Choosing a Device - Struggling with my decision

[rbt2011]

I have read some previous topics in the devices section but wanted to get some updated opinions on devices (the last one I could find was back in 2010).

I need a hip resurfacing and obviously I want it to last for the rest of my life.  Because of this site and because of all the great people that have shared their input, I feel confident that I have the information I need to pick the best surgeon possible.  My struggle is picking the device.

I am 36 and the idea of an uncemented device appeals to me.  The concept of my own bone growing into the device becoming permanently attached and never having to worry about cement breaking down just makes sense to me.  But, I am not a doctor, I am not a scientist, and I don't necessarily want to choose a device that has a lower survivability rate.  One well known surgeon recently told me the BIOMET device is made of "soft" metal when compared to the "hard" metals of the Birmingham.  He also referenced Dr. Gross' financial interest, which he has in my opinion been completely forthright about, and the fact that both components are not FDA approved as a reason not to choose them.   

On the other side.....

The BHR has great results.  There are some fantastic athletes that are accomplishing great things with their devices.  However, the cement issue concerns me because even if it last for 25 years, I will be replacing a hip and will be relatively young.  The Birmingham is definitely the leader in terms of long term, clinical data supporting high survivability.  It's also the choice of some serious athletes, many of which are on this site. 


It seems like doctor's choose one device and basically use that exclusively (with a few exceptions).  My question is this? 

How did you pick your device and what information is relavent to making an informed decision?  Does the size of the carbides matter, does cement really break down after 20 years, is the BIOMET soft in comparison to the Birmginham, etc, etc, etc?  When does the research into devices from a layman's perspective become counterproductive?

Thanks to everyone in advance for their stories and insights.  From someone that has not yet had the procedure your postings and stories mean a lot. 

[newdog]

One well known surgeon recently told me the BIOMET device is made of "soft" metal when compared to the "hard" metals of the Birmingham.  He also referenced Dr. Gross' financial interest, which he has in my opinion been completely forthright about, and the fact that both components are not FDA approved as a reason not to choose them.   

rbt,

Who is this "well known surgeon"? It amazes me about the ignorance that is out there in the medical world.

#1  The Biomet device is made of "soft" metal? Surely you don't believe this guys crap. A device made of anything but a hard material would not last very long. Biomet makes there implants out of cobalt chrome material. It is extremely durable and wear resistant.

#2 About Dr.Gross' financial interest. Dr. Gross worked with Biomet to develop an implant that is capable of accepting bone in growth. You can't just take a cement type of implant such as the Birmingham and install it with no cement. It won't work. The most difficult part was developing a method to spray the rough titanium coating inside of the femur cap. It is this coating that the bone grows into. He worked with another company before Biomet and they could not give him an acceptable implant because they could not do this spray coating to his satisfaction. He has performed over 1000 totally cementless surgeries over a two year period and HAS NOT HAD ONE loosening of the femoral component. It's over two and one half years now. Is this "well known surgeon" suggesting that Dr. Gross is using an inferior device for his own financial gain?

#3 The Biomet device IS approved by the FDA. Where did he get his information?

I highly suggest that you do some more reading and research. Don't go by the "that's what I heard crowd". They are wrong every time. Contact Dr. Gross' office and request information about cementless implants. Get on his website and read up on it. He has nothing to hide and is the most transparent doctor I have ever dealt with. Another thing, I would stay away from the "well known surgeon". He's full of feces.   

[lori.36]

I was 37 when I got my surgery.  I was thinking like you about the cementless and future surgeries, but I chose the BHR because I trusted a local surgeon to perform the operation.  I have a family that I would have had to fly out to S.c., no thNks
No real proof, but I do understNd the concept.
Best of luck making your decision

[Dannywayoflife]

Hay rob,
           I like you was all over the cementless concept, until I saw the video of mark Bloomfield on vickys site. He explained alot of the history and as to why cement became unpopular especially in the states. The reason he gives is not as was then thought he says the cement doesnt fail. The video is well worth a watch. Also I saw something I think by dr Bose and I'm sure he said that we wouldn't really know about the success of cementless for another few years. He argued that it was something to do with the vasculation of the new bone I think and wouldn't be apparent for around 5 years.
Hope this helps bud and you find the device and doc that makes you happy!
Danny

[Lopsided]

I did get uncemented, and I think it is a good decision.

The Birmingham does not have an uncemented version, but it is not the only good device.

The alloy that all the resurfacing devices are made from is cobalt chrome. This is not hard, or soft, it is extremely hard. Cobalt chrome is one of the few alloys known as 'stella' alloys because of their exceptional properties.

Some devices use this alloy as cast, and some are heat treated. There is some debate about whether heat treatment is detrimental, and this seems to stem from one study alone, and is used as a marketing feature of the Birmingham.

From what I have read, there has been no device fail because the alloy was heat treated. Those that have failed are either because of bad design or more importantly, bad placement.

The Conserve Plus that I got is heat treated, but there are papers to show that wear levels are better than that of the Birmingham. It did not get FDA approval by being soft!

The Biomet is as cast, not heat treated - the same as the Birmingham.

I agree with Newdog that your surgeon seems wrongly informed, and is wrongly informing you.

I think uncemented is the way to go. There are probably only a few surgeons in the world that are both capable of doing uncemented, and work closely enough with the device manufacturers to get supplied with those devices.

D.

[newdog]

The Biomet is as cast, not heat treated - the same as the Birmingham.

lop,

Thanks for the correction about the heat treating. I removed that from my prior post.

[stevel]

RPT,

It took about 9 years for the FDA to approve the Conserve Plus total hip resurfacing device.
Only the BHR, Cormet and Conserve Plus are approved in the US.
Problems with the Durom and ASR device escalated as time went by and these devices were never approved by the FDA and were withdrawn from the market.
The Biomet device (cemented or uncemented) is not approved by the FDA for marketing as a total hip resurfacing device.
Mr. McMinn has not had one loosening of the BHR due to cement failure for 3000 plus installations since 1997.
A prototype to the BHR was heat treated in 1994 or 1995 and had problems so Mr. McMinn went back to the "as cast" condition to begin the BHR in 1997.
Check out the Australian registry or European registry to compare the different devices.
The BHR has the best results and longest track record.
Your insurance may pay for a Biomet uncemented but you have to feel comfortable with the device, as it does not have a track record beyond 5 years.
It is speculation to assume the BHR cement will break down in 20, 30 or 40 years.
Somebody plants this scare tactic and some people start believing it.
I have not found any evidence of cement breakdown of the BHR device since 1997 when it was first installed.

[John C]

Others have done a great job of answering your key questions arising from the "top surgeon", but I would like to take a shot at summing up.
1. There is no soft metal. All resurfacing implants are made from Cobalt Chrome alloys. There is a difference between brands as to whether they are left "as cast", or have subsequent heat treatment, with conflicting studies cited by each side to support which is best. BHR and Biomet are both "as cast".
2. Dr. Gross does have a financial interest in Biomet, since he has spent many hundreds of hours working with them to develop the cementless design, and the tools and system for installing the device. He has always been very open about this, and it is well deserved. It is my understanding that many top surgeons receive some form of compensation from the manufacturer of whatever device they choose for their patients.
3. Both the femoral cap and the acetabular cup from Biomet have been individually approved by the FDA. What has not yet been completed is the trials that would need to be completed to approve them for use together as a "resurfacing system". Dr. Gross has a thorough explanation of this on his site. It is my conjecture that since both components are approved for use by the FDA so that surgeons are free to use them, the time and cost of going through the trials to get them approved as a "system" is probably a low priority, though I do think I read that some trials are underway.

Personally I agree with the arguments for cementless, but everyone agrees that it will be years before it will become clear as to whether either approach will turn out to be better.

Good luck with whatever you decide.

[einreb]

One thing that I don't follow w/regards to the statement associated with McMinn... does that mean that he has had zero femoral caps loose?  What exactly is 'cement failure'?  The problem with cement isn't that it 'breaks'. Its not a really a glue in orthopedics, its a filler.  Historically, there are lots of potential problems with cement. I suspect that's why McMinn tried to avoid using it in his early resurfacing attempts.  There is a lot of historical evidence to suggest that it would be good to not use cement.  Its also good to note that the BHR has a good track record with cement.  Nothing is cut and dry.  Any surgeon that says otherwise is full of it.

As a mechanical engineer, I analyzed this stuff way to much in my decision.  The data and literature that I saw showed very little significant differences between the BHR and Biomet with the exception of the cement.  The C+ is also very similar with the exception of the heat treating and that it appears to hold a slightly tighter tolerance (Desmet claims its shown better long term wear rates).  The one oddball, was the ASR (go figure).

One thing I'll say about Dr Gross is that his numbers with the Biomet and results are there to see.  I don't see any other doctor doing that.  He identifies the smallest little failure mode and attacks it to make it even less likely.  That combination (Gross/Uncemented) is where I felt most comfortable.  Someone else may be more comfortable somewhere else.  Nothing wrong with that.

[stevel]

In Mr. McMinn's interview on Vicky's Marlow's website, he states that he has had no loose femoral caps (cemented) and no loose acetabular cups (uncemented) since 1994 for all of his patients.
He doesn't discuss cement failure only that he has had zero loosenings since 1994.

[rbt2011]

Thanks to everyone for their posts!

Much appreciated.

[Anniee]

Interesting discussion to which I do not have a whole lot to add, except that it made sense to me to go cementless - on less foreign substance introduced into my body.  As others have said - time will tell whether this is the way to go.  However, I find it interesting that most, if not all, surgeons do not cement the socket part.  If there is no danger of the cement breaking down, why not use it in both places?

Also, while Dr. Gross does have a financial interest in Biomet, he makes no profit from the Biomet devices he personally installs in his patients.

[John C]

Hi Ainniee,
The most common concern that I have read about going cementless on the femoral side, was whether there would be sufficient vascularization in the femoral head after surgery to support good bone ingrowth. It is commonly accepted that there is compromised blood flow to the femoral head after surgery, and the question was about if, and for how long, that would be a problem. Dr. Gross researched how much the blood flow was affected, and how well it returned to normal. His conclusion was that the problem was only temporary, and would not be an issue for bone ingrowth. He also hypothesized that the heat from the cement curing might damage the vascularization, and therefore the problem with blood supply for bone ingrowth would be less if cement was not used.
The only other concern that I remember reading about regarding cementless, was whether there would be sufficient bone contact all around the inside of the cap. That is why Dr. Gross spent a lot of time redesigning the system for preparing the femoral head so that it produces  a very tight fit inside the cap. As someone pointed out, cement has always acted as a kind of spacer or grout, and without it, the fit is much more critical. He has emphasized that this will be key for any other brand that wants to come out with a cementless option.

[einreb]

he states that he has had no loose femoral caps (cemented) and no loose acetabular cups (uncemented) since 1994 for all of his patients.

Any idea what his resurfacing failures have been?  Those two failure modes seem to be the most common and I'd be a bit surprised if he had neither of those two.  I've never seen much in the way of published details from him.

There are several different 'survival percentages' tossed around associated with McMinn... but they get mentioned as simple numbers with no context or details.  I'm not saying that he doesn't get great results, just curious as to the details.

[stevel]

Check out his website at www.mcminncentre.com to find more information about various studies and results. 

[einreb]

The graphs on the 'Results' tab bottom of this page are interesting...

http://www.mcminncentre.co.uk/birmingham-hip-resurfacing.html

The 'projected' 93% survivorship for women vs 97% for men is quite the difference.

[Anniee]

John C, thanks for that info!  In regards to Dr. McMinn, he does not seem to provide much detail about any failures, only that the reasons include....  I'm not trying to take anything away from this obviously very skilled surgeon, I'm just saying a little more info would be nice!

[rbt2011]

Found this earlier today and wanted to share it.  Conceptually, I would think this data may in some ways be extrapolated to hips but I don't know.  I just figured I would share it:

Looks like approximately 9 years of data on cemented/uncemented total knees. 


http://proceedings.jbjs.org.uk/cgi/content/abstract/93-B/SUPP_III/375-d   

[stevel]

Although Mr. McMinn began hip resurfacing in 1991 with uncemented femoral cap and uncemented acetabular cup, the long term results are unacceptable with 63 % success.
Dr. Gross has significantly improved the design of the femoral cap so the bone grows into the underside and he machines the bone for the femoral head to a press fit finish.
The short term results have been excellent but not any better than his results for the cemented Biomet femoral cap/ uncemented acetabular cup.

I have to wonder about cement break-down when the cement in the root canal of my upper molar deteriorated after 20 years and I needed another dental surgery to replace the filler in the root canal.  Presumably cement has improved in 20 years.

Check out the Mr. McMinn's video "Longevity of hip resurfacing?  With statistics of cementless resurfacing" on Vicky Marlow's website.

[Tin Soldier]

This one thread is packed full of great info and links.  Thanks all.

I don't get the issue about financial interest.  Is there a problem with a doc who has put a lot of time and research into making a great product and then promotes it and maybe has some financial interest in it?  What about Amstutz with the C+ or McMinn with the BHR?  I could understand if there wasn't a good track record and they kept on promoting it, but most of these have good track records.  Plus you'd be an idiot to push something that hadn't been well studied with our lawsuit happy culture. 

On the hardness issue, is it possible that the surgeon was referring to De Smet's paper on BHR vs C+?  It gets back to the "as cast" vs heat treated deal.  Same alloy, but maybe a slight difference in hardness.  Heat treating does make certain alloys harder.  De Smet talks about carbon "icebergs" getting worn down creating a lubricating surface of sorts in the BHR and those get evened out with heat treating.  Not sure it matters over the life of the product and I think a lot of it boils down to the placement of the acetabular cup with regards to excessive unsymmetrical wear.

On the topic of cemented vs cementless - there is lots of discussion on this topic on a few other threads.  I don't know enough about it, but I have a cemented BHR and I sure hope the cement isn't going to wear out on me.