PIONEER NUBAC STUDY

[FGAMNB]

TWO WEEKS POST-OP. GOOD RESULTS SO FAR. I FEEL BETTER EVERY DAY AND HAVE LONGER MOMENTS OF BEING PAIN FREE.



DDD L5-S1

[sharman]

Hard to find much on this device thru google.

Looks like a nucleus replacement device is a mechnical ball-and-socket thingy, rather than a gel or poly thingy--yes?

Was this a clinical trial? Was it in conjunction with a discectomy, or just as a treatment for back pain? Is (was) your pain back or leg pain?

And best of luck! we're all rooting for you. Let us know how things progress.

[Harrison]

I posted a release from Pioneer on Christmas day, but we’ve not heard much from anyone on this technology. See the post:

http://adrsupport.org/eve/forums/a/tpc/f/7901036081/m/8...401028322#8401028322

Before that release, there’s another one:

Pioneer Surgical Technology Begins NUBAC Intradiscal Arthroplasty(TM) System U.S. Clinical Trials for Patients With Degenerative Disc Disease
Aug 1 2006

http://www.genengnews.com/news/bnitem.aspx?name=4031272

Here’s their website:

http://www.pioneersurgical.com/main.htm

PJS, can you tell us a bit more about the trial, your spine, the procedure when you can? Thanks.

[sharman]

Ok, now I'm annoyed.

1) I still can't figure out what the darn thing is. It's less invasive than ADR, leaves the annulus in place and consists of "articulating PEEK-on-PEEK material." It's some kind of nucleus replacement that's mechanical, rather than gel/spongey? Is it?

2) This is a recurring pet peeve. How comforting is it, when most of what you kind out about a new spine device is from press releases issued by the company marketing the device? When you know more about the company's latest private placement or mezzanine financing, than about whether this thing is likely to fix you?

3) IT'S NOT EVEN ON THE COMPANY'S FREAKING WEBSITE.

4) That is the most annoying website I've ever tried to navigate.

Ok, that's all.

[FGAMNB]

I was one of 20 patients to have the device implanted. It is part of a investigational study to see if the FDA will OK the device for use.
The device consist of top and bottom plate with a ball snd socket joint made of PEEK plastic. It is a nucleus replacement device and is mechanical rather than a gel or similar device on the market now.

A discectomy was performed and then the device was placed into the space where the disc was. Annulus was left intact as this is what holds the device in place. All this was performed next to my belly button about eight inches long.
I was in the hospital for 4 days, up and walking the next evening. Getting out of bed was the hardest thing that I did during this time. Later was asked by a nurse why I wasn't given a brace. Most of the pain was from the muscles being cut in my belly. After a week of pain from getting up and down from laying down, at home I started wearing a brace to support my stomach and was relieved to discover this reduce my pain to almost nothing. I have been walking a geat deal every day, up to 2 miles. Range of motion is better than before surgery and have not felt this good in years.
Before surgery I had pain in the lower back into my buttocks and down my right leg. After talking with 2 orthtopods and a neuro, all told that I had DDD at L5-S1 and early signs at the next three. I had the standard work up before this, MRI, discogram, x-rays, and lots of pain meds. Orthopods wanted to do the usual fusion, but was woried about the effects up my spine. ADR was offered but I knew that insurance paying would be a fight. Neuro offer the NUBAC, said that it is least invasive of the three and could be reversed if it failed. I am in medical sales so a had this done with one eye open the whole time.
I never saw the device , just pics and x-rays from other patients. Not much info on the companies web page or anywhere else except investment news on the web.
I have been hopeful of the early relieved I had so far, I am three weeks postop and almost pain free. Don't know how long this will work, but will keep my fingers crossed.

[LBP]

Does anyone know,....is this IDE trial limited to one level too?

[FGAMNB]

At this time it was just one level, I think study is closed at least with my doc.
First day back at work, 6 hrs in a car, six hours standing around in the OR trying to make a neuro doc happy. Kept waiting on the back pain to kick in. Was a little sore at the end of the day, but not as bad as I expected.

[FGAMNB]

Update on 6 week post op. Better than expected results so far. Pain is almost gone. Just starting a rehab program for core and back conditioning. X-rays show implant is just where it needs to be. Heard that trials for Nubac and ADR are to start this summer, random on which device you get.

[ZorroSF]

[dahmers]

im two weeks post-op on the next study for the nubac....this study you either get the nubac or pro...i got the nubac they went in through the side around the love handle area if got them....doc says it went great my back is still week and the incision is very sore and bruised...started weinnninig off the pain meds today the surgery was no walk in the park but i don't think there is a back surgery out there that is so good luck to anyone who takes the leap.....mine was done in Marquette Mighigan at MGH.....L4/L5