ROYAL OAK, Mich., July 13 /PRNewswire/ -- Orthopedic surgeons at Beaumont Hospital have performed the first spinal fusion surgery using a new, genetically engineered protein.
The experimental surgery using the protein known as rhGDF-5 is part of a clinical trial underway at Beaumont and five other sites across the United States. The protein is placed on a specially-designed sponge and inserted between the vertebrae to encourage bone growth and stability at the fusion site.
Currently, spinal fusion surgery, where one or more of the vertebrae of the spine are fused together so that motion no longer occurs between them, actually consists of two separate invasive procedures. The first involves removing small pieces of bone from the patient's pelvis. The second involves implanting those pieces into the spine at the fusion site to encourage the vertebrae to fuse together. Approximately 400,000 spinal fusions are performed nationally each year for the treatment of back and leg pain.
Doctors believe the use of rhGDF-5 may eliminate the need to surgically harvest pelvic bone for the fusion surgery, a procedure that can result in significant post-operative pain and complications such as pelvic fracture or infection.
"Our goal is to determine the safety and effectiveness of rhGDF-5 in patients undergoing spinal fusion surgery as compared to the traditional method," says Jeffrey Fischgrund, M.D., Beaumont orthopedic spine surgeon, and the hospital's principal investigator for the study.
The investigation of this protein and HEALOS, its delivery system, is sponsored by DePuy Spine, Inc., a Johnson & Johnson Company. RhGDF-5 was discovered by Biopharm GmbH, which partnered with DePuy Spine to create this combined product now under evaluation. NOTE: Although HEALOS has been cleared
for sale as a bone graft substitute by the U.S. Food and Drug Administration (FDA), when combined with rhGDF-5, it is considered an investigational device and not currently approved for sale in the U.S.
Beaumont has Orthopedic Centers at the Royal Oak and Troy hospitals offering hip and knee replacements, shoulder, hand, foot and ankle surgeries, non-surgical treatments and pediatric orthopedics. In addition, it is one of the nation's highest-volume spine surgery centers.
A member of the 2004 U.S. News and World Report's top 50 list in Orthopedics, Beaumont has also been listed in "Ten of a Kind -- Top 10 Knee-Hip Orthopedic Hospitals" in the AARP Modern Maturity magazine and named to the Solucient "100 Top Orthopedic Hospitals -- Knee Replacement, Hip Replacement."
Beaumont HospitalCONTACT: Online - Brian Bierley, bbierley@beaumonthospitals.com, orRadio\TV - Brian Taylor, btaylor@beaumonthospitals.com, or Print - IleneWolff, iwolff@beaumonthospitals.com, all for Beaumont Hospital,+1-248-551-0740
