Health Problem: It is estimated that 1.5 million bone-grafting operations are performed annually in the United States. One major application of bone grafting is in lumbar and cervical spinal fusion. Spinal fusion is performed for a variety of reasons, including trauma, herniated intervertebral discs, and degenerative disease. Spinal fusion has traditionally been performed with bone grafted from the iliac crest of the patient’s pelvis, which can cause complications at the donor site, including pain, injury to local nerves or vessels, hematoma, infection, and gait disturbance.

Technology Description: Recombinant human bone morphogenetic proteins (rhBMPs) are being evaluated as replacements for bone autografts to avoid the pain and other potential complications associated with harvesting of bone from the patient. The procedure involves 3 components: a spinal fusion cage, an rhBMP, and a carrier or scaffold for the BMP and resulting bone. Since rhBMPs are water soluble, they readily diffuse in body fluids. In order to stay confined within the region of repair, rhBMP must be used in conjunction with a suitable carrier, such as powdered collagen, a collagen sponge, or putty that contains collagen.

Controversy: Use of rhBMPs may not be necessary to achieve fusion and may cause complications, such as excessive bone growth around the site of spinal fusion. There is also controversy about whether the growth-stimulating effect of rhBMP could increase the risk of cancer.

Key Questions:

  • Is rhBMP-2 effective in promoting fusion or improving symptoms and function, and how do these products compare with autografts for achieving fusion in patients treated for lumbar, cervical, or thoracic degenerative disc disease?
  • Are rhBMP products safe compared with autografts for lumbar, cervical, or thoracic spinal fusion?
  • Have definitive patient selection criteria been established for the use of rhBMP products in spinal fusion as an alternative to autografting?

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