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Future of Orthobiologics in
Trauma Procedures
Daniel N. Segina, M.D.
Orthopaedic Service Line Medical Director
Vice Chairman, Department of Orthopaedics
Health First, Holmes Regional Trauma Center
Melbourne FL
Disclosures
Consultant:
Stryker
Breg
3M
Muzihosi
Owner / Shareholder:
Genesis Medical Devices
Breaking Away Consulting
Objectives
1. Understand the spectrum of orthobiologics used in orthopaedic trauma cases
2. Differentiate the facts versus the hype in orthobiologic clinical applications
3. Appreciate the economic impact orthobiologics represent
in orthopaedic trauma care
“BIO” Warfare
BIO-logyBIO-mechanics
Spectrum of products
Allograft (Old school)
Cancellous void filler
Structural cortical graft
Osteochondral graft for defect
Tendon
DBX
Allograft (New School)
Placental/Embryonic tissue
Autograft
Cortical/cancellous bone
Tendon
PRP
BMA/MSC
Ceramics/Synthetics
Injectable +/-
Ca+P/S/OH
BMPs
Spectrum of choices
Biologics Basics for Orthopaedic Trauma:
Bone Formation Requirements
Biologics: Specifics
Osteogenic Material
Autograft
Allograft?
Autologous bone marrow
Autologous blood concentrates?
Demineralized bone matrix?
Amniotic products
Osteoconductive material
Ceramics/synthetics
Autograft
Allograft
Osteoinductive factors
BMPs
Autograft
Orthopaedic Trauma and Fracture Care
Fill voids – case examples
Metaphyseal bone loss
Enhance healing – case examples
Index injury
Nonunion
Replace structure – Case examples
Structural bone/cartilage loss
Fill Voids
65-yo female fall in hospital parking lot
Enhance Healing/Replace Bone
Loss
33-yo female retired police officer
18 month F/U
Replace tissue loss
34-yo high velocity GSW
while wild boar hunting
Good and Bad News
Neuro/vasc intact
PCL, post capsule, MCL
Med Fem Condyle
75% Medial Plateau
50% Lat Fem Condyle
LCL, ACL, Patellar Tendon
Ant soft tissue +
Ant Menisci
50% lateral plateau
Maintained Missing
Synthes impl
Fact vs. Hype
Clinical data supporting the
use of orthobiologics
Fact vs. Hype
Clinical data supporting the use of
biologics in orthopaedic trauma care
?
Physician’s Prospective
Levels of Evidence:
Evidence Based Practice
Level I
Prospective randomized trial
Level II
Prospective cohort study
Level III
Case-control Study
Level IV
Uncontrolled case series
Level V
Expert opinion
FDA vs. Reality
Most biologics are classified as devices
Most orthopaedists do not think of
biologics as devices
Demineralized Bone Matrix:
Hype
“readily available
bone void filler
with growth
factors”
Data
No level I or II human data
Pico grams of
growth factors
Major variability in quality
Calcium Salts/Ceramics
CaCO3 / Ca3(PO4)2 / Ca5(PO4)3OH / CaSO4
Hype
Void filler /
Osteoconductive
matrix
Better than
autograft???
Data
Level I data
“The Gold Standard in
Tibial Plateau
Fractures?
A Prospective
Multicenter Randomized
Study of AIBG vs.
Alpha-BSM”
Russell TA et.al.
Allograft
Hype
Void filler /
Osteoconductive
matrix
Small amounts of
growth factors
Data
Level II and III
Autograft
Hype
“Gold
Standard”
Data
Assumed
“Gold Standard” until
proven otherwise
15%-38% combined
complication rate
Platelet Concentrates (PRP)
Hype
“small bags full
of growth
factors”
Data
No Level I or II
Pico grams!
Bone Marrow Concentrates
Hype
“Better than the
gold standard”
Data
Minimal level I or II
BMP/growth factors
Hype
“long awaited
Holy Grail of
orthopaedics”
Data
Minimal Level I data
Narrow FDA
indications
Amniotic Fluid Products
Hype
Novel allogenic
source for stem cells
Data
Should not be
considered stem cell
therapies
Amniotic Fluid Products
$8.4B
$11.9
B
2016 2020
Biologics represent a large spend for U.S Hospitals
The economic impact of
orthobiologics in orthopaedic
trauma care
Biologics
Product Types
Market Size
Cost data:
Bone Void Fillers (ASPs)
DBMs ($125-$175/cc)
Allograft cancellous bone ($15-$30/cc)
Cellular Allografts ($350-$600/cc)
Synthetics – non hardenings ($125-$250/cc)
Synthetic – Hardenings ($225-$350/cc)
Infuse BMP
Large kit $5,300
BMA 60-120cc
1 “spin” $1,500
Cost and utilization data for
“routine” tibial nonunion:
Recent tibial nonunion repair cost analysis
Traditional Implants
Tibial nail - $3,000
Interlocking screws (4) - $1,400
Disposables (wires, bits) - $350
$4,750
Biologics
BMA - $1,500
30cc allograft chips - $450
BMP large kit - $5,300
$7,250
System Spend For Biologics:
~ 1200 spine procedures, 1400 fractures, 1600 TJA
Default Choices?
Void filler ?
Biologic
Activity?
Void Filler
Allograft
Demineralized Bone Matrix
Calcium Salts
Biologic activity needed
Autologus Bone
BMC + Allograft
What does the future have in
store?
Concern that “misinformation” from marketing of largely
unproven biologic treatments may erode the public trust and the
responsible investments needed to bring legitimate biologic
therapies to patients…minimal standards for product
characterization and clinical research should be followed.
Translated: We need quality data!
Special Thanks:
Mr. Roberto Bracone
Director of Biologics Marketing, Stryker
Orthopaedics
Thank You
The Future of Orthobiologics in Trauma Procedures

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