Artificial Disc Study

The area of the spinal column in the neck region is called the cervical spine. The cervical spine is made up of seven bones, called vertebrae. These vertebrae are connected by several joints, which allow people to bend, twist and move the neck. The main joint between two vertebrae is called a disc. The disc is a soft spongy material that holds the two bones together while still allowing for movement. Because of the demands put on the disc, it sometimes can tear and wear down. This disease process is called degenerative disc disease (DDD).

DDD of the cervical spine can cause neck pain, along with pain, numbness, tingling, and/or weakness in the arms or shoulders. If more conservative treatment methods are not successful, the current standard treatment for these symptoms is to have surgery to remove the disc and then to fuse the two vertebrae together. This treatment usually relieves pain and other symptoms, but results in a loss of motion in the fused joint.

The purpose of this study is to evaluated whether the Porous Coated Motion Artificial Disc (PCM) is a safe and effective treatment for the symptoms described above. The PCM has been designed to support the spine, while preserving motion. The study will compare the outcome of disc surgery using the PCM artificial disc versus fusion surgery.

The PCM is a study device; it has not been approved by the Food & Drug Administration (FDA). The implant has three parts: two metal (cobalt chromium molybdenum alloy) endplates and one plastic (polyethylene) spacer. These materials are the same as the ones used for hip and knee replacements.

There will be about 825 subjects enrolled in this study from areas across the United States. Two-thirds of the subjects will have surgery to remove the damaged disc and replace it with the study device (PCM). The other subjects will receive the current standard treatment. They will have surgery to remove the damaged disc and then have the vertebrae fused together.

You may be eligible to participate in this trial if:

You are between the ages of 18 and 65
You have been diagnosed with radiculopathy or myelopathy of the cervical spine with either radiculopathy symptoms (pain, paraesthesias) or paralysis in a specific nerve root distribution from C4-C8
You are symptomatic at only one level from C3-C4 to C7-T1
You have radiographically determined pathology at level to be treated correlating to primary symptoms

This is a partial list of eligibility criteria. If you would like to inquire about your eligibiility for this study, please call the number provided. If you choose to reply by e-mail, please include a phone number where you can be reached during the day and refer to the study title in your message.