FDA approves implantable total ankle replacement

Medgadget reports that the FDA approved Small Bone Innovations' implantable ankle.

This implantable total ankle replacement system is intended for use in patients where there is severe arthritis or other deformities that hinder the range of motion of the joint.

Small Bone Innovations claims that this design of the STAR system is the first of its kind because it relies on movable bearings that glide across the surface of polyethylene. The advantage is that this still affords some joint movement as opposed to traditional fusion surgeries that join the tibia to the talus bone for additional strength but severely limit motion.

FDA approves implantable total ankle replacement

[TroofSeeker June 1, 2009 10:11 AM]

Good morning, Mark.
My ankles are fine, but I never saw any results from the Haiku contest. Who and what won?

[Brainspore June 1, 2009 10:12 AM]

One step closer to Weapon X! (Or does this count as two steps?)

[Takuan June 1, 2009 10:35 AM]

hmmmmph.. I had always thought that by this time the lame would be thrown into the protein vats.

[Agit June 1, 2009 1:01 PM]

hopefully this means I won't ever have to have my bad ankle fused!!!

YAY!!! Thanks FDA!

[GustasusSimilisPullus June 1, 2009 1:42 PM]

I just wanted to add this:

"A company announcement said that the STAR system has more than 19 years of clinical experience and the current design has been implanted in over 15,200 patients worldwide. Additionally, there have been 35 peer-reviewed clinical outcomes papers published on STAR. SBi believes that this number of papers is more than any other mobile-bearing total ankle arthroplasty device."

In other words - this is old technology!

Thanks for making it take so long FDA!

[GustasusSimilisPullus June 1, 2009 1:51 PM]

Quote from article on this at Orthpedics This Week:
http://ryortho.com/index.html

"Now Americans can get access to the same motion preservation technology that patients around the world have been getting for years."

Great!

Wait!

Huh?

[agoodsandwich June 1, 2009 4:20 PM]

Gust's posts (#5 & #6) make me wonder whether there are medical advancements that have not been approved in the USA that seemed good at first but in practice turned out disastrous. Presumably, there must be some advantages to a slow-moving system like the FDA.

[Teresa R June 1, 2009 6:11 PM]

Previous total ankle arthroplasty prostheses have had catastrophic failures. It's a lot of weight on a very small weight bearing surface.

I'm really hopeful that this one works out. But I guarantee you that none of the doctors that I work for will do them for at least five years after they've been in the field. And I can think of three patients off of the top of my head that would benefit from a total ankle. One of which we saw today.

[lesliedotcom June 2, 2009 6:41 AM]

I work for a major medical institution that participated in the trials for the STAR ankle-- we've been implanting them for 5 years. Amazing stuff...

[GustasusSimilisPullus June 2, 2009 11:05 AM]

Gust's posts (#5 & #6) make me wonder whether there are medical advancements that have not been approved in the USA that seemed good at first but in practice turned out disastrous. Presumably, there must be some advantages to a slow-moving system like the FDA.

===

The opposite - check out the spinal artifical disc fiasco.....

They had been around in Europe for close to 20 years when the first one got approved in the US. That product was sold to J&J for hundreds of millions of dollors, so all of J&J's competitors had to have one too. Billions of dollars have been spent on artificial discs...

Guess what? In Europe they hardly use them.

[Halloween Jack June 2, 2009 11:49 AM]

Bah. I'm still waiting for my kung-fu grip.

[Anonymous July 22, 2009 7:00 AM]

I had a TAR last March 2008. Since then, I have undergone three more successive surgeries - for removing scar tissue, bone, and finally - just this past April, for taking out and replacing the Talus piece.

Has anyone ever heard of so many surgeries and complications from this surgery?

Thanks

[cross July 22, 2009 4:17 PM]

can anyone recommend a awesome ankle replacement doctor on the west coast?

[Anonymous August 10, 2009 1:41 PM]

Yes Dr. Smith in long beach

[Anonymous October 18, 2009 8:00 PM]

Eric Horton, MD
Foot and Ankle
5555 Reservoir Drive
Suite 104
San Diego CA 92120
[phone]

I'm 1 month post-op w/ the new STAR replacement. Dr. Horton is amazing.

[sculptr replied to comment from Anonymous October 22, 2009 6:42 AM]

Just curious, as I am getting ready for a TAR - what system did they use? My surgeon is using the InBone system as I have a bone disease that causes low blood supply to the bone.