Am I a Candidate?
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.
How do I get pre-screening for Simplify Trial?
Click here to take an online questionnaire.
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 – US Only
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:
- Alleviate pain and restore natural function
- Permit the full diagnostic imaging capability of MRI
- Minimize radiation exposure from CT scans
- Treat a broad range of patients, with disc heights starting at 4mm
If you are experiencing numbness, tingling or pain in your neck, shoulder or arm, these may be symptoms of cervical disc disease.
Cervical Spine Education
Overview of the Cervical Spine:
- There are seven (7) bones called vertebrae in the cervical spine
- Discs filled with a cushioning gel-like substance separate the vertebrae
- Discs stabilize the neck allowing it to turn smoothly from side to side and bend forward to backward
- Discs provide a cushion or shock absorber during normal activities
- Discs degenerate over time, which may have a major impact on quality of life
- Symptoms of disc degeneration include:
- Radiating pain
- Numbness or tingling in shoulders, arms and hands
- Weakness in shoulders, arms and hands
- If you experience these symptoms you should see your doctor
Overview of Cervical Disc Disease:
- Symptomatic cervical disc disease (SCDD) is:
- Neck or arm pain
- Functional or neurological deficit
- Imaging confirmation of:
- Herniated disc
- Loss of disc height
- Bony growth
- Clinical research indicates that 60% of people over 40 years old have some degree of cervical disc degeneration
- As SCDD progresses, the neck becomes less flexible and neck pain and/or stiffness may result
- SCDD results in pain because:
- The disc space narrows and the disc bulges (herniation) and causes nerve roots to become pinched
- A herniated disc is where a disc breaks open or bulges out, and creates pressure on the spinal cord or nerve roots
- SCDD may occur over time or it can occur after an injury or trauma to the neck
Cervical disc disease is diagnosed through:
- Medical history:
- Onset and severity of symptoms
- Improvement or worsening of symptoms
- Neurological exams:
- Feeling in the arms or hands
- Imaging tests to visualize spinal cord and determine source of neck pain:
- Magnetic resonance imaging (MRI)
- Computed tomography (CT) scans
Symptomatic cervical disc disease (SCDD) is typically treated without surgery. Treatment options may include:
- Over-the-counter (OTC) pain and anti-inflammation medications, e.g., Tylenol®
- Non-steroidal anti-inflammatory medications, e.g., Motrin®
- Steroids or narcotics
- Exercise and stretching
- Physical therapy (PT)
- Cervical traction and manipulation of muscles and joints
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.
- Fusion is known as anterior cervical disc fusion (ACDF)
- ACDF is the most common surgical treatment option for SCDD
- In ACDF the degenerated disc is removed and a small piece of bone is implanted in the space between the vertebrae
- The vertebrae above and below the removed disc form a solid rigid unit
- ACDF restores disc height and stabilizes the segment
- ACDF also eliminates motion at the treated segment
- Total disc replacement (TDR)
- TDR replaces the natural disc with an artificial disc
- TDR is clinically proven to provide the same benefits as ACDF
- TDR is designed to maintain motion at the treated segment
Frequently Asked Questions
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.
MRI vs. CT Scan: Which is Safer?
- CT Scans and MRIs are imaging tools that provide detailed information to evaluate, diagnose and treat patients
- CT Scans use highly specialized X-ray equipment to produce images
- CTs expose patients to high doses of ionizing radiation
- Ionizing radiation may cause a small increase in a person’s lifetime risk of developing cancer
- There may be possible reactions to IV contrast agent, or dye, which are used to improve visualization with CT imaging
- MRI is the preferred method for imaging soft tissue in the spine and, unlike a CT Scan, there is no exposure to potentially harmful high-dose ionizing radiation
- With metallic implants, MRI is of limited use because metal produces a large black hole or artifact, which distorts the image
- Simplify® Disc has material components that are clearly visible when using MRI, providing the physician with clear imaging without exposing the patient to high-dose ionizing radiation
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 »