Outcomes of Spine Surgery Fusion and the Use off BMP-2: Facts and - - PowerPoint PPT Presentation

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outcomes of spine surgery fusion and the use off bmp 2
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Outcomes of Spine Surgery Fusion and the Use off BMP-2: Facts and - - PowerPoint PPT Presentation

Apr 28, 2023 7 likes •412 views

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,

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Facts and Fiction

Outcomes of Spine Surgery Fusion and the Use off BMP-2:

Scott D. Boden, MD The Emory Orthopaedics & Spine Center

Evolving Technique:

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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)

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Off-Label Warning

฀ BMP-2 is approved for

ALIF with some cages and

  • pen long bone Fx

฀ All other applications

shown and discussed are

  • ff-label (physician

directed)

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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

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BMP: The Osteoinductive Principle

Rat ectopic implant assay

Bone formation 14 days post-implantation of rhBMP-2/ACS

Physiologic bone in an ectopic location – NOT ectopic bone… stupid (H. Reddi)

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Conduction vs Induction

Transverse Process

Ceramic without BMP Ceramic with BMP

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Healing Is Species Specific R Ra at t 0. .0 02 2 2 2-

  • 3

3 w wk ks s R Ra ab bb bi it t 0. .0 05 5 3 3-

  • 4

4 w wk ks s D Do

  • g

g 0. .3 35 5 6 6-

  • 8

8 w wk ks s M Mo

  • n

nk ke ey y 1 1. .5 50 3 3-

  • 5

5 m mo

  • s

s H Hu um ma an n 1 1. .5 5-

  • 2

2. .0 3 3-

  • 6

6 m mo

  • s

s

mg/cc Time

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Autograft x 5 wk

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rhBMP-2 Collagen

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Rhesus NeOsteo 10 mg x 12 wk

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Rhesus NeOsteo 10 mg x 24 wk

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Pilot III - Patient #7 (25 mg + LB)

3m 24m 12m 6m

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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

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Pivotal ALIF Trials - BMP-2: CT scan Fusion Results (2yr)

฀99.8% InFuse/LT cage Open ฀97.8% InFuse/LT cage Lap

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ACS carrier limitations

ACS is a good carrier when protected from compression Future use of ACS in applications under compression require “bulking agents”

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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

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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

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SLIDE 24

6 months 12 months 24 months

ICBG and rhBMP-2

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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

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LBG and rhBMP-2

6 months 12 months 24 months

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BMP Local Side Effects

฀ Seroma/ Edema

฀ ACDF, PLF, PLIF, TLIF

฀ Bone Formation in track

฀ PLIF ฀ TLIF

฀ Transient Bone Resorption

฀ Interbody

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BMP Local Side Effects

฀ Seroma/ Edema

฀ ACDF, PLF, PLIF, TLIF

฀ Bone Formation in track

฀ PLIF ฀ TLIF

฀ Transient Bone Resorption

฀ Interbody

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InFUSE™ Bone Graft/Bone Dowel Serial CT Review

Right Dowel Left Dowel Coronal View

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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

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BMP + Retrograde Ejaculation

฀ Most commonly reported

with laparoscopic ALIF

฀ 1-4% ฀ ? unclear mechanism ฀ Studies support and

refute, mostly refuted

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Pooled Results Cancer Risk (Percent)

1 2 3 4 5 6 7

Medtronic Wyeth Total

BMP-2 Control

p = 0.11 p = 0.95 p = 0.17

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Cancer Risk from BMP Exposure in Spinal Fusion

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Cancer Risk from BMP Exposure in Spinal Fusion

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Relative Risk – BMP to Control

Lower Risk Higher Risk

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Meta-Analysis BMP Fusions

Location Control BMP-2 Delta

Indicated?

ACDF (2+) 85.8 95.4 9.6% YES- 2+ ALIF 79.1 88.0 96.9 97.8 17.8% 9.8% ? TLIF 93.0 89.5 95.0 95.7 2.0% 6.2% NO PLF 75.3 83.1 95.2 93.6 19.9% 10.5% YES

2016 J Neurosurg Spine Hofstetter CP, Hofer AS, Levi AD (n=5890) 2015 Spine Galimbert F, Lubelski D, Healy AT et al (n=1794)

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rhBMP-2 Limitations

฀ Expensive ($5-7k/dose) ฀ Only approved for limited

use (so most off-label)

฀ Local Side Effects ฀ ? Cancer

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