DuraGen Plus® Clinical Trial Closure
Pinnacle Brain & Spine Center and The Watson Neuroscience Foundation are pleased to have been part of the FDA investigative study – clinical trial NCT00387829- “Randomized Controlled Trial of DuraGen Plus ® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy”.
The study to evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group receiving standard care, began in October of 2006 and involved 347 volunteer patients.
Pinnacle Brain & Spine Center was the only Alabama located Neurosurgery practice involved in the study which was sponsored by Integra LifeSciences Corporation. Other notable participants of the 36 strong study group included Cedars-Sinai Medical Center, University of South Florida, University of Miami, The Cleveland Clinic Spine Institute and Johns Hopkins Hospital.
Asked for comment, Dr. Juan Ronderos M.D. replied:
“We are proud to be selected among the best institutions in the country for a project as important as an FDA study.”
Dr. Shawn B. Clark M.D. responded:
“It gives us great pride that manufacturers such as this, will place their trust in our skill and reputation, and allow us to be part of trials that could ultimately lead to great benefits for people suffering from spinal injuries.”