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Biologic Bone Grafts Compared to Conventional Bone Graft Substitutes

A large selection of bone graft substitutes now exists as clinicians continue to look for a good alternative to autograft bone -- long considered the gold standard bone graft. Today, the two main categories of bone graft substitutes include conventional, inactive bone graft substitutes (simple scaffolds) and a new class of biologic bone grafts with active osteogenic properties.

 

i-FACTOR™ is an “Attachment Factor”

i-FACTOR Biologic Bone Graft is a new type of bioactive bone graft that mimics the body’s natural bone healing response. i-FACTOR is an "attachment factor" that uses a novel mechanism of action centered around the cell binding of osteogenic cells via α2β1 integrins to a patented, synthetic small peptide (P-15™).

The Ideal Bone Graft

From a surgeon's perspective, the ideal bone graft substitute should be:

  1. Osteoinductive and osteoconductive
  2. Easy to use when handling
  3. Safe to use, without causing ectopic bone growth or other adverse events

 

A New Biologic Option

Marshall R. Urist, MD, defined osteoinduction as “a process that supports the mitogenesis of undifferentiated mesenchymal cells leading to the formation of osteoprogenitor cells with the capacity to form new bone.”1 Therefore, any material that induces this process could be considered to be osteoinductive.i-FACTOR is proven to enhance cell binding and stimulate the natural production of bone morphogenic proteins and growth factors, resulting in new bone formation.3

i-FACTOR is the only biologic bone graft that combines the synthetic small peptide P-15™ with anorganic bone mineral (ABM). This unique combination replicates the organic (Type I human collagen) and inorganic (calcium phosphate) components of autograft bone and creates the ideal template for new bone formation.

What Makes Biologic i-FACTOR Unique

i-FACTOR Biologic Bone Graft possesses three unique characteristics that allow it to compete effectively against other bone graft substitutes:

  1. i-FACTOR demonstrates efficacy equivalent to autograft.4
  2. i-FACTOR is a biologically active medical device that stimulates natural bone growth.5
  3. i-FACTOR (ABM/P-15) has been used clinically for more than a decade, in an estimated 500,000 cases, with a solid safety profile.  
 
 
1. Urist MR. Bone transplants and implants. In: Urist MR, editor. Fundamental and Clinical Bone Physiology. Philadelphia: Lippincott Williams and Wilkins; 1980. p 331-68.
 
2. Bone Grafts and Bone Graft Substitutes in Orthopaedic Trauma Surgery. A Critical Analysis. De Long, W.G. Jr., Einhorn, T.A., Koval, K., McKee, M., Smith, W., Sanders, R., Watson, T.  J Bone Joint Surg Am. 2007;89:649-658. doi:10.2106/JBJS.F.00465.
 
3. Biomimetic collagen scaffolds for human bone cell growth and differentiation. Yang, X.B., Bhatnager, R.S., Li, S., Oreffo, R.O.C. Tissue Engineering. 2004; Vol. 10, 7/8:1148-59.
 
4. Evaluation of ABM/P-15 versus autogenous bone in an ovine lumbar interbody fusion model. Sherman, B.P., Lindley, E.M., Turner, A.S., Seim, H.B. 3rd, Benedict, J., Burger, E.L., Patel, V.V. European Spine Journal; DOI 10.1007/s00586-010-1546-z.
 
5. P-15 small peptide bone graft substitute in the treatment of non-unions and delayed union: A pilot clinical trial. Gomar, F., MD; Orozco, R., MD; Villar, J.L., MD; Arrizabalaga, F., PhD. International Orthopaedics. 2006.