Overview of the Cervical Spine:
Overview of Cervical Disc Disease:
Cervical disc disease is diagnosed through:
Symptomatic cervical disc disease (SCDD) is typically treated without surgery. Treatment options may include:
If significant pain, numbness or weakness continues, you should discuss treatment options with your healthcare provider.
Surgery for SCDD typically involves either fusion or disc replacement.
MRI vs. CT Scan: Which is Safer?
Only your physician can decide if you are a candidate for Simplify Disc. You may be a candidate if you have clinical evidence of symptomatic cervical disc disease (SCDD) at one level from C3-C7.
SCDD may include symptoms in the neck and/or arm pain, presence of progressive symptoms (e.g., increasing numbness or tingling), nerve root compression, and a minimum of 6 weeks of nonoperative treatment.
It is important to understand that there are conditions that may exclude you from being a candidate for Simplify Disc.
Available by prescription only. This device complies with the requirements of Council directive 93/42/EC concerning medical devices.
Caution: Investigational device in the United States. Limited by United States to investigational use.
Simplify Trial is a non-randomized U.S. FDA study (which means all patients accepted will receive Simplify Disc). Simplify Trial involves research into the safety and effectiveness of Simplify Disc for patients who are undergoing a discectomy (removal of a cervical disc) at one level due to arm pain and/or neurological symptoms (such as weakness or numbness) with or without neck pain and have specific findings on imaging studies such as X-ray, CT, or MRI.
Simplify Trial will compare outcomes after surgery with Simplify Disc to outcomes after ACDF (cervical fusion) surgery.
Simplify Trial evaluates surgical treatment with Simplify Disc, an investigational device designed to:
If you are experiencing numbness, tingling or pain in your neck, shoulder or arm, these may be symptoms of cervical disc disease.
Post-operative imaging depends a number of factors, including on how you feel following surgery. It is ordered by your surgeon to determine if the disc is currently in the optimal position. With Simplify Disc, no CT scans are required. Your physician can best determine your post-operative needs. In some cases, your doctor may request a CT scan due to a medical issue unrelated to Simplify Disc.
Typically up to 6 weeks after a cervical disc replacement or ACDF. Consult your physician as to when you may resume normal activities, such as driving, at your first postoperative visit.
A total disc replacement will typically require a couple of days in the hospital.
The upper and lower endplates are made from PEEK, which is a well-known polymer used in spine surgery for many years. The surfaces of the device that contact bone are coated with titanium, which the vertebral bodies will attach to over time. The middle of the device is ceramic composite, which has a long history in orthopedic implants. Simplify Disc permits the full diagnostic capability of MRI, minimizing patient exposure to high-dose ionizing radiation from CT scans.
Epidural Steroid Injections are a common method of treating inflammation associated with neck pain. The spinal nerves become inflamed and painful due to narrowing of the passages where the nerves travel as they pass down or out of the spine.
Like many joints in the body, the discs in your neck experience wear and tear. This is called degenerative disc disease (DDD). A number of conservative treatments are available, including physical therapy and steroid injections. However, a small percentage of patients require surgery. This may include anterior cervical discectomy and fusion (ACDF), which removes the old disc and fuses the two vertebra adjacent to the degenerated level. Cervical total disc replacements (cTDR) have been increasing in popularity. In cTDR the degenerated disc is replaced with an artificial disc that moves and is designed to reduce the stresses on adjacent disc segments. Your spine surgeon will determine which procedure is most appropriate for you.
Treatment of neck pain is usually nonoperative, although there are instances when surgery is necessary. Neck pain lasting more than six weeks needs to be evaluated by a spinal specialist.
Simplify Medical is committed to educating patients on neck disability due to symptomatic cervical disc disease (SCDD) and in providing radiation safety data as a service in the public good.
For additional resources on cervical spine disorders, diagnosis, and treatment, please see the following links:
American Academy of Orthopeadic Surgeons (AAOS) – OrthoInfo, Neck pain »
Cervical Spinal Stenosis
Webmd, a-to-z-guides. Cervical spinal stenosis »
Cervical Degenerative Disc Disease
Spinehealth.com, conditions, cervical-degenerative-disc-disease »
Diagnosing Cervical Disc Disease
MedicineNet – What Causes Degenerative disc disease? »
Cervical Disc Arthroplasty
American Academy of Orthopedic Surgeons, Cervical Disc Arthroplasty (pdf) »
CT Scans and Cancer Risk
FDA Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging»
Scientific American. How Much do CT Scans Increase the Risk of Cancer? »
NY Times, Opinion – We Are Giving Ourselves Cancer »
FDA.gov – Radiation Emitting Products, Medical Imaging »
US News & World Report – CT Scans Boost Cancer Risk in Young Patients »