Rahul Shah, MD, Orthopedic Spine and Neck Surgeon at Premier Orthopedic Spine Associates talks about the spinal fusion neck surgery clinical trial study.
Tell me about the Fuse trial.
Dr. Shah: The Fuse trial is being done in a randomized fashion to investigate the shims that go on the back of the neck to see if they help outcomes for people that have had neck surgery.
Tell me how it is being conducted.
Dr. Shah: Randomized means that once someone enrolls into the study, they receive an additional surgery, which is adding the shims in or they may not get that. Then we will see how they do. If it turns out they are not doing well or they want to have the shims put in later, they still qualify for that. But at the initial surgery, they do not know if they get both surgeries or one surgery.
What are the shims and what are they designed to do?
Dr. Shah: Let me give you a simple idea. Essentially, when the neck moves, it moves with one bone on top of another, almost like a tripod rocking back and forth. As they telescope one over another, the nerves that go through the center can sometimes be affected if the area between the two bones wears out. You can have either disc herniations, protrusions or something pinching off the spinal cord or nerves. If people do not get better with the standard processes like physical therapy, activity modification, medications, or even spinal injections then we talk about doing something to take the pressure off the nerves. Now, sometimes some people have bad necks where multiple levels are affected. In those people sometimes the bones do not mend together the way we want them to and for those people it is recommended to have the front part of the spine addressed where the nerves are often pressed and the back part of the spine stabilized so that that whole area heals together and mends together as one bone. Traditionally, we always do the front part of the surgery, but we are reluctant to add the back of the surgery to stabilize.
Why is that?
Dr. Shah: Because when you go through the front of the neck, there are few muscles that must be mobilized to get to that area. You do not cut the muscles, so it does not hurt as much. But you have a lot of muscles in the back of your neck so if you go to the back of the neck and you disrupt those muscles, it hurts a lot and people aren’t as happy because they get stiff. But with the posterior cervical spine fusion, using a minimally invasive, tissue sparing approach, we’re able to make very small corridors and work with something that is about the size of a metal straw to be able to put these shims in to help increase the amount of support the spine has. As a result, through surgery we have taken away pressure on the spinal cord and are holding those bones still and allowing them to knit together, much like healing a broken bone. If the bone breaks, sometimes the muscles pull the bone apart, and then you put a cast on. But sometimes the cast is not enough, and you must have surgery to hold it still so that the bones knit together. It is the same stability that we are looking to add to the neck, and these shims help to augment that stability.
What is the benefit for the patient to have this minimally invasive approach as opposed to separating muscle?
Dr. Shah: If you just separate the muscles as compared to making a cut, the cuts are just in different sides. People that have had back and neck surgery know the cuts can be this long or this long. We work with a metal straw and the cuts are about the size of a dime or less, so they heal almost looking like little pimples as compared to a bigger cut. So, there is less tissue scarring, less movement, and less retraction of the muscles. So, the muscles bounce back quicker, and their function is better. Although we still must prove that with the study.
How long have you been using this approach?
Dr. Shah: I have been doing this multiple level neck surgery with the shims about four years. I did it for those who had significant pain from the back of the neck or had significant risk of not healing as well and we wanted to get them the appropriate amount of healing from the beginning. Now we have the paper, but that has not been with a control arm where we randomize and say, we don’t know if you’re going to get it, and we’re going to watch you like a hawk and make sure that one is better than the other. Are they the same or is one worse? That is what we are trying to figure out.
What is the procedure called?
Dr. Shah: The procedure is a 360-degree spinal fusion for the neck. It is 360 degrees because it is from the front and the back. Circumferential fusion is another name for that type of procedure.
What could cause a patient to have this disc condition?
Dr. Shah: There are a lot of reasons. People that have been in a car accident or have had a sports injury. We are also finding a subset of people that just have problems with bad backs or bad necks. We all know people that have a bad knee or a bad ankle, and people that have necks or backs that are more prone to having an injury. Those folks sometimes need this procedure done.
Is the 360-degree the gold standard of this type of surgery?
Dr. Shah: The North American Spine Society does recommend for those that are having three levels of fusion, to have front, back or 360-degree fusions be done, of course at the discretion of the surgeon.
With the fusion there is less movement, but it eliminates the pain.
Dr. Shah: Yes. This is what we are finding out and we are working to quantify it with this study. By and large, when you remove the disc between the bones, there is a void that is created. To fill that void, you use an artificial disc replacement, or you use a fusion type procedure. The fusion type procedure has been around a lot longer and is more than two levels. There is not an FDA indication currently for disc replacement, but there is for the fusion. So that is what we do for those that have extensive disease.
Who is a good patient for the 360-degree and Fuse study?
Dr. Shah: We are inclusive and not ruling people out. Anybody that has a significant problem with neck and arm pain, has three levels of disease and qualifies for the anterior surgery is typically a candidate for the Fuse study. The only exclusionary criteria we have are those over the age of 80, and those that have bad osteoporosis. But most people are included. So those that have diabetes, smoke, or might be slightly overweight are still allowed to be in the study, which allows this to be a very wide group of people and allows us to see the true effectiveness or lack of effectiveness of this type of procedure.
When you mentioned levels, are you talking about the cervical spine level?
Dr. Shah: What I mean is there are seven bones in the neck. They range from C one to C seven. Levels from C three through C seven that are three in a row and that somebody needs to have addressed would qualify for this study.
Have you had any patients who have needed all seven or is that something that is not normally done?
Dr. Shah: For the sake of this study, it is limited to three levels. I have done this type of procedure in people that have needed more than three levels done for sure.
You were talking about the fact that the nerves are either getting pinched or irritated.
Dr. Shah: The actual surgery itself takes the pressure off the nerve. If you lay on your arm the wrong way and your hand falls asleep, it is a natural reaction to move your arm and get the pressure off the nerve. It is not something you even think about. But when that happens in the neck and there is something squashing a nerve or causing a nerve to be irritated, we think twice because if something goes wrong, there is a fair bit of concern around that. So, we do all sorts of other things to try and take the pressure off. That is where physical therapy comes into play including yoga, meditation exercises, spinal injections, and chiropractic care. Many different remedies are used. Sometimes you cannot get the pressure off and at that point, you think I am losing too much function, I am having too much pain, and this is not working. I must do something to salvage what I have. That is where surgery typically comes into play.
Your patient, Robert. He was having significant pain for a pretty long period of time.
Dr. Shah: This is a guy who has worked with his hands his whole life. He has incredibly strong hands and upper body. Yet I could overcome him with my examination. He was dropping things and not even recognizing it, attributing it to old age or other areas that were not exactly the reason. The reason was his nerves were squashed and he was having difficulty with his balance and could not hold on to simple objects. These are the subtle things that, if you let them go, sometimes they will come back. I am always amazed by patients that have this problem and have gone through life and made so many adaptations because nobody can see your pain, they don’t understand how pervasive and all-encompassing it is, and how much it limits them. In many ways, he was stuck in this area where he was not making progress. In my view it is amazing how much of a recovery he has made.
Is there anything you want people to know about degenerative disc disease or the Fuse trial?
Dr. Shah: If this trial shows that there is some benefit to this, we will be able to help people heal quicker because we are able to do the surgery that they need for the stability they need without having to see if they fail, and then having them need a bigger surgery because of the tissue splitting approach, which is the standard procedure. So, there is a real chance that we may be able to launch this forward in terms of how neck surgery is done.
Do you know how many centers do this procedure?
Dr. Shah: Fifteen sites is what it was the last I checked.
Did they have the number of patients that they wanted to enroll?
Dr. Shah: About 300 patients is the goal.
Over what period?
Dr. Shah: Over two years.
And where are we in that?
Dr. Shah: That I do not know, because it keeps changing. I want to say we are in the infancy of that, probably the first 25-30 percent.
Interview conducted by Ivanhoe Broadcast News in.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Tori Sichta
646-632-4571
Sign up for a free weekly e-mail on Medical Breakthroughs called First to Know by clicking here
