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.

Mark Frauenfelder is the founder of Boing Boing and the editor-in-chief of MAKE and Cool Tools. Twitter: @frauenfelder. Come and hear Mark speak at the ALA conference in Chicago on July 1.

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Teresa R

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.
GustasusSimilisPullus

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.
Agit

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

YAY!!! Thanks FDA!
Halloween Jack

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

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…
- Anonymous
  
  Leslie, I am looking for the most experienced doctors who have been doing the STAR implants for a while now and are not just learning the proceedure. I need to have a total ankle replacement and am willing to travel for the most experienced surgeons. Can you help me?
GustasusSimilisPullus

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!
Anonymous

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
- sculptr
  
  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.
GustasusSimilisPullus

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?
TroofSeeker

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

One step closer to Weapon X! (Or does this count as two steps?)
lask48180

Hello to everyone. I am 29 and was in a motorcycle accident 3 years ago, Both of my feet and ankles were messed up real bad.I had my left ankle fused last year and now they want to do the right one. I want to try the star. what kind of recovery time does this take? how long are they sopposed to last in you? could I also have it done on my left ankle sence it has alreadt been fused? I live in detroit michigan, does anyone know a doctor? thanks for your time.
- Anonymous
  
  Lask48180 – Once your ankle is fused, you can not have a replacement. Whether your other ankle is a candidate or not will largely depend on a) how intact the bone structure is 2) how strong your tendons and ligaments are. Recovery is very hard on the tendons and ligaments and if they are not strong enough to see you through recuperation and rebuilding of strenght, then you may not be able to do it. I am 4 months post surgery and I’m walking better than I have in years, and I just got the ok to start back to biking, etc. I still have a road ahead of me building my muscles back (atrophy from the cast/boot afger surgery) but I’m excited to be able to do the things I have avoided for the past few years -without the problems and lack of sleep from the pain of arthritis. I’m only 44…maybe now I can get back to feeling 44!!!
cross

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

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

dear members,
would you please share your experinece of tar .
are they any successfull
any loosening occur as in the near past
and what hospital doktor would you suggest in germany
or in istanbul.
regards
Anonymous

You can obtain a list of qualified surgeons in your area by contacting SBI in PA. They supply the replacement for the surgeons. mgoodwin@totalsmallbone,com
Anonymous

Eric Horton, MD
Foot and Ankle
5555 Reservoir Drive
Suite 104
San Diego CA 92120
(619) 286-9480

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

Yes Dr. Smith in long beach
agoodsandwich

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.
bikeandski

I am 7 months post op from a TAR I had a Wrights Inbone prosthesis put in by Dr. Lian in Sacramento CA. I am hiking bike riding and windsurfing. I have just a little soreness and am very thankful to have my life back.