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New Artificial Cervical Disc Clinical Study

ceveleighcceveleigh Posts: 2
edited 12/21/2015 - 6:25 AM in Back Surgery and Neck Surgery
Dear Spine-health Forum Members,

I am pleased to announce a new addition to the clinical trials section on Spine-health. The Spinal Kinetics M6-C artificial cervical disc clinical study is now recruiting patients with symptomatic degenerative cervical (neck) radiculopathy. If you have been diagnosed with cervical radiculopthy and are considering an artificial cervical disc, you may be eligible to participate in this clinical research study. To learn more, please visit:


Katie Eveleigh


  • Along with other injuries I fractured my C4-5 vertebrae in a fall nine months ago. After time, treatments and physical therapy I still have terrible pain in my neck, shoulders, arms and hands along with numbness and weakness, especially on the left side. Parts of the broken vertebrae are compressing and sticking in the left side of my spine. I am going in two weeks for prescreening for the M6 Artificial Cervical Disc Replacement Clinical Trial. I hope I qualify and can receive the M6 to relieve the pain and stabilize my neck.
  • ML said:
    I am going in two weeks for prescreening for the M6 Artificial Cervical Disc Replacement Clinical Trial. I hope I qualify and can receive the M6 to relieve the pain and stabilize my neck.
    Best of luck to you ML. I hope they can help ya out with the pain.
  • For those interested I did apply and was turned down. This is for a single level in the cervical spine but does NOT include the c7/T1 since the T1 is not a part of the cervical area.

    Good luck to those of you applying to the study.
  • I applied as well and was declined because this study is only for one level. If you have other issues that need to be addressed you will not qualify.
  • Funny I answered all of the questions and think I would have qualified if I had not been a type 1 diabetic. Oh well!
  • My neurosurgeon says I'm a good candidate for a cervical disc replacement (ruptured disc at C5-C6- no other levels involved). However it's unclear whether my insurance will cover the procedure as it's considered "experimental" despite the presence of several FDA approved discs already on the market. The spinal fusion will definitely be covered but that would not be my first choice.

    I live near the university hospital that is conducting the M6-C trial. I understand this new generation disc has already been on the market in Europe for the past 7-10 years. Although my neurosurgeon is on staff at that hospital, he is not participating in the trial. He also told me that the two surgeons running the study have less experience with spinal arthroplasties whereas he himself has had 8 years of experience installing cervical discs and performing spinal fusions.

    My first choice would be to have my insurance cover the disc replacement procedure (using FDA approved discs) so it can be done by my surgeon whom I trust. If this scenario doesn't happen, I'm not sure what my plan B will look like: clinical study or spinal fusion.

    Assuming that I'm accepted into the study, the procedure will be paid for by the disc manufacturer. However, I was told by the research coordinator that they've installed the M6-C disc in only ONE patient since the hospital embarked on this project in January. This makes me a bit nervous.

    On the other hand, the spinal fusion option is well established and readily covered by my insurance. My surgeon says I would barely notice the decreased range of motion. But I'm not thrilled about the high likelihood the fusion would cause strain on the adjacent vertebra over the next several years with the strong possibility of future surgeries in those areas.

    Both plan B options will definitely be paid for. I'm torn between having the hoped for disc and placing myself in less experienced hands; versus the safer option of the spinal fusion but with high likelihood of future problems. I'm hoping to get feedback from the other forum members. Thanks for listening.
  • I was accepted into the trial and had the surgery July 1st of this month. I had an amazing surgeon and am very happy with the results!
  • marijommarijo Posts: 1
    edited 07/31/2015 - 6:42 AM
    I had cervical disc replacement her in the UK about 4 years ago, at two levels, for prolapsed discs in my neck. I am delighted with the results. I have much better movement than I would have had with a fusion, which my friend had at the same time. I do get occasional problems with my left arm, but I had those before, and I put them down to carol tunnel and old age. I think disc replacement is the way to go. Its Brilliant surgery with the right surgeon. Incidentally, I had spinal fusion at L5 level with screws etc, and the surgeon misfired the screws placing one of them through my spinal canal, and (I believe) caused fairly severe neurological damage to my pelvic region. The operation was a disaster, and left me in constant and chronic pain, My bowel packed up, and eventually I lost it due to nerve malfunction. I now have an ileostomy. Im very happy with the neck surgery though.

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  • ablandinaaablandina Posts: 2
    edited 10/12/2015 - 8:52 AM
    Hi everyone, I had two discs installed on July 2013 in Brasil by a neurosurgeon.
    Levels C4-5, C5-6.
    I AM allergic to pain medication derived from morphine, and after surgery when I woke up the pain was so great that I allowed it. Not say that I went into a 4 days spree of vomiting and rashes all over my body. The vomiting made the discs move from the original location a little but I did not need a new surgery. Needless to say there was an increase in recovery from a month to 6 months with no phisical activity.
    And add to that the only pain medication was advil... The pain was really awfull for 20 days and then started to faint. People recorded no pain on their arm on the affected side, my pain shift to the non affected arm and took 10 days to get better. So if you are going for it prepare mentally that it is a very hard road.
    My surgery was initially scheduled for two hours, it took six and half hours due to new findings when the neck was opened, be prepared for that.
    I had two weeks of meals pre prepared and frozen, firts three days of soups. And I hired someone to stay with me during the day and night for ten days as I had no family that could that for me. After my complication I had to hire someone to do house work for three months every day...Save money for things like that before hand, arrange friends and family to stop by for more time than you have initially antecipated ,just in case.
    I had to sendo my son on a trip with my Mom for a month it was vacation and he stayed with her for a month.
    When classes started I had to find extra class activities for him as classes go from 7-12:00 here in Brasil. I had to find strenght to walk him over there. And to wait for him. I could not drive him to school, there are no school buses here só I had to hire that as well.
    The financial impacto on me and my son was imense, I am se partes and my husband finds all kinds of excuse not to pay support. But that is another story.
    Be prepared for the financial impacto and for a long financial recovery, I am still riding this road.
    My wages went from 90kk/year as a procurement manager to pratically nothing. And it is amazing how fast reserves are depleted.

    My doctor prescribed even low usage of car trips since here in São Paulo it is almost worst than dirty roads.
    It has been two years and I still have ephisodes of pain, headaches and vomiting. My excercise is limited to walking, PT, and RPG. I have a son who is 8, and there are days I feel good, and we play toghether outside very little running, when I do so and lightly it takes me 2 days to recover, meaning I am all painfull for at least two days, have muscle spasm in my arm, hand, upper back and sometimes.the neck itself. I use a collar to alleviate pain, sleep with it for a week to be sure.
    So I am not so sure that been able to move my neck has been só helpful as I thought it would. I still got stress on adjacent levels that may require further surgery as setnosis is growing towards the dura.
    I cannot find a job that will allow me to walk around every hour for at least 20 minutes, and that will accomodate me with appropriate chair and computer level.
    I have been surviving from teaching elementary school kids after school helping them with HW, and was able to manage 1 renovation of a small flat where I had a quite a few days of stops because of pain, and I was not doing phisical work just orienting labor and buying materials.
    So if you decide for it decide with an open mind as everyone's body responds differentely and good luck!
  • SavageSavage United StatesPosts: 5,476
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