title: Grafton and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions.
abstract: METHODS
  Prospective multicenter randomized clinical trail.
  
  
  OBJECTIVE
  The goal of our 2-year prospective study was to perform a randomized clinical trial comparing the outcomes of Grafton demineralized bone matrix (DBM) Matrix with local bone with that of iliac crest bone graft (ICBG) in a single-level instrumented posterior lumbar fusion.
  
  
  BACKGROUND
  There has been extensive research and development in identifying a suitable substitute to replace autologous ICBG that is associated with known morbidities. DBMs are a class of commercially available grafting agents that are prepared from allograft bone. Many such products have been commercially available for clinical use; however, their efficacy for spine fusion has been mostly based on anecdotal evidence rather than randomized controlled clinical trials.
  
  
  METHODS
  Forty-six patients were randomly assigned (2:1) to receive Grafton DBM Matrix with local bone (30 patients) or autologous ICBG (16 patients). The mean age was 64 (females [F] = 21, males [M] = 9) in the DBM group and 65 (F = 9, M = 5) in the ICBG group. An independent radiologist evaluated plain radiographs and computed tomographic scans at 6-month, 1-year, and 2-year time points. Clinical outcomes were measured using Oswestry Disability Index (ODI) and Medical Outcomes Study 36-Item Short Form Health Survey.
  
  
  RESULTS
  Forty-one patients (DBM = 28 and ICBG = 13) completed the 2-year follow-up. Final fusion rates were 86% (Grafton Matrix) versus 92% (ICBG) (P = 1.0 not significant). The Grafton group showed slightly better improvement in ODI score than the ICBG group at the final 2-year follow-up (Grafton [16.2] and ICBG [22.7]); however, the difference was not statistically significant (P = 0.2346 at 24 mo). Grafton showed consistently higher physical function scores at 24 months; however, differences were not statistically significant (P = 0.0823). Similar improvements in the physical component summary scores were seen in both the Grafton and ICBG groups. There was a statistically significant greater mean intraoperative blood loss in the ICBG group than in the Grafton group (P < 0.0031).
  
  
  CONCLUSIONS
  At 2-year follow-up, subjects who were randomized to Grafton Matrix and local bone achieved an 86% overall fusion rate and improvements in clinical outcomes that were comparable with those in the ICBG group.
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA. kangjd@upmc.edu
authors.forename: James
authors.initials: J
authors.lastname: Kang
authors.forename: Howard
authors.initials: H
authors.lastname: An
authors.forename: Alan
authors.initials: A
authors.lastname: Hilibrand
authors.forename: S Tim
authors.initials: ST
authors.lastname: Yoon
authors.forename: Eoin
authors.initials: E
authors.lastname: Kavanagh
authors.forename: Scott
authors.initials: S
authors.lastname: Boden
mesh_terms: D000368:Aged; D016025:Bone Transplantation / Q000379:methods*; D001842:Bone and Bones; D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D005990:Glycerol; D006801:Humans; D007085:Ilium; D008137:Longitudinal Studies; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D013123:Spinal Fusion / Q000379:methods*; D013168:Spondylolisthesis / Q000601:surgery*; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: C497176:Grafton demineralized bone matrix gel; D005990:Glycerol