Journal of neurosurgery. Spine
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Randomized Controlled Trial Multicenter Study Comparative Study
Twelve-month results of a multicenter, blinded, pilot study of a novel peptide (B2A) in promoting lumbar spine fusion.
Failure of fusion after a transforaminal lumbar interbody fusion (TLIF) procedure is a challenging problem that can lead to ongoing low-back pain, dependence on pain medication, and inability to return to work. B2A is a synthetic peptide that has proven efficacy in achieving fusion in animal models and may have a better safety profile than bone morphogenetic protein. The authors undertook this study to evaluate the safety and efficacy of B2A peptide-enhanced ceramic granules (Prefix) in comparison with autogenous iliac crest bone graft (ICBG, control) in patients undergoing single-level TLIF. ⋯ Prefix appears to provide a safe alternative to autogenous ICBG. Prefix 750 appears to show superior radiographic fusion when compared with autograft at 12 months after TLIF, although no statistically significant difference was demonstrated in this small study. Prefix and control groups both appeared to demonstrate comparable improvements to ODI at 12 months.