1. E-Poster #510 Mineralized Collagen and Bone Marrow Aspirate in Anterior Interbody Carbon Fiber Cages Achieve High Fusion Rates in Multilevel Adult Spinal Deformity Richard Hostin, M.D.; Eric Klineberg, M.D.; Shay Bess, M.D.; Munish Gupta, M.D.; International Spine Study Group

2. Presenter: Presenter: Richard Hostin(a,d) DePuy Spine; (e) Axial Biotech Co-Authors: Eric Klineberg(a) OREF; (b) Synthes; (d) DePuy Spine, Stryker, Synthes (e) AO Shay Bess(a,b) DePuy Spine; (b) Allosource; (c) Pioneer Munish Gupta(b) DePuy Spine, Osteotech, Lanx; (c) DePuy Spine, J&J, Pioneer, Proctor & Gamble, Acrotech, Pfizer; (d) AO, Medtronic International Spine Study Group(a) DePuy Spine a.Grants/Research Support b.Consultant c.Stock/Shareholder d.Speakers’ Bureau e.Other Financial Support 18th International Meeting on Advanced Spine Techniques Authors Disclosure Information E-Poster #510 Mineralized collagen and bone marrow...

3. Summary  Single-center, blinded radiographic and patient outcome analysis of multilevel anterior spine fusion rates using bone marrow aspirate and mineralized collagen in anterior interbody fusion cages in adult spinal deformity patients.  Fusion grades based on published Lenke-Bridwell grading scale  1 – Complete fusion  2 – Probable fusion with no lucencies  3 – an intact graft with lucency at the top or bottom of the graft  4 – nonunion with resorption of the graft

4. Introduction  Many factors can affect success of spine fusion  Patient co-morbidities  Position of implant  Mechanical and/or biological deficiencies  Debate continues regarding the “proper” method of assessing union with bone graft replacements as well as the cost vs benefit of available osteobiologics

5. Introduction  Surgical exploration and radiographic analysis continue to be acceptable options for evaluating fusion success  Purpose: To determine the ability of bone marrow aspirate and mineralized collagen placed in carbon fiber polymer cages to achieve multilevel anterior fusion in adult spinal deformity patients.

6. Methods  Prospective, consecutive, adult spinal deformity patients who required long fusions to the pelvis underwent multilevel anterior spine fusion using bone marrow aspirate/mineralized collagen and a carbon fiber interbody device, combined with instrumented posterior spinal fusion  Radiographic analysis included preop and minimum 1 year postop full length coronal and sagittal radiographs, lumbar flexion/extension radiographs and postop lumbar CT scans

7. Methods  Anterior spine fusion status at each level (T11-S1) evaluated minimum 1 year postoperatively by 3 independent surgeons using the Bridwell-Lenke grading scale  Grades <2.5 classified as fused  Grades >2.5 classified as not fused  Pre and post op HRQOL measures included: VAS, SRS-22, and ODI

8. Methods  Statistical analysis:  Comparison analysis using paired t-tests was performed with minimum of 1 year follow up  Changes in ODI scores from preoperative to 1 year postop decreased significantly by an average of 12.53 (p=0.02)  Changes in ODI scores from preop to 2 year post op decreased significantly by an average of 10.80 (p=0.02)  There was no statistical change in ODI scores between the two post op periods (year 1 to year 2)  Similar results were observed for SRS and VAS scores

10. Results  From 2006-2008, 23 adult spinal deformity patients received 109 anterior spine fusions (mean 4.7 levels/patient)  Follow up = 1.6 years  95% of levels were classified as fused on plain radiographs  86% of levels classified as fused on CT  Improvement demonstrated for all HRQOL measures  No statistically significant differences in outcome measures between patients classified as fused versus non-fused

11. Results Pre OP (mean) 1 – yr PostOP (mean) P value ODI31.519.20.02 VAS4.92.6<0.01 SRS Function3.03.8<0.01 SRS Mental Health3.33.8.02 SRS Pain2.73.5<0.01 SRS Satisfaction3.24.20.01 SRS Self Image2.73.8<0.01 SRS Total3.03.8<0.01

12. Conclusion  Bone marrow aspirate/mineralized collagen demonstrates high fusion rates and improved patient outcomes for multilevel anterior spine fusions at intermediate follow-up.  Bone marrow aspirate/mineralized collagen is a viable osteobiologic alternative for anterior spine fusion in adult spine deformity patients receiving combined anterior and posterior spinal fusion.

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