Your cervical spine is made up of seven bones (vertebrae), with an intervertebral disc between each vertebra. The disc has a thick outer layer (annulus) that surrounds the soft gel-like center (nucleus). Each vertebra also contacts neighboring vertebrae in the back (posterior) portion of the spine at the articulating joints (facets). The natural motion of the spine involves movement between each vertebra, compression of the disc and sliding contact of the facet joints. The disc acts as a shock-absorber between vertebrae.
Neck
and/or arm pain is a common aliment of the cervical
spine, which may be due to impingement (compression)
of the spinal cord or nerve roots. With normal everyday
activities and over many years, the soft nucleus may
become thinner and more brittle, causing the spaces
between the vertebrae to become narrower. This
degenerative process may result in compression of the
spinal cord or nerve roots, causing pain. Slipped or
herniated discs (herniated nucleus pulposus) are conditions
in which all or part of the nucleus protrudes through
a weakened part of the annulus. This also causes pressure
on the spinal cord or nerve roots, resulting in neck
and/or arm pain. Such pain may also be caused by excessive
growth of bone (osteophyte formation) near the spinal
cord.
Spinal fusion remains the treatment of choice for many degenerative conditions; however the results of standard fusion techniques vary significantly. Motion-sparing non-fusion devices such as artificial disc replacements may provide alternatives for treatment of these conditions.
The SECURE®-C Cervical Artificial Disc was developed as a potential alternative to spinal fusion. SECURE®-C is an artificial disc replacement device inserted anteriorly into the cervical spine, designed to help alleviate pain and retain or improve function.
Following surgery, patients return to their study physician for scheduled visits to report on their outcomes, including pain relief and function, etc. These outcomes will be used to evaluate the safety and efficacy of the procedure.
Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7, defined as neck or arm (radicular) pain, or functional or neurological deficit and radiographic confirmation (by CT, MRI, X-ray, etc) of any of the following:
Herniated nucleus pulposus
Radiculopathy or myelopathy
Spondylosis (defined by the presence of osteophytes)
Loss of disc height
Failed at least 6 weeks of conservative treatment
Age 18-60 years
Additional inclusion criteria as defined in the study protocol
More than one level requiring treatment
Prior fusion surgery adjacent to the vertebral level being treated
Prior surgery at the level to be treated
Severe spondylosis at the level to be treated as characterized by any of the following:
Bridging osteophytes
A loss of disc height greater than 50%; or
Absence of motion (<2º)
Pregnancy
Systematic disease including AIDS, HIV, Hepatitis
Additional exclusion criteria as defined in the study protocol
Caution -- Investigational Device, Limited by United States Law to Investigational Use.
The information provided by Spine-Health in this Clinical Trials listing section is designed to help patients find clinical trials that are ongoing in the field of spine medicine, and to provide information to help patients contact the centers conducting the research. Spine-Health is not involved in conducting any of these trials and is not promoting the trials or research.
This is a listing of industry-sponsored clinical trials that are actively recruiting patients. These clinical trial listings are not edited or peer-reviewed by Spine-health.com.
