| CLOSE |
CHARITÉ® ARTIFICIAL DISC CLINICAL TRIAL DATA PUBLISHED IN PEER-REVIEWED JOURNAL, SPINE
First Prospective, Randomized Multi-Center FDA-Regulated Trial Comparing Total Disc Replacement to
Anterior Lumbar Fusion
RAYNHAM, MA, July 18, 2005 – Safety and effectiveness data from the CHARITÉ®
Artificial Disc clinical trial that led to its approval by the U.S. Food and Drug
Administration (FDA) was published today in two parts in the July 15th
issue of the peer-reviewed journal, Spine, recognized internationally as
the pre-eminent journal in the field.
The randomized, multi-center study
compared the safety and effectiveness of total disc replacement with the
CHARITÉ Artificial Disc to anterior lumbar interbody fusion with BAK cages for
the treatment of single-level degenerative disc disease, a cause of disabling
back pain. DePuy Spine, Inc., a Johnson
& Johnson company, sponsored the study that was part of the company’s Pre
Market Approval (PMA) submission to the FDA.
In the two-year study, patients from
both treatment groups improved significantly following surgery, but the CHARITÉ
Artificial Disc patients had a shorter hospital stay, recovered faster, had
lower levels of disability, maintained range of motion and were more satisfied
with their procedure after 24 months.
The complication rate was similar in both groups and the rate of
reoperations was significantly less for the CHARITÉ group (5.4% compared to
9.1%).
“This clinical trial provides
further evidence of the safety and effectiveness of the CHARITÉ Artificial Disc
for properly selected patients,” said Scott Blumenthal, MD, lead author of the
clinical outcomes part of the study and an orthopaedic spine surgeon from the
Texas Back Institute in Plano.
The second part of the paper published today,
described the radiographic outcomes of the two procedures and analyzed the
correlation between radiographic and clinical outcomes. Results showed that CHARITÉ Artificial Disc
patients had on average, a 13.6% increase in flexion/extension range of motion,
compared to an 82.5% decrease in fusion patients.
CHARITÉ Artificial Disc patients also had a significantly better restoration of
disc height and significantly less subsidence than anterior interbody fusion patients.
Researchers also found that the greater the surgical technical accuracy of placement,
the greater the improvement in flexion/extension range of motion and prosthesis
function.
“Improvements in range of motion, disc space height and less subsidence strongly
support that total disc replacement has an important role to play in advancing
the treatment of degenerative disc disease,” said Paul McAfee, MD, lead author
of the radiographic outcomes part of the study and an orthopedic surgeon from
the Spine and Scoliosis Center in Baltimore. “The study shows, however, that the
greatest results are achieved from well trained surgeons with excellent technique
who perform the procedure on patients who meet the selection criteria outlined
in the study and on the device’s label.”
Study
Details
In the study, 304 patients from 14 centers across the
U.S. were randomized in a 2:1 ratio; 205 received the CHARITÉ Artificial Disc
and 99 had lumbar fusion with BAK cages and iliac crest bone graft. Data was collected pre- and
peri-operatively, at 6 weeks, and at 3, 6, 12, and 24 months following surgery.
Range of Motion
Range of motion decreased in both groups at three
months, but then increased in CHARITÉ patients and decreased in fusion patients
at 6, 12 and 24 months. At 6 months,
range of motion for CHARITÉ patients was 92.4%
of what it was before surgery and at 24 months it was 113.6%, 13.6%
better than it was before surgery. As
expected, patients in the fusion group demonstrated a decrease in average range
of motion throughout the study timeframe showing an 82.5% decrease at 24 months
compared to range of motion before fusion surgery.
Patient Satisfaction
At the 24 month follow-up, patients in the CHARITÉ
Artificial Disc group demonstrated a higher rate of satisfaction at 73.7%
compared to 53.1% in the fusion group.
When asked if they would have the same procedure again, patients with
the CHARITÉ Artificial Disc responded “yes” at a rate of 69.9% compared to 50%
in the fusion group.
Hospitalization
According to the study, the duration
of hospital stay was significantly shorter in the CHARITÉ Artificial Disc
group, which averaged 3.7 days vs. 4.2 days for the fusion group.
Pain
Relief and Function
In the study, both the CHARITÉ
Artificial Disc and spinal fusion patients experienced improvements in pain and
functional test scores compared to their pre-operative status, however CHARITÉ
Artificial Disc patients experienced clinical improvement faster than fusion
patients.
At 24 months, patients in the CHARITÉ Artificial Disc had an average improvement
of 48.5% in Oswestry Disability (ODI) scores, and the fusion group had an improvement
of 42.4%, compared to preoperative scores. Back pain visual analog scores (VAS)
improved 40.6 points on a 0-100 scale in the CHARITÉ Artificial Disc group vs.
34.1 points in the fusion group, compared to preoperative levels.
Complications
and Reoperations
The overall complication rate was
equivalent between the two groups. The rate of neurological complications was
also equivalent and previously published by Fred H. Geisler, MD, PhD and
clinical investigators in the September edition of the Journal of Neurosurgery: Spine.
Pain at the bone graft donor site occurred in 18 (18.2%) of the fusion
patients; CHARITÉ Artificial Disc subjects were spared the requirement for bone
graft harvesting. Device failures
requiring reoperation, revision or removal occurred in 11 (5.4%) CHARITÉ
Artificial Disc patients and 9 (9/1%) fusion patients. There were no catastrophic device failures
resulting in death or injury in either group.
About
the CHARITÉ Artificial Disc
The CHARITÉ Artificial Disc is made
of two metallic endplates and a movable high-density plastic center that, once
implanted, is designed to help align the spine and preserve its ability to
move. Spinal discs maintain the
position of the spine and allow for bending. The CHARITÉ Artificial Disc is
also available in more than 30 countries throughout Europe, Asia, North
America, Africa and Latin America.
Artificial
Disc Replacement and Lumbar Spinal Fusion Surgery
Lumbar spinal fusion surgery is a
common surgical treatment for low back pain or degenerative disc disease. In the U.S., more than 200,000 people each
year have lumbar spinal fusion surgery.
Potential Risks and Complications
Artificial disc replacement is not for everyone.
As with any major surgery, there are possible complications that can occur
singly or in combination. They include: allergic reaction to the implant materials; bladder
problems; bleeding which may require a blood transfusion; death; implants that
bend, break, loosen or move; infection; pain or discomfort; paralysis; side
effects from anesthesia; slow movement of the intestines; spinal cord or nerve
damage; spinal fluid leakage; the need for additional surgery; tears of the
dura (a layer of tissue covering the spinal cord); problems with your blood
vessels other than bleeding; incision problems. Patients should ask their doctors to see if artificial
disc replacement is appropriate for them.
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. The company is committed to advancing the
knowledge of all health care professionals and their patients in addressing
spinal pathologies