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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.



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