To help spine surgeons answer this question with greater certainty, the National Spine Network (NSN) has embarked on a prospective, randomized, multi-center clinical trial comparing the outcomes of spinal cord stimulation with repeat spine surgery for patients suffering from Failed Back Surgery Syndrome (FBSS). The announcement of the study, which begins enrolling patients this month and is sponsored by Medtronic (NYSE: MDT), was made here today at the American Academy of Orthopedic Surgeons (AAOS) meeting.

Approximately 200,000 Americans annually undergo an initial spine surgery for the treatment of chronic low back pain, according to a 1998 survey of spine surgeons commissioned by Medtronic. The same research indicates that about 25 percent of these patients continue to experience unresolved pain after surgery. And, despite a second procedure to relieve the pain, more than 13,000 patients still suffer from unresolved pain.

"This landmark NSN study promises to yield the data we need to make the best treatment recommendations for patients with low back pain that remains unresolved after a successful spine surgery," said Bruce Fredrickson, M.D., an orthopedic surgeon specializing in spine procedures at the SUNY Upstate Medical University in Syracuse, N.Y. and the principal investigator for the study. "For the first time, we are undertaking research of sufficient scope to predict which patients are most likely to benefit from additional surgery and which patients are better candidates for spinal cord stimulation."

The study also seeks to determine which treatment option -- spinal cord stimulation or repeat spine surgery -- provides reduced pain, greater functional status, improved quality of life and reduced disability to patients with unresolved low back pain.

"The National Spine Network advocates an interdisciplinary approach to the treatment of spine disorders, including chronic low back pain," said Harry Freedman, executive director of NSN, an association of the country's leading comprehensive spine centers. "Our involvement in this study demonstrates the NSN's commitment to improve the cost-effectiveness, consistency and quality of spine care."

Eleven NSN members are participating in the study: Washington University Medical Center in St. Louis, Mo.; Emory Spine Center in Decatur, Ga.; Hospital for Joint Diseases in New York; Hospital for Special Surgery in New York; Nebraska Spine Center in Omaha; Swedish Medical Center - Providence Campus in Seattle; Rush Presbyterian-St.Luke's Medical Center in Chicago; SUNY Upstate Medical Center in Syracuse, N.Y.; Texas Back Institute in Plano; University Hospitals of Cleveland in Ohio; University of Iowa Medical Center in Iowa City.

The study calls for the enrollment of 150 patients by early 2003. Once enrolled, each patient will be followed for 24 months with follow-ups at three, six, 12, 18 and 24 months. The final results of the study are expected to be published by 2005.

Candidates for the study must meet all entry criteria, including previous back surgery more than a year prior to enrollment, failure of alternative treatment measures such as medical or physical therapies, disabling pain that has limited their social and vocational activities, age 20 or older, no medical contraindication to surgery (including pregnancy) and clearance from a clinical psychiatrist if indicated.

Spinal cord stimulation and spine surgery can significantly reduce chronic low back pain of neuropathic etiology. Spinal cord stimulation works by blocking pain signals from reaching the brain, where they would be perceived as pain. Spine surgery works by either decompressing pinched nerves that cause pain or connecting two or more bones in the spine.

As with any treatment, side effects can occur. Because spinal cord stimulation systems are surgically placed, infections are possible. Potential complications from spinal cord stimulation may include undesirable changes in stimulation, lead migration and loss of pain-relieving effects in some patients. Risks of surgery include excessive bleeding and an adverse reaction to anesthesia. Since spine surgery involves the nervous system, nerve damage is another risk. Both spinal cord stimulation and reoperation are standard medical procedures used to treat chronic pain.

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com. Medtronic makes a full range of implanted medical devices, instrumentation and image-guided surgery systems for the treatment of spinal disorders, including chronic low back pain.

The National Spine Network (NSN), based in Marietta, Ga., is a non-profit organization comprised of 28 independent centers of excellence for spine care. NSN's mission is to improve the cost-effectiveness, consistency and quality of spine care. Its Internet address is www.NSNonline.org.