In the largest clinical trial of its kind, the PRESTIGE® Cervical Disc proved to be a safe, effective alternative to fusion for patients with single-level cervical disc disease.
The PRESTIGE® Cervical Disc, used in a procedure called cervical disc arthroplasty, or cervical artificial disc replacement, has been studied in the most rigorous manner possible. Its safety and effectiveness as an alternative to anterior cervical discectomy with fusion (ACDF) for the treatment of radiculopathy and/or myelopathy related to single-level cervical disc disease has been evaluated in a Level 1, multi-center prospective randomized controlled study that involved 541 patients — the most extensive clinical study of its kind ever conducted and completed for the cervical spine.
The goal of the PRESTIGE® Cervical Disc clinical trial was to compare the outcomes associated with cervical artificial disc replacement with the PRESTIGE® Cervical Disc and 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 symptomatic single-level cervical disc disease with associated neurologic involvement that had not responded to non-surgical treatment for at least 6 weeks, were randomly assigned to the PRESTIGE® Cervical Disc or ACDF investigational groups.
- 276 patients in the PRESTIGE® Cervical Disc study group received an anterior cervical discectomy and decompression followed by placement of the PRESTIGE® Cervical 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 pre-operatively, and at routine follow-up periods post-operatively.
According to the study, patients who underwent cervical artificial disc replacement with the PRESTIGE® Cervical Disc achieved equivalence to all treatment outcome parameters and superiority in neurologic success and overall success at 24 months, compared to the outcomes of patients in the ACDF treatment group.
Some key findings of the PRESTIGE® Cervical Disc clinical trial include:
- At the 12 and 24 months follow-up points, the PRESTIGE® Cervical Disc patient group reported more improvement in their neck pain and a greater ability to go about their daily activities than the fusion control group.
- Patients receiving the PRESTIGE® Cervical Disc maintained sagittal (front and back) angular motion averaging more than 7 degrees in the normal physiologic range of motion. Pre-operatively, the PRESTIGE® Cervical Disc group had a mean angular motion of 7.55 degrees, which increased to an average of 7.59 degrees at 12 and 24 months post-operatively.
- On average, patients receiving the PRESTIGE® Cervical Disc had a median return to work that was 16 days earlier than those in the ACDF treatment group.
- Patients in the PRESTIGE® Cervical Disc group experienced no implant failures or migrations.
- Fewer patients in the PRESTIGE® Cervical Disc group required secondary surgical procedures than those in the ACDF investigational group.
The PRESTIGE® Cervical Disc is 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 two 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.
There are some risks associated with the use of the PRESTIGE® Cervical Disc including, but not limited to, early or late loosening of the components, component sizing issues, and anatomical or technical difficulties. Patients may also experience possible tissue reaction; formation of bone that may reduce spinal motion or result in a fusion, either at the treated level or adjacent levels; and the development of new radiculopathy, myelopathy, or pain. For more information, please click here for links to important safety information or the patient information brochure which contains the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.
Traditionally considered the "gold standard" for the treatment of cervical disc disease, ACDF involves removing the affected disc material then fusing, or creating a bond between, the vertebrae on either side of the disc space. The procedure has been successful in many patients; however, a potential disadvantage associated with spinal fusion is the loss of motion and flexibility in the treated vertebral segment.
Find out if you are a candidate for treatment with the PRESTIGE® Cervical Disc.
For more information about the PRESTIGE® Cervical Disc, talk to your spine surgeon. To find a doctor near you, visit our physician locator.
Important Safety Information
It is important that you discuss the potential risks, complications, and benefits of the PRESTIGE® Cervical Disc with your doctor prior to receiving treatment, and that you rely on your physician\'s judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.