Allograft waiting list

[JG]

Hi Missy,

Your decision is interesting...not the decision to go with PKR versus allograft, but to go with something that hasn't been used in patients for years.   I have an insiders knowledge about clinical trials and physicians relationships with for profit companies (pharmaceutical, device, etc.).  Physicians don't do clinical trials free.  There are multiple forms of "payment" they receive.  If I had a life threatening condition or had exhausted all existing treatment options, I would be happy to participate in clinical trial.  However, there are so many established options for you.  Yes some may require you to be on crutches for a long period of time, other not.  But to go with a "device" that is not been seen in 1,000 of patients for a knee condition for me personally is not something worth risking.  If this goes bad, what's next?  And the fact that he pushed it and wanted to do it less than 24 hours after your appointment is to me a little suspect.  Did he present any other PKR products or just this one?  Did he present the informed consent form?  Also, he should have explained the allograft a little better.  Plugs versus who hemichondyle is a huge difference in terms of recovery.  When it came down to really deciding to go with what I did, I sat down with my physician and asked tons of questions.  And this was after all the second opinions I received so the procedure was explained to me over and over.

I do understand why you don't want to be on crutches for any extended period of time.  Instictually, I want to say that the PKR will take care of your pain better than allograft long term.  The reality of it, this procedure is a pain management option.  You've obviously exhausted medications and the reparative procedures so some type of restorative procedure is all you have to manage the pain.  I've been lucky with pain.  I tend to form stress fractures and it doesn't effect my life very much.  My problem was the underly bone was not very healthy and the cartilage just did have any firm edges and kept falling off the bone.  I still don't understand why they would need to to send a tissue sample to the tissue bank.  Really doesn't make any sense since cartilage is avascular and tissue typing is not required for allografting.

Well I'm rambling...good luck with whatever you do.

Janice

[stgiles16]

Janice, You are right, this is a pain management option. I have done everything that the OSs and pts have said for almost 5 yrs now and my pain is increasing, not decreasing. My body does not act like most people's. I have dealt with unsuccessful ligament reconstruction and then revision, unsuccessful microfracture and revision  which then triggered arthrofibrosis. I have dealt with bone spurs, plica syndrome (which was cut out but grew back) I had my fat pad removed because of scar tissue and it has grown back. My microfracture has now worn out and the scar tissue is causing much pain. I am forced to use a cane and my  knee collapses without warning on a daily basis. I am only 42 yrs old with two active teenagers. I want my life back. I have known of the option of alllograft for quite some time but have dreaded it. I do have the option of the traditional PKR but I would rather try this new version. It has been oked in Europe. It has been oked for the hip and shoulder in the US. It is not like I am letting them do some out of this world weird thing to me. I will still have enough bone left to convert to a traditional PKR or TKR in the future. I have spent approx. 2 1/2 years out of the last 5 on crutches, the idea of not using crutches after this surgery is REALLY appealing.

As for the OS being paid to be in the trials, who cares? The man is brilliant and is more than happy to do a different surgery if I wish. He is not pushing me either way. He said that he would do the LOA and PKR the next day most probably to mess with my head. He knows me well enough to know that I fight every surgery and we will argue back adn forth for weeks before I finally give in. We have a unique relationship. I mess with his head, he messes with mine. He did not present a consent form because he knew that I was going to think about what I want done and get back to him. He did offer the traditional PKR. He has also explained the allograft procedure on other occassions. He has been my OS for quite a while.

I did not ask about the tissue sample being sent off because I would rather not have allograft surgery PERIOD. My microfracture wore out in 2 yrs, I dont havve much faith in my own body healing like it should. IF a piece of metal will improve my pain for 10 yrs, sign me up. I dont expect to be painfree, I do hope to have less pain. I have been in pain management for a year and wont stop just because of this surgery because I also have fibromyalgia so I hurt anyway. If I did not trust my OS, I would not let him do ANY surgery on me. I do trust him and if the finances work out, I will go ahead with this surgery next month. IF someone didnt agree to be in clinical trials, there would never be any medical advancement.

The one thing that I dont understand from your post is why does it bother you that it is a pain management solution? I would not have any surgery if I were not in pain. To me, pain management is the entire idea of having surgery. I will post when I make my final decision and when I schedule my surgery.

missy

[JG]

Missy,

You've misuderstood my post.  This doesn't bother me, why would that bother me?  Given that you don't want to deal with being on crutches and your pain levels are high, PKR is a great option, probably much better than allograft.  I was responding to your post that basically read like, "my doctor gave me two options, allograft or a clinical trial PKR" (not that he discussed at length other options or that you two have a unique relationship).  All I knew was he offered you was an experimental PKR (and within 24 hours), I was trying to give you a counterpoint about having a non-FDA approved product placed in your knee.  The physician being paid was a reaction to the 24 hours issue.  The manufacturer-physician relationship more often than not influences how physicians advise patients, just look how sales reps do it every day with drug samples.  Heck, how do I know that you have this unique, "I mess with his head, he messes with my head" relationship?   Yes I understand it's approved for other joints and other countries, but not in the US for the knee.  And yes I do understand that if people don't participate that new drugs or devices won't move through the development process.

Again, good luck with the PKR.  I'm sure it will work out great.

[stgiles16]

I sure hope it works. I have not signed on yet. I have to see about the financial stuff first. One positive note about this surgery is that it leaves plenty of bone for a traditional PKR or TKR, whatever is needed in hopefully 20 or more years. How is that for optomism? I have researched everything that I can on this new thing and plan to have a meeting with my OS with all of the questions that I have written as I researched. IF I decide to go with the allograft, I will deal with the crutches. I have to keep in mind, that if it sounds too good to be true, it usually is,,,, so I am going to check this out further before I commit.

thanks for your caring.

missy

[hopalongcasualty]

Has anyone heard what the largest plug Allograft used is?  I would need either a mosiaplasty or a 50MM plug, just wondering.  MY doc is working with the vendor on tools for this procedure and has not given me a final decision on what exactly he is wanting to do.  Ahhhh Limbo... 

He has explained the allograft procedure and all that will go along with it, just I hate not knowing exactly what tools and the detailed action plan for the procedure.  I am an engineer and am used to getting minute details on most everything I work with. 

I keep getting asked by medical professionals, if I am a doctor because I ask so many questions and seem to already have the answers they are suspicious because they know I am quizzing them on thier knowledge and experience in the subject at hand.  I wish all patients would have researched the subject before going to the office visit, because the doctors would have to step up thier "A" game all the time. 

[blackbeltgirl]

The largest allografts are "shell" allografts - where the transfer an entire femoral condoyle.  The doctors seem to have their own preference, between a shell allograft and mosaicplasty. 

The largest of my 3 lesions is just a little bigger than yours.  We'll have to compare notes as we go through our recoveries, for the rare others with lesions as big as ours.  If you haven't noticed, most of the folks who've been treated for cartilage damage have much smaller lesions (not necessarily small, but small in comparison to the 15-18 sq cm you and I are facing).

Do you know which your doctor is planning?
Jess

[hopalongcasualty]

I think he is on the fence based on tools and the availability of a fully compatable shell graft or if he has to use a plug(s) due to the geometry. 

I am going to start putting a bit of gentle pressure on his PA to get me more info, I know I am not his only patient, however, I AM one of his more interesting procedures  .  LOL

[hopalongcasualty]

I swear that the lesion feels like it is bigger than before.  I also have had some catching on the anterior-lateral meniscus the last couple of weeks and the patella feels like it is catching at on the lateral aspect of the trochlea groove at about 30 degrees during extension.  I am fearfull that I am having degenteration of the knee fairly quickly and hope that by the time they are ready to do the procedure there is not more CRAP wrong in there that will require more surgery.   I am not too worried about the patella thing, with my hx of scar tissue buildup it is likely that that is all it is I HOPE 

[JG]

A shell allograft is very different than taking the entire chondyle.  I have pictures (or link to pictures of this).  Shell allografts are much bigger than plugs (and not round) and I'm not sure what they us in terms of "tools".   Bugbee does a bit of this.  Typically they use a entire chondyles to tibia plateaus in traumatic events (like severe fractures).  These are totally two different things.   The rehab for a shell is similar to a typical OATS or ACI.  The rehab for an allograft chondyle is like months and months on crutches.  I will post pictures later tonight.

Janice

[JG]

Here is a picture of the shell allograft, as you can see it just a odd shaped plug rather than the entire chondyle.

http://radiology.rsnajnls.org/cgi/content/full/219/1/35

Janice

[blackbeltgirl]

Thanks for the correction Janice.  I thought a shell allograft was an entirte condoyle.  Learn something new every day.
Jess

[hopalongcasualty]

Janice,

Thanks for the link, Really Cool!!! What a great resource.  I am going to pester my PA for what the decision was for plug vs. shell in my case. 

Regards,

Phil
aka "Hopalongcasualty"

[JG]

Phil,

There are lots of ways to go for the surgeon.  I think if they use a shell, the process is a tad more rigorous in terms of the match.  I think (but don't really know) they take various measurement of the chondyle.  Then they find a suitable donor.  That could take a long time.  When we talked to Bugbee (second opinion doc for me) and this was brought up he was worried because I have a very deep trochlear groove and it would take a very long time to find a suitable donor had I gone with a shell.  In my case with the plugs they don't worry about that and we too the first available graft.  By using many plugs and being on a CPM machine for 8 weeks the contour of the chondyle was allowed to be shaped with that of the surrounding bone/cartilage.

I'm just taking my first break from work today so when I find the pictures of the allograft I will post the link.  I think they are on my old laptop that died on me. 

Jess, I corresponded with a women who saw Dr. Gross in Canada.  He did an large allograft procedure on her.  He is the king of this stuff.  Her recovery was scarey long in terms of being on crutches (like over 6 months).  She was in MVA and crushed her TP.  My physician said this was an option for my TP in the future, but after talking to her, I was like "no way!"  I would rather have a retrograde plug which is very very technically challenging before that.  Large allograts are very extreme and for traumatic injuries it sounds like.  Now you know why I can't wait to hear about your ACI on the TP.  ACI might not be good for me since I am a fairly significant scar tissue former and the chances of my over scarring would be pretty good.  However, if they can get in your knee and do it, I'm in!  I would definitely try it.  I been waiting for someone to tell me they've had it done on their TP. The place where I work out (my PT office) said they've seen an increase in shell procedures (especially on young athletes) rather than microfracture when the defect is large.  They really don't see too many ACIs even though my PT wrote the original PT protocols for the ACI procedures (for Genzyme). 

Janice

[blackbeltgirl]

Janice -

I'll keep you updated.  My surgeon was supposed to be calling the insurance company yesterday for a peer-to-peer review.  I'm trying to practice moderate patience, and will wait until tomorrow to call and see how it went.  2 of the 3 reasons they denied the coverage in the first place were the "off-label" uses - lesion greater than 10cm squared, and tibial lesion.  I have yet to see any articles or studies that address tibial lesions, so I don't know how that will play out.  Keep your fingers crossed, and I'll let you know how it goes.

Jess

[hopalongcasualty]

Jess and/or Janice,

Have either of you found studies on the "appropriate" size protocol for the different procedures.  I know the GUIDELINES are out there; however, I have yet ro find the documentation.

microfracture is effective upto X sq cm.
ACI is effective upto Y sq cm.
OATS is effective upto Z sq cm.
etc, etc, etc.

I realise that there may be different criteria for each joint and that there might be a different criteria going from the Femur vs. the TP.

IF either of you or anyone else out there have links it would be wonderful. 

Thanks,

Phil