Evolving Technique: Outcomes of Spine Surgery Fusion and the Use off BMP-2: Facts and Fiction Scott D. Boden, MD The Emory Orthopaedics & Spine Center
Disclosures Past (before 2008) Consultant (Medtronic, Osteotech, Sulzer/Zimmer) Royalties (Osteotech) IP/Patents (Medtronic) Current Royalties (Medtronic– DBM) IP (Emory/SkelRegen- Sm Mol) Consultant (SeaSpine, Bone Biologics Corporation)
Off-Label Warning BMP-2 is approved for ALIF with some cages and open long bone Fx All other applications shown and discussed are off-label (physician directed)
Spine Fusion: A Clinical Problem 1,000,000 BG procedures / year 50% spine fusion 5 - 40% nonunion 10-25% morbidity graft harvest Biology poorly understood
BMP: The Osteoinductive Principle Rat ectopic implant assay Physiologic bone in an ectopic location – NOT ectopic bone… stupid (H. Reddi) Bone formation 14 days post-implantation of rhBMP-2/ACS
Conduction vs Induction Ceramic with BMP Ceramic without BMP Transverse Process
Healing Is Species Specific mg/cc Time Ra at t 0. .0 02 2 2- -3 3 w wk ks s R 0 2 Ra ab bb bi it t 0. .0 05 5 3- -4 4 w wk ks s R 0 3 Do og g 0. .3 35 5 6- -8 8 w wk ks s D 0 6 Mo on nk ke ey y 1. .5 50 0 3- -5 5 m mo os s M 1 3 Hu um ma an n 1. .5 5- -2 2. .0 0 3- -6 6 m mo os s H 1 3
Autograft x 5 wk
rhBMP-2 Collagen
Rhesus NeOsteo 10 mg x 12 wk
Rhesus NeOsteo 10 mg x 24 wk
3m 6m Pilot III - Patient #7 (25 mg + LB) 24m 12m
InFUSE™ Bone Graft/LT-CAGE™ Clinical Study Results InFUSE™ rhBMP-2 ACS absorbable collagen sponge Tapered fusion cage Boden, Zdeblick, Sandhu, and Heim, Spine, 2000
Pivotal ALIF Trials - BMP-2: CT scan Fusion Results (2yr) 99.8% InFuse/LT cage Open 97.8% InFuse/LT cage Lap
ACS carrier limitations ACS is a good carrier when protected from compression Future use of ACS in applications under compression require “bulking agents”
Use of Recombinant Human Bone Morphogenetic Protein-2 as an Adjunct in Posterolateral Lumbar Spine Fusion: A Prospective CT-Scan Analysis at One and Two Years Kern Singh MD, Joseph Smucker MD, Scott D. Boden MD The Emory Spine Center Department of Orthopaedic Surgery Emory University School of Medicine
Arthrodesis Success Rate (CT Scan) Adjunctive rhBMP-2 96.9% fusion rate (124/128 levels) 93.8% Definite fusion ICBG alone 77.3% fusion rate (34/44 levels) 45.5% Definite Fusion
6 months 12 months 24 months ICBG and rhBMP-2
Arthrodesis Success Rate (CT) rhBMP-2 + LOCAL BONE GRAFT 98.0% fusion rate (44/49 levels) 89.8% Definite fusion rhBMP-2 + ICBG 96.9% fusion rate (124/128 levels) 93.8% Definite fusion ICBG alone 77.3% fusion rate (34/44 levels) 45.5% Definite Fusion
6 months 12 months 24 months LBG and rhBMP-2
BMP Local Side Effects Seroma/ Edema ACDF, PLF, PLIF, TLIF Bone Formation in track PLIF TLIF Transient Bone Resorption Interbody
BMP Local Side Effects Seroma/ Edema ACDF, PLF, PLIF, TLIF Bone Formation in track PLIF TLIF Transient Bone Resorption Interbody
InFUSE™ Bone Graft/Bone Dowel Serial CT Review Right Dowel Left Dowel Coronal View
BMP-Induced Radiculitis Most commonly reported with TLIF (also endplate resorption – self limited 5-20% (not dose related) ?Combination of root distraction + BMP? No evidence in PL Fusions
BMP + Retrograde Ejaculation Most commonly reported with laparoscopic ALIF 1-4% ? unclear mechanism Studies support and refute, mostly refuted
Pooled Results Cancer Risk (Percent) 7 p = 0.11 p = 0.95 p = 0.17 6 5 4 BMP-2 3 Control 2 1 0 Medtronic Wyeth Total
Cancer Risk from BMP Exposure in Spinal Fusion
Cancer Risk from BMP Exposure in Spinal Fusion
Relative Risk – BMP to Control Lower Risk Higher Risk
Meta-Analysis BMP Fusions Location Control BMP-2 Delta Indicated? ACDF (2+) 85.8 95.4 9.6% YES- 2+ 79.1 96.9 17.8% ALIF ? 88.0 97.8 9.8% 93.0 95.0 2.0% TLIF NO 89.5 95.7 6.2% 75.3 95.2 19.9% PLF YES 83.1 93.6 10.5% 2016 J Neurosurg Spine Hofstetter CP, Hofer AS, Levi AD (n=5890) 2015 Spine Galimbert F, Lubelski D, Healy AT et al (n=1794)
rhBMP-2 Limitations Expensive ($5-7k/dose) Only approved for limited use (so most off-label) Local Side Effects ? Cancer
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