Prestige
Cervical Disc

Clinical Outcomes

The Prestige® Cervical Disc is designed to maintain motion in the neck for patients experiencing radiculopathy and myelopathy resulting from disc degeneration in the neck.

Overview

Incorporating 17 years of design evolution, the Prestige® Cervical Disc was the first artificial disc to be approved by the U.S. Food and Drug Administration for use in the cervical spine, and the first of a family of spinal artificial discs under development by Medtronic. Constructed of 2 pieces of stainless steel in a ball-and-trough configuration, the device is designed to be inserted into the remaining intervertebral disc space after a diseased or damaged disc has been removed.

The safety and effectiveness of the Prestige Cervical Disc as an alternative to anterior cervical discectomy with fusion (ACDF) has been evaluated in a Level 1, multicenter, prospective, randomized, controlled study that involved 541 patients – the largest clinical study of its kind conducted and completed for the cervical spine.

Risks

Along with the benefits of this technology, there also are potential risks. Risks associated with the Prestige Cervical Disc include, but are not limited to:

  • Early or late loosening of the components
  • Component sizing issues
  • Anatomical or technical difficulties
  • Possible tissue reaction
  • Formation of bone that may reduce spinal motion or result in a fusion, either at the treated level or adjacent levels
  • The development of new radiculopathy, myelopathy, or pain

Medtronic cervical artificial discs should only be used by surgeons who are experienced in the surgical procedure and who have received adequate training with the device. A lack of adequate experience and/or training may result in a higher incidence of adverse events, which may require additional surgery for correction.

For complete information regarding indications for use, warnings, precautions, adverse events, and methods of use, please reference the device’s package insert and instructions for use, and the Indications, Safety, and Warnings link.

Study Design

The goal of the Prestige® Cervical Disc clinical trial was to compare the outcomes associated with cervical artificial disc surgery with the Prestige Cervical Disc and anterior cervical discectomy with fusion (ACDF). It was conducted at 32 study sites across the United States and treatment took place between October 2002 and August 2004.

Patients in the study, who had to be at least 18 years of age with documented cervical disc disease conditions/symptoms and associated neurologic involvement that had not responded to nonsurgical treatment for at least 6 weeks, were randomly assigned to the Prestige Cervical Disc or ACDF investigational groups.

  • 276 patients in the Prestige disc study group received an anterior cervical discectomy and decompression followed by placement of the Prestige disc.
  • 265 patients in the fusion control group received an anterior cervical discectomy and decompression with the placement of an interbody ring allograft and the Atlantis® Cervical Plate System (also by Medtronic).
  • Patients in both groups underwent tightly controlled radiographic and clinical examinations preoperatively, and at routine follow-up periods postoperatively.

Key Findings

Key findings of the Prestige® Cervical Disc clinical trial include:

  • The Prestige Cervical Disc was proven to be statistically superior in Overall Success at 24 months; statistically superior in Neurological Success at 24 months; and similar in NDI results.
  • The group of patients receiving the Prestige disc had a median return to work that was 26% earlier than the median for the spinal fusion treatment group.
  • The Prestige disc has statistically fewer revision surgeries at 24 months vs. the control group. (Revision surgery is defined as a procedure that adjusts the original implant configuration.)
  • There were no device failures (ie, breakages) associated with the Prestige Cervical Disc.
  • At 24 months, there was only 1 reported case of bridging bone in the Prestige Cervical Disc group.

Risks

Along with the benefits of this technology, there also are potential risks. Risks associated with the Prestige Cervical Disc include, but are not limited to:

  • Early or late loosening of the components
  • Component sizing issues
  • Anatomical or technical difficulties
  • Possible tissue reaction
  • Formation of bone that may reduce spinal motion or result in a fusion, either at the treated level or adjacent levels
  • The development of new radiculopathy, myelopathy, or pain

Medtronic cervical artificial discs should only be used by surgeons who are experienced in the surgical procedure and who have received adequate training with the device. A lack of adequate experience and/or training may result in a higher incidence of adverse events, which may require additional surgery for correction.

For complete information regarding indications for use, warnings, precautions, adverse events, and methods of use, please reference the device’s package insert and instructions for use, and the Indications, Safety, and Warnings link.

Last updated: 22 Sep 2010

Medtronic Spinal and Biologics

(800) 876-3133