The Prestige Artificial Cervical Disc was approved by the FDA on July 17th, 2007
Patients who suffer from a herniated disc, ruptured disc, or degenerative
disc disease, and have failed conservative therapy are often treated
with an Anterior Cervical Discectomy and Fusion. An Anterior Cervical
Disectomy and Fusion has been the gold standard of treatment. For
certain patients, with specific conditions, the Artificial Cervical
Disc is now an option. The Prestige Artificial Cervical Disc has
been rigorously tested in clinical trials. On July 17, 2007 the Prestige
Disc was approved by the FDA for use.
About the PRESTIGE® Cervical Disc Clinical Trial: The PRESTIGE® Cervical Disc was the largest cervical spine clinical study to date. The study was a single-level prospective, 1-to-1 randomized controlled clinical trial involving 541 total patients enrolled at 32 sites across the United States. Surgeries took place between October 2002 and August 2004.
276 investigational patients were randomized and received the PRESTIGE Cervical Disc.
265 control patients were randomized and received the current standard of care, an anterior cervical discectomy and fusion.
Patients underwent radiographic and clinical examinations preoperatively, and at routine follow-up intervals for at least two years postoperatively.
Statistical superiority of the PRESTIGE Cervical Disc group to the control group was demonstrated for overall success and neurological status success. PRESTIGE patients in the clinical trial also had statistically significant outcomes in Neck Disability Index (NDI) scores. NDI scores quantify how much a patient’s neck pain affects their ability to manage everyday activities.
Mean improvements in NDI at 12 months – 34.8 points
Mean improvements in NDI at 24 months – 35.2 points
There were no adverse events in the clinical study, no failures,
no fractures or breakage of the implant, and no implant migrations
were reported. The patients maintained or improved their neurological
status According to the study, PRESTIGE Cervical Disc patients
had a median return to work that was 26% faster than ACDF patients.
Furthermore, a recent study indicates that the Prestige
Cervical Disc surgery is more cost effective than the Anterior
About the PRESTIGE® Cervical Disc:
Approximately 200,000 people per year have surgery for Degenerative Disc Disease, with symptoms that have not responded to conservative therapy. Symptoms include: neck pain, arm pain, and numbness or tingling in their arms as a result of a pinched nerve in the cervical spine. The gold standard of treatment is the Anterior Cervical Disectomy and Fusion. For certain patients, an Artificial Cervical Disc Replacement may be an option.
The Artificial Cervical Disc is designed as a replacement for a damaged or diseased spinal disc. (see spinal anatomy), The disc is replaced with an artificial disc.
The Prestige Artificial Cervical Disc is constructed with stainless steel, and has two articulating components (a ball on top and a trough on the
bottom) that are inserted into the disc
space and attached to the vertebral
bodies on either side. The surgical approach for a Cervical Artificial Disc is to identical to the surgical procedure for an Anterior Cervical Disectomy and Fusion. An artificial disc is inserted between the vertebra rather than a bone graft. The components of the artificial disc function like a joint, replicating the
motion (yes and no motion) and
preserving the natural curvature of the spine.
Inclusion Criteria for the Prestige Artificial Cervical Disc:
Degenerative Disc Disease or Disc Herniation at C3, C4, C5, C6, or C7
Radicular symptoms in the arms corresponding with affected disc (tingling, numbness, shooting pain)
Failed conservative therapy
Exclusion Criteria for the Prestige Artificial Cervical Disc: