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 July 18, 2005 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 |
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