Activ L Trial Question

[mmglobal]

Am I imagining things or was this thread moved from Arthroplasty Central to the Big Bucket?

[letteski]

I needed the search tool to find threads I was reading this AM, your not mistaken Mark. I guess the FDA nature takes the cake over new technology.

Thanks for finding out more info on the Activ-L Study. Does anyone know the configuation of the prong/spike endplate? From what David said he was looking at March to be in the study. Dr D has said to me several times �that they don�t have to have a meeting�, I thought this was wired but maybe this is like the question posted by Maria- 510k approval process.

As all these post have ended up in the Big Bucket. I am beginning to see some similarity here.

BLW great discussion on revision, something I hope and pray I will never have to face especially with a ProDisc. I was under the impression that fusion took place over the top of the ProDisc because of the difficulties getting out the endplates. But how is the bone going to grow together if the medal end plates are in the way.

[Ann F]

Mark,
According to Dr Yue, they expect the pro disk to be approved Feb 2006 and Activ-L trials will start 90 days later. I'm interested in this thread since I have elected to be a candidate. May won't work for me with my job so I'm hoping I can put off my surgery until September, as long as my back can hang in...

Ann F

[mmglobal]

Ann... Dr. Yue doesn't have a better crystal ball than anyone else... what is expected may happen, but????

Paulette... you are correct... often, revisions of ADR's are posterior instrumentation, leaving ADR in place as a fancy 'interbody spacer'.

I hope we get an answer about location of this thread. This is a very important question... was this thread about an arthroplasty device clinical trial moderated off the arthroplasty forum, or is there a technical problem?

Mark

[Justin]

The Big Bucket
All issues not easily categorized in the above forums are here. Comments on insurance, FDA trials, general health, diet, "getting comfortable," and more are here. If you are new, please introduce yourself here!

The title of this thread is: Activ L Trial Question.

Seems to be in the right place to me...the "meat" of the thread is a lot more interesting than its location.

Mike, I would contact Dr. Yue directly, as he is the Principle Investigator on the study and would know the exact details better than our second-hand knowledge here. Thanks Ann F for your help with the possible date for ProDisc approval!

James, J. Yue, M.D.
Yale University
Department of
Orthopaedic Surgery
800 Howard Avenue
New Haven, CT
203-737-5656

Please contact (203) 737-5662 for more information on all clinical and research inquiries.

Justin

[mmglobal]

Arthroplasty Central is for: "Discussion, news and insights that focus specifically on artificial disc replacement and next generation technologies..."

The Big Bucket is for: "All issues not easily categorized in the above forums."

This thread is all about arthroplasty. Yes, the meat of the thread is especially interesting. That is why it is especially frustrating to have to search for a thread about arthroplasty when it disappears from the arthroplasty forum.

Just my humble opinion....

Mark

[Harrison]

Thanks Justin for saving me the time. In the meantime, sorry to waste most peoples� time, but I need to remind members of the guidelines here:

http://www.adrsupport.org/private-cg...b=agree_review

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[letteski]

This has been a very good and informative discussion, (one of the best in a while). We are very fortunate to have members here that are willing to tackle, discuss and bring information to the patient community on difficult issues that we may not want to admit, face or discuss.

Thank you for reminding us what the back of our ADR-Support Lift Ticket says: USE AT YOUR OWN RISK I have and I am very pleased and satisfied with the outcome.

I look forward to more informative discussions here in the future.