has not approved the total device for marketing in the US (socket and femoral cap).  My insurance only allows total hip resurfacing devices that have been approved for marketing.  Investigational or experimental devices do not qualify.

Dr. Schmalzried allows impact sports at 3 months.  I'm going to ask him about this via the chat tonight.  He installs typically installs the ASR device, which has also not been approved by the FDA for marketing.

I hope all of the surface hippies are informed and educated about the risks involved before the go "under the knife."

[Bionic]

I believe you guys are part of the group that is undergoing clinical trials of the biomet uncemented total hip resurfacing device.  Only Dr. Gross is doing the surgery in the US.  FDA has not approved the total device for marketing in the US (socket and femoral cap).  My insurance only allows total hip resurfacing devices that have been approved for marketing.  Investigational or experimental devices do not qualify.

The Biomet Recap/Magnum implants that Dr. Gross uses in his uncemented technique are already FDA approved.  They are not "experimental," and he is not going through clinical trials for the FDA, as far as I know.

The uncemented Recap femoral implant was originally approved in connection with hemi-resurfacing, and the Magnum cup was originally approved in connection to THR.  However, neither device is limited to these procedures.  The FDA allows doctors to use these devices "off label" in any procedures they deem appropriate.

My insurance (BC/BS) covers the implants, since they are FDA approved, in spite of their off-label use.

From Dr. Gross's website:

For the last five years, he has worked with BIOMET to design and develop a new and improved Metal-on Metal Hip Surface Replacement System as well as a Large Bearing Total Hip Replacement System.  The BIOMET Recap Femoral and Magnum Acetabular System as well as the Magnum Large Bearing Femoral Head for Stemmed Total Hip Replacement were cleared by the FDA and released for sale in the United States in December 2004.  In the U.S. use of the Recap Femoral component together with the Magnum Acetabular component for a Total Hip Resurfacing Procedure constitutes an off-label use.  (This is legal:  It is up to the surgeon to decide how he wishes to use these implants).  In the remainder of the world, total resurfacing faces no restrictions, and BIOMET can market the Recap and Magnum as total hip resurfacing devices. Because of our FDA, this country is probably the only one where is it difficult to get a total hip resurfacing done.

Also,

The Birmingham (Smith & Nephew, Richards) total HSR was the first to get FDA approval in the US based on an unprecedented FDA decision to approve this implant on the basis of single (developing) surgeon’s foreign data. Cormet 2000 (Corin Ltd., Stryker) total HSR was the first to be approved based on the usual mechanism of a US run Multi-center FDA study( approval 7/2007, I was the lead investigator). Therefore, there are now 2 implants available in the US that have an FDA indication for total HSR.

The Recap/Magnum (Biomet), Conserve Plus (Wright Medical) and ASR (Depuy) are all also FDA approved implants in the USA. They may be legally used by any surgeon for the purpose of total Hip Surface Replacement. (The FDA does not regulate how surgeons may use approved implants.) However, the implant companies may not promote them as total HSR devices. (The FDA does regulate how implant companies may market approved implants.)

Approximately 20 different companies sell total HSR implants on the worldwide market, including all of those mentioned above.

A specific use of an implant (or drug) that is approved by the FDA is termed an FDA approved indication. As soon as a company has received one indication for use of their implant (or drug), the implant (or drug) is FDA approved. The use of this same implant (or drug) for a purpose other than for the approved indication is termed an off–label use. Off-label use is legal. In fact, much of American medical practice involves off-label use of drugs and implants. It would be impossible for the FDA to regulate doctors’ practice in every situation. Actually the Supreme Court has expressly stated that this is not the FDA role (see Rehnquist opinion).

Many insurance companies do have contract clauses that deny payment for "experimental" treatment. How to define what is experimental is very controversial. However, "experimental" is something altogether different than off-label use of implants and drugs.

Therefore, an insurance company would be treading on thin ice if they were to use FDA indications as a basis to deny payment.

http://www.grossortho.com/doctor.htm

[stevel]

Bionic,

I read the following (seventh paragraph) from Dr. Rogerson's website "Why the Birmingham Hip Resurfacing System, A Personal Message from John S. Rogerson, MD:"
"Since the current resurfacing prostheses undergoing FDA IDE clinical investigation are still considered experimental, most insurance companies are not remibursing their use.  Because the costs in Europe for resurfacing were approximately half those in the States, most patients I have referred for this procedure have chosen to go abroad up to this point.  All of these implants have been the Birmingham and I'm extremely impressed with how they are performing.  With the recent FDA approval of the Birmingham hip resurfacing prosthesis, insurance companies are now obligated to provide coverage for this particular prothesis in the United States.  They are not obligated, however, to pay for any other type of resurfacing procedure.  Attempts to bill another type as a traditional total hip replacement are risky with the patient later getting stuck with the entire cost when the adjuster notices it is a resurfacing."

Since this letter, the Cormet device was approved by the FDA, which underwent extensive clinical trials by several Drs..  Dr. Rogerson, Dr. McMinn and Dr. Rorabeck testified before a FDA review panel in September, 2005 regarding the Birmingham Device, which was approved in 2006.  The other devices, Wright Conserve Plus, ASR and Biomet are under review and awaiting approval.

See www.orthorogerson.com for Dr. Rogerson's personal message.

[Bionic]

Well, Dr. Rogerson certainly has a different point of view from Dr. Gross. 

It would be good to know whether Dr. Rogerson has any data to support this claim:

Attempts to bill another type as a traditional total hip replacement are risky with the patient later getting stuck with the entire cost when the adjuster notices it is a resurfacing.

Is this a fact-based statement or a fear-based statement?  Have patients actually been denied coverage or is Dr. Rogerson merely assuming that they might?  More to the point, has this ever happened to any of Dr. Gross's patients?

Dr. Gross seems to get around the denial of coverage issue by using devices that are FDA approved, albeit for indications other than total hip resurfacing.  He appears to be saying that their off-label use does NOT place them in the dreaded "experimental" category, since they are, after all, FDA approved devices.

[stevel]

Bionic,

One could inquire via email to each doctor or ask during the upcoming Dr. Chats (Dr. Schmalzried, tonight, 9 PM EST, Dr. Rogerson on 2/9 and Dr. Gross on 2/17).  I believe Dr. Su installs the BHR, Wright Conserve Plus and Biomet devices.  I believe in one case, Dr. Su installed the uncemented Biomet, because the patient was allergic to cement.  Otherwise, he must install the cemented Biomet, if Dr. Gross is indeed the only surgeon who installs the uncemented Biomet.  Dr. Su answers common surface hippy questions at his website www.hipresurfacingnewyork.com.

[Bionic]

I think Schmalzreid uses the ASR implant, which is also FDA approved but not for total hip resurfacing.  I think I'll ask him tonight if I can get the kids in bed on time.

[stevel]

Hey B.I.L.L,

Check out Dr. Schmalzried's chat last night regarding revising a steep angle socket.  He says "Can Do!"  I asked the question for you.  If I were you, I would beg, borrow or steal my way down to LA to have Dr. S review your case and correct it if needed.

[B.I.L.L.]

Hey B.I.L.L,Check out Dr. Schmalzried's chat last night regarding revising a steep angle socket.  He says "Can Do!"  I asked the question for you.  If I were you, I would beg, borrow or steal my way down to LA to have Dr. S review your case and correct it if needed.

Thanks Steve !!, I contacted Dr. Schmalzried and a consultation with him is $360.00, or $180.00 for a phone consultation...   It looks like I'll will be going to Dr. Klug in Roseville Ca. for the revision.  He has done over 200 resurfacings, is on Pats list, has seen my x-rays and says he can do the cup revision and keep the femoral implant intact, and most importantly is in the Kaiser system, (cant really afford to go out of the Kaiser system) I was aware of him before the original surgery but felt confident in the Dr. I had in Fontana, hindsight is 20/20 obviously but I wish I would have gone there first.  Roseville is about an 8 hour drive one way for us but seems like a small issue in the grand scheme of things. Funny thing, I just got a message tonight that I have a revision surgery scheduled for march 3rd. in Fontana, so tomorrow I have to cancell it and get them on the same page.  The decision to travel farther to a more experienced doctor is much easier now.  And who knows they'd  probably do it fine the 2nd time around because they would be "under the gun" a little bit after having the first one turn out wrong, but my gut instinct is to travel the extra distance for the more experienced Dr. (with re-surfacings) so thats where were headed.  It's nice to be out of limbo and have a game plan.  Hey I met Wayne-o today and he told me about the chat last night too, (super nice guy by the way), if your reading this Wayne-o, nice to meet you today and I gotta say your work looked very nice,  Good Stuff !!Thanks again Steve, I'll keep you all posted. 

[hawaiieric]

Bill,

I am the fix it myself guy...you mentioned that things are improving for you.  I know its a touchy subject and all, and I give you all my support, but can you ask your doctors this one..if I let it go for a few years, can you redo me then or does it have to be now?  Why I am asking you this is because for me, I might die anyways in my lifestyle..yeah right some people say...but if you can get 5 years out of what your operation gave you..and then you can still do the same surgery...just buying time.

Who knows, from your xray pics..looks like your going to be the best Motorcross racer out there, and if you like bull riding..your approved..

just a thought from a friend,
Eric

hands on info...go by what you feel

[obxpelican]

Bill,

So glad to hear that you're going to get that done and be on the road to walking straight lines pain free.

Glad to also see you posting again.


Chuck

Hey B.I.L.L,Check out Dr. Schmalzried's chat last night regarding revising a steep angle socket.  He says "Can Do!"  I asked the question for you.  If I were you, I would beg, borrow or steal my way down to LA to have Dr. S review your case and correct it if needed.

Thanks Steve !!, I contacted Dr. Schmalzried and a consultation with him is $360.00, or $180.00 for a phone consultation...   It looks like I'll will be going to Dr. Klug in Roseville Ca. for the revision.  He has done over 200 resurfacings, is on Pats list, has seen my x-rays and says he can do the cup revision and keep the femoral implant intact, and most importantly is in the Kaiser system, (cant really afford to go out of the Kaiser system) I was aware of him before the original surgery but felt confident in the Dr. I had in Fontana, hindsight is 20/20 obviously but I wish I would have gone there first.  Roseville is about an 8 hour drive one way for us but seems like a small issue in the grand scheme of things. Funny thing, I just got a message tonight that I have a revision surgery scheduled for march 3rd. in Fontana, so tomorrow I have to cancell it and get them on the same page.  The decision to travel farther to a more experienced doctor is much easier now.  And who knows they'd  probably do it fine the 2nd time around because they would be "under the gun" a little bit after having the first one turn out wrong, but my gut instinct is to travel the extra distance for the more experienced Dr. (with re-surfacings) so thats where were headed.  It's nice to be out of limbo and have a game plan.  Hey I met Wayne-o today and he told me about the chat last night too, (super nice guy by the way), if your reading this Wayne-o, nice to meet you today and I gotta say your work looked very nice,  Good Stuff !!Thanks again Steve, I'll keep you all posted. 

[B.I.L.L.]

Bill,

I am the fix it myself guy...you mentioned that things are improving for you.  I know its a touchy subject and all, and I give you all my support, but can you ask your doctors this one..if I let it go for a few years, can you redo me then or does it have to be now?  Why I am asking you this is because for me, I might die anyways in my lifestyle..yeah right some people say...but if you can get 5 years out of what your operation gave you..and then you can still do the same surgery...just buying time.

Who knows, from your xray pics..looks like your going to be the best Motorcross racer out there, and if you like bull riding..your approved..

just a thought from a friend,
Eric

hands on info...go by what you feel

Hey Eric,  Trust me I've been over every scenario a million times, What if I leave it and it's fine ?  What if its almost in the same position as the first one after the revision ?   Theres been alot going on in my brain throughout this whole deal and it comes down to a few things I just can't deal with.  Insurance is one issue, we have Kaiser through my wifes work right now but it looks like that will end in september of this year. I tried to buy my kaiser policy myself but they will not sell it to me, you can't just "transfer" it from them to me. Once the policy expires through my wifes work they will NOT insure me, I'm 50, have high cholesterol, a little overweight blah blah blah....bottom line is they will not accept me.  Another thing is I really want to keep the resurfacing for as long as possible and I can't live knowing that failure is eminent in "2 to 3 years"  ??  maybe I'll get lucky and it will last 6-7 years ?  I'm hoping to get 15-20 years out of the thing, then I'll be over 65 years old, and if I have to revise to a thr then thats fine.  If you would have seen the doctors face when he said "yes you are right it is much steeper than we like, but lets keep an eye on it and maybe it will be alright"  Then when I asked the next dr. how many cups at my angle have been around 10 years, none he new of, and he attended the resurfacing convention in LA awhile back (the same one Pat went to) and estimated 2 to 3 years before it would be a problem.  Also it was pretty clear that if I waited for it to fail a thr would be the only option, if I want to keep my resufacing the sooner we fix it the better, and all the doctors agreed on that, fix it soon or wait and see what happens....F-that I can't live that way, lets just get it right and move on.  I have a lot of things I want to do between now and say 65 and I do not want to go through this again for a LONG time.  So the doctor who did it admits it not right and 2 other doctors say lets revise as soon as possible, I gotta go with that. Plus I can't live my life knowing it's wrong and may fail anytime, I just can't live that way.  Lets just get it right, right ? 
    Lets say you have a sail boat and want to sail to the mainland to catch a few waves with say B.I.L.L. and Wayne-o, :D but there was a hole in the hull that was patched by a guy who isn't really a perfectionist and said "lets just keep an eye on it and see what happens" and then two other glassers look at it and say you should re-do it if you want it to last, would you grab a pair of fins and an innertube, charge it and hope for the best, or would you fix it right and have a nice relaxing journey ?     Or heres a better one, 2 years from now when I am 52 do I want to be 2 years out of surgery with properly positioned implants, or 2 1/2 years out with a mal-positioned cup.....Know what I mean ??
I know it sucks but I got go for it, I just gotta, don't know what else to say. And I know what you mean about maybe I won't make it 5 years anyways, shit I drive California freeways everyday ha ha ha, but I'm a hopeless optimist I guess, I plan on being around for awhile...
Talk to you all later, Bill.


Hey sgoulet,  Sorry this thread got hijacked !!  Back to you now ;)

[obxpelican]

Bill,

Your reasons for doing it are well founded.  It's your hip, it's your life, personally I think you've made the choice I would have made.  This way you will have peace of mind.

In defense of Eric, I do not know if he knew all of what was going on with your situation and I know he was trying to be helpful, and of course I think you realize that too, or at least I hope.

You're going to end up fine, just think positive.


Chuck

[hawaiieric]

Bill,

I can totallly understand how you feel about it.

You have all my support, and that means we can go hit some waves later in life, and with beers-sunsets-and full on relaxation, whether it be in Cali or Hawaii.

Eric

[B.I.L.L.]

Thanks you guys it's all good, it will work out I'm sure.  Sounds good Eric, I vote for ...........Hawaii  Ha Ha !!   Actually I am going to scorpion bay as soon as I can surf, my old neighbor has a house there and said come and stay as long as you like.  I gave him one of our old atc "Beach Cruza"  3 wheelers.  Not a bad trade huh ? An old atc and this honda express thing we had for a week or so at scorpion bay,  DONE !!