Advice needed on considering Coflex (study) vs. Fusion

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swkath505

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Hi everyone. I am wondering if anyone out there has either heard about--or undergone--the investigational study for getting a Coflex device implanted in the spine (versus as traditional fusion). The study is being conducted by Paradigm Spine in something like 20 U.S. centers. It is supposed to preserve some amount of movement/motion. It's randomized, so some candidates might be getting a traditional fusion. I am scheduled in May for a traditional fusion but am wondering if this is worth exploring.

If any of you are interested in looking at the information at their website, you'll see there are LOTS of unanswered questions. Since I have lurabar slippage (spondylolisthesis) of L4 to L5 (about 6-8 mm), I have NO idea if I should consider getting an investigational device! I would have to travel over 300 miles every few months for two years, and what would I do if I hurt or needed medical spine-related care? I probably wouldn't have a local doctor . . . A year ago after my partial laminectomy, it took me a very long time to heal and recover from pain. Any informed opinions would be very helpful! Many thanks.

kathy:confused:
 
Hi Kathy ~

Welcome to the board.

It is always confusing when trying to figure out whether it is worth it to participate in a clinical trial. I just had a PLIF at L4-5 6 weeks ago and prior to that I spent almost 3 years trying to avoid surgery! I investigated a nuraber of new devices that had recently been approved and was also offered a spot in a clinical trial for something that sounRAB very similar to the Coflex. I was not given the name of the product at the time I was talking to the doctor. I decided against participating in the study because it really bothered me that it was a blind study and I wouldn't know what was inside my body.

Do you know if you'd be a candidate with your spondylolisthesis? It sounRAB like the coflex is designed for stenosis rather than for stabilization. Also the fact that you'd have to travel so far would be a negative to me. I almost had my surgery done at a university clinic that is 90 miles away from me, but I changed my mind at the last minute based solely on the mileage involved!

I wish you well in making a decision.
 
Kathy,
When my daughter was ready to have her two level fusion, I searched the web for a nuraber of different possibilities instead of fusion. I was even looking at the German sites, even though I know we would have never pursued them. There were some clinical trial being started at that time for the flexible fusion systems. I never actually called the drs, but after reading online found out that she wasn't a candidate because she was under 18. My daughter later told me that she didn't want to be used as a guinea pig and laughed. As a mom I was searching for anything besides surgery. I seem to remeraber with some things I read that if you had spondylolisthesis she wouldn't be a candidate. So I would certainly check with that.

As with Marlosmom, we got a second opinion at a university hospital but decided to stay at our hospital ten minutes from home. It has worked out with us.

Good luck with your decision. Do lots of research. cas
 
Dear Marlos Mom: Thank you for providing questions that will give me an opportunity to reflect more on what to do. I am quite concerned about the issues you raised regarding this study, and nothing on the company's website answers any of my worries about how to stabilize the slippage I have. And of course, not having a choice of WHAT is put into my back (fusion vs. blind study for the coflex) is also bothersome. For what it's worth, a friend who is a dr. and also has back problems said he heard that the coflex may in fact not take care of these kinRAB of problems and could generate multiple surgery interventions in the future. Sobering, huh? Bless your heart for answering both of my posts as a newbie! I'm hoping you're starting to feel much better!
 
Thanks, Cas, for raising those questions. They underlie my worries--especially since the study's staff hasn't been able to address them regarding the stabilization issues. My next course of action will be to seek a 2nd opinion about getting a standard fusion--based on my MRIs and reports. THEN I'll think about whether to even bother with seeing a dr. out of town about this study. I sincerely appreciate your response; this can all seem so overwhelming at times--especially when facing such serious surgery. I'd like to believe that if I choose the "right" surgery, I can get my life back and get back to fully enjoying traveling, more time to spend with frienRAB, etc. Thank you so much for your advice!

kathy
 
Hi Kathy,

If it helps any, fusion at L4-5 is a common procedure and with the spondylolisthesis the success rate is higher than without spondylolisthesis -- it is something around 90% or higher.

I may be jinxing myself, but I had this surgery about 6 weeks ago and am feeling very well. I cannot tell that I have something in my back. I have been lying on the floor and can't feel anything. Of course I haven't been able to move around a lot yet to test it out, but I don't think I am going to feel like my movement is restricted by the fusion. Of course this would be different if I had more than one level fused.

So far, I have been pleased with my surgery. My sciatic pain is gone. I do have some new nerve pain in the top of my thigh, but I am hopeful that it will eventually go away. It is a product of the compression or it could be pain from the femoral nerve being scrunched (my very technical, medical term!!) as I lay on my stomach on the operating table for 3 1/2 hours. I had x-ray and MRI at 3 weeks and all the instrumentation was where it is supposed to be...so I have to believe the doc that the nerves will regenerate and the pain will go away.

One other problem with participating in a clinical study is that you really do have to kind of give up your "normal" patient rights. It is my understanding that you can't ask all the questions you might otherwise ask your surgeon, because he can't tell you which procedure you are having. Thus he can only give you generalized answers. You have less control over what's happening and you have much less information than you would otherwise be able to get. You truly are a "guinea pig" and you just have to turn yourself over to the surgeon. I'm glad there are people in the world who are willing to do this. They provide a wonderful service to the rest of us. I just decided I wouldn't be comfortable being one of them -- not knowing for years what had been done to me!!

Good luck making your decision. If you have questions about a fusion, I'm happy to tell you my experience.

xx MM;)M
 
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