The Bryan Artificial Cervical Disc was approved by the United States FDA for distribution on May 12, 2009.
The Bryan Disc is approved for use in patients with a single level degenerative disc disease or disc herniations between C3-C7, with intractable radiculopathy, and has failed 6 weeks of conservative therapy. Read the details in the approval letter and package contents. The Cervical Artificial Disc has been widely used in Europe for several years.
Dr. Pashman has been utilizing artificial discs as a treatment option since 2002. He is at the forefront of the technology, and part of a small group of physicians in the United States currently utilizing the Bryan Artificial Disc, and who will provide training for surgeons interested in learning this new technique. Dr. Pashman’s group will have a designated set of equipment to perform this procedure.
Dr. Pashman will continue to use the Prestige Artificial Disc (FDA approved in July 2007) as well as the Bryan Artificial Disc. Our physicians are well versed in both of these Cervical Artificial Discs, and continue to participate in clinical trials for upcoming Artificial Discs.
The most common questions about the Cervical Artificial Disc are:
- Am I a candidate for the Cervical Artificial Disc?
- How is the Cervical Artificial Disc different than the Lumbar Artificial Disc?
- Can the Cervical Artificial Disc be used on more than one level?
- Is the Cervical Artificial Disc revisable?
- What is the difference between the Cervical Artificial Discs?
- What is your experience with the Cervical Artificial Disc?
Am I a candidate for the Cervical Artificial Disc?
Your physician will determine if you the cervical artificial disc is a treatment option for you based on your symptoms, diagnosis, and spinal anatomy. At this time, the cervical artificial disc is not for every patient with neck pain or radiculopathy. Our prediction is that as the techniques evolve cervical total disc replacement will be applied to an increasing array of clinical situations. Currently the exclusion criteria are: severe stenosis with spinal cord injury, severe facet arthritis, cervical kyphosis, and primary bone pathology such as infection.
How is the Cervical Artificial Disc different than the Lumbar Artificial Disc?
- The cervical spine had a greater degree of motion than the lumbar spine. It is functionally more important to maintain the movement in the cervical spine. Most of the motion assumed to originate from the lumbar spine, is actually a function of the hips
- The approach to the cervical spine is technically easier than the approach to the lumbar spine. The cervical spine is easily accessed by parting the muscles in the front of the neck. In order to reach the lumbar spine, many internal organs are moved in order to access the front of the spine.
- Placement of the cervical artificial disc or revision of a failed cervical artificial disc is less complicated. The cervical disc procedure has the same surgical risks as an Anterior Cervical Disectomy and Fusion. With a lumbar artificial disc, if a revision is necessary, it must be approached from the anterior of the spine, and in every case is life threatening.
- The outcome for patient who receive the cervical artificial disc are better than patient who receive the lumbar artificial disc. This is due to a difference in the indications for using the artificial discs. The lumbar artificial disc is a treatment option for axial back pain. (pain that is localized to the lower back, and does not travel into the buttocks or legs). The cervical artificial disc is a treatment option for herniated disc and nerve compression that causes radiculopathy. (pain, tingling, numbness that travels into the arms
Can the Cervical Artificial Disc be used on more than one level?
The United States Food and Drug Administration will approve the first cervical total disc replacement for single level use. What emerged from some of the European and American off label experiences is that the usefulness of the cervical artificial disc will be greater for multiple level applications. Most degenerative cervical pathologies encompass more than one level and therefore the implications of decreased functional movement with a multilevel fusion are more significant. The spine surgeon faced with a single level disk herniation causing single level nerve compression will have to carefully weigh the pros and cons of including an adjacent segment in cervical total disc replacement as opposed to subjecting the patient to a repeat operation when the adjacent segment inevitably wears out.
Is the Cervical Artificial Disc revisable?
One of the greatest advantages of cervical artificial disc replacement versus lumbar artificial disc replacement is the revision potential. The cervical spine is more accessible than the lumbar spine, and it is easier to approach the cervical spine again if necessary. It is not the approach which makes revision of cervical artificial disc challenging, but will depend more on the design of the fixation points of each of the cervical disc products. Of each of the various types. For example, a keeled implant requires a sagittal groove in the vertebral body which potentially could cause it to cleave leaving massive bone loss a challenge for ultimate reconstruction. By definition a more constrained prosthesis will impart increase forces to the fixation and plates which may also produce more bone loss as the implant ages. Most cervical artificial discs are designed with roughened plate edges to allow in growth between the bone and metallic interface. The extent of this bony in-growth may have implications on bone loss with revision.
What is the difference between the Cervical Artificial Discs?
There are six cervical artificial disc that the FDA may approve in the near future. The properties of the discs such as the material it is constructed from, how the disc is secured between the intervertebral bodies, the level of difficulty in removing the disc in case of implant failure, and the shock absorbing properties of the devise are all considerations in selecting an artificial disc.
What is your experience with the Cervical Artificial Disc?
As with most spine surgery, the best chance of good outcome is the choice of the right patient, the correct indications, a good technical application. Inherently, cervical fusion surgery will be a more forgiving operation because it doesn’t include the added dimension of short and long term maintenance of motion. On the other hand, it may not be best to maintain or create motion in every cervical pathology. True contraindications for the use of cervical artificial disc replacement will be severe facet arthritis, cervical kyphosis, severe cervical stenosis, and primary bone pathology such as infection. Our prediction is that as the techniques evolve cervical total disc replacement will be applied to an increasing array of clinical situations. Primary neck pain or axial neck pain may not easily be solved with cervical disc replacement because of the relationship of this pathology with arthritis of the small joints in the back of the neck. Since the small joints are not being replaced during the surgery, and motion increases the effect of arthritis in generating pain, replacement of the disc may not improve the patient’s symptoms. If your surgeon cannot find a a reason to explain axial neck pain and suggests that you undergo discography, this might serve as a red flag that a cervical total disc replacement ultimately may not fix your underlying problem.
We have also learned that sizing the implant to match the patient’s anatomy is critical. That is because this distraction will influence the tightness of ligaments which may inhibit or enhance intervertebral motion after the cervical artificial disc is placed. A problem termed “overstuffing” means that it’s too large an implant is placed the ligaments can get too tight which ultimately inhibits motion of the implant, increases bone implant interface stress which can ultimately lead to implant failure. Many of us to do large numbers of disc replacement realized that more motion is not necessarily good and that each case needs to be individualized. This is especially true when dealing with artificial disc replacements adjacent to a previous fusion. Because so much stress is placed on this adjacent segment, more motion may actually put the reconstruction at risk. By adapting ligament tightness, artificial disc choice, and implantation techniques to each individual patient outcomes can be greatly improved.
Doctors Pashman has published this abstract, and several peer reviewed journal articles about the Bryan Artificial Cervical Disc. The latest published research can be found on Medline.