DEPUY SPINE CHARITÉ™ ARTIFICIAL DISC CLINICAL TRIAL RESULTS
PRESENTED AT MAJOR SPINE SCIENTIFIC MEETING
Study Results Related to Pain, Range of Motion
and Recovery Time of Patients Implanted with
CHARITÉ™ Artificial Disc Compared Favorably
to Spinal Fusion Patients
San Diego, CA (March 18, 2004) --
Results from a two-year clinical study of patients implanted with
the
CHARITÉ™ Artificial Disc indicate they improved or maintained
their range of motion and experienced earlier pain reduction in comparison
with spinal fusion patients.
Sponsored by DePuy Spine, a Johnson & Johnson company, the findings
were presented at the 20th Annual Meeting of the AANS/CNS* Section on
Disorders of the Spine and Peripheral Nerves. The randomized prospective
clinical trial was part of a Premarket Approval Application (PMA) submitted
to the U.S. Food and Drug Administration (FDA) earlier this year by DePuy
Spine.
“Study results suggest that the CHARITÉ™ Artificial Disc has
a significant positive effect on pain, functionality and range of motion
after back surgery,” said Fred Geisler, M.D., Ph.D, a clinical
investigator and neurosurgeon at the Illinois Neuro-Spine Center at Rush
Copley Medical
Center near Chicago, who made the presentation during an official session.
In the clinical trial, both patients implanted with the CHARITÉ™ Artificial Disc and spinal fusion patients experienced improvement in pain and functional
test scores compared with their
pre-operative status. However, patients implanted with the CHARITÉ™ Artificial Disc improved more quickly, and their pain and functional test
scores were statistically superior to those of the fusion patients at
all points through 12 months and numerically superior at 24 months. Also,
on average, patients implanted with the CHARITÉ™ Artificial Disc
were discharged from the hospital a half-day sooner than fusion patients.
Radiographic findings included average range of motion of 6.9 and 7.4
degrees for patients implanted with the CHARITÉ™ Artificial Disc
at 12 and 24 months, respectively. Disc space height was restored from
an average of 5.7 mm pre-operatively to 13.0 mm at 12 months and maintained
at an average 12.9 mm at 24 months.
Patients were evaluated immediately following surgery, again at 6 weeks,
and at 3, 6, 12 and 24 months. More than 90% of patients were seen at
key follow-up time points, an important measure for this type of study.
Two-thirds of the 304 patients enrolled in the pivotal study received
the CHARITÉ™ Artificial Disc and one-third had traditional spinal
fusion surgery with an FDA-approved interbody fusion device. Both devices
were implanted using the same anterior surgical technique to minimize
variables related to surgical approaches.
At 24 months, 88% of patients implanted with the CHARITÉ™ Artificial
Disc expressed satisfaction with the procedure, compared with 81% of
fusion patients. When asked if they would have the same procedure again,
82%
of the patients implanted with the CHARITÉ™ Artificial Disc said
they “probably would” or “definitely would” decide
to undergo the procedure, compared to 65% of fusion subjects who answered
the same way. Dr. Geisler reported similar complication rates for both
groups of patients, most being resolved with standard medical care.
If approved by the FDA, the CHARITÉ™ Artificial Disc would provide
doctors and patients an alternative to lumbar spinal fusion surgery, which
helps reduce or stop back pain, but limits a patient’s range of
motion and may unnaturally stress the adjacent anatomy. Lumbar spinal
fusion surgery is performed on more than 200,000 people each year in
the
United States.
The CHARITÉ™ Artificial Disc is made of two metallic endplates and
a polyethylene core that articulates between them and has been the subject
of clinical trials at 15 centers throughout the United States. A product
of DePuy Spine, Inc., the CHARITÉ™ Artificial Disc is an investigational
device limited by U.S. (Federal) law to investigational use in the USA.
It is available outside the U.S. in more than 30 countries.
About DePuy Spine
DePuy Spine, a Johnson & Johnson company, has worked and partnered
with leading clinicians, researchers, and thought leaders to develop
products
to treat spine disorders for over 20 years. Today, DePuy Spine stands
in the forefront of the worldwide spine market. The company is committed
to advancing the knowledge of all health care professionals and their
patients in addressing spinal pathologies.
