Custom Fit Total Knee Replacement

Patients beware...The "Custom Fit Knee" is a gimmick to attract patients.
1) The knee implants themselves are not custom, they are the same implants everyone else uses
2) The claims made by the advertisements are not scientifically valid. They do not even make sense.
3) The physicians highlighted on the OtisMed site are not even fellowship-trained in joint replacement surgery.
4) This is a great example of "Hot phrase" marketing. Key words are used to attract patients to a practice. Nobody who really understands joint replacements thinks that this technology is an advance.

This post is to warn patients not to choose a surgeon based on a gimmick technology. Choose your surgeon based on how comfortable he/she makes you feel....and their credentials (fellowship training in joint replacement surgery).

Joint Surgeon,

I have to respectfully disagree with your anaysis here.

First, Dr. Joseph Vernace, who is listed on the Otismed site, is a Rothman Joint Replacement Fellow trained at Thomas Jefferson Medical Center in Philadelphia. He has done over 150 of these custom knees, and his results have been excellent to this point.

More importantly, the majority of Total Knee Replacements done in this country are performed by non-Fellow trained orthopedic surgeons, and most do a very good job. Total knee replacements have become routine for many general orthopaedic surgeons. This technology helps make it even more accurate and easier for the average orthopod.

Your quote "Nobody who really understands joint replacements thinks that this technology is an advance." couldn't be farther from the truth. This technology drew standing room only crowds of orthopaedic surgeons this week alone in both the Boston and Philadelphia areas to hear surgeons who have used the custom knee cutting blocks relay their experiences. The numbers of surgeons in some markets who are signing up to utilize this technology is unlike anything ever seen according to industry veterans who have covered total joint replacements for 25 years or more.

You may think it's a "gimmick", but that's exactly what some folks also said when arthroscopic surgery was introduced in the late 80's for certain knee reconstruction procedures. Within only a few years, arthroscopy quickly became the gold standard. I predict this MRI-based technology will do the same for total knees over the coming years as well.

Big B...

It might be nice...and may be easier to cut the bone with custom cutting blocks.
But to claim faster recovery, less pain is absolutely ridiculous and clearly false advertising to attract patients.
To claim that this leads to a knee with natural motion, and a natural feel is also completely misleading and nonsensical. I expect this from implant companies but not from MDs...its embarrassing to hear these claims come out of an MDs mouth.
Furthermore, to depend on the cutting blocks is dangerous. The surgeon I heard talk claimed perfect balance resulting from this technology. He lied. What about flexion contractures, osteophytes, valgus knees, etc. Does he know what he is talking about? The theoretical considerations he suggested were wrong, and even some of my residents asked if he really understood what he was talking about.
This may become a technology that is used by many in the country at the expense of more health care dollars. It may make doing the knee a little easier for those who don't feel comfortable with their cuts. But to claim that this is the biggest advance in 25 years, to claim less pain, more natural motion...come on you have to be honest to respect our profession.

Wow, a joints blog

I agree with Joint Surgeon.

This technology is a neat idea, but not what this article claims.

"OtisKnee physicians and patients have reported a quicker and less
painful recovery, increased range of motion, a more "natural" feeling
knee, and greater ease in performing normal living activities such as
golfing, biking and gardening."

-------This statement suggests that the custom cutting blocks lead to
less pain and better recovery. That is sort of crazy.

"The results I've seen to date have been tremendous, with 83 percent
of patients walking without a cane at 4 weeks and 70 percent driving
their car at four weeks."

--------Also misleading. First of all, these results are not that
impressive as most of my patients without the custom technology walk
without a cane at 2-3 weeks. Secondly, any joint surgeon seeing this
comment knows that the custom blocks have nothing to do with this
early outcome.

Brilliant marketing campaign. Unfortunately qualifies as misleading
advertising.

Joint Bloggers,

I have to agree with my friend Big B and add that the part that is missing from the story is that fact that no soft tissue releases are done. It is my understanding that pain and swelling often comes from this part of the procedure. Now you may disagree that you can do a knee without soft tissue releases but if they are not done you would have to agree the patient would feel different post-op. The other point I feel is important is that if balancing of the knee was that easy to do on the table why according to many sources is instability the second highest cause of revision knee surgery. If this system balances the knee properly than again the patient would be able to tell that their knee feels "normal" and certainly different than an improperly balanced knee.

Before you can say that the OtisMed technology is misleading you would have to know that these patients are not realizing the benefits that they claim. Let's face it, the chances are you are doing a knee now that has a claim of some sort. Does every patient realize those benefits?. There have been at least 4 different Ad campaigns on TV recently. This "custom ft knee" not "custom knee" at least adresses the way it is put in. Using the actual MRI of the the patient's knee ,as a guide not an arbitrary number of degrees that we have selected for most patients seems like a resonable we of assuring the proper fit.

Joint Caddie,

You argue that the custom fit knee makes soft-tissue release unnecessary.
Some surgeons out there use the tensioning technique for knee replacement. It is the ultimate form of customization, favoring soft tissues over cut angles. Even these surgeons need some soft tissue releases before the tensioning is done, to place the knee within reasonable alignment. Two of these (very famous) surgeons are in the city of Philadelphia. Are you suggesting that their releases before tensioning are unnecessary? Should they just take any knee angle that results from the tension? There are 3 Chapters in "The Adult Knee" discussing releases. Are you suggesting the Drs. Ranawat and Laskin make unnecessary releases?

Secondly, the claim that "pain and swelling after knee replacement are from soft tissue release" is absurd. Most releases are subtle, minimal efforts. Compared to cutting bone, arthrotomy, and anterior dislocation of the tibia....subtle releases are nothing.

Third, even with the custom fit knee, you still cut the ACL, lose medial pivot, and replace the distal femur with a sagittal curve that is likely not like the patients natural anatomy. To call it a natural knee with natural motion is misleading. If you got the top 5 knee surgeons together to try and decide on perfect cuts based on anatomy...they would disagree. Fact of the matter is that we still do not completely understand knee kinematics. I guess you have solved that problem at OtisMed.

Finally, pointing out that other false claims have been made is not helpful and almost an admission of fault. You are an MD with obligation to the public, your patients, and yourself. What do you think that the American Academy of Hip and Knee Surgeons would say about the claims in your press release? Probably not a good thought.

Have fun with the custom cutting blocks, spend an extra thousand dollars on each patient, honestly its fine. But do not have a press release with MDs making claims that have no backing or data without control groups. It is misleading to the public.

As in everything, time will tell if this is a significant advance or not.

But, here is something to consider. Dr Vernace has reported early three month results using knee score models for pain, flexion, and overall satisfaction. These results are statistically significantly better than either conventional TKA or navigated TKA results at 6 months. Normally, three month scores are worse than six month scores, and as the patient gets further away from the surgery date the results tend to improve the first couple of years anyways.

If these results hold, and are replicated by other custom block users (the studies are underway), than I must believe that this is indeed a significant advance in performing TKA. Neither Dr Vernace nor Dr Howell in Sacramento has had to do a soft-tissue release on over 150 knees apiece, and I'm told Dr Meade in Allentown has also not had to do any releases on any of the over 75 custom block TKAs he's performed. Is this a fluke, or a solid trend?

Your point about Drs. Ranawat and Laskin is really not relevant. When they wrote their papers and chapters on soft tissue releases, they did not have an MRI-generated custom cutting block to use, only standard conventional blocks and jigs that have essentially remained the same (at least in technique terms - intramedullary vs. extramedullary/anterior vs. posterior referencing/ etc.) for the last 15 or 20 years. Navigation has been an interesting aide, but the most recent studies out there show no significantly and consistently better results for the additional time and expense that nav adds to a case.

Given the rapidly growing number of surgeons who are now starting to use these blocks, we should know relatively soon exactly how good or not this technology is. But the reality is that it is surgeons, not a marketing campaign to patients, that is driving the intense and in some respects unprecedented surge in interest in this technology. It really is a bolt out of the blue, which very few of us in the business saw coming.

I have to say that this makes no sense.
#1) my discharge times, ROM, and activities are better than those you guys reported...without custom blocks. My patients are discharged 1-2 days after surgery to home and are walking without a cane at 2 weeks. Trust me on this...the immediate results have nothing to do with the blocks.
#2) If even those using tensioning techniques (the ultimate form of customization) use some releases , I don't see how custom blocks can avoid releases. Maybe the surgeons you commented on should be doing more releases to get better balance.
#3) I don't know how these blocks could adjust for flexion contractures or attenuated ligaments.
#4) even if the Blocks are MRI designed to fit perfectly, it is unavoidable that the dissection, soft tissues, and block pinning lead to slight changes in cutting angles.
#5) It appears that none of the surgeons involved in this whole idea have done any significant joint replacement research in the last 15 years. Why aren't there any more famous surgeons from the Hip and Knee Society on this project.

I'll wait and see the results, and will be happy to do the revision replacements when the wrong surgeons use these blocks.

Do the math.

Even if you place a component in 3 degrees of malalignment, and the implant is average size, the resulting change in gaps is only 1mm. Thats because the sine of a very small degree is a very small number.

Even if the custom fit knee does get it perfect (and I have no idea who decides what perfect is), the resulting change at the joint line is miniscule.

So unless a surgeon is placing components in horrible malalignment, there is very little change at the joint line with small changes in angulation. Most joint surgeons are actually quite accurate with component positioning, this is one of the reasons that navigation did not help so much. And if a surgeon has trouble with balancing, he probably should be using the custom blocks either.

I my practice, getting a balanced knee is not a problem, and I hardly make any serious releases.

The idea that this lead to a faster recovery and better feel is moronic...but hey, it may make a company some money...good business.

It is concerning that a company is telling an MD where to cut a knee. I thought that we don't even understand joint mechanics. If you cut the ACL, how can you claim natureal normal feel? How can you really know how much bone has been lost? Does the MRI extend to the ankle? What about people with a bowed tibia?

I do not like this trend, where we tell patients about something great before it is proven. There is absolutely no proof yet, and the press release claims a breakthrough. We must be cautious with experimental technologies.

This cooke-cutter approach is potentially dangerous.

Boy is this idea good marketing. I can smell the patients running in to have a custom knee done.

I am happy to see that most people on this blog see through the technology. Likely the comments are mostly by surgeons. The number of assumptions, false claims, and theoretical flaws is astounding. I can't believe that insurance is willing to pay for this. It is even more shocking to see the claims of faster recovery. Seriously, these MDs should be embarrassed of themselves.

JointMan,

What false claims are you referring to? The surgeons who are using these blocks (the number is growing weekly, and they are in many parts of the country) are all reputable, well-established guys, some of whom have performed thousands of TKA's prior to this technology becoming available. THEY say they are getting better results overall with faster recovery times in many cases. Are they all conspiring together on some master plan to fool other surgeons or patients? C'mon....

If you don't believe them, contact them directly. They are more than willing to talk to fellow orthopods and explain their results and experiences. Skepticism is very healthy when it comes to this type of thing, and these surgeons have been convinced by their own experiences with this technology.

We'll know a lot more in about 6 months or so, as the numbers steadily grow.

Just heard a talk on the custom fit knee. I can't believe how this makes no sense and it is being presented as a breakthrough.

How does the MRI know how much osteophyte I will remove? How does the MRI know where the ankle is for leg alignment? Who decides what the anatomy was like before arthritis came on? What about flexion contractures? How does the MRI know the patients normal ligamentous laxity?

The claims are completely unsubstantiated.

This should really be reported to the AAOS department of standards of professionalism for the way this has been prematurely presented.

We used this system for the first time 2 weeks ago on 4 patients. It performed exactly as noted above, with earlier discharge from the hospital, much better range of motion, decreased operating time, and decreased turnover time, when compared with our traditional knees.

Our physical therapists independently requested that we switch all patients to the Otismed system.

I think this actually is a real breakthough in technology.

Dr. H

Why can't anyone answer just a few questions about this technology, because I honestly feel that the comments here are false, misleading, and outright unethical.

#1. Many patients have flexion contractures. The cause varies from a tight posterior capsule to tight collateral ligaments. Joint replacement surgeons traditionally attempt a variety of techniques to rid the contracture...for example a posterior capsular release, a more significant distal femur cut, etc. How can the MRI and custom knee blocks predict exactly how this situation can be adjusted?

#2. The surgeon removes osteophytes from the femur and tibia. How can Otismed be sure that the MRI assumptions on "natural anatomy" will be perfectly matched by the surgeons osteophyte removal? Once the surgeon removes the osteophytes, the MRI becomes irrelevant.

#3. The argument for faster rehab and discharge relates to ligament releases. The majority of patients undergoing knee replacement do not need releases even with traditional methods. So why would the custom jigs make a faster discharge and less pain for everyone?

This technology reminds me of commercials for nutriceuticals and herbal remedies. It is being pushed by people who have no name in their field, without any scientific proof, and the base science doesn't even make sense. Dr. H's comments are hilarious, he is changing the way he does knee after an N=4. What a joke.

And I have no reason to dislike this technology. I have access to it and I could use it if I wanted to. But I was born with a brain and went through enough education to see through this scam.

Joint Surgeon: I agree with you. If you have such significant doubts about this technology, then you personally should not try it. Wait till more definitive results get published. Papers on this are being submitted to the AAOS in preparation for the March '08 meeting in San Francisco, so you'll know more by then.

But do understand this. There is a growing number of surgeons across the country who are trying this technology, and who all are consistently seeing the same overall results and benefits. These surgeons cover a wide spectrum of experience and training, from younger sports-trained orthopods to veteran joint-fellow surgeons with tons of experience. The guys I know who are doing this or who want to at least try it out have very solid overall reputations as orthopaedic surgeons. They too, like you, have brains and went through a similar education track. They would NOT be doing this if they didn't think it offered advantages to their patients, the hospitals, and themselves, and they certainly would have nothing to do with any type of "scam", to use your words.

Based on the number of surgeons who are converting the bulk of their TKA's to this technology after trying it out a few times, there is growing confidence that this technology does offer the potential for significant advantages. So, it's fine for you not to use it, as I'm sure you're probably already getting great results overall. But at least be fair and admit the possibility that this could be a breakthrough, and that time will tell us if these guys are right. I believe they are.

Everyone notice my questions were not answered.

Why doesn't anyone have the answers to these simple questions?

I know some of the players listed that are "champion surgeons" for this system. NOT IMPRESSIVE. If you could only see their xrays. femoral flexion of over 25 degrees, tibial resections near 15 degrees of varus, consistently. I'd love to see them present their xrays at a resident run conference and even the second year residents would know that there was a problem. Oh well, gentlemen, if your going to promote yourself with this technology you better by prepared to walk the walk.

Big B, I think your last post sums things up nicely. Joint Surgeon's questions deserve an answer, and maybe that will come, at least to some extent, at the '08 meeting. Ultimately, time will tell, and anecdotal results will become statistically significant as more and more of these procedures are done. As for "in the know", the comment isn't worthy of a response...I think the term these days for that post is "flaming".

JC...still no answers to my questions. These are theory questions not results questions. I have had OtisMed pushed onto me by a couple of people now, and when I ask these questions they look at me dumbfounded. I sat at a table of surgeons who seemed excited to try it....and when I brought these issues up they all agreed that it did not make much sense. The very arguments made by the surgeons supporting the technology are flawed, and reflects a lack of understanding regarding knee arthroplasty.

My questions are clear, unambiguous and direct. Anyone with a specific education in joint arthroplasty can understand these questions without hesitation. The fact that there are no answers to these theoretical questions is very concerning.

I remain horrified at the implications, claims, and lack of understanding displayed by OtisMed and its supporting surgeons. The adverstising and claims of the OtisMed Custom Fit Knee are irresponsible, and present a misleading product to patients. The surgeons behind this technology should be embarrassed of their shameful behavior. It is unprofessional and unethical.

JC. Obviously you are vested heavily in this project. Either a stryker/biomet vendor supporting the claims of your surgeons while you enjoy some transient success. As for my remarks being inflammatory, they are meant as such. Surgeons need to present their data honestly and without bias. The early results are NO BETTER than a navigated or traditional cutting guide TKR. The big fear with this system is the early result that this technology will enjoy. The reason for this is that in the majority of patients the jig system will allow for a functional knee replacement. If the trend continues thousands will be implanted with generally acceptable medium term results. With the malpositions that will be typical and the mechanical disadvantages that I mentioned in my last posting, we will see intermediate failures (4-8years) with early loosening and Kaplan-Meir survivorship curves that will fall off steeply there after. If you are not in the business of revision surgery as many of these champion surgeons are NOT, this will merely be a blip in their practice as they move onto yet another "custom fit knee". That will leave arthroplasty experts like myself holding the bag and biteing our lips as we attempt to help patients understand why this happened to their "custom fit knee". The educated responders on this site understand this concept as we are at the end of the funnel for complex reconstructive cases.

hello
i have petient reques for hand fitting of a custom prosthesis let me no if you can this for my petient

thanks
dr oyewole

Joint Surgeon, I agree that your questions lead to much head scratching, in attempting to make logical sense of the procedure. My only point was that if there should be intermediate (or preferably long term) hard data confirming OtisMed's asserted benefits, we couldn't ignore it, even if we don't understand it. Unless and until that occurs, however, I share your concern about the ethics of agreeing to use the procedure at all, much less recommending it to patients.

There have been enough instances of the next big thing in tka turning out not so good to be wary of the early adoption of any new technology, much less a procedure which, assuming it to be true, still arguably doesn't significantly improve upon the results obtained by a competant surgeon.

In the know, I may have misjudged you, but your last post makes sense only if the xray results reported in your first post are accurate, and you gave no credible explanation as to how you came by that information. If you can do so, I'll stand corrected. By the way, my preference is Zimmer.

Can a lawyer weigh in here? I'm 55 yrs old, and do civil litigation, including medical malpractise. I also am looking at bilateral total knee replacement at some point in the future. Here's a recent article on OtisKnee which says it all: http://news.bostonherald.com/news/regional/general/view.bg?articleid=1035041

Let me summarize. During the last 18 months, about 700,000 knees have been replaced, and all of 1200 of those have been OtisKnee. The doc who did the surgery which is reported in the article is quoted as saying "they've got back their normal knee" (how about that for hyperbole?), but there is no peer reviewed data to confirm the efficacy of the procedure, particularly over time. I leave the medicine to the docs, but if "joint surgeon" posted correctly, any reasonable and prudent orthopaedic surgeon would know that OtisKnee doesn't represent the current standard of care in total knee replacement. The informed consent form hasn't been drafted that will avoid liability for knee failures resulting from a surgeon's recommendation to go with OtisKnee, assuming the predictions of "in the know" hold out.

My suggestion is to find a good doc who does LOTS of knee replacements, confirm his reputation, and rely on his advice...I'll be shocked if he tries to sell you on OtisKnee.

I found a good doc that does LOTS of knee replacements, confirmed his reputation, relied on his advice, and he sold me a custom fit Otisknee. He did a complete left knee replacement using the MRI Otisknee replacement process. Surgery on Oct 1, 2007, walked passed 6 rooms to nurse station and back to my room with a walker on Oct 2, 2007, checked out of hospital around noon on Oct 3, 2007, home theropy including walking with walker Oct 4, 5, 6, walked without walker Oct 7, 2007, drove car first time Oct 8, 2007, removed 16 staples from my knee on Oct 10, 2007, started therapy at a Physical Therapy Center Oct 11, 2007 and will be doing this three times a week. Everything so far has went well. Decide for yourself whats best for you.

"satisfied customer", I hope that your long term result is equal to the first 10 days post-op. Just curious...what is the doc's name and practise location, and did he address the issues raised by "joint surgeon" and "in the know"? Is he now exclusively using OtisKnee, and if not, what are his criteria for recommending it?

To satisfied customer.....the early results you describe are actually quite common these days after a knee replacement. In fact, many centers have patients going home walking the day after surgery. So the early result has absolutely nothing to do with OtisKnee. There are 2 reasons that people are questioning Otis Med.

#1) The surgeons using it suggest that it makes you have a faster recovery. This is misleading, and your described early outcome is no different than any of my patients'...as 40% go home the day after surgery. Trust me on this...the claims made by those using it are unsubstantiated.

#2) Although the focus after knee replacement is on the early recovery...what you should really care about is the long term recovery. OtisMed is experimental, and no one can predict the long-term results. The fact that OtisMed does not include release of the deformity results in some malalignment, and potentially faster long term failure of the implants.

Don't be alarmed, your knee is probably fine, but it angers me that some of my colleagues feed their patients such crap. I don't think that any of the well-respected knee surgeons in the Knee society are using OtisMed. The only guys I have seen using it are the less well-known suburban surgeons. They like it because it attracts patients (custom sounds so nice) and because then they can do the knee without as much thinking during the case. I know of 1 surgeon...who I actually respect very much...who tried OtisMed on 5 patients. He no longer uses it.

I am sure most of the OtisMed knees will be fine. But I am concerned about longterm results. The surgeons using it should have a disclaimer that points out that the technology is experimental and may have suboptimal longterm results.

Whow! After reading these comments I am concerned about the custom fit knee. I am an unknowing patient in need two knee replacements and thought I had found the most recent updated treatment. Now I am reconsidering. Thanks for your honesty and conversations. This is something patients need to hear from doctors other than our own.

OK, time for a few words. If "joint surgeon" was a busy joint surgeon, I wouldn't think he or she ( but probably not because most females are not that arrogant) would have so much time to devote to this amazingly unscientific forum.
Posterior releases are not necessary with Otis Knee. I would think that most "joint surgeons" know what ostephytes look like and remove them quite regularly at surgery. If joint surgeon doesn't know what osteophytes look like or how to remove them, then certainly he/she would have a difficult time with TKR.
Ligaments do not tighen and contract like we have been told for all these years. When you do a total hip on a patient that has a siginicantly shortened limb from femoral head collapse, perhaps with osteonecrosis, etc, do you do capsular releases for that patient, or do you restore anatomy and let things take care of themselves?? When you restore natural alignment, the ligaments are restored to their normal lengths and do not need compensatory release for inapproriate bone cuts.
Insall, Laskin, and the boys knew we were doing compensatory releases as well. Why do we extenally rotate the femur?? To make up for cutting the tibia perpendicular to the ankel instead of in varus where it belongs....the flexion gap has to be adjusted to accomadate a lose lateral ligament due to this nonanatomic cut.

You are missing the point that the MRI is used to make a 3D model of the arthritic knee, and then corrected to make a 3D model of the patient's non-arthritic knee, replacing worn cartilage and bone, giving us a view of the patient's previous normal anatomy. If you were looking at a normal knee and for some reason wanted to do a total knee on that patient and their knee was such that the tibial was in 3 degrees of varus and the overall limb alignment was 2 degree of valgus, would you put the knee in in that position to reproduce normal anatomy or would you do what you do now which is to put the tibia peerpendicular to the ankle and in 5 or 6 degrees of valgus. If you did that, don't you think the collateral ligaments would be "tight" or "loose" because you didn't restore natural alignment. We always try to restore anatomy in orthopaedics, escept for total knees. We haven't had the technology to do that up until now.

The reason it seems that patients have a faster rehab is that their knees are more normally aligned, their ligaments are not on stretch or too loose, and the overall balance of the knee is better. It isn't the physical act of not having to do releases that makes them feel better, it is the more normal alignment. If the door is not on the door frame perfectly, it still works as a door, but it jams on the floor, or the tp of the frame, or doesn't open or close all the way. If it is aligned properly, it opens and closes more easlily and moves more freely. That is what we think happens with custom fit knees. The alignment is better so the knee moves more naturally and therefore the rehab is faster.

Just some food for thought. When total knees were first done, they cuts were done by hand and eye, there were no instruments. Then we had some crude intial instruments, then they got better and we could get things lined up better. The problem is that we are aligning things mechanically and not naturally. The idea of CFTK is to allow us to use better instruments to better align the knee and give us better results. This technology is in its infancy and we expect to take some heat for it. Every thing that is new in orthopaedics goes through this type of criticism.....knee arthroscopy, shoulder arthroscopy, arthroscopic rotator cuff repairs, outpatient ACL surgery, putting metal in open fractures, etc. Remember when we were all taught not to fix clavicle fracture because they all did well??? Now the lead article in JBJS in Jan 2007 says we should fix displaced fractures becuase they do bette. For fifty years we were told it was the wrong thing to do...

We can't give you published results yet, we are gathering data, but it takes time to put it together, and all of you know it takes time to get it published. Our early results are extremely encouraging. Some of you hold on to the concepts of not putting the tibia in varus, worry about the overall limb alignment having to be 5 or 6 degrees of valgus, etc. I understand what you have been taught...I was taught the same things. Go back and read the literature on varus tibias and see what terrilble iimplants were being used. Look at the article by Collier in June 2007 JBJS about tibial alignment not making a difference. Look at the graph in that paper about poly wear and black out the left side of the graph were th overall limb alignment is worse that 3 degrees varus and then look at the plotted points again. The wear line becomes horizontal. That means if the overall limb alignment is between 3 degrees varus and 7 degrees valgus, the wear rate is the same. Our intial data with CT scout films on our CFTK puts our overall limb alignment in that range with an oveall slightly better valgus alignment than some of the papers in the literature looking a t conventional and CAOS surgeries.

I don't have the time time argue about this on blogs like this..someone point out to me what was being said, and after reading the comments, I felt it necessary to respond this one time. I will not continue to visit and respond. I understant the concerns, I understand the doubts, especially when we have been taught differently for so many years. I am not asking you to convert to this technology, but consider how much has changed in the last 30 years and how often you have said to yourself that "that isn't right" or "that can't work" or "that is crazy" and then a few years later you were doing just those things you were criticizing.

We are offering our experience with new technology. Advances are made by disruptive technology.
Time will show if we are correct or not. but from our early results that show improved recovery and 96% of patients who report on their WOMAC scale that their knee feels "normal" or "nearly normal", I am encourage that this is new technology that is here to stay. More surgeons are agreeing with us everyday, and perhaps in a few years, once we are published and can show our results more definitvely, maybe even joint surgeon will agree with us......if he doesn't blow a gasket and have a stroke first........calm down, you will live longer and happier.
Thank you for taking the time to read this. I hope it makes sense and sheds a little bit of light on what we are trying to do. I was very busy before I started this project. I didn't do it to get busier, I did it because I thought it was the right thing to do for patients and to try to advance TKR into the future.

just a few words.....

Beyond the obvious oxymoron reflected by the post of "just a few words", it is clear that he has a personal interest in OtisKnee, and that's o.k. This procedure may in fact represent a significant improvement in tka someday, or at least it may allow the orthopod who does 40 knees a year to get results comparable to a specialist doing hundreds of them year in and out, but whose crystal ball is clear enough to see that far into the future? As "Bill" noted, there isn't any long term data on outcomes (or intermediate data for that matter), which doen't mean that OtisKnee isn't a step up from current surgical technique...but it DOES mean that there isn't any data yet to prove that. If you can afford to wait for years until the results come back, then by all means do so. Otherwise, you are counting on being lucky to go with OtisKnee before then.

Here's an excerpt from the first peer reviewed article on OtisKnee:

"The custom OtisKnee system guides recommended alignment of the components that was more than 3' off of mechanical axis. The potential for malalignment with this system places implants at high risk of early failure."

See this link for the entire article, which was published in the January 2008 issue of The Journal or Arthroplasty: http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WHB-4RGF98B-6&_user=10&_coverDate=01%2F31%2F2008&_rdoc=7&_fmt=full&_orig=browse&_srch=doc-info(%23toc%236846%232008%23999769998%23677736%23FLA%23display%23Volume)&_cdi=6846&_sort=d&_docanchor=&_ct=36&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=7f603841d245dfc64c1d9e061fe60022

The docs who sold OtisKnee to their patients, particularly any making unfounded claims that "they've got back their normal knee" deserve to be disciplined, but that will never happen. Too bad.

Lawguy,

The article you refer to in the January JOA is quite possibly the most worthless and laughable medical research piece I've ever seen. The doctors should be really embarassed to publish it, as should the journal.

Their sample size was four (4) knees? That right there is a tremendous Red Flag, as anyone who has a lick of knowledge about good research principle would know. Given that there are surgeons out there who have done hundreds of these knees and are reporting excellent results overall, who is more credible??

I would have loved to see the the results of the first 4 knees done by these doctors using any method, especially navigation. Any orthopod worth his salt will tell you you need to do at least a dozen or two of ANY system to get a little bit familiar with it so that you're doing it properly. This article really is worthless ijn my opinion.

Walt,

The paper in the Journal of Arthroplasty shows that The Custom fit Knee Results in a Knee with a mechanical alignment that can be up to 5 degrees off (a crooked leg). Historically, this has been associated with early failures, including loosening and wear. Furthermore, the Otis med custom cuts resulted in a knee that did not extend to 0 degrees of extension, because the preop flexion contracture was not addressed. Finally, the surgeons doing the study are very experienced, and if they aborted using OtisMed Custom knee on 2 cases, doesn't this tell you something went wrong.

I have no doubt that the early results of the custom fit knee are good, just like any total knee replacement does well early on. Even knees that are done poorly do well early on, any surgeon knows that. What the paper suggests is that the Otis Med knee results in malaligned knees, which will lead to early (3-10 years) failures. I could care less what the early results are like.

Conclusion: If you are a surgeon or hospital supporting the OtisMed technology, and even 1 knee fails early, you are at a legal risk based on this paper.

Jointdoc,

I don't care how you spin it, but a "research study" involving only 4 knees is what's known as a joke in our industry, and you should know that.

Speaking of the "very experienced surgeons" who did the "research study", what you may or may not be aware of is that at least one of them may have very significant monetary reasons to see that the Otismed knee fails, because he is developing a different type of technology for a major orthopedic company that he will potentially make royalties on. The Otismed knee has leapfrogged ahead of what he was developing, so all of a sudden his future royalty payments may be evaporating rapidly. So maybe everything isn't as it appears here, huh?

Another fact I find interesting is that the other three big ortho companies that currently can't use Otisknees because of design issues with their implants are now all out there telling doctors that they are putting "top priority" on developing their own type of custom fit knee MRI blocks, and also that they are coming out with a single radius axis knee like Biomet and Stryker have so their implants can be used with the Otisknee blocks. Apparently those companies all believe in the technology too. Very interesting how this is shaking things up big time......

I am a general surgeon with 35 years of experience and even did orthopedics for 2 years in the service. I fell upon this website while considering options for having my own knees replaced and am still unsure of what to do. There are pros and cons, cautions and indications, for every innovation. What is sad is that, whether the procedure is a bust or a boom , societal parasites like "lawguy" are lurking on the fringes waiting for the opportnity to feed.

"Surgeon", you are absolutely right, and those who advocate this unproven "breakthrough" to patients to their detriment deserve to be fed upon by my colleagues and me, should there in fact be an unusually high incidence of early failure, as the JOA article suggests. JointDoc makes sense. Think about it...if OtisMed did what it purports to do, why would there be even a singe instance of malalignment?

Your profession does an even lousier job of policing itself than we do. However, we aren't afraid to sue another of us for failing to properly represent a client, to the end of making the injured client whole, to the extent it can be done. Who is going to cover the cost of doing the revisions on OtisKnee patients, if the long term data proves the procedure to be flawed? Just a wild guess, but I doubt that the surgeons recommending OtisKnee in the first place will be picking up the tab...unless, of course, somebody like me forces them to do that in a court of law.

For professionals who "practice" for a profession to get all flustered about a new "practice" is simply professional jealousy.

I have been waiting, wisely, for as long as possible in hopes that advances would come along that were worth waiting for. Sure, I could have had a stryker, good thing I didn't. I waited.

As a patient, I have met few docs who didn't ooze self esteem. While being self confident is fine, failure is a fact of the world and when it occurs, which I have felt painfully, a little humility is better than " so, sue me". At least a doc who is proactive can offer me the hope that what the future may hold is worth going after. I still haven't met a single TKR that was really happy about their knee. Every last one says it beats being in pain. Thats a far cry from what some of you old schoolers rant.

I'll be patient a while longer and let the numbers and skill levels rise and who knows, maybe this type of new TKR will be worth the wait.

I also ask every ortho doc I've seen about new development and few will even acknolege there even are ideas out there. Makes me wonder who is doing their homework and who is counting bank deposits.

I've read this entire blog and maybe wish I hadn't. I'm having an otismed knee next week. I actually understood it was a "custom" knee made exactly from my knee, hummmm. not exactly I see. I understand the "template" is made from my mri so the knee will fit properly. It seems to me that thisis a better way of insuring that the fit is correct. I am confident that my surgeon is well experienced - even tho... believe it or not - I have never seen the man. I only saw his PA and the decision was made to have the TKR. I'm tired of the pain - so I'm going for it. Just hope in a few years I don't regret my decision.
this guy only does knees .

need knees, I underwent bilateral TKA in early December. I had interviewed 3 docs, and opted for the one who does more TKA's in my state than anyone else. The hospital also had a brand new center which was devoted solely to patients having knees and hips replaced. Although I only met with him once, before the surgery, the appointment lasted 11/2 hours, and finished only when all of my questions had been answered. In response to my queston about OtisMed, he said that it would be several years before there was any meaningful data on it, and that it should be introduced with caution, given that existing technique yields a good to excellent result about 95% of the time. His response on this, and not "counting bank deposits" best explains why few docs acknowedge that there are new and improved techniques in the pipeline...it takes 20 years to know whether a new technique will equal the likely result of using the existing approach.

I think that you are wise in waiting as long as possible to have your knees done. I'm doing well, but the early weeks are still fresh enough in my mind that I might try to wait another year or two, if I had it to do over again. Good luck to you, when you finally take the plunge.

The sad thing about this site is it is all about scare tactics. Joint Guy and Law Guy I would be willing to bet are neither. These guys are probally joint reps who do not sell Custom Fit Technology and are out there scaring people. You should all be ashamed of yourselves. There is no way a orthopedic surgeon has the time to write on this blog so much. After seeing patients in the office, covering call, rounding and handling the business end of the practice that we are forced to do these days.
I don’t do custom otis knees but I am not scared of it and I am watching it with interest. Don’t be so quick to discredit things so quickly if nothing else time has shown us that we should not be closed minded.

One more thing as I was looking around other sites tonight it seems "joint Surgeon" has something to say on every otis knee blog or website. You are a joke and have been uncovered. If you are in fact a surgeon and stand by all your comments. Where is your practice and what is your name?

I am a phyisical rehab nurse who now finds herself in the position of needing knee replacement surgery. I have been avoiding it as long as I possibly can. I've tried just about everything. I take Mobic twice a day, use Soothanol X2, take Lyprinol and have tried Orthovisc injections. But I have bone on bone in my left knee now and I just don't think I can avoid it any longer.

Reading the things that all of you have written makes me feel less that secure now about joint replacement surgery. I've been surfing the web and doing some of my own research, and wonder if any of you have heard about "Regenexx". They take some of your own stem cells from your iliac crest, treat it and inject into your knee. They claim that they are having success. I see at Clinicaltrials.gov that there is a research study about to start for this in Terhan, Iran. Not going there! Also, what are your feelings on the Sigma Rotating Platform Knee? I like to walk and hike and would like to get as much movement with stability as possible. I am 55. Thanks in advance for your input.

Rep,

I do not intend to scare anyone. I promise. And I do love new technology.

But since when can a company with a new medical technology advertise a "breakthrough" or "advance" with such little data. Especially when it flies in the face of joint replacement standards.

I agree that the technology may work....but it also may fail miserably. Don't you think that the average patient deserves to know that it is experimental? Don't you think that the average patient deserves to understand it is controvertial? Well guess what...they have no idea.

In my area patients think that it is actually a custom implant. They think it is an accepted advance in joint replacement. They have no idea of its experimental status. Furthermore, none of the "famous or experienced" surgeons in the area are using it because they don't agree with the concept. It is the community surgeons with less experience who are trying it because it is easier to do.

I have seen these patients' xrays from a local surgeon and honestly its not pretty.

I am not trying to scare people...but people have the right to know that this is a controvertial technology, that may result in inferior results, and most patients do not understand this.

We live in a society where disclosure is important....people have rights. I do not believe that patients having the OtisMed knee really understand what is being done to them.

Thanks to all for the interesting comments. I have an idea why this technology sounds interesting to some and worrisome to others, that hasn't explicitly been noted.

The described MRI custom fit cutting guides are essentially a way of performing CAOS without having the computer in the operating room. The computer is used to create a customized cutting guide. One can see the advantage of precisely placing the cutting guide, and would hope to gain the accuracy advantage noted by other CAOS techniques that have documented improved accuracy of alignment.

The Otis information does not seem to include an assessment of the limb alignment. Unlike other CAOS systems designed to correct the deformity by creating a neutral limb axis it seems that the goal is to recreate the patient's pre-arthritis anatomy. Unfortunately, many patients have anatomic alignments that are not neutral to begin with that probably are part of the causation of their arthritis, and that if reproduced would lead to reproducing an alignment that may risk of early prosthetic failure.

I am an orthopaedic surgeon with a general orthopaedic practice (not joint fellowship trained) who frequently performs primary total knee replacement. I have not used (or invested in) this system. I wonder how well it would work to create a custom cutting guide with this technology that created a neutral axis and took advantage of the computer's ability to improve the accuracy of creating the desired bone cuts with high accuracy without the delays and extra steps of in the OR computer systems (a hybrid of these two technologies). I also wonder if the Otis system can do what is claimed, essentially reproduce the patient's pre-arthritis anatomy to the extent possible with an off the shelf design with enough accuracy to restore pre-arthritis soft tissue tensions. It is easy to imagine that it could improve short term results in the way described, but I would still wonder more about the long term prognosis. The burden of proof is on them, but it will be interesting to learn of the results of the relevant studies. There is already good data to show that even in the hands of experienced experts consistent high accuracy of alignment is not achieved with conventional cutting blocks. A malalignment in that setting is not necessarily equivalent in prognosis to an accurate reproduction of non-ideal patient anatomy.

My dad is about to have total knee replacement surgery on both knees at the same time. One late night I happened upon a local cable station's showing of Ronald L. Teed, MD (Portland, OR) discussing the Otis knee. His talk was very informative and sounded like Otis was the only way to go. Did anyone attend the AAOS annual meeting recently in SF and if so do you hear any new reviews from surgeons using the method?

What happens if the femoral component is too large ... or too small? Is a revision necessary?

I have been reading the pros and cons of the OtisMed Custom Fit TKR on this site before during and after my bilateral OtisMed replacement with a Stryker Titanium X3 prosthesis on March 27th almost 9 weeks ago. I went into the operation with eyes wide open about how new the method is. My surgeon with 17 years experience had just started using the blocks in November.

I could not be happier that the method was available to me. I have 140 degrees flexion in my right leg and -1extension while my left is 132 flexion with 0 extension.

The big thing to me is that for three years every day I was a little worse as my knees worked their way to bone on bone and now every day I am a little better. Every day I have another story. My triumph two days ago was after launching my boat I got to the dock in my small rubber digney. I was sitting on the rubber floor of the digney and I had to get to an upright standing position so I could climb the dock ladder. After thinking about it and laughing I rolled over and pushed up onto one knee and then holding onto the ladder I stood up on the rubber raft floor. I was then able to climb up the ladder out of the digney onto the dock. I was just plain grateful and happy I actually did this.

Anyway, the bottom line is I get better every day. The pain is mostly from building new quad and hamstring muscles that I have not used in a long time. The stiffness is less and less as I continue to work with my Physical Therapist three times a week.

Do the other methods work as well as OtisMed? I don't know. But what I do know is that I have a new life at 61 and the OtisMed CFTKR was a contributing factor.

Any person who is not willing to sign their name to their response doesn't have anything worthy to say or be believed. It is clear that LawGuy and Joint Surgeon have an ax to grind. It is likely that they themselves have their own "commercial interests" that are being protected by their positions.

Ron Clark, M.D.
South Bend Clinic, IN

I was just wondering how current knee replacements were designed to work optimally? Do they function best when loaded in the mechanical axis or anatomic axis? Which would be preferred? What happens if they are loaded in varus or valgus? It would seem to me that the "custom fit knee" would be best suited with a an actual "custom fit" implant but that is not what happens currently correct? Are there design limitations in current knee replacements that would make them less than ideal for the Otis Med procedure. Why is a single radius of curvature preferred for Otis Med? I understand the two companies that are invoveld with Otis Med are Stryker and Biomet and only Stryker makes a single radius of curvature knee so why would somone use Biomet?

joint surgeon is a fraud. I can smell it, and I'm just a person looking for the best knee replacement. It's a "he" with a vested interest. If you are real, state your name. My name is carol ann dwyer 405-620-7020. caroldwyer@hughes.net