title: Clinical evaluation of an allogeneic bone matrix containing viable osteogenic cells in patients undergoing one- and two-level posterolateral lumbar arthrodesis with decompressive laminectomy.
abstract: BACKGROUND
  Trinity Evolution® cellular bone allograft (TE) possesses the osteogenic, osteoinductive, and osteoconductive elements essential for bone healing. The purpose of this study is to evaluate the radiographic and clinical outcomes when TE is used as a graft extender in combination with locally derived bone in one- and two-level instrumented lumbar posterolateral arthrodeses.
  
  
  METHODS
  In this retrospective evaluation, a consecutive series of subject charts that had posterolateral arthrodesis with TE and a 12-month radiographic follow-up were evaluated. All subjects were diagnosed with degenerative disc disease, radiculopathy, stenosis, and decreased disc height. At 2 weeks and at 3 and 12 months, plain radiographs were performed and the subject's back and leg pain (VAS) was recorded. An evaluation of fusion status was performed at 12 months.
  
  
  RESULTS
  The population consisted of 43 subjects and 47 arthrodeses. At 12 months, a fusion rate of 90.7 % of subjects and 89.4 % of surgical levels was observed. High-risk subjects (e.g., diabetes, tobacco use, etc.) had fusion rates comparable to normal patients. Compared with the preoperative leg or back pain level, the postoperative pain levels were significantly (p < 0.0001) improved at every time point. There were no adverse events attributable to TE.
  
  
  CONCLUSIONS
  Fusion rates using TE were higher than or comparable to fusion rates with autologous iliac crest bone graft that have been reported in the recent literature for posterolateral fusion procedures, and TE fusion rates were not adversely affected by several high-risk patient factors. The positive results provide confidence that TE can safely replace autologous iliac crest bone graft when used as a bone graft extender in combination with locally derived bone in the setting of posterolateral lumbar arthrodesis in patients with or without risk factors for compromised bone healing.
  
  
  BACKGROUND
  Because of the retrospective nature of this study, the trial was not registered.
authors.affiliation: Triangle Orthopedics, 120 William Penn Plaza, Durham, NC, 27704, USA. dmusante@triangleortho.com.
authors.forename: David B
authors.initials: DB
authors.lastname: Musante
authors.affiliation: Campbell School of Osteopathic Medicine, Campbell University, 4350 US-421, Lillington, NC, 27546, USA.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Firtha
authors.affiliation: Atkinson Biologics Consulting, 9189 Fox Fire Way, Highlands Ranch, Littleton, CO, 80129, USA.
authors.forename: Brent L
authors.initials: BL
authors.lastname: Atkinson
authors.affiliation: Orthofix Inc., 3451 Plano Parkway, Lewisville, TX, 75056, USA.
authors.forename: Rebekah
authors.initials: R
authors.lastname: Hahn
authors.affiliation: Orthofix Inc., 3451 Plano Parkway, Lewisville, TX, 75056, USA.
authors.forename: James T
authors.initials: JT
authors.lastname: Ryaby
authors.affiliation: Orthofix Inc., 3451 Plano Parkway, Lewisville, TX, 75056, USA.
authors.forename: Raymond J
authors.initials: RJ
authors.lastname: Linovitz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001857:Bone Matrix / Q000502:physiology / Q000637:transplantation*; D016025:Bone Transplantation / Q000379:methods*; D002470:Cell Survival / Q000502:physiology; D019299:Decompression, Surgical / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007796:Laminectomy / Q000379:methods*; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010012:Osteogenesis / Q000502:physiology; D010147:Pain Measurement / Q000379:methods; D012189:Retrospective Studies; D013123:Spinal Fusion / Q000379:methods*; D014182:Transplantation, Autologous / Q000379:methods
keywords: Bone graft extender; Cellular bone allograft; Lumbar spine fusion; Spinal arthrodesis; Trinity Evolution