title: Twelve-month results of a multicenter, blinded, pilot study of a novel peptide (B2A) in promoting lumbar spine fusion.
abstract: OBJECTIVE
  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/cm(3) granules, n = 8), and a Prefix 750 group (treated with Prefix 750 μg/cm(3) 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.
authors.affiliation: McGill University Health Centre, McGill University, Montreal, Quebec;
authors.forename: Zeeshan
authors.initials: Z
authors.lastname: Sardar
authors.forename: David
authors.initials: D
authors.lastname: Alexander
authors.forename: William
authors.initials: W
authors.lastname: Oxner
authors.forename: Stephan
authors.initials: S
authors.lastname: du Plessis
authors.forename: Albert
authors.initials: A
authors.lastname: Yee
authors.forename: Eugene K
authors.initials: EK
authors.lastname: Wai
authors.forename: D Greg
authors.initials: DG
authors.lastname: Anderson
authors.forename: Peter
authors.initials: P
authors.lastname: Jarzem
mesh_terms: D000328:Adult; D000368:Aged; D002170:Canada; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010455:Peptides / Q000627:therapeutic use*; D010865:Pilot Projects; D019106:Postoperative Hemorrhage; D011994:Recombinant Proteins / Q000627:therapeutic use*; D012447:Sacrum / Q000601:surgery*; D016037:Single-Blind Method; D013123:Spinal Fusion / Q000379:methods*; D016896:Treatment Outcome
chemical_list: C505367:B2A2 peptide; D010455:Peptides; D011994:Recombinant Proteins
keywords: BMP; ICBG = iliac crest bone graft; ODI = Oswestry Disability Index; PEEK = polyetheretherketone; Prefix; TLIF; TLIF = transforaminal lumbar interbody fusion; VAS = visual analog scale; bone graft; degenerative disc disease; lumbar; rhBMP-2 = recombinant human bone morphogenetic protein-2; spine fusion; spondylolisthesis