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Triangle Doctors Successfully Perform Cutting-Edge Disc Replacement
Posted: 03-07-2007 : DURHAM, N.C.
DURHAM, NC – Surgeons at Triangle Orthopaedic Associates, the Triangle’s premier, physician-directed orthopaedic practice, successfully implanted the DISCOVER Artificial Cervical Disc in a female patient suffering from degenerative disc disease late last week. Triangle Orthopaedic Associates is one of only 30 facilities nationwide chosen to participate in this randomized clinical trial. This was the latest of three artificial disc-replacement, FDA trials initiated by Triangle Orthopaedic Associates since May 2005.
Sponsored by DePuy Spine, Inc., a Johnson & Johnson company, the trial will evaluate short and long-term safety and efficacy of the device for single and two-level cervical degenerative disc disease, a common cause of neck and arm pain. Data from the trial will be submitted to the U.S. Food and Drug Administration (FDA) as part of an application seeking approval for use of the device in the U.S.
“The patient is recovering well, as expected,” said Dr. David Musante, M.D., the spinal surgeon at Triangle Orthopaedic Associates who performed the surgery. “We are excited to monitor her progress in order to better understand treatment options for patients suffering degenerative disc disease.”
Surgeons performed the procedure at North Carolina Specialty Hospital, partly owned by, and located adjacent to, Triangle Orthopaedic Associates. Together, the facilities are gaining a national reputation for orthopaedic research. This allows patients suffering from painful orthopaedic conditions, such as degenerative disc disease, to choose among several treatment options to best meet their individual needs.
Consisting of a ball and socket design constructed from titanium and polyethylene, the DISCOVER Artificial Cervical Disc is being evaluated on safety and its ability to positively impact pain, range of motion, disc height, and adjacent level disease. In addition, biomechanical stability will be compared to spinal fusion surgery.
Approximately 200,000 cervical spinal fusions are performed in the U.S. each year, making it the most common surgical treatment for cervical degenerative disc disease. During this procedure, a bone graft is inserted in the cervical disc space and a plate is implanted to fuse the segments together and relieve pain.
“The DISCOVER Artificial Cervical Disc study represents our continued commitment to advancing spine arthroplasty,” said Richard Toselli, M.D., vice president of research and development at DePuy Spine, Inc. “We look forward to seeing the results.”
Currently, the DISCOVER Artificial Cervical Disc is limited by federal law to investigational use. The device is in a limited release in select European markets.
About Triangle Orthopaedic Associates Triangle Orthopaedic Associates, P.A. is the Triangle’s largest physician-directed medical practice, caring for patients with musculoskeletal and pain problems through state-of-the-art medical treatment, surgery, physical medicine and 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 it serves. www.triangleortho.com
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. Today, DePuy Spine stands in the forefront of the worldwide spine market, with a substantial sales organization in the U.S. and an expanding worldwide distribution network. The company is committed to advancing the knowledge of all health care professionals and their patients in addressing spinal pathologies. www.depuyspine.com
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