Wallis vs ADR trial

LBP · #1 02-15-2007, 11:53 PM

I just got wind that the Wallis device is being tested against Charite and Prodisc. Then I read that Wallis is a one AND TWO level trial. Fist 2 level trial since prodisc. Has anyone seriously checked into this, been a part of this trial, or know anyone with Wallis system implanted?

There was some previous mention of Wallis on this site but I couldn't find anyone stating they actually had one implanted.

Alastair · #2 02-16-2007, 02:59 AM

Wallis is a stabilising system, there are links to this in the FAQs as usual.

This has been done at the AlphaKlinik for the last couple of years, it is hoped to replace fusions with Wallis in some instances. It does not increase disk space as does Dynasys. I Have not seen any reference to it in the USA or the UK as yet.
best,
Alastair

LBP · #3 02-16-2007, 08:05 AM

Yeah when I did a "find" for wallis here I notice your last comment that you didn't know anyone with it implanted yet.

I'm interested in entering the study if there's a good chance I can get a 2 level prodisc as the "control" part of the study...just wanted to know if anyone has a wallis in case I should get that product if in the study.

I'm not sure I have a disc space problem. I am under the impression my pain is from the fluid leaking from the disc. I just don't know if Wallis is good for people with annular tear problems.

Harrison · #4 02-16-2007, 08:10 AM

LBP, I believe the study is closed (see Cutting Edge, clinical trials topic). But you can contact the company to doublecheck:

http://us.abbottspine.com/

Good luck, please let us know if the trials are still going on outside the U.S.

LBP · #5 02-16-2007, 10:29 AM

Harrison,

I am at a deadend. My old surgeon's office in San Diego area said they are just starting a Wallis trial against prodisc and charite.

I don't understand it. I look at spine-health.com and it says they had a 1 and 2 level trial but it's no longer enrolling new patients.

When I ask the research contact at the surgeon's office, he offers no explanation just says they have a one level wallis trial and that's it. ARGHHHHH

This is reminiscient of back when prodisc was closed but somehow some people were still getting in but I was not making any progress with my dr's office

ZorroSF · #6 02-17-2007, 04:37 PM

As I recall, people were still being admitted into those trials because the products had not cleared FDA approval yet, but the data was finished being collected and had already been sent to the FDA. Trial surgeons were allowed to proceed with surgeries as long as they had the manufacturer's approval.

I could be wrong, but that's what I've witnessed here in san francisco

LBP · #7 08-05-2007, 03:31 PM

Harrison, I don't understand your latest "update" re Wallis clinical trials. see my old questions in Feb! http://adrsupport.org/eve/forums/a/tpc/f/7701036081/m/1...371016332#1371016332

I just emailed the company again today... what information do you have about trials in WI? Do you know what office/dr?

Harrison · #8 08-06-2007, 05:23 PM

LBP, I talked to a patient (Rena) who provided the information last week; I'll ask her to email or post with the details...she lives in Wisconsin and gave me the scoop (which surprised me a bit).

LBP · #9 08-06-2007, 06:01 PM

Thanks Harrison. I'd love to hear from someone with info in WI!

RNmommy · #10 08-07-2007, 08:01 AM

This is Rnea, wife of Jim. Working with surgeon here in Liwaukee to obtain insurance coverage for Pro-Disc. Ineffective results at this time with that route. I am constantly searching for trials as going to Europe is not currently an option for us. I found a Wallis trial on line. It said the site in Illinois is taking participants. I emailed the adress and asked if they would be adding any sites in Wisconsin.The resposne was yes, in Green Bay. The site in Green Bay is in the approval for participation stages. It should be reveiweing potential participants by the beginning of September. I have been in touch with the nurse in the prorgam, and all this is definitely in progress. We have not received further information at this time, but were told not to expect anything further until the end of August at the earliest. I emailed this gentleman for information, Jose Naviera at jose.naveira@abbottspine.com. I originally found the trial at this site: http://www.spine-health.com/research...is/wallis.html. The inclusion/exclusion information is there also. At this time, we are still just waiting for initiation of the site. I will try to update when we hear more. Hope this helps others.
Rena
wife of Jim, Herniated L4L5 April 2006
Ineffective epidural injections in 2006 x3
Ineffective physical/hydro therapy x 1 month 2006
Surgeon wants to do fusion, but says ADR ok too
Insurance won't cover ADR
we can't do Europe at this time - so here we sit