Twelve-month results of a multicenter, blinded, pilot study of a novel peptide (B2A) in promoting lumbar spine fusion

OBJECT: 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. METHODS: Twenty-four patients with single-level degenerative disorders of the lumbar spine at L2-S1 requiring TLIF were enrolled between 2009 and 2010. They were randomly assigned to 3 groups: a control group (treated with ICBG, n = 9), a Prefix 150 group (treated with Prefix 150 μg/cm³ granules, n = 8), and a Prefix 750 group (treated with Prefix 750 μg/cm³ granules, n = 7). Outcome measures included the Oswestry Disability Index (ODI), visual analog pain scale, and radiographic fusion as assessed by CT and dynamic flexion/extension lumbar plain radiographs. RESULTS: At 12 months after surgery, the radiographic fusion rate was 100% in the Prefix 750 group, 78% in the control group, and 50% in the Prefix 150 group, although the difference was not statistically significant (p = 0.08). At 6 weeks the mean ODI score was 41.0 for the control group, 27.7 for the Prefix 750 group, and 32.2 for the Prefix 150 group, whereas at 12 months the mean ODI was 24.4 for control, 31.1 for Prefix 750, and 29.7 for Prefix 150 groups. Complications were evenly distributed among the groups. CONCLUSIONS: 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.