Indicated for the treatment of an established nonunion acquired secondary to

trauma, excluding vertebrae and all flat bones

Definition of Nonunion – Prior to June 1998, this was defined as a minimum of 9

months, now a nonunion is considered to be established when the fracture site
shows no visibly progressive signs of healing.

Contraindication:
Use of this device is contraindicated where the individual has synovial
pseudarthrosis.

What are some of the Common Treatment Options for Fractures?

 Casts or Splints are most commonly used treatments to stabilize a

fracture.
 External Fixation is used for moderately severe cases.
 Internal Fixation and/or Bone Graft Surgery are used by physicians for the
most severe cases.

What is a Nonunion Fracture?

Most fractures (approximately 95%-98%) heal in roughly four to twelve weeks.

The remaining 2%-5% of fractures that do not heal in the normal timeframe are
referred to as nonunion fractures. If a fracture reaches the nonunion stage, it will
require some form of intervention to stimulate the natural healing process of the
body.

What are some of the Common Factors that Can Lead to Nonunion Fracture?

 Smoking
 Diabetes Mellitus
 Obesity
 Osteoporosis
 Excessive consumption of alcohol
 Many more individual risk factors

How Does the OL1000 Help a Nonunion Fracture?

In a nonunion fracture, the healing process stops. The OL1000 has been shown
to “kick-start” the body’s natural healing process so that the fracture can continue
to mend. The electromagnetic field sent out by the device tells the bone cells to
essentially “wake up” and start doing their job…bone growth. For more detailed
information on the physiological processes initiated by the OL1000 and
SpinaLogic®, as well as benefits to the patient, please visit the Basic Science
and Product areas of the Medical Professionals section.
The OL1000 is a lightweight device and comes in 5 sizes which accommodate a
large variety of fracture sites. The treatment is initiated with the press of a button,
and the unit counts down from 30 minutes and lets the patient know treatment is
finished with an audible tone.

The OL1000 Bone Growth Stimulator is indicated for the noninvasive treatment
of an established nonunion acquired secondary to trauma, excluding vertebrae
and all flat bones. A nonunion is considered to be established when the fracture
site shows no visibly progressive signs of healing.

Fracture Healing

What are some of the Different Types of Fractures?

Fractures can occur in any bone in the body and with different levels of severity.

Transverse Fracture:

 Clean break across the bone at a 90o angle

 Most common type of fracture

 Likely to heal

Oblique/Spiral Fracture:

 Moderately severe

 Break is at an angle and/or twisted

 
 Comminuted Fracture:

 More severe
 Bone breaks into several pieces

 More difficult to heal

In addition to the descriptions above, fractures can be either closed, or still contained
within the skin and tissues of the body, or open, which indicates the fracture
fragments have broken through the tissues and skin and are exposed to the external
environment.

Open Fracture

 More severe
 Typically occur from a strong force

 May be exposed to substances outside of body

such as dirt, bacteria or other harmful substances

Fracture Healing
OL1000 Bone Growth Stimulators are portable,
battery-powered medical devices indicated for
use in the noninvasive treatment of an
established nonunion fracture acquired
secondary to trauma, excluding all vertebrae
and flat bones. The device has the following
features:
 Light-weight and comfortable
 Easy-to-use & Noninvasive
 Requires simple, one-button operation
 Device is worn for only 30 minutes per
 day

 Can be used with internal or external

fixation or over a cast
This treatment has been shown in pre-clinical studies to help the body’s own
healing process begin working. Clinical studies have shown an increased
chance of healing of 60.7% in patients with nonunions that averaged 29.3
months from injury. Registry data on over 2300 patients reports a heal rate
of 75.1%.
 

Regentek's Combined Magnetic Field (CMF) Signal

The signal is what differentiates the OL1000 and SpinaLogic® from other
products. Prior to the OL1000, technologies dated back to the mid-1970’s, and
the science behind these technologies remains unexplained. The founder of the
OL1000 began research in the 1980’s to understand the dynamics of EMF
technology and to identify specifically which signal characteristics stimulate bone
cells and in turn promote healing.
The OL1000 CMF signal is actually a combination of two "waves", an alternating
EMF superimposed in parallel over a static EMF (Fig. 3). Having these two fields
is the main feature that differentiates our products. The frequency of the
alternating EMF is exactly 76.6Hz and the amplitude is .2-.4 gauss (a measure of
electromagnetic energy).

The reason CMF technology is potent (and only requires 30 minutes per day) is
because 100% of the signal falls within the optimal range of frequencies.
Researchers also found that CMF treatment continued beyond 30 minutes had
no statistically significant incremental healing affect.

Combined magnetic fields accelerate and increase spine fusion: a

double-blind, randomized, placebo controlled study.

Linovitz RJ, Pathria M, Bernhardt M, Green D, Law MD, McGuire RA,

Montesano PX, Rechtine G, Salib RM, Ryaby JT, Faden JS, Ponder R,
Muenz LR, Magee FP, Garfin SA.

San Dieguito Orthopaedics, Encinitas, California 92024, USA.

rjlmd@pacbell.net

STUDY DESIGN: The clinical study conducted was a prospective,

randomized, double-blind, placebo-controlled trial. OBJECTIVES: The
purpose of this study was to evaluate the effect of combined magnetic
fields on the healing of primary noninstrumented posterolateral lumbar
spine fusion. SUMMARY OF BACKGROUND DATA: Combined magnetic
fields, a new type of biophysical stimulus, have been shown to act by
stimulating endogenous production of growth factors that regulate the
healing process. This is the first placebo-controlled study to assess the
effect of an electromagnetic stimulus on primary noninstrumented
posterolateral lumbar spine fusion surgery as well as the first evaluation of
combined magnetic fields as an adjunctive stimulus to lumbar spine
fusion. METHODS: This multicenter investigational study was conducted
at 10 clinical sites under an Investigational Device Exemption from the
United States Food and Drug Administration. Eligible patients had one-
level or two-level fusions (between L3 and S1) without instrumentation,
either with autograft alone or in combination with allograft. The combined
magnetic field device used a single posterior coil, centered over the fusion
site, with one 30-minute treatment per day for 9 months. Randomization
was stratified by site and number of levels fused. Evaluation was
performed 3, 6, and 9 months after surgery and 3 months after the end of
treatment. The primary endpoint was assessment of fusion at 9 months,
based on radiographic evaluation by a blinded panel consisting of the
treating physician, a musculoskeletal radiologist, and a spine surgeon.
RESULTS: Of 243 enrolled patients, 201 were available for evaluation.
Among all patients with active devices, 64% healed at 9 months compared
with 43% of patients with placebo devices: a significant difference (P =
0.003 by Fisher's exact test). Stratification by gender showed fusion in
67% of women with active devices, compared with 35% of those with
placebo devices (P = 0.001 by Fisher's exact test). By contrast, there was
not a statistically significant effect of the active device in this male study
population. In the overall population of 201 patients, repeated measures
analyses of fusion outcomes (by generalized estimating equations)
showed a main effect of treatment, favoring the active treatment (P =
0.030). In a model with main effect and a time by treatment interaction, the
latter was significant (P = 0.024), indicating acceleration of healing.
Performed in the full sample of 243 patients, results of the intent-to-treat
analysis were qualitatively the same as in the evaluable sample of 201
patients. DISCUSSION: This investigational study demonstrates that
combined magnetic field treatment of 30 min/d increases the probability of
successful spine fusion, and statistical analysis using the generalized
estimating equations model suggests an acceleration of the healing
process. This is the first randomized clinical trial of noninstrumented
primary posterolateral lumbar spine fusion, with evaluation by a blinded,
unbiased panel. This is the first double-blind study performed to date
assessing noninstrumented fusion outcome with extremely critical
radiographic criteria. The lower overall fusion rates in this study are
attributed to the high-risk patient group with an average age of 57 years,
the use of noninstrumented technique with posterolateral fusion only, and
the reliance on extremely critical radiographic and clinical criteria and
blinded panel for fusion assessment without surgical confirmation.
CONCLUSIONS: In conclusion, the adjunctive use of the combined
magnetic field device was statistically beneficial in the overall patient
 population, as has been shown in previous studies of adjunctive bone
growth stimulation for spine fusion. For the first time, stratification of fusion
success data by gender demonstrated that the female study population
responded positively to the adjunctive combined magnetic field treatment,
with no statistically significant effect observed in the male study
population. Adjunctive use of the combined magnetic field device
significantly increased the 9-month success of radiographic spinal fusion
and showed an acceleration of the healing process.

Publication Types:

         Clinical Trial

         Multicenter Study

         Randomized Controlled Trial

PMID: 12131732 [PubMed - indexed for MEDLINE]

 
The effect of low-frequency electrical fields on osteogenesis.

McLeod KJ, Rubin CT.

Department of Orthopaedics, School of Medicine, State University of New York, Stony

Brook 11794-8181.

An in vivo animal model of disuse osteopenia was used to determine the osteogenic
potential of specific components of electrical fields. The ability of a complex pulsed
electrical field to inhibit loss of bone was compared with the remodeling response
generated by extremely low-power, low-frequency (fifteen, seventy-five, and 150-hertz)
sinusoidal electrical fields. The left ulnae of thirty adult male turkeys were functionally
isolated by creation of distal and proximal epiphyseal osteotomies and then were
exposed, for one hour each day, to an electrical field that had been induced exogenously
by means of magnetic induction. After a fifty-six-day protocol, the remodeling response
was quantified by a comparison of the cross-sectional area of the mid-part of the
diaphysis of the functionally isolated ulna with that of the intact contralateral ulna. Disuse
resulted in a 13 per cent mean loss of osseous tissue, which was not significantly different
than the 10 per cent loss that was caused by disuse treated with inactive coils. Exposure
to the pulsed electrical fields prevented this osteopenia and stimulated a 10 per cent mean
increase in the bone area. The osteogenic influence of the sinusoidal electrical fields was
strongly dependent on the frequency; the 150, seventy-five, and fifteen-hertz sinusoidal
fields, respectively, generated a -3 per cent, + 5 per cent, and + 20 per cent mean change
in the bone area. These results suggest a tissue sensitivity that is specific to very low-
frequency sinusoidal electrical fields, and they imply that the induced electrical fields
need not have complex waveforms to be osteogenic. Since the frequency and intensity
range of the sinusoidal fields producing the greatest osteogenic response are similar to the
levels produced intrinsically by normal functional activity, these results support the
hypothesis that electricity plays a role in the retention of the normal remodeling balance
within mature bone.

OL1000 Brief Prescribing Information

INDICATION FOR USE

Noninvasive treatment of an established nonunion acquired secondary to trauma,

excluding vertebrae and all flat bones. A nonunion is considered to be
established when the fracture site shows no visibly progressive signs of healing.

CONTRAINDICATIONS:

Use of this device is contraindicated in individuals having a synovial

pseudarthrosis. Demand-type pacemaker operations may be adversely affected
by exposure to magnetic fields. Physicians should not prescribe the OL1000 for
applications that may place the treatment transducers in close proximity to the
the pacemaker. Further screening by the attending cardiologist is recommended
(such as with an electrocardiogram). The OL1000 should not be used in the
presence of external or internal fixation devices that are constructed from
magnetic materials. (NOTE: Almost all fracture fixation devices implanted today
are made from non-magnetic materials).

WARNINGS:

The safety and effectiveness of the use of this device on individuals lacking
skeletal maturity has not been established. Animal studies conducted to date do
not suggest any long-term significant adverse effects from use of this device.
However, long-term effects in humans are unknown. Teratological studies have
not been performed with this device. The safety of use of this device during
pregnancy or nursing in humans has not been established.

PRECAUTIONS:

Weight bearing is not advised in the presence of extreme motion at the nonunion
site. In the presence of a malaligned nonunion, careful consideration of the use
of this device must be undertaken on an individual basis, as treatment with this
device is not intended to alter or affect the degree of malalignment. The safety
and effectiveness of the use of this device on individuals with nonunion
secondary to, or in conjunction with, a pathological condition has not been
established. This device should not be used if there are mental or physical
conditions which preclude patient compliance with the physician and device
instructions. When conditions of atrophy are present or when fractures have
remained unhealed for long periods of time, there may be less successful results.
ADVERSE EFFECTS:

No known significant adverse effects have resulted from the use of this device.

CAUTION:

Federal law (USA) restricts this device to sale by or on the order of a physician.
For full prescribing information, contact Regentek, a division of dj Orthopedics,
LLC.

13. Will I still heal if I don’t use it?

You may heal. However, clinical study results show that using SpinaLogic® for
30 minutes a day can increase your chances of healing by up to 21 percentage
points. Nearly 2400 patients were reviewed in the OL1000 post-registry data
and demonstrated a 75% chance of healing when using the OL1000.

FDA Summary - Draft Released for comment on: March 18, 1998
Based upon the potential for serious risk associated with chronic exposure to
electrical, electromagnetic, and ultrasound energies at the cellular and molecular
levels, the Food and Drug Administration (FDA) regards all bone growth
stimulators as significant risk devices.

For the purposes of this document, a non-union is defined as a fracture that is

acquired secondary to trauma, excluding vertebrae and all flat bones. For the
purposes of the IDE clinical study protocol, and to reduce the potential for a
heterogeneous population with respect to the age and type of fracture, the
decision that a non-union has been established should not be made until a
minimum of nine months has elapsed since the injury, and the fracture site has
shown no visibly progressive signs of healing, i.e., no change in the fracture
callus, for the final three months (i.e., six months to be considered a nonunion
plus three additional months to verify (for study purposes) that the non-union is
established).

ABBREVIATIONS USED IN THE DOCUMENT

Bone growth stimulator (BGS)

Center for Devices and Radiological Health (CDRH)
Division of Life Sciences (DLS)
Division of Physical Sciences (DPS)
Division of General and Restorative Devices (DGRD)
Division of Small Manufacturers Assistance (DSMA)
Food and Drug Administration (FDA)
Health Industry Manufacturers Association (HIMA)
Institutional Review Board (IRB)
International Standards Organization (ISO)
Investigational Device Exemption (IDE)
Office of Device Evaluation (ODE)
Office of Science and Technology (OST)
Orthopedic and Rehabilitation Devices Advisory Panel (ORD Panel)
Premarket Approval Application (PMA)
Pulsed electromagnetic field (PEMF)

Competition –
Bioelectron is now part of EBI - http://www.ebimedical.com/ 1-800-526-2579

EBI Bone Healing System-

 10 hours per day

 Can be worn during the day or while sleeping

OrthoPak Bone Stimulator/CurvTek TSR System

Smallest lightest weight available with unequaled patient comfort and
compliance

INDICATIONS FOR USE

The OrthoPak® Bone Growth Stimulator system is indicated for the treatment of
an established nonunion acquired secondary to trauma, excluding vertebrae and
all flat bones, where the width of the nonunion defect is less than one-half the
width of the bone to be treated. A nonunion is considered to be established when
the fracture site shows no visible progressive signs of healing. The original
approval was based on a PMA study which included 69 patients with efficacy of
72.5%. An additional cohort of 21 recalcitrant patients with multiple prior
procedures and unsuccessful electrical stimulation with different modality was
added and yielded efficacy of 33.3%. Seventy-nine patients out of the 90 treated
had at least 4 years follow-up after the date of treatment termination for a follow-
up rate of 88%. The follow-up results were 45 patients healed; four previously
healed patients had died; three patients, who were "healing" at the end of the
treatment, were healed with additional treatment. Counting only the 45
unconditionally healed patients, the efficacy at 4 year follow-up was 50%. A
subsequent survey of 295 patients conducted from March 1988 to September
1990 by an independent agency, yielded an efficacy of 73.2%.

CONTRAINDICATIONS

The use of this device is contraindicated if the individual has synovial

pseudarthrosis.

WARNINGS

Utilization of this device allows full weight bearing on the casted extremity unless
gross motion (greater than 5 degrees in any plane) at the nonunion site is
present. In such cases, weight bearing is not advised and should not be
permitted as this may compromise the effectiveness of the treatment. The safety
and effectiveness of the use of the device on individuals lacking skeletal maturity
has not been established. Animal safety studies indicate that the OrthoPak Bone
Growth Stimulator does not interfere with the normal intrinsic activity of the heart.
However, the Stimulator does interfere with the operation of certain pacemakers.
The concomitant use of the device and a pacemaker must be assessed on an
individual basis, prior to use (such as with an electrocardiogram). The safety and
effectiveness of the use of this device on individuals with nonunion secondary to,
or in conjunction with, a pathological condition has not been established. Animal
studies conducted to date do not suggest any long term adverse effects from the
use of this device. However, long term effects in humans are unknown. Although
laboratory teratological studies performed with this device demonstrates no
adverse findings, the safety of use of this device during pregnancy and nursing in
humans has not been established. This device should not be used if there are
mental or physical conditions which preclude patient compliance with the
physician and device instructions.

ADVERSE EFFECTS
NOTE: With the exception of the following, no known adverse effects have
resulted from the use of this device:
General tissue sensitivity at the skin/electrode site with unknown specific etiology
may occur. This tissue sensitivity may be caused by the electrode gel, excess
perspiration or a combination of both. Such a reaction generally resolves
spontaneously following diagnosis and correction of the underlying cause.
Original Developer and largest provider – EBI Bone Healing Medical System

The first bone growth technology product, the EBI Bone Healing System®,
received FDA approval in 1979 and became commercially available in
1980.

Dose Response and Importance to Patient

 Healing may occur earlier when the EBI Bone Healing System is worn for
the recommended 10 hours per day*
 CONTRAINDICATIONS:
Nonunion fractures in which a synovial pseudarthrosis (fluid filled gap)
exists
 Low energy pulsed electromagnetic field (PEMF)
 May be completely ambulatory
 Can’t use on metacarpals
 EBI – Electromatic -
 Capacitine Coupling –
 Electrical & Ultrasonic
o Electrical is amplifying
o Ultrasonic – Creates stress
 More than 20 minutes a day=Problems
o 30 minutes – 10 hours
o 17 quarters depth
 Over 300 studies PEMF/20 Ultrasound
o Sound waves vs. PEMF OK on cast or clothing
 Ultrasonic – Windows wound possible weakening of
mechanism to steady site
o Ultrasonic needs gap

Exogen Inc – Exogen 2000

  Ultrasound SAFHS (Sonic Accelerated Fracture Healing System) /Low
Intensity
 20 minutes per day
 Patient Compliance Monitor (PCM)
 The Smith & Nephew Exogen Patient Services 1-800-396-4326
 Money Back Guarantee – Must use for 160-180 days

Orthofix, Inc. –

 Physio-Stim Lite
 PEMF pulsed electromagnetic field
 The minimum daily treatment time is three hours per day.
 Battery powered
 The Physio-Stim® Lite System is intended for daily application of a
minimum of 3 hours per day, for a minimum of 90 days and maximum of
180 days.
 Money back guarantee