Triangle Orthopaedic Associates is the First in the U.S. to Begin New Spinal Study
Posted: 03-22-2007 : DURHAM, N.C.

Researchers investigate alternative to traditional back surgery

Durham, N.C. - Triangle Orthopaedic Associates, one of North Carolina's leading orthopaedic centers, is the first in the country to begin a clinical trial to compare surgical treatments for a common back disorder affecting thousands of adults every year.

Spinal stenosis, a common disorder affecting the lower back, is caused by deterioration of the joints and discs and leads to pressure on the spinal nerves. Leg pain, numbness and weakness when walking are common symptoms. Back pain and spinal instability are also frequently associated. When non-operative treatment options fail, spine surgeons often recommend surgical removal of the nerve compression and fusion of the deteriorated vertebrae.

However, fusion surgery, in which vertebrae are fused together most commonly with bone grafting, metal rods and screws, limits spinal mobility and may be associated with numerous other risks. For many years, surgeons and their patients have sought alternatives to this traditional procedure.

This clinical trial will compare fusion to the Stabilimax NZ Dynamic Stabilization System. Requiring no tissue removal or replacement, Stabilimax NZ uses a less invasive surgical procedure than fusion. Minimizing surgical trauma can reduce morbidity and recovery time, providing a more rapid return to the activities of daily life.

Stabilimax NZ utilizes a novel dual-spring and ball-and-socket mechanism that is intended to provide maximum stabilization to the spine, decreasing the motion that causes pain while preserving the patient's motion. Maintaining motion may decrease the risk of adjacent level disc degeneration and the need for additional surgery.

"Spine fusion used to be the only option for patients suffering from chronic back and leg pain," said Tom Wood, president and CEO of Applied Spine Technologies (AST), developer of Stabilimax NZ Dynamic Stabilization System and sponsor of the clinical trial. "Many years of research have lead to the development of the Stabilimax NZ. This device is designed to be a dramatic advance in back and leg pain treatment by stabilizing the spine without eliminating motion. This therapy has the potential to be far less invasive than fusion and the technique can be easily adopted by most spine surgeons. Equally important, the Stabilimax NZ may delay or prevent progression of degenerative spine disease, while leaving the door open to future treatments, such as fusion, should they become necessary."

Triangle Orthopaedic Associates will perform these surgical procedures at the newly relocated North Carolina Specialty Hospital (NCSH), a top-ranked, 5-star facility in Durham. Participants will be recruited from primary care referrals, self-referrals or from other orthopaedic surgeons who are aware of the study. Triangle Orthopaedic Associates is the first of 20 sites nationwide expected to participate in this randomized, controlled clinical trial.

"This clinical trial has the ability to expand and improve treatment options for people suffering from this common spinal condition," said Thomas A. Dimmig, M.D., a spine surgeon with Triangle Orthopaedic Associates and Principal Investigator for the clinical study. "Not only is this research incredibly important today, but it also has the potential to reduce pain and suffering for millions of baby boomers as they age. We are incredibly excited to move forward."

Because of the strong reputations held by their spinal surgeons, specifically Dr. Dimmig, Dr. David Musante and Dr. Ralph Liebelt, Triangle Orthopaedic Associates and NCSH were selected to participate. The team's strong work ethic and heightened commitment to this cause helped them become the first site to begin work on the trial.

Other designated sites including Yale University Spine Center, UCLA Medical Center and the Texas Back Institute are expected to initiate their trials within the next 60 days. It is anticipated the study will take approximately five years to complete, including all patient follow-up, which is a minimum of two years. Researchers plan to submit their results to the U.S. Food and Drug Administration (FDA) for approval and release of the Stabilimax NZ by the end of 2012.

Triangle Orthopaedic Associates
Triangle Orthopaedic Associates, P.A. is the Triangle's largest physician-directed orthopaedic medical practice, caring for patients with musculoskeletal and pain problems through state-of-the-art medical treatment, surgery, physical medicine & rehabilitation, physical therapy, occupational (hand) therapy, a chronic pain program, and other medical and diagnostic services responsive to the needs of patients living within the counties they serve.

www.triangleortho.com