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Clinical Trials Open for New Treatment of Spinal Stenosis

Hospital for Special Surgery First NYC Hospital to Offer this Procedure

New York, NY—November 14, 2002

Hospital for Special Surgery is now conducting a clinical trial on the usage of OP-1 Putty for the treatment of spinal stenosis, a degenerative condition of the spine that is characterized by pain in the lower back that radiates down to the buttocks and lower legs.

OP-1 Putty is a new method of spinal fusion that is especially advantageous to elderly patients because it offers a one-site surgical procedure that is not only less invasive and less painful but also affords patients a quicker recovery time. OP-1, or osteogenic protein, is a genetically produced recombinant human protein known as a bone morphogenetic protein (BMP). BMPs are naturally occurring factors known to induce the body to grow its own bone where needed.

According to Dr. James Farmer, an attending spine surgeon at HSS, “As our lifespan continues to grow longer, spinal stenosis will inevitably become more and more common. OP-1 enables us to offer a treatment that eliminates a second surgical site. As a result, the operation has less postoperative pain and shorter surgical time.”

Who is eligible for this clinical trial?

The ideal candidate for this trial is a skeletally mature adult under 81 years of age who requires fusion because of abnormal movement in the spine caused by degenerative changes. These patients often have severe pain in their lower back and legs. They are diagnosed as having degenerative lumbar spondylolisthesis with spinal stenosis, which requires decompression and fusion at one spinal level. It is estimated that as many as 400,000 Americans, most of them over 60, may currently be experiencing symptoms of lumbar spinal stenosis.

How does OP-1 work?

Surgeons in the operating room prepare the OP-1 (Osteogenic Protein-1) Putty by combining the protein in powder form with sterile saline solution to become a putty. The putty is packed onto the tissue surrounding the 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, fusing the vertebrae together.

Traditional Spinal Fusion vs. OP-1

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, increase blood loss, increase hospital stay, increase recovery time, and increase 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 OP-1 stimulates a patient’s own cells to make more bone, it eliminates the need for obtaining bone grafts from the hip. As a result, it is less invasive and less painful.

OP-1 Putty is produced by Stryker Biotech, headquartered in Hopkinton, MA, http://www.op1.com.

 

About HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the eighth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2017-2018). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

 

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