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Age, injury, poor posture, or diseases such as arthritis can lead to degeneration
of the bones or joints of the cervical spine, causing disc herniation or bone
spurs to form. Often, patients can be treated effectively through conservative,
nonsurgical methods, but many will require surgery. Many of the patients who
undergo cervical spine surgery will have a spinal fusion (arthrodesis) performed.
Spinal fusion is an operation that creates a solid union between two or more
vertebrae. Various devices (like screws or plates) may be used to enhance fusion
and support unstable areas of the cervical spine. This procedure may assist
in strengthening and stabilizing the spine and may thereby help to alleviate
severe and chronic neck pain.
Researchers recently compared return-to-work data for a total of 972 patients
undergoing cervical disc surgery through spinal fusion, as well as replacement
with two different types of artificial discs. The results of this study, Return
to Work Analysis of Patients Treated with an Artificial Cervical Disc or an
Arthrodesis, was presented by Vincent
C. Traynelis, MD, 4:15 to 4:30 p.m. on Monday, April 24, 2006, during the
74th Annual Meeting of the American Association of Neurological Surgeons in
San Francisco. Co-authors are Paul A. Anderson, MD and Newton H. Metcalf, BS.
Artificial cervical discs were developed and approved for use outside the United
States in the last decade. In the United States, both the BRYAN® Cervical Disc
System and PRESTIGE® Cervical Disc System have undergone comprehensive FDA-approved
Investigational Device Exemption (IDE) clinical trials in the last two years.
These artificial discs are designed to replace a diseased disc that is removed
from a patient's cervical spine and to maintain or restore spine flexibility.
"From both a medical and economic standpoint, it is important to analyze the
efficacy of cervical spine surgery," stated Dr. Traynelis. Both studies prospectively
followed patients with single-level symptomatic cervical spinal disc disease
who failed to respond to conservative nonsurgical treatment. Patients were randomized
to be treated with a disc excision followed by either a fusion or placement
of either the Bryan or Prestige artificial disc.
The Bryan group included 240 patients who received a Bryan artificial cervical
spinal disc replacement and 222 patients who underwent fusion. The Prestige
group consisted of 250 patients who received a PRESTIGE® artificial cervical
disc replacement and 260 individuals who underwent fusion.
Both devices provide spinal stability and allow for normal motion. A fusion
provides stability but eliminates spinal motion across the segments which are
fused. In both studies, the group of patients receiving an artificial disc was
statistically similar to the group of patients receiving a fusion (age, sex,
associated medical conditions, etc.).
The following outcomes were noted:
- Bryan Group: Median return to work was 50 days for the artificial disc group,
and was 74 days for the spinal fusion group.
- PRESTIGE® Group: Median return to work was 46 days for the artificial disc group,
and was 63 days for the spinal fusion group.
"The data from these two studies, comprised of a total of 972 patients, shows
that patients treated with an artificial cervical disc return to work more rapidly
than those treated with a fusion, with statistically significant differences,"
stated Dr. Traynelis.
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SpineUniverse Update: The PRESTIGE® Cervical Disc was approved by the U.S. Food and Drug Administration July 16, 2007.
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