Comparison of Two Different Demineralized Bone Matrices to Autologous Bone Graft in an Athymic Rat Posterolateral Lumbar Fusion Model Antonio T. Brecevich, B.A.1; Paul D. Kiely, MCh, FRCS (Tr&Orth)2; B. Victor Yoon, M.S.1; Joseph T. Nguyen, MPH1; Frank P. Cammisa, M.D., FACS1; Celeste Abjornson, Ph.D.1 1Hospital 2Miami for Special Surgery, New York, NY Children’s Hospital, Miami, FL Introduction Iliac crest autologous bone graft (ABG) is considered the “gold standard” graft in spinal fusions. There is significant harvest morbidity associated with ABG, which led to the development of alternatives. Demineralized bone matrix (DBM) is a bone graft substitute. 2 Comparison of Two Different Demineralized Bone Matrices to Autologous Bone Graft in an Athymic Rat Posterolateral Lumbar Fusion Model Objective Comparison Groups 3 Novel DBM putty Established DBM putty “Gold Standard” • Accell Evo3® • Integra LifeSciences Corporation, Plainsboro, NJ • Grafton® • BioHorizons®, Birmingham, AL • Iliac Crest ABG Comparison of Two Different Demineralized Bone Matrices to Autologous Bone Graft in an Athymic Rat Posterolateral Lumbar Fusion Model Material and Methods 48 mature male athymic rats Uninstrumented bilateral intertransverse process fusion, using Evo3®, Grafton®, or ABG Euthanasia at 3 and 12 weeks post-surgery Evaluation techniques: Manual Palpation Radiographic Assessment of Fusion (Post-op, 3 weeks, 9 weeks) – Graded with Lenke classification Nondestructive Mechanical Testing – Lateral bending (both planes), flexion, and extension Histology Statistical Analysis Descriptive statistics (α = 0.05) 4 Comparison of Two Different Demineralized Bone Matrices to Autologous Bone Graft in an Athymic Rat Posterolateral Lumbar Fusion Model Results – Manual Palpation Fusion assessment at the time of sacrifice Three blinded observers At both the 3-week and 9-week intervals Fusion Rates 5 Evo3 Grafton ABG 3 Weeks 4/4 (100%) 4/4 (100%) 1/4 (25%) 9 Weeks 8/12 (66%) 12/12 (100%) 4/12 (33%) Comparison of Two Different Demineralized Bone Matrices to Autologous Bone Graft in an Athymic Rat Posterolateral Lumbar Fusion Model Results – Radiograph Fusion Rates Evo3 (A) Grafton (B) ABG (C) A 12/16 (75%) 12/16 (75%) 4/16 (25%) B 4/16 (25%) 4/16 (25%) 5/16 (31%) C - - 6/16 (38%) D - - 1/16 (6%) Lenke Clasification A. B. C. D. 6 Definitely Solid Possibly Solid Probably not Solid Definitely not Solid Comparison of Two Different Demineralized Bone Matrices to Autologous Bone Graft in an Athymic Rat Posterolateral Lumbar Fusion Model Results – Mechanical Testing The mean stiffness (N/mm) for each group determined and categorized by the directional force 7 Flexion, extension, and left and right lateral bends No statistical difference between the groups in all 4 directions 100 90 80 70 60 50 40 30 20 10 0 Extension Flexion ICGB Evo3 Comparison of Two Different Demineralized Bone Matrices to Autologous Bone Graft in an Athymic Rat Posterolateral Lumbar Fusion Model Left Bend Grafton DBM Right Bend Results – Micro CT The 3D fusion masses of Evo3® (A, B), and Grafton® (C, D) were more mineralized and appeared more complete than ABG (E, F) Evo3® and Grafton® treated groups had consistent bone formation BV/TV was greater than 85 % 8 Comparison of Two Different Demineralized Bone Matrices to Autologous Bone Graft in an Athymic Rat Posterolateral Lumbar Fusion Model Results - Histology Significant and coherent bone formation and remodeling in both DBM groups Figure A demonstrates new bone (green) forming around the demineralized bone material of Evo3® (red) 9 weeks post-op 9 A B At 10X magnification (Figure B), new osteoid surfaces are present at a higher prevalence than osteoclastic activity highlighting a highly active phase of bone formation Comparison of Two Different Demineralized Bone Matrices to Autologous Bone Graft in an Athymic Rat Posterolateral Lumbar Fusion Model Discussion Our results showed that both DBM groups induced fusion at a substantially and significantly higher rate than ABG at 9 weeks in this athymic rat posterolateral lumbar spine fusion model, and that both DBM were able to induce spinal fusion as early as 3 weeks We placed equal 0.2 cm3 doses of both DBM graft products and ABG on the intertransverse fusion beds in this study, effectively eliminating a dosing bias No adjacent level fusions were seen in this model 10 Comparison of Two Different Demineralized Bone Matrices to Autologous Bone Graft in an Athymic Rat Posterolateral Lumbar Fusion Model Conclusion ABG is the “gold standard” graft in spinal fusions However, there is significant harvest morbidity associated with ABG DBM putty is an alternative to ABG that eliminates the harvest morbidity Using an athymic rat posterolateral fusion model, we compared Evo3®, Grafton®, and ABG The DBM treated groups achieved a significantly higher rate of fusion than the ABG treated group at 9 weeks in this model Successful fusion was also demonstrated in the DBM treated groups at 3 weeks 11 Comparison of Two Different Demineralized Bone Matrices to Autologous Bone Graft in an Athymic Rat Posterolateral Lumbar Fusion Model Disclosure 12 Nothing to disclose Comparison of Two Different Demineralized Bone Matrices to Autologous Bone Graft in an Athymic Rat Posterolateral Lumbar Fusion Model