CHARITÉ™ Artificial Disc
Photo Courtesy of DePuy Spine, Inc.
Lives Improved
The lives of millions of patients will change for the better. Having been one
of the original United States (US) investigators during the Food and Drug Administration
(FDA) study of the CHARITÉ™ Artificial Disc during the last four and one-half
years, I can honestly say that this is one of the most satisfying operations
that I perform. To see patients who have suffered with chronic back pain for years
only to return to normal pain free lives is truly amazing.
Patient Outcomes
But the patient must be wary, because not all patients can expect to be "normal".
The FDA study of the CHARITÉ™ Artificial Disc showed that patients had less
pain and better function than the fusion patients and that they were happier.
They were not however totally pain free. In my personal series, about 40% of
patients were pain free while the others were improved.
Surgical Challenge
We have learned through our studies that patient selection is extremely important
and proper placement of the artificial disc is important to obtain the best
possible results. The challenge for the surgical community is to select patients
by adhering to the same strict criteria of the study, obtain proper training
in the implantation of these devices, and perform the surgery properly to maximize
the results.
Realistic Expectations Necessary
The challenge for the patient is to have realistic expectations. Not every patient
will be able to be pain free or "hit the home run", as I explain to my patients.
The patient should choose his or her surgeon based on the surgeon's experience with
such surgery. Do not be afraid to ask how many surgeries the surgeon has done.
Finally the patient should do his or her research. There will be at least three other artificial discs released in the next couple of years: ProDisc® (Synthes Spine), Maverick™ (Medtronic Sofamor Danek), and Flexicore™ (Stryker Spine). They all will be compared with the CHARITÉ™ Artificial Disc, which has a 17-year track record outside of the US.
For information about Dr. Guyer's practice: Click Here
It would be unrealistic to believe that artificial disc replacement is going to be significantly superior to our classic treatment (lumbar fusion) given the results of the U.S. IDE study for the Charite device. Patients, however, may be more mobile earlier with disc replacement.
Cautious adoption and careful long-term study will better identify the strengths and weaknesses of this exciting technology.
