FDA tells OTISMED to stop providing t...

FDA tells OTISMED to stop providing the Custom Fit Knee

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Joint surgeon

Newtown Square, PA

#1 Sep 27, 2009
I heard that the FDA asked Otismed to stop manufacturing the Custom Fit Knee until a higher level of approval is attained.

Also, many new papers in the literature showing the importance of the mechanical axis to TKA function and survival.

Hate to say I told you so.
Janice

United States

#2 Sep 29, 2009
I was scheduled for an Otis knee replacement next week. Can either have the surgery using the older method or wait for FDA approval. I only have pain walking uphill so it is not urgent. Any advice?
Joint surgeon wrote:
I heard that the FDA asked Otismed to stop manufacturing the Custom Fit Knee until a higher level of approval is attained.
Also, many new papers in the literature showing the importance of the mechanical axis to TKA function and survival.
Hate to say I told you so.
NY RN

Schenectady, NY

#3 Sep 29, 2009
Here's some advice: The person who started this topic is no more a "joint surgeon" than I am The Pope.

A "joint smoker" maybe? Hahahhaaaa!

Obviously he/she has some kind of investment in a competitor's product.

I'd personally wait for OtisMed. If you aren't sure, ask your surgeon for a referral and talk to other patients who've had it done. That will tell you what you need to know.
bignee

Mesa, AZ

#4 Sep 29, 2009
joint surgeon
give us your sources (new papers) and websites to support your post info. you do your fellow man no service with gross generalizations.
Janice

United States

#5 Sep 29, 2009
Thank you NY RN, I have a very experienced surgeon (Dr. Stephen Howell, Sacramento), who has done both Otis and traditional replacements. He will use my mri but not the actual cutting guides. Have good post-op reports as well as some from people in the OR, so I am ready to go--Janice
NY RN wrote:
Here's some advice: The person who started this topic is no more a "joint surgeon" than I am The Pope.
A "joint smoker" maybe? Hahahhaaaa!
Obviously he/she has some kind of investment in a competitor's product.
I'd personally wait for OtisMed. If you aren't sure, ask your surgeon for a referral and talk to other patients who've had it done. That will tell you what you need to know.
bignee

Ashburn, VA

#6 Sep 30, 2009
Janice. Why is he not using the guides?
Janice

United States

#7 Sep 30, 2009
He's not using the guides because of the FDA's position that Otisknee's cutting guides are a class 2 device so they need FDA approval of their "marketing plan." FDA said yesterday that they hope to have a decision in about 90 days.
bignee wrote:
Janice. Why is he not using the guides?
bignee

Phoenix, AZ

#8 Sep 30, 2009
Janice wrote:
He's not using the guides because of the FDA's position that Otisknee's cutting guides are a class 2 device so they need FDA approval of their "marketing plan." FDA said yesterday that they hope to have a decision in about 90 days.
<quoted text>
Thanks Janice. I have been considering Dr.Howell for my TKR's so will be very interested in your experience with him. Best to you.
NC man

United States

#9 Sep 30, 2009
July issue of journal of arthroplasty..2 papers..the mechanical alignment is important.

Ritters review of his database of knees.....knees that are not within 3 degrees of mechanical alignment have a much higher risk of failure...

Guess what...the custom fit knee ignores mechanical alignment...the story is getting more interesting...the more data that comes out, the more it looks like otismed may be dangerous.

I bet the FDA makes OtisMed remove most of its claims...since they are unfounded.
bignee

Glendale, AZ

#10 Sep 30, 2009
NC man wrote:
July issue of journal of arthroplasty..2 papers..the mechanical alignment is important.
Ritters review of his database of knees.....knees that are not within 3 degrees of mechanical alignment have a much higher risk of failure...
Guess what...the custom fit knee ignores mechanical alignment...the story is getting more interesting...the more data that comes out, the more it looks like otismed may be dangerous.
I bet the FDA makes OtisMed remove most of its claims...since they are unfounded.
It would be beneficial if you cited the title and author of the studies you are referring. Particularly as there apparently is not a July issue of the Journal of Arthoplasty.

Recent work suggests that a 0 mechanical axis does not need to be restored because reproducing a 0 mechanical axis did not improve the 15-year survivorship (Parratte S, Trousdale R, Berry DJ, et al. Reproducing the mechanical axis did not improve the 15-year survival of 398 modern TKA. In: American Association of Hip and Knee Surgeons Fall Meeting. 2007;Dallas (Tex).

and because changing the alignment of the leg to 0 mechanical axis malaligns 98% of knees (3Eckhoff DG, Bach JM, Spitzer VM, et al. Three-dimensional mechanics, kinematics, and morphology of the knee viewed in virtual reality. J Bone Joint Surg Am. 2005;87(Suppl 2):71.

Which claims are unfounded?
North

United States

#11 Oct 1, 2009
Bignee,

The Berry paper was on only 399 knees. Thats not big enough for an outcome study. Look at Merrill Ritters paper on 5000 knees that just came out. The outliers (more than 3 degrees from the mechanical axis) had a much higher failure rate.

Notice that OtisMed took the "find a surgeon" section off its site...I wouldn't want to be embarrassed by being on that list either.
North

United States

#12 Oct 1, 2009
What a giant joke. Surgeons who used to use custom fit knees are telling their patients that its OK...they'll still use the MRI and kinematic concepts without the custom cutting blocks. What a giant joke, then why ever spend all that money on the Otismed technology. The surgeons need to get their story straight. They advertise all of these unfounded advantages of the Otismed knee. If they really believed in these advantages, then they would ask their patients to wait for it to be available again. I guess the technology is not that much of an advance hugh? The sad thing is that the surgeons using the Otismed technology are generally the surgeons who where not really known as good knee surgeons before advertising of the Otismed spread their name. If my surgeon was using the Otismed and the FDA yanked it...I would go to another surgeon.
North

United States

#13 Oct 1, 2009
I almost guarantee that the FDA is going to make Otis med completely change its marketing claims. They are clearly misleading and unfounded. The entire Otismed philosophy is based on a few, small papers that were not even done very well. On the other hand, there are a lot of newer better studies contradicting Otismeds underlying claims.
Titianlady

AOL

#14 Oct 2, 2009
North wrote:
What a giant joke. Surgeons who used to use custom fit knees are telling their patients that its OK...they'll still use the MRI and kinematic concepts without the custom cutting blocks. What a giant joke, then why ever spend all that money on the Otismed technology. The surgeons need to get their story straight. They advertise all of these unfounded advantages of the Otismed knee. If they really believed in these advantages, then they would ask their patients to wait for it to be available again. I guess the technology is not that much of an advance hugh? The sad thing is that the surgeons using the Otismed technology are generally the surgeons who where not really known as good knee surgeons before advertising of the Otismed spread their name. If my surgeon was using the Otismed and the FDA yanked it...I would go to another surgeon.
I'm sorry, but 95% of human beings DO NOT have natural 0 degree alignment. Almost every person has some degree of varus, or valgus anatomy.(Varus means slight bowl leg from the 0 degree, and valgus means some inward turning or knock knee from the 0 degree)This is especially true of women who tend towards the valgus alignment naturally.
It makes no sense to me to align everyone to a degree that goes against their natural skeletal structure! Too many people who have this "mechanical axis alignment" complain that the knee does not feel or move naturally compaired to their remaining good knee, and in some cases the rotation of the tibia to accomodate that alignment causes them problems.
ALL implants are designed to allow for some degree of difference in alignment from the 0.

“ Now....John 49”

Since: Aug 09

Location hidden

#15 Oct 3, 2009
Titianlady wrote:
<quoted text>
I'm sorry, but 95% of human beings DO NOT have natural 0 degree alignment. Almost every person has some degree of varus, or valgus anatomy.(Varus means slight bowl leg from the 0 degree, and valgus means some inward turning or knock knee from the 0 degree)This is especially true of women who tend towards the valgus alignment naturally.
It makes no sense to me to align everyone to a degree that goes against their natural skeletal structure! Too many people who have this "mechanical axis alignment" complain that the knee does not feel or move naturally compaired to their remaining good knee, and in some cases the rotation of the tibia to accomodate that alignment causes them problems.
ALL implants are designed to allow for some degree of difference in alignment from the 0.
Titian lady, you are too cool. So lets see, I was talking to my Dr. the other day about this. I really didn't have a lot of a bow to my legs to begin with. Now I didn't research a deeply as you have but to me if you give a person a 0 degree alignment how will that effect a person's hips and back after being adapted to working with the persons natural alignment?
Just curious.
Barbara

Raynham, MA

#16 Oct 4, 2009
I am worried about the knee taken off market..so isn't my surgeon who has a great reputation...
Titianlady

AOL

#17 Oct 6, 2009
North wrote:
What a giant joke. Surgeons who used to use custom fit knees are telling their patients that its OK...they'll still use the MRI and kinematic concepts without the custom cutting blocks. What a giant joke, then why ever spend all that money on the Otismed technology. The surgeons need to get their story straight. They advertise all of these unfounded advantages of the Otismed knee. If they really believed in these advantages, then they would ask their patients to wait for it to be available again. I guess the technology is not that much of an advance hugh? The sad thing is that the surgeons using the Otismed technology are generally the surgeons who where not really known as good knee surgeons before advertising of the Otismed spread their name. If my surgeon was using the Otismed and the FDA yanked it...I would go to another surgeon.
Surgeons don't ask their patients to wait because a great deal of them CAN'T wait or don't wish to wait. They also don't ask them to wait because they can fall back on the traditional surgery and still get a reasonable result.
The Otis cutting block guides make the surgery go quicker as the surgeon does not need to "eyeball the cut as he goes along". The Otis cutting guides take the guess work out of the cutting. A cutting guide can reduce the time of surgery from 78 to 90 minutes to as little as 45 minutes with more precise results! Also, the guides guarantee that the knee will be aligned properly without the need for the interarticular rod that is slid (or inserted with the use of a malet) into the femer bone to use as an alignment guide to make sure the leg is straight! The use of that rod in the femur is the reason there is risk of fat emboli breaking loose!! Ever wonder why knee replacement patients are given blood thinners prior and after traditional surgery?
With the use of the Otis cutting block guides there is less risk of fat emolism. Most of Dr Howell's patients are given 2 enteric coated asprin after the surgery for 28 days, NOT Coumadin, a prescription blood thinner with risks of its own.
Never the less, if someone needs surgery and cannot wait, Dr's will do the surgery without the guides as that is the way it has been done for years. Longer recouperation time is a small price to pay for some patients that are dealing with an unlivable degree of pain or disability because of their knee.
I personally will wait it out until the OtisMed guides are back in action
Titianlady

AOL

#18 Oct 6, 2009
John 48 wrote:
<quoted text>
Titian lady, you are too cool. So lets see, I was talking to my Dr. the other day about this. I really didn't have a lot of a bow to my legs to begin with. Now I didn't research a deeply as you have but to me if you give a person a 0 degree alignment how will that effect a person's hips and back after being adapted to working with the persons natural alignment?
Just curious.
John48, you are so right! That 0 degree mechanical axis alignment can cause lots of problems in people who are not genetically aligned that way naturally. In people that are valgus or varus naturally, they have to rotate the femur to get that 0 degree mechanical alignment, and it can cause pain, an unnatural tracking, and even fractures of the femur!
The ligaments have to be tensioned or released etc...
I may be in lots of discomfort right now because of my knee, but I will hang with it until I can get the surgical technique I know will be the best for me.. Otis Custom Fit

“ Now....John 49”

Since: Aug 09

Location hidden

#19 Oct 6, 2009
Titianlady wrote:
<quoted text>
John48, you are so right! That 0 degree mechanical axis alignment can cause lots of problems in people who are not genetically aligned that way naturally. In people that are valgus or varus naturally, they have to rotate the femur to get that 0 degree mechanical alignment, and it can cause pain, an unnatural tracking, and even fractures of the femur!
The ligaments have to be tensioned or released etc...
I may be in lots of discomfort right now because of my knee, but I will hang with it until I can get the surgical technique I know will be the best for me.. Otis Custom Fit
I'll wait until this time next year to get my right one replaced with the Otis procedure. Seems like a good time of year for it, no snow, ice or too cold and I won't loose my summer.
Ohio Ortho MD

United States

#20 Oct 7, 2009
Titan Lady,

with all due respect, you are not correct. Many knee surgeons, yes even those not using the Otismed, have started using aspirin after TKA. This has been in the literature for 20 years and had good data for working even before otismed. The use of aspirin has nothing to do with Otismed.

Most fellowship trained surgeons can do a knee in 45 minutes...yes without otismed.

There is also good recent data that the small rod up the femur does not cause emboli. This is now accepted by surgeons. There is no consequence of placing the intramedullary guide into the femur. This is an "old wives" take that has now been proven wrong by recent research. If you learn how to use pubmed, the database of peer-reviewed publications, you will find this information yourself.

You are way too swayed by your surgeon. I am sure he has good intentions, but the statements you are making are truly not accurate.

Titan lady. I am really a nice person and have nothing against Otismed. But reading your comments make me concerned that you have misinformation. Please educate yourself in an unbiased way, because to be honest, I am saddened by your misunderstanding of the facts.

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