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Amplex: Bone Graft Materials  |  Bone Graft Materials  |  Mechanism of Action

Bone Graft Materials

Back pain and spine fusion

Back pain is the second most common reason for doctors’ visits in the U.S.1, afflicting 60-80% of adults in their lifetime. Frequently, back pain is caused by degeneration of the discs between vertebrae of the spine which collapses the boney vertebrae onto nerve roots that radiate from the spinal cord. For those patients with chronic pain that is not relieved by more conservative treatment, spine fusion is an option. Spine fusion is a surgical procedure to alleviate this pain by first relieving pressure on the nerves and then fusing the vertebrae together so that recurrent collapse and pain is eliminated. Fusion is achieved by placing a bone graft between the two vertebrae with the goal of stimulating bone to grow between the two vertebrae. Hardware (plates/rods/screws) is typically used as an “internal cast” to stabilize the joint as it fuses.

Iliac Crest Bone Autograft – the “Gold Standard”

The gold standard in bone grafting for spinal fusion is to use bone graft surgically removed from the patient’s pelvic bone along the iliac crest of the hip. This requires an additional surgical procedure to harvest the bone which is typically morselized and placed in the intervertebral space.

Disadvantages of autograft for spinal fusion are well known and include:

  • increased surgical time
  • increased blood loss
  • added costs and risk of increased hospitalization time
  • the risk of chronic hip pain
  • limited supply over a persons lifetime

Bone Graft Alternatives

Within the orthopedic community, there is a strong desire to develop alternative techniques and materials that would replace iliac crest autograft material. Recombinant bone morphogenic proteins (rBMPs) have recently received Food and Drug Administration’s (FDA’s) approval and are intended to be replacements for iliac crest autograft.

Find out more. Visit the North American Spine Society website for more information on bone graft alternatives.

Disadvantages of rBMPs: rBMPs are expensive, adding substantial cost to the price of the surgery with controversial cost effectiveness2,3. Also, there is an increasing number of studies4-8 demonstrating unanticipated adverse events associated with clinical use of rBMP-2.

Find out more. Visit the North American Spine Society website for more information on bone morphogenetic proteins.

The Amplex™ Alternative

Amplex is currently in development to eliminate iliac crest autograft harvest, effectively and reliably promote spinal fusion, and provide a safe and cost effective alternative to products containing recombinant proteins. Find out more.


  1. Frymoyer JW, Cats-Baril WL. An overview of the incidences and costs of low back pain. Orthop Clin North Am 1991;22:263-71.
  2. Garrison KR, Donell S, Ryder J, Shemilt I, Mugford M, Harvey I, Song F. Clinical effectiveness and cost-effectiveness of bone morphogenetic proteins in the non-healing of fractures and spinal fusion: a systematic review. Health Technol Assess 2007;11(30):1-150, iii-iv.
  3. Khan SN, Lane JM. The use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in orthopedic applications. Expert Opin Biol Ther 2004;4(5):741-8.
  4. Buttermann GR. Prospective nonrandomized comparison of an allograft with bone morphogenic protein versus an iliac-crest autograft in anterior cervical discectomy and fusion. Spine J 2007.
  5. Komai Y, Morimoto S, Saito K, Urushibara M, Sakai K, Ikeda S. Possible involvement of bone morphogenetic protein 2 in heterotopic ossification in metastatic lesion from urothelial carcinoma of bladder. Int J Urol 2006;13(8):1126-8.
  6. Joseph V, Rampersaud YR. Heterotopic bone formation with the use of rhBMP2 in posterior minimal access interbody fusion: a CT analysis. Spine 2007;32(25):2885-90.
  7. Robinson Y, Heyde CE, Tschoke SK, Mont MA, Seyler TM, Ulrich SD. Evidence supporting the use of bone morphogenetic proteins for spinal fusion surgery. Expert Rev Med Devices 2008;5(1):75-84.
  8. Wong DA, Kumar A, Jatana S, Ghiselli G, Wong K. Neurologic impairment from ectopic bone in the lumbar canal: a potential complication of off-label PLIF/TLIF use of bone morphogenetic protein-2 (BMP-2). Spine J 2007.