To: Mike who wrote (599 ) 2/4/1999 3:36:00 PM From: Asymmetric Read Replies (1) | Respond to of 2001
ADCON-L Improves Clinical Outcome Following Lumbar Discectomy Data Presented at American Academy of Orthopaedic Surgeons Meeting ANAHEIM, Calif., Feb. 4 /PRNewswire/ -- Gliatech today announced findings presented at the American Academy of Orthopaedic Surgeons Annual Meeting demonstrating that reduced peridural scar is associated with improved clinical outcome following lumbar discectomy surgery. Donald R. Johnson, M.D. and Steven Poletti, M.D. of the Carolina Spine Institute in Mt. Pleasant, South Carolina authored the presentation entitled: ''Reduced Peridural Scar is Significantly Associated with Improved Clinical Outcome Following Lumbar Discectomy: Results From a Prospective, Randomized, Controlled, Double-Blind Clinical Study.'' The clinical results presented were part of Gliatech's prospective, randomized, controlled, double-blind clinical trial evaluating ADCON®-L. The study was conducted in 298 patients undergoing first-time lumbar discectomy at nine clinical centers in Europe. Patients were evaluated at 6 months after surgery for the extent of peridural fibrosis, radicular pain, low back pain, the incidence of activity related pain (ARP) and straight leg raise exam (SLR). This analysis showed that, regardless of treatment group, extensive peridural scar was significantly associated with radicular pain (p=0.003), low back pain (p=0.01), ARP (p=0.008), and poor SLR exam (p=0.05). Patients with reduced peridural fibrosis or scarring had better clinical outcomes. This study further showed that patients treated with ADCON®-L had significantly less peridural scar (p=0.002), and showed significant improvement in clinical outcomes as measured by low back pain (p=0.047), ARP (p=0.026) and SLR exam (p=0.037). The analysis concluded that this controlled clinical trial confirms that the presence of extensive peridural fibrosis and scarring can result in poor clinical outcome.''We are very pleased to have these dramatic results of our clinical trial presented at the premier orthopaedic meeting in the United States by such a respected surgeon group led by Donald R. Johnson, M.D.,'' said Thomas O. Oesterling, Ph.D., President and Chief Executive Officer of Gliatech Inc.