orthobiologic injections
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OrthoBiologic Injections A New Frontier
Matthew A. Tao, MD
Assistant Professor
UNMC Orthopaedic Surgery
2.18.2020
Disclosures
Editorial Board – Current Reviews in
Musculoskeletal Medicine
Objectives
Learn biologic
injection options
Understand
indications
Review evidence
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My Background
My Practice
Sports medicine surgeon
Shoulder
Knee
Locations
Lauritzen
Oakview
Injection Options
Steroids
Viscosupplementation
Biologics
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Perspective…
www.orthoguidelines.org/topic?id=1005
Steroids
“Results of corticosteroid compared with placebo showed both a
statistically and clinically significant reduction in pain at 1 week,
with an average difference between groups of 22%. […] We
concluded that intra-articular corticosteroids reduce knee pain for
at least 1 week and that intraarticular corticosteroid injection is a
short-term treatment of a chronic problem.”
2009
Steroids
“In the comparisons between intra-articular (IA) corticosteroid and IA
placebo, some evidence for efficacy was detected for pain and patient
global assessment, at 1 week post injection, with evidence also for
continuing efficacy at 2 and 3 weeks post-injection. Thereafter, there is
diminishing evidence for efficacy, partly due to an absence of data, and
partly to an inability to detect statistically significant differences in longer
term follow-up.”
2006
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Viscosupplementation
Viscosupplementation
2009
4 wk 8 wk
STEROID > HA STEROID = HA STEROID < HA
Viscosupplementation
2015
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OrthoBiologics
‘stem cells’
PRP
BMAC
Adipose
Amniotic
Definition
“Orthobiologics are substances that orthopaedic
surgeons use to help injuries heal more quickly.
They are used to improve the healing of broken
bones and injured muscles, tendons, and ligaments.
These products are made from substances that are
naturally found in your body. When they are used in
higher concentrations, they may help speed up the
healing process.”
https://orthoinfo.aaos.org/en/treatment/helping-fractures-heal-orthobiologics
Mechanism of Action
Lopa S. KSSTA 2019.
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FDA Regulation
Public Health Service Act (PHSA)
Regulation pathways
361
– Minimally manipulated
– Homologous use only
– No combination of cells/tissue
– Not required to obtain pre-market
Approval by FDA
Paul Gadiock. Arendt Fox LLP. 2/15/17.
FDA Regulation Public Health Service Act (PHSA)
Regulation pathways
361
351
– Requires Biologics License Application
– Examples
Unrelated allogeneic hematopoietic stem cells
Cultured cartilage cells
Paul Gadiock. Arendt Fox LLP. 2/15/17.
A Word of Caution
2019
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PRP
Platelet rich plasma
“Portion of the plasma fraction of
autologous blood having a
platelet concentration above
baseline suspended in a small
amount of plasma”
Hall M. JAAOS 2009.
Function
Alpha granules
– IGF-1
– TGF-B
– PDGF
– B-FGF
Delta granules
– 5-HT
– Adenosine
– Dopamine
– Calcium
– Histamine
– ADP
– ATP
– Catecholamines
Ingredients
Hall M. JAAOS 2009.
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Preparation
Wang KC. Arthrosc Techn 2017.
Leukocyte Poor Leukocyte Rich
Preparation
Arthrex.com
Leukocyte Poor
Anti-inflammatory
Preparation
Leukocyte Rich
Arthrex.com
Pro-inflammatory
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Evidence
2016
No difference
PRP > HA
2016
WOMAC pain
WOMAC function
2017
2019
IKDC “Both treatments were effective in
improving knee functional status
and reducing symptoms. The
comparative analysis showed no
significant intergroup difference at
any follow-up point in any of the
clinical scores used.”
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2015
Leukocyte poor
>
Leukocyte rich
My Indications
LP-PRP
Arthritis
Anti-inflammatory in young joint
LR-PRP
Tendinopathy
Cost: $800 / 2000
Case Correlation
48 yo F mild knee OA
Prior scope
Steroid x1, Visco x2
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BMAC
Bone marrow aspirate concentrate
Goal = mesenchymal stem cells
Age matters…
– Young: 1/50,000
– Elderly: 1/1,000,000
Khan SN. JAAOS 2005.
Preparation
Arthrex.com
Mayoclinic.org
Evidence
“[…] there still remains a paucity of high-quality studies. The studies
included in this systematic review reported varying degrees of
beneficial results with the use of BMAC with and without an
additional procedure for the treatment of chondral defects and early
stages of osteoarthritis. Most articles present the use of BMAC as a
safe procedure and report good results.”
2016
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2016
No difference
2017
2019
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My Indications
OR
Osteochondral allograft
ACL revision
Nonunion
Cost: ???
Case Correlation 29 yo M OCD MFC
2 prior surgeries
Case Correlation
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Adipose
Fat-derived stem cells
Understandinglipogems.com
Evidence
“ADSCs are currently used in the form of stromal vascular
fraction (SVF). While SVF may produce favorable clinical
outcomes with minimal risk of side effects on osteoarthritis,
the variability in the data and the use of biological adjuvants
have confounded the effectiveness of ADSCs.
2018
My Indications
None…
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Amniotic
Amniotic suspension allografts
Amniotic fluid cells
Micronized amniotic membrane
Organogenesis.com
Evidence
2019
Behavior Synovial fluid
2019
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My Indications
Arthritis
S / M / L joints
Tendinopathy
Cost: $1000 / 1500 / 2000
Case Correlation
44 yo M medial OA
Recent scope
Steroid x1, Visco x1
Objectives
Learn biologic injection options
Understand indications
Review evidence
