Orthofix Bone Growth Stimulation. The Healing Advantage

ORTHOPEDICS
Pulsed Electromagnetic Field
Bone Growth Stimulation
Orthofix Bone Growth Stimulation.
The Healing Advantage
®
PULSED ELECTROMAGNETIC FIELD (PEMF) ACTS ON BONE FORMATION
• PEMF bone growth stimulation
generates a time varying magnetic
field within the body. This, in turn,
induces an electrical field that
cannot be produced from a static
magnetic field. The electric potential
created by PEMF stimulates fracture healing.
PEMF increases vascularity, increases mineralization of
osteoid material, and promotes osteoblastic migration
in bone healing.1
• In a recent animal study, the callus volume and rate of callus
formation was 25% and 55% greater at day 16 with
Orthofix PEMF compared to untreated limbs.5
+
• Animal testing of an alternate proprietary waveform did not
increase callus volume or rate of callus formation.
ORTHOFIX PEMF HEALS FRACTURE
NON-UNIONS
The effect of Physio Stim PEMF on fracture non-unions was
demonstrated in an open trial PMA study7,8 which followed 181
patients with 193 fractures who had not healed on their own
after nine or more months. In addition, Orthofix Patient Registry
Data of 724 patients presenting 859 individual fractures treated
with Physio-Stim resulted in the following outcomes:
0.9
0.8
0.7
Success Rate
EXTERNAL PEMF
• PEMF enhances the electrical polarity
by inducing an electrical field at the
fracture site which supports the
natural healing process and
stimulates fracture repair.1,2,6
Orthofix PEMF expedites callus formation
EXTERNAL PEMF
Bone has electrical qualities. In its
healthy physiological condition,
bone maintains a dynamic balance
+ +
between positive and negative charges.
Bone fracture changes the polarity at the
fracture site to a electronegative
+
environment.
This negative polarity indicates that the
body's natural repair process has begun.
In certain cases the electronegative environment may not be
sufficient to maintain the natural healing process and nonunion
may occur.1,2,6
88%
85%
80%
85%
Overall
Overall
Registry
Data
0.6
0.5
0.4
0.3
0.2
0.1
0.0
PEMF stimulates growth
of blood vessels2
3-6 mm
0-3 mm
Fracture Gap
PMA Study
PEMF stimulates
osteoblasts3
Orthofix PEMF is proven successful in treating all
of the following:7,8
PEMF stimulation expedites
callus formation and
initiates calcification4,5
• Open and/or closed fractures
• Casted and/or non-casted fractures (without windowing)
• Fractures treated with internal and/or external fixation
The effective treatment area
within the body generated by
the Physio-Stim magnetic field.
1. Bassett CAL: Critical reviews in Bio Med Eng 17: 451-529, 1989.
2. Yen-Patton GP, et al: J Cell Phys 134: 37-46, 1988
3. McElhaney, JH: J. Bone Joint Surg. 49A:1561, 1967.
4. Marino, AA and Becker, RO: Nature 228:473, 1970
5. Midura RJ, et al. Pulsed electromagnetic field treatments enhance the
healing of fibular osteotomies. J Orthop Res. 23(5):1035-46, 2005
6. Zoltan: Seminars in Orthop. 1:4 242-252, 1986.
7. “Long-term Follow-up of Fracture Nonunions Treated with PEMFs”,
Douglas E Garland, M.D., Barbara Moses, M.B.A., B.S.N., R. N.,
William Slayer, M.D.135 total fractures, gaps of 0-3, 3-6, 6-10,
>10 mm and not measurable. 108 fractures healed; 80% overall.
8. Physio-Stim PMA 850007 – 02/21/86, Supplement – 12/23/86
CELLULAR RESEARCH
Peer reviewed studies demonstrate the rapid effect of the Orthofix
PEMF signal on cellular signaling pathways which lead to bone
formation:
PEMF activates mTOR early in the cellular response
mTOR and PI3-kinase are important signaling components
for osteoblasts
• Kozawa et al., 2001, reported that BMP-4 also leads to
phosphorylation of p70 S6 kinase, raising the possibility
that PEMF and BMPs affect osteoblast function by activation
of the same signal transduction pathway(s).9,10
S6 activation is considered an indicator of cellular anabolism
• Patterson et. al.,9 showed that mTOR, its immediate downstream
target (p70 S6 kinase) and the p70 S6 kinase downstream target
(the ribosomal protein S6) were all phosphorylated by PEMF in
MC3T3-E1 cells.
F
M
PE
• Patterson et. al.9 report for the first time that the mTOR
pathway is activated within minutes of PEMF exposure.
mTOR is a critical protein in the mediation of cell growth
and proliferation.
Cellular
Signaling
Pathway
• Exposure of bone cells to the Orthofix PEMF signal induces
immediate intracellular signal transduction events consistent
with those associated with anabolic bone cell responses.11
• PEMF induces rapid phosphorylation reactions of select
intracellular signaling molecules in an osteoblast-like
cell line, clearly indicating that bone cells immediately
recognize this physical stimulus in real time.11
PEMF Exposure
mTOR
IRS-1
eNOS 11
S6
Activates Signaling
Components
• These results show that PEMF can induce intracellular
signaling responses of comparable kinetic time frame and
approximate intensity level to those induced by short-term
insulin or PTH exposure.11
9. Patterson et al. Exposure of Murine Cells to Pulsed Electromagnetic Fields Rapidly Activates the mTOR Signaling
Pathway. Bioelectromagnetics 2006; Vol. 27: 535-544.
10. Kozawa O, Matsuno H, Uematsu T. 2001. Involvement of p70 S6 Kinase in Bone morphogenetic protein signaling:
Vascular endothelial growth factor synthesis by bone morphogenetic Protein-4 in ostheoblasts. J Cell Biochem 31:430-436.
11. Schnoke, M. and Midura, R. J. Pulsed Electromagnetic Fields Rapidly Modulate Intracellular Signaling Events in
Osteoblastic Cells: Comparison to Parathyroid Hormone and Insulin. Journal of Orthopaedic Research, July 2007: 933-940.
CASE STUDY
A 60-year-old arthritic female presents with delayed union
of a closed proximal radius fracture. A Physio-Stim Model
3202 was prescribed eight weeks post-injury.
Effect of PEMF on the amount
of phosphor-mTOR
Amount of mTOR (% of control)
PEMF induction of intracellular signaling events
associated with anabolic bone cell responses has
been validated
300
Increases
Osteoblastic
Activity
250
200
150
100
50
NEW BONE FORMATION
0
0
10
30
60
Time of PEMF exposure (min)
Patterson et al. Bioelectromagnetics. Copyright © 2006
Wiley-Liss, Inc. Reprinted with permission of Wiley-Liss, Inc.,
a subsidiary of John Wiley & Sons, Inc.
14 weeks post-injury, after
six weeks of Physio-Stim
treatment
7-1/2 Months
post injury
Instant information panel
with LCDs for ongoing
operational status
New design provides
more flexibility and
comfort
Model 3202
Primary Treatment Sites:
Radius, Carpals and
Metacarpals
Model 3313
Primary Treatment Site:
Clavicle
Model 3314R & 3314 L
Primary Treatment Site:
Right and Left Proximal
Humerus
LCD treatment
countdown
clock shuts off
automatically
when treatment
is complete
Self-contained unit allows
unrestricted patient mobility.
No restraining cords, control
units or battery packs
Adjustable strap
for comfortable fit
Worn over a cast,
brace or clothing
3 hour wear time
Model 3202
Primary Treatment Sites:
Distal Tibia and Fibula,
Tarsals and Metatarsals
Model 3303
Primary Treatment Sites:
Distal Tibia and Fibula,
Tarsals, Metatarsals and
Casted Applications
Model 3303
Primary Treatment Sites:
Distal Tibia and Fibula
Model 3313
Primary Treatment Sites:
Distal Femur, Tibia
and Casted Applications
Model 3315
Primary Treatment Sites:
Femoral Head and Neck,
Greater and Lesser
Trochanters
BREG Vectra Boot with
Model 3303
Primary Treatment Sites:
Distal Tibia and Fibula,
Tarsals, Metatarsals
Smart technology can provide outcome reports
and hardcopy patient compliance monitoring
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Adult & Pediatric Deformity Correction I Foot & Ankle I Bone Growth Stimulation I Fixation
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