title: A prospective pilot study of B2A-coated ceramic granules (Amplex) compared to autograft for ankle and hindfoot arthrodesis.
abstract: BACKGROUND
  To reduce fusion nonunion, autogenous bone graft is often incorporated into foot and ankle fusion procedures. B2A peptide-coated ceramic granules, with encouraging results in pilot studies of transforaminal lumbar interbody fusion, were here reformulated into Amplex with a coating concentration of 225 μg B2A/cm(3) ceramic granules (B2A-granule) with the goal of eliminating autogenous bone graft in foot and ankle arthrodesis. The purpose of this study was to perform a multicenter prospective randomized pilot clinical trial designed to compare the safety and effectiveness of B2A-granule to autogenous bone graft in patients undergoing foot and ankle arthrodesis surgery.
  
  
  METHODS
  This study was a multicenter, prospective, randomized, pilot clinical trial designed to compare safety and effectiveness of B2A-granule to autogenous bone graft in patients undergoing foot and ankle arthrodesis surgery. Twenty-four patients were enrolled and randomized (1:1) into 2 groups: autogenous bone graft control and B2A-granule. Primary outcome measures at 6 months (with follow-up at 9 and 12 months) included radiographic fusion assessed by computerized tomography and Ankle Osteoarthritis Scale scores for pain and disability.
  
  
  RESULTS
  Radiographic fusion success rates were similar in both groups (100% in the B2A-granule group, 92% autograft). Both the B2A-granule group and the autograft group had improvements in the pain and disability scores over the course of the study. Graft harvest-site pain affected only autograft-treated patients. There were no adverse events attributed to the graft material in either the B2A-granule or autograft group.
  
  
  CONCLUSIONS
  The results of this pilot study are supportive of a larger clinical trial to assess the safety and efficacy of B2A-granule as a bone graft substitute in foot and ankle fusions.
  
  
  METHODS
  Level II, prospective comparative study.
authors: Dalhousie University, Halifax, NS, Canada. markglazer@ns.sympatico.ca
authors: Mark
authors: M
authors: Glazebrook
authors: Alastair
authors: A
authors: Younger
authors: Kevin
authors: K
authors: Wing
authors: Karl-Andre
authors: KA
authors: Lalonde
mesh_terms: D000328:Adult; D000368:Aged; D001174:Arthrodesis / Q000379:methods*; D018786:Bone Substitutes / Q000008:administration & dosage* / Q000737:chemistry; D016025:Bone Transplantation / Q000379:methods*; D002516:Ceramics; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000601:surgery; D010455:Peptides / Q000008:administration & dosage* / Q000737:chemistry; D010865:Pilot Projects; D011446:Prospective Studies; D011859:Radiography; D013639:Tarsal Bones / Q000000981:diagnostic imaging / Q000601:surgery*; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D018786:Bone Substitutes; D010455:Peptides
keywords: B2A; ankle fusion; arthrodesis; bone graft; clinical trial; synthetic peptide