CHARITE™ Artificial Disc

• Introduction
• What is the CHARITE™ Artificial Disc?
• What Are the Potential Benefits and Risks of Disc Replacement Surgery?
• When to Consider Disc Replacement?
• Who is a Candidate?
• Treatments
• What Happens During the Surgery?
• What Should I Expect After Surgery?
• Life After Disc Replacement

When to Consider Disc Replacement

If you or someone you love suffers from Degenerative Disc Disease in the lumbar spine, and have failed at least six months of conservative treatment without adequate results, you may be a candidate for Artificial Disc Replacement.

Who is a Candidate?

The CHARITÉ™ Artificial Disc is an alternative to spinal fusion for patients that have one diseased disc between L4 and L5 or between L5 and S1. Degenerative Disc Disease (DDD) is defined as a disc that has worn out or become injured and causes back pain. The disc deterioration is confirmed by history and x rays or other diagnostic imaging. Patients with DDD whose vertebrae (bones) have moved less than 3mm (0.12in) may still receive the CHARITÉ™ Artificial Disc. Patients receiving the CHARITÉ™ Artificial Disc should have failed at least six months of treatment such as pain medication, a back brace, or physical therapy. Patients who have had some types of minor lower back surgery may still receive the CHARITÉ™ Artificial Disc.

Your doctor can help you determine if you are a candidate for the CHARITÉ™ Artificial Disc.

Who is a Not a Candidate?

While the use of an artificial disc is considered to be an extremely effective option for patients with degenerative disc disease, this technology is not appropriate for everyone. The CHARITÉ™ Artificial Disc should not be used if:

• you have either an infection throughout your body or localized to your spine; or,
• you have disc deterioration or instability at more than one spinal level; or,
• if you have poor bone quality (osteoporosis or osteopenia).

Your occupation or activity levels, your weight, the condition of other levels of your spine, whether or not you are pregnant, and any allergies you have may influence whether you should have surgery with the CHARITÉ™ Artificial Disc. If any of these factors apply to you, please discuss them with your doctor.

Diagnostic Tests for Degenerative Disc Disease

The most common diagnostic tests used to diagnose degenerative disc disease are ordinary X rays and MRI scans.

If your doctor suspects disc degeneration, X rays can be used to verify a decrease in the height of space between vertebrae. A decrease often indicates the the disc is damaged, may be bulging outward, and may have lost water content.

An MRI shows the spine in very clear detail. Through the use of an MRI, your doctor can verify if there is loss of water in a disc.

Treatments

Conservative Treatment

Back specialists often use the term "conservative treatment" to describe any treatment option that does not involve surgery. Treatment will depend on the seriousness of your condition. In many low back pain cases, simple therapies can help alleviate low back pain, including:

• Mild pain medications to relieve immediate pain
• Rest to take the pressure off your spine and the muscles around it
• Physical Therapy and Exercise to assist in calming pain and inflammation, and improve mobility and strength

Epidural steroid injections (ESI) are also sometimes used to relieve the pain of stenosis and irritated nerve roots, as well as to decrease inflammation. These injections can also help reduce swelling from a bulging or herniated disc. The steroid injections are a combination of cortisone (a powerful antiinflammatory steroid) and a local anesthetic that are given through the back into the epidural space. ESIs are not always successful in relieving symptoms of inflammation. They are typically used only when conservative treatments such as those listed above have failed.

The goal of treatment is to make you feel comfortable, reduce further degeneration, and get you back to normal activity as quickly as possible. As a last resort, and only if all other conservative treatments fail, surgery might be considered.

Spinal Fusion

One of the main goals of any surgical procedure on the skeletal system is to stop the pain caused by joints that have worn out over time, also called degenerative joints. One of the most reliable ways to reduce pain from degeneration is to fuse the joints together. A fusion is an operation where two bones, usually separated by a joint, are allowed to grow together into one bone. The medical term for this type of fusion procedure is arthrodesis.

Spinal fusion has been used successfully for over forty years to address a variety of conditions of the lumbar spine, including degenerative disc disease. Over the past decade, there have been dramatic improvements in the way that spinal fusion operations are performed. One major improvement has been the development of new and innovative fixation devices to promote successful fusion of the vertabrae in the affected area and maximum stability for the patient post surgery.

During a spinal fusion, a bone graft is used to join two or more vertebrae. The vertebrae grow together during the healing process, creating a solid piece of bone. The bone graft helps the vertebrae heal together, or fuse. The bone graft may be taken from the hip at the time of surgery.

Many bone grafting technologies are comprised of allograft or donor tissue from licensed tissue banks. Other technologies are manufactured of synthetic materials that mirror the characteristics found in human bone. The use of allograft or synthetic materials in spine fusion surgery has been shown to promote bone formation, effective fusion of the vertabrae, cell proliferation and faster healing times without the need for a second procedure to harvest bone from the hip area.

Ask your doctor for more information on Bone Grafting Technologies and Lumbar Spinal Fusion for the treatment of Degenerative Disc Disease.

Artificial Disc Replacement

Early research in the development of artificial disc replacement began in the 1960's. Because of the complications sometimes associated with lumbar spinal fusion, a renewed interest in artificial disc replacement resurfaced in the 1990's. Since then, the number of studies and overall level of research and design efforts relative to disc replacement has increased significantly.

During disc replacement surgery, the surgeon will remove the damaged disc and replace it with an artificial disc. The goal of this and most all spine surgeries is to help to reduce your pain and restore activity.