New York, NY—July 2, 2002
With its recent FDA approval, the use of rhBMP-2 for spinal fusion surgeries is now available at Hospital for Special Surgery. rhBMP-2, or recombinant human bone morphogenetic protein, is a genetically produced biologic protein that can induce the body to grow its own bone where needed. This new method for spinal fusion offers patients a procedure that is not only less invasive and less painful but it also affords patients a quicker recovery time.
According to Dr. Harvinder Sandhu, an attending spine surgeon at HSS, “rhBMP-2 has the potential to not only completely change the way surgeons do spinal fusions but to revolutionize all orthopedic surgeries.” Dr. Sandhu, who has been a Lead Investigator on the clinical trials of BMP-2 for more than six years, further noted, “This medical advance is an example of the wonderful benefits that mankind will derive from the efforts of genetic research and the human genome project.”
Who is eligible for this procedure?
The ideal candidate for this procedure is anyone who has been diagnosed with degenerative disc disease, arthritis of the spine, instability of the spine, and spondylolisthesis.
How does rhBMP-2 work?
Surgeons in the operating room prepare the rhBMP-2 (InFUSE™ Bone Graft) by combining the protein in powder form with saline solution and a collagen sponge about the size of a thumbnail. The sponge is then implanted into a titanium spinal fixation cage that itself is inserted in place of a damaged disc.
Cells that encounter the protein are prompted to start a process called osteogenesis, or bone creation. After a shortened healing period, bone grows through the collagen sponge and around parts of the cage, fusing the vertebrae together.
Traditional Spinal Fusion vs. rhBMP-2 Spinal fusion surgery involves the joining or fusing of one or more vertebrae to reduce pain and stabilize the spine. Traditionally, spinal fusion requires the transplant of bone chips from a patient's pelvis to the spinal vertebrae to help "fuse" them together. Although this procedure can be very effective for the treatment of certain spinal disorders, the bone transplantation procedure (bone grafting) can prolong surgery and increase blood loss, hospital stay, recovery time, and recovery pain. Nearly 40% of patients who have had bone grafting experience some discomfort even two years after surgery. Moreover, the bone grafting technique does not always reliably result in successful fusion of the vertebrae because of occasional inadequate bone growth. Since rhBMP-2 stimulates a patient’s own cells to make more bone, it eliminates the need for bone grafts from the hip. As a result, it is less invasive and less painful.
History of rhBMP-2
The process of stimulating bone growth within the body is known as osteoinduction. One of the pioneers in the science of osteoinduction was Dr. Marshall Urist, Professor Emeritus of the Department of Orthopaedic Surgery at the UCLA School of Medicine. More than 35 years ago, Dr. Urist discovered that the proteins that directed bone to heal itself were contained within its own matrix, or substance. It was not until 1988 that these proteins were individually identified and genetically reproduced. Thereafter, it was quickly discovered that rhBMP-2 could, by itself, direct the repair and regeneration of bone in various parts of the skeleton. In several laboratory experiments performed from 1993 to 1997, rhBMP-2 was shown to effectively stimulate bone growth along spinal vertebrae.
In 1997, rhBMP-2 was used for the first time in patients undergoing spinal fusion. In this initial clinical trial, all eleven patients who had been implanted with rhBMP-2 achieved successful fusion within 6 months from the time of surgery. In fact, 10 of these 11 patients had achieved their fusions within 3 months of surgery. Because these patients did not require bone grafting from the pelvis, their hospital stays were shorter and their post-surgical pain was less than typically seen with traditional bone grafting techniques. These promising initial findings were then studied in several larger clinical trials throughout the United States.
The latest study, which won the Volvo Award for Spine Research from the International Spine Society (May 2002) demonstrated that patients who were implanted with rhBMP-2 (InFUSE™) were able to achieve consistent spinal fusion even without the use of metal implants (rods and screws). These patients had shorter surgical time, less blood loss and less postoperative pain.
rhBMP-2 (InFUSE™) is produced by Medtronic Sofamor Danek, headquartered in Memphis, Tenn. Their website is located at www.medtronicsofamordanek.com.
About Hospital for Special Surgery
Hospital for Special Surgery (HSS) is the world’s leading academic medical center focused on musculoskeletal health. HSS is nationally ranked No. 1 in orthopedics and No. 2 in rheumatology by U.S. News & World Report (2016-2017), and is the first hospital in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. HSS has one of the lowest infection rates in the country. HSS is an affiliate of Weill Cornell Medical College and as such all Hospital for Special Surgery medical staff are faculty of Weill Cornell. The hospital's research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. Hospital for Special Surgery is located in New York City and online at www.hss.edu.