This study is the first prospective, controlled, long-term trial performed to date on ABM/ P-15 for use in PLIF. 14ġ5 ABM/P-15 was originally developed and approved by the FDA for use in dental applications, with demonstrated clinical superiority to both demineralized bone matrix and allograft 18ġ9 and a solid safety profile and it has been in human clinical use in periodontal osseous defects for more than a decade. This study seeks to add to the dialogue by evaluating the clinical results, safety, and efficacy of a novel osteobiologic peptide enhanced bone graft material (i-FACTOR, Cerapedics Inc., Westminster, Colorado USA) for use in PLIF.ĪBM/P-15 combines anorganic bone mineral (ABM, a natural defect hydroxyapatite) and P-15, a synthetic 15 amino acid polypeptide which acts as an attachment factor for osteogenic cells 13– 17 and which stimulates new bone formation. 8– 12 Clinicians and researchers continue to explore bone graft alternatives that are safe, economical, and comparably effective to autologous bone. 6ħ One promising alternative, rhBMP-2, has recently come under increased scrutiny. There are a variety of bone graft substitutes available. 2 While autologous bone remains the gold standard for bone graft material in PLIF, associated risks of graft site morbidity ranging up to 25.3%, including chronic pain and other complications, have been well documented. 1 When degenerative disease is the cause and unresponsive to conservative therapies, posterior lumbar interbody fusion (PLIF) is an effective surgical technique to address chronic pain. Low back pain is common, with a lifetime incidence of 85%.
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