Coflex?or X-Stop Spacer anybody?

[bellyrm]

Hello there beautiful people members of this comunity, I'm glad forums like this exist to be able to share ideas learn and inform ourselves of all this "spine, back ,things".

This is Arabella, 29 years old 5.5'' 125 lbs. good health always until 10 months ago that bend to pick up something from the floor and felt a terrible pain going from the lower back right side to the leg and foot.

I have a ruptured disc at level L5 S1. I have tried physical therapy epidural shots, nerve block shot and traction machine you name it! I have seen many doctors and the last one I spoke to mentioned the COFLEX interspinous spacer device to be the best solution to my problem. I can't walk and or sit longer than 5-10 minutes and lately there is not good position for sleeping either. My life is being affected in different ways. I am not longer active and my quality of life is getting worse with time...

1-Has anybody out there had the COFLEX procedure done?
2-Would you recommend the procedure? Is your pain and quality of life better than before the procedure?
3- Did you do it through clinical trial?
4- Is this device already approved to be use in the general public patients or is still in clinical trial in the USA?
5-Is the COFLEX similar to the XStop Implant?
6- Do you happen to know if the COFLEX device causes undue pain or complications can it be removed?
7- Is it advisable for level L5 S1?
8- Do you know what is the cost of the procedure?
9- Any website that you would recommend?

I thank you a lot for answering these questions.

Sincerely,
Arabella.

[CharlesinCharge]

Arabella,

This is what I found about the Coflex:

"The coflex(TM) device is a U-shaped titanium alloy surgical implant indicated for use in patients with moderate to severe spinal stenosis, with neural element compromise, resulting in claudication and/or radicular symptoms isolated to 1 or 2 levels, in the region of L1 to L5. It is currently classified in the U.S. as an investigational device only."

Clearly this new device is still in the testing stages and not FDA approved, so you would have to get into a clinical trial because your insurance would never pay for such a device. I can only speak for myself, but I am not sure I would want to be a "guinea pig" for such a new device.

Are you sure you have stenosis, and not Degenerative Disc Disease? Is there any reason why you could not have a minimally invasive fusion (like the XLIF) to cure your stenosis rather than an investigational device? I would ask you doctor why he recommends such a new procedure over some of the more time tested ones, and whether or not you can get into a clinical trial. Also bear in mind that usually when you get into a clinical trial they pay for the device, but YOU are still responsible for the surgery bills (hospital, surgeon, anesthesiology, etc.). With your insurance not paying, that could really add up.

Good luck,

[annapurna]

Did you ask why the doctor would recommend an interspinous device for DDD or herniated disk? It seems a little odd to jump to and interspinous device when you've mentioned disk problems with no apparent facet problem and onset of your symptoms recently enough that wouldn't expect a lot of facet problems to have developed.

To answer some of your questions, Coflex has been in regular use in Europe for at least a few years. I don't know for certain about the X-stop but I seem to remember that it came onto the scene there about the time that the Coflex was becoming more widely accepted so it's newer by something like a year or more if I remember correctly. One doctor recommended an interspinous device for Laura if her facets continued to hurt and did tell her the one he had in mind could be removed if the facet replacements came out but we hadn't pursued the question far enough to know if they could be removed without enough damage to require facet replacements.

I seem to remember that Coflex was originally not available for L5S1, though that might have changed.

[bellyrm]

Thanks for your responses ... I am comming to find out that Stenosis is a "symptom" worsening of DDD condition ... My other option will be to have an anterior fusion or ADR and as these are 2 major surgeries I am scared to death to try them so that is why I'm considering COFLEX but I am not still sure why is not recommended for level L5 S1 hope someone could answer this question ....
Thanks for reading and replying
friendly
Arabella.

[annapurna]

The back side of L5S1 is different than the back of the other lumbar joints. The sacrum, S1, doesn't have the same parts to hook the Coflex to so it wasn't originally offered for that level.

Stenosis isn't always a symptom of DDD. It is a common one but it is worthwhile making sure you have it if they are suggesting Coflex to treat stenosis. To me, it also seems like they are treating your stenosis while ignoring the cause of the stenosis. It's like they are suggesting you put wheels on your car jack and drive around on it rather than changing your flat tire.

[CharlesinCharge]

Arabella,

I agree with Annapurna, stenosis is sometimes a symptom of DDD but definitely not always. Many people on this board had DDD and thus ADR or fusion surgery, and never had any stenosis. Stenosis is actually much more common in people over 60 (my father-in-law had it and he was about 70) and he had a fusion at that level.

If you have DDD and it is causing pain from the disc, that must be fixed and while you are rightfully afraid of having ADR or fusion there may not be a choice (unless you are willing to live with the pain). But, just treating the stenosis if it is a side effect of DDD does not make sense as Annapurna said, because the DDD will still be there. Usually they would do an ADR or fusion surgery and also open up the spinal canal at the same time, thus treating the stenosis.

Sounds like maybe you need to get a couple of more opinions from some new doctors.

Good luck,

[bellyrm]

This is terrible .... I have gotten so many different opinions about my condition that it is so hard to decide on what to do ... 2 doctors have told me I need a fusion or ADR but 2 other ones said those are major invasive surgeries and I'm too young to have them (29) ... Las doctor said he would put COFLEX or a silicone implant interspinous spacer and clean the area that is causing pain due to my ruptured disc in Peru my home country but here in the USA I'm finding out they don't put COFLEX at my level L5 S1 because they say the space is too small and yes as you say Charles Stenosis seems to be a symptom illness that affects older people ... Is anterior fusion suppossed to last for a life time at level L5 S1? Or I would need another fusion in time? My pain has increased and when lying down on my back it hurts a lot like I have a bruise or a cut in my lower back so I have to change positions but generally speaking it is hard to find a position to go to sleep because of the pain ... My only ok position is standing ... Sitting and walking hurts a lot ...
Thanks for your responses

Arabella.

[symara]

Arabella,

I too have the problem sleeping, not so much falling asleep until here recently, but staying asleep. I wake up and my back aches terribly and I have to try to find a position that doesn't kill it. But then I'm waking up the rest of the night.

I'm 30 and hope that I get to do ADR, I don't care what they say about my age, but I know I'm too young to get a fusion!!!! It seems like ADR would be a better choice for us than us having to live with fusion the rest of our life and having to have surgery on the other closer discs later.

[bellyrm]

I am very scared of ADR because after reading here many posts I see that there are very successful cases but others are not ... The disc has to be put perfectly in order to be successful ... I also found out that it might take you 3 months to be ok if everything is as I said is "perfect" but there are many people writting that it took them 6 months 9 months 18 months and others had to get the ADR's out because their pain didn't go away and or increased due to improper placement of the ADR .. Plus ADR is a major surgery with death involved and nerve damage and blalblallblallblalal ... but yes the pain is so bad that something has to be done ... I hope to find the right solution soon ... cant live like this ..
Symara for how long have you been with the pain? Can you sit and or walk for 10 minutes or more? What have the doctors tell you? Which is your diagnosis? Have you had a Discogram done? I have no insurance but because of my symptoms doctors think I need ADR or a Fusion but this last doctor talked to me about COFLEX as an alternative to Fusion and ADR .....

Arabella.

[symara]

Originally Posted by bellyrm

I am very scared of ADR because after reading here many posts I see that there are very successful cases but others are not ... The disc has to be put perfectly in order to be successful ... I also found out that it might take you 3 months to be ok if everything is as I said is "perfect" but there are many people writting that it took them 6 months 9 months 18 months and others had to get the ADR's out because their pain didn't go away and or increased due to improper placement of the ADR .. Plus ADR is a major surgery with death involved and nerve damage and blalblallblallblalal ... but yes the pain is so bad that something has to be done ... I hope to find the right solution soon ... cant live like this ..
Symara for how long have you been with the pain? Can you sit and or walk for 10 minutes or more? What have the doctors tell you? Which is your diagnosis? Have you had a Discogram done? I have no insurance but because of my symptoms doctors think I need ADR or a Fusion but this last doctor talked to me about COFLEX as an alternative to Fusion and ADR .....

Arabella.

I am not so bad to the point that I can not sit for awhile. I work 8-9 hrs a day sitting at a computer. I am doped up most of the time on pain meds, so not sure what my pain level would be without out them, but I'm not in so much pain to where I can't do it yet.

I've had pain on and off pretty much since it all started in 2004, but here lately it's been constantly since October last year, and before that it has been going since my second surgery, just not to the point of taking pain meds everyday until this past October.

As far as walking I'm ok if I've taken my pain pills, if not, the pain gets pretty bad going down my legs, and my feet kill me after sitting for a bit regardless of the medication. But only after I get up and start walking, and they have swelled like balloons, this is a recent development in the last couple days.

I just had my MRI and the same L4-5 disk is protruding and "impinging" on the nerve root. I talk to the surgeon about the results Monday, so not sure yet what he's going to say. After my last surgery though, he said Fusion or ADR would be my next option when (not if) I had my next surgery.

In my head I weigh it out this way. I would rather try ADR and have it fail then not try it and just go straight to having the fusion done. But that is if I have the insurance cover it. I guess if the insurance doesn't cover it I'll just live with the pain until either my back goes completely out or they change their policiy to cover ADR. I'm just so against the fusion right now, I want it to be my absolute last resort. That is just me though, I want to try something that may give me at least the opportunity to NEVER have surgery again, even if it ends up not working. Fusion, odds are I will have to have it on the other disks again, and right now, according to what I can read on my MRI, everything in my back is perfect, except for the L4-5.