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Spinal Roundtable Discuss Coflex Confusion (concerns???) in the General Discussion forums; I recently had a consultation with my local Orthapaedic Surgion (highly respected spine surgeon). I'm waiting for the written report, ...

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Old 01-21-2011, 04:04 AM
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Default Coflex Confusion (concerns???)

I recently had a consultation with my local Orthapaedic Surgion (highly respected spine surgeon). I'm waiting for the written report, but his recommendation was for decompression (i.e. remove some bone to relieve pressure on the nerves) and dual level Coflex-f implants (interspinous stabilization devices that go in between the spinous processes) at L4-L5 and L5-S1.

Anticipating comments about Coflex not being FDA approved, I was told that it just got approved though I couldn't find any documentation online confirming this.

My doctors recommendation is due to the fact that he believes that my symptoms are primarily caused by the spinal stenosis and not the problems I'm having with my discs.

I don't have a question about spinal stenosis being a problem, but I also have DDD at L4 through S1 with significant disc narrow at L4-L5. I can't help but think that this contributes to the stenosis and pressure on the nerves.

I asked about my disc problems and ADR, but he recommended against this and said that the disc narrowing would be improved by the Coflex implants and that ADR could allow for to much increased range of motion and could aggrevate my problems.

I tried to find online information on the Coflex-f implants but there doesn't seem to be much information online. I also investigated some other Interspinous stabilization devices (Aspen/Lanx, Octave/lifeSpine, Affix/Nuvasive), but didn't find much that addressed my questions and concerns.

The information that I could find indicated that this device is "intended for use with an interbody cage as an adjunct to fusion at a single level" (from Paradigm Spines literature and their 510(k) report). My doctor is not recommending an interbody coge/fusion.

My questions and concerns follow:

1. Does any know where to find more information about Coflex-f?

2. I'm concerned that my doctor is planning on using the Coflex standalone (i.e. no interbody cage / fusion) contrary to the literature that I've seen.

3. I'm concerned about is recommendation for dual level implants again contrary to the literature that I've seen.

4. I'm concerned about the idea that the 2 Coflex implants would support the spine from the back (support is at the spinal processes) instead of under the vertebral body where it normally occurs, and the possible implications that this would have on future spine health...

5. I've previously had a Laminotomy at L4 (I thought it was a Laminectomy). My doctor looked at my Xrays and thinks that this won't cause any problems with the implant at L4-L5.

My doctors credentials are stellar and from what I've been able to find out, he is probably among the very top spine surgeons in the country. Regardless of this, I can't say that I'm comfortable with his recommendations at this point in time.

I'd appreciate any educated opinions that this Forum may be able to offer!
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1984 - Herniation/Annular tear @ L4-L5
1994 - Discectomy @ L4-L5 / Laminectomy @ L4
2010 - Herniation/Annular tear @ L5-S1
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Old 01-21-2011, 12:02 PM
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Hi Colorado,

I searched and found 8 other coflex-related topics. Therein, there are some that may address a few of your concerns. You can PM some of the Coflex patients too; let me know if you don't hear back from them...
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Old 01-21-2011, 03:30 PM
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Ran across this Coflex clinical trial:
Clinical Trials
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Joey Sue - 46 years old
9/28/2011: Hybrid STALIF TT interbody fusion at L5-S1 and M6-L ADR L4-5 with Nick Boeree, UK - forever grateful to you Nick!
Prior to the fix: Severe DDD L4-5 and L5-S1 with moderate facet degen at L5-S1, but only mild facet degeneration at L4-5.
Still lurking: L3-4 Small annular tear and mild DDD, L2-3 mild DDD. Cervical discs a bit of a mess too, but no symptoms in any of these areas.
http://healthyback2011.blogspot.com/
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Old 01-22-2011, 04:31 AM
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Hi Harrison,

I had already searched and found these older threads, but hadn't thought to PM anyone. From what I can tell, only one person had actual experience with the Coflex and I'm trying to contact them now.
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1984 - Herniation/Annular tear @ L4-L5
1994 - Discectomy @ L4-L5 / Laminectomy @ L4
2010 - Herniation/Annular tear @ L5-S1
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Old 01-22-2011, 04:35 AM
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Jstuckey - Thanks for the pointer to the clincal trial. I had seen information like this, and it is this information that is fueling my questions.

The problem remains that I have questions, not answers.
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1984 - Herniation/Annular tear @ L4-L5
1994 - Discectomy @ L4-L5 / Laminectomy @ L4
2010 - Herniation/Annular tear @ L5-S1
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Old 01-28-2011, 04:08 AM
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I'm not having much luck with my research on Coflex though I'm beginning to think that I must be misinterpreting the literature that makes me think that this is used in addition to a fusion...

Of course I have a new concern about using the Coflex at L5-S1 because this level wasn't part of the trial.

Finally, I also looked at the X-Stop and it looks like it would be able to be implanted with less trauma to the interspinous ligaments. It isn't clear to me how much of an advantage this is.

I'm thinking that at this point my best option is for a second and/or third opinion...
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1984 - Herniation/Annular tear @ L4-L5
1994 - Discectomy @ L4-L5 / Laminectomy @ L4
2010 - Herniation/Annular tear @ L5-S1
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Old 01-28-2011, 01:51 PM
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Yes, more opinions will bring more information, options, and probably questions too!
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Joey Sue - 46 years old
9/28/2011: Hybrid STALIF TT interbody fusion at L5-S1 and M6-L ADR L4-5 with Nick Boeree, UK - forever grateful to you Nick!
Prior to the fix: Severe DDD L4-5 and L5-S1 with moderate facet degen at L5-S1, but only mild facet degeneration at L4-5.
Still lurking: L3-4 Small annular tear and mild DDD, L2-3 mild DDD. Cervical discs a bit of a mess too, but no symptoms in any of these areas.
http://healthyback2011.blogspot.com/
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Old 01-29-2011, 04:11 AM
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Quote:
Originally Posted by Jstuckey View Post
Yes, more opinions will bring more information, options, and probably questions too!
Hi Joey Sue,

As I'm learning more about my condition, I'm beginning to understand the terminology and anatomy a little better and I've noticed some similarities between your and my problems. Though you seem to be worse off, I think I'm heading down a very similar path with the same 2 problem discs (L4-S1), the same 3rd disc that's showing degeneration (L3-4 bulging), and foraminal stenosis which sounds similar to foramen narrowing (possibly worse in my case?).

I'm hoping that you have some insight into a question that I have based on the research and consultations that you've done for your problems.

My question is, have you discussed with your physicians anything about any relationship between loss of disc height, ADR, and Foramenal narrowing or Stenosis?

I did read your blog (healthyback2011.blogspot.com) and the plans that you mention seem to address your disc issues, but don't directly address the foramen narrowing or facet degneration.

The reason that I'm asking is that my doctor (here in the US) is suggesting attacking my problems from the back of the spine by doing a decompression, and using the Coflex device between my spinous processes. While this will probably relieve my pain, the disc issues will remain and probably continue to worsen (why wouldn't they?).

The questions that I really want answered are:

1. Is the procedure that my doctor is recommending only a band-aid?

2. Is he recommending this procedure because it is all that we can do here in the US while better options exist internationally?

3. Would ADR not only address my disc problems but also improve the Foramenal stenosis?

I know that you can't answer these questions, but I'd be interested in what you may have been told about any relationship between loss of disc height, ADR, and Foramenal narrowing or Stenosis.

I wasn't able to ask my doctor about these and other questions when I originally visited him (I didn't know what questions to ask at that time). I am planning on another visit and a 2nd opinion, but I'm trying to be as prepared as possible so that I know what questions to ask.

Thanks for your interest in my posts, and here's to hoping that you finally get the healthy back that you want and deserve in 2011!

Paul
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1984 - Herniation/Annular tear @ L4-L5
1994 - Discectomy @ L4-L5 / Laminectomy @ L4
2010 - Herniation/Annular tear @ L5-S1
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Old 01-29-2011, 09:05 AM
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Good morning. Sorry to see you're awake at 3am. That's my time of non-sleep too!
I don't recall a conversation specific to ADR and foraminal stenosis, but I would think it would be logical to assume that restoring disc height is one of the main reasons for ADR in our case - to create a normal space in the area where nerves exit. I think my/your problems are not the same as recent injured/torn/bulging discs that still have normal disc height. Those types of problems (and I'm not a doctor, but just make assumptions here) cause nerve pressure from a similar problem: the physical structures aren't where they belong. However, when your disc height is deteriorated, you have the added problem of structures rubbing on each other ("chronic appearing endplates", facet degeneration) and your body trying to heal those areas (osteophytes) causing even more structural space issues in addition to the disc height loss. So I make the leap that the surgeon believes restoring the disc height reduces pressure not only on the nerves trying to pass through the foramen, but also reduces/stops the irritation causing the formation of the extra crap I'm growing trying to heal myself.
I was directed mutliple times to read the contraindications to ADR on this site, and that being my biggest concern, asked Nick Boeree extensively about those issues (scoliosis and facet degeneration). He did say that ADR will relieve pressure on the facets. And regarding scoliosis, mine was mild and not rotated, so he was not at all concerned with ADR for me.
I really never asked my US surgeon much of anything, as I didn't have the knowledge at the time a few months ago, and the longer this goes on, I'm not so sure he does either. Yes, the FDA limits in the US are not only a source of limitiation in what is recommended, but what your surgeon's knowledge. You can't be an expert in something your not able to practice.
Sorry I can't comment on coflex at all, so not sure about the "band-aide". With just about any spinal procedure though, I think they all have some long-term limitations or unknowns. I just know the deteriorating disc is not going to improve on it's own, so I'm thinking I'll try what seems the most promising.
I would highly recommend sending your medical reports overseas, even if you don't plan to have surgery there. Although a bit of a pain to assemble them all (I took them to Staples to have them put on a CD and copied several CDs), it was simple to acquire the addresses, pop them in an envelope with a detailed letter of your history and symptoms ($12 to maill them to 4 locations), and wait for the emails from the surgeons. They will answer your questions for free (although I found the emails somewhat brief, you can continue to push for more details). The fee for Nick Boeree's consultation was very much worth the money, and I was very pleased with his attitude, time spent with me, and ability to speak to me in understandable terms.

Happy to continue to try to help. Everyone's help online is how I've moved forward myself.
__________________
Joey Sue - 46 years old
9/28/2011: Hybrid STALIF TT interbody fusion at L5-S1 and M6-L ADR L4-5 with Nick Boeree, UK - forever grateful to you Nick!
Prior to the fix: Severe DDD L4-5 and L5-S1 with moderate facet degen at L5-S1, but only mild facet degeneration at L4-5.
Still lurking: L3-4 Small annular tear and mild DDD, L2-3 mild DDD. Cervical discs a bit of a mess too, but no symptoms in any of these areas.
http://healthyback2011.blogspot.com/
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Old 01-29-2011, 02:37 PM
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Hi Joey Sue,

As I'm sure you know, sleep can be a problem, but it was only 1am in Colorado...

FYI, I do have normal disc height at L3-L4, and near normal at L5-S1. L4-L5 is a different matter with only about 4mm of disc height left.
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1984 - Herniation/Annular tear @ L4-L5
1994 - Discectomy @ L4-L5 / Laminectomy @ L4
2010 - Herniation/Annular tear @ L5-S1
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