Article

Subjective and novel objective radiographic evaluation of inflatable bone tamp treatment of articular calcaneus, tibial plateau, tibial pilon and distal radius fractures

Department of Orthopaedics, 3000 Arlington Avenue, University of Toledo Medical Center, Toledo, OH, United States. Electronic address: .
Injury (Impact Factor: 2.14). 04/2013; 44(8). DOI: 10.1016/j.injury.2013.03.020
Source: PubMed

ABSTRACT

There is a growing need to develop tools that allow for better reductions of difficult to treat fractures in minimally disruptive ways. One such technique has been developed using the inflatable bone tamp and a fast setting calcium phosphate. KYPHON(®) XPANDER Inflatable Bone Tamp and the KYPHON(®) Osteo Introducer(®) System were used to reduce the articular fractures and a fast-setting calcium phosphate was introduced into those voids and metal hardware was applied as deemed necessary. Subjects were skeletally mature patients treated for articular fractures of the calcaneus, tibial plateau, tibial pilon, or distal radius. Post-operative day zero and week 12 radiographs were objectively and subjectively evaluated by three independent orthopaedic surgeons. Their objective scores were then translated into subjective categories based on the Heiney-Redfern scaled scoring (H-R score) system established herein. Overall, the thorough radiographic analysis by independent reviewers indicates that the technique is capable of obtaining and maintaining articular reductions in a good or adequate manner at 12-weeks post-operatively. Introduced is a potential novel evaluation scale scoring system for these articular fractures that evaluates the important anatomic considerations reproducibly in fracture reductions. There are many potential benefits that remain speculative to this type of tool within a procedure, and therefore this tool and technique warrants further research.

Full-text

Available from: Roberta Redfern, Sep 27, 2015
Subjective
and
novel
objective
radiographic
evaluation
of
inflatable
bone
tamp
treatment
of
articular
calcaneus,
tibial
plateau,
tibial
pilon
and
distal
radius
fractures
Jake
P.
Heiney
a,
*
,
Roberta
E.
Redfern
b,1
,
Stephen
Wanjiku
b,2
a
Department
of
Orthopaedics,
3000
Arlington
Avenue,
University
of
Toledo
Medical
Center,
Toledo,
OH,
United
States
b
Sponsored
Research
Department,
2142
North
Cove
Blvd,
Toledo
Hospital,
Toledo,
OH,
United
States
Introduction
Calcaneus,
tibial
plateau,
tibial
pilon,
and
distal
radius
fractures
continue
to
increase
in
numbers
in
modern
society
with
a
growing
economic
cost
related
both
to
the
expense
of
treatment
as
well
as
ongoing
disability.
1
Articular
fractures
in
these
locations
are
especially
known
for
their
high
rates
of
wound
complications.
2,3
Co-morbidities
including
but
not
limited
to
obesity,
diabetes
mellitus
and
smoking
continue
to
complicate
wound
and
fracture
healing.
4–6
The
significance
of
these
complications
is
heightened
by
the
fact
that
these
fractures
often
occur
in
younger
patients
and
our
society
continues
to
live
longer.
7,8
In
order
to
reduce
fracture
non-unions
and
wound
complica-
tions,
new
minimally
invasive
techniques
for
fracture
manage-
ment
continue
to
be
developed.
It
has
been
shown
that
minimal
internal
fixation
with
calcium
phosphate
cement
can
result
in
good
outcomes
in
tibial
plateau
fractures.
9
One
minimally
invasive
technique
that
has
had
great
success
in
clinical
practice
is
balloon
Kyphoplasty
(Medtronic
Spine
LLC,
Sunnyvale,
CA),
10,11
which
until
recently
has
been
relegated
to
the
treatment
of
compression
fractures
of
the
spine.
Several
studies
on
balloon
Kyphoplasty
in
the
spine,
including
a
prospective
randomized
controlled
trial,
10
have
reported
improved
quality
of
life,
improved
disability
measures
and
a
reduction
of
back
pain
using
this
technique.
10,12
Kyphoplasty
is
generally
performed
using
an
inflatable
balloon,
known
as
the
Inflatable
Bone
Tamp
(Fig.
1;
IBT,
Medtronic
Spine
LLC,
Sunnyvale,
CA).
The
IBT
is
designed
to
‘‘compress
cancellous
bone
and/or
move
cortical
bone
as
it
inflates’’.
13
The
characteristics
of
the
device
allow
it
to
be
used
in
potentially
any
bone,
simply
as
a
conventional
bone
tamp
or
as
a
percutaneous
bone
tamp
with
fluoroscopic
guidance.
Pre-market
testing
in
cadaveric
fractured
tibial
plateaus
and
unfractured
vertebrae
has
been
performed,
demonstrating
that
IBTs
can
reduce
cortical
fractures
and
create
voids
in
cancellous
bone
in
the
same
manner
as
conventional
bone
tamps.
Safety
testing
also
demonstrated
no
increase
in
risk
over
conventional
bone
tamps.
13
Injury,
Int.
J.
Care
Injured
44
(2013)
1127–1134
A
R
T
I
C
L
E
I
N
F
O
Article
history:
Accepted
18
March
2013
Keywords:
Inflatable
bone
tamp
Articular
fractures
Calcium
phosphate
Kyphoplasty
in
extremities
BRAMIF
A
B
S
T
R
A
C
T
There
is
a
growing
need
to
develop
tools
that
allow
for
better
reductions
of
difficult
to
treat
fractures
in
minimally
disruptive
ways.
One
such
technique
has
been
developed
using
the
inflatable
bone
tamp
and
a
fast
setting
calcium
phosphate.
KYPHON
1
XPANDER
Inflatable
Bone
Tamp
and
the
KYPHON
1
Osteo
Introducer
1
System
were
used
to
reduce
the
articular
fractures
and
a
fast-setting
calcium
phosphate
was
introduced
into
those
voids
and
metal
hardware
was
applied
as
deemed
necessary.
Subjects
were
skeletally
mature
patients
treated
for
articular
fractures
of
the
calcaneus,
tibial
plateau,
tibial
pilon,
or
distal
radius.
Post-operative
day
zero
and
week
12
radiographs
were
objectively
and
subjectively
evaluated
by
three
independent
orthopaedic
surgeons.
Their
objective
scores
were
then
translated
into
subjective
categories
based
on
the
Heiney–Redfern
scaled
scoring
(H-R
score)
system
established
herein.
Overall,
the
thorough
radiographic
analysis
by
independent
reviewers
indicates
that
the
technique
is
capable
of
obtaining
and
maintaining
articular
reductions
in
a
good
or
adequate
manner
at
12-weeks
post-operatively.
Introduced
is
a
potential
novel
evaluation
scale
scoring
system
for
these
articular
fractures
that
evaluates
the
important
anatomic
considerations
reproducibly
in
fracture
reductions.
There
are
many
potential
benefits
that
remain
speculative
to
this
type
of
tool
within
a
procedure,
and
therefore
this
tool
and
technique
warrants
further
research.
ß
2013
Elsevier
Ltd.
All
rights
reserved.
*
Corresponding
author.
Tel.:
+1
419
517
7533.
E-mail
addresses:
jakeheiney@ameritech.net
(J.P.
Heiney),
roberta.redfern@promedica.org
(R.E.
Redfern),
stephen.wanjiku@promedica.org
(S.
Wanjiku).
1
Tel.:
+1
419
824
1084;
fax:
+1
419
824
1763.
2
Tel.:
+1
419
291
8027;
fax:
+1
419
479
6125.
Contents
lists
available
at
SciVerse
ScienceDirect
Injury
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ur
n
al
ho
m
epag
e:
ww
w.els
evier
.c
om
/lo
cat
e/inju
r
y
0020–1383/$
see
front
matter
ß
2013
Elsevier
Ltd.
All
rights
reserved.
http://dx.doi.org/10.1016/j.injury.2013.03.020
Page 1
The
placement
of
fast-setting
calcium
phosphate
cements
into
fresh
orthopaedic
fracture
sites
has
been
proven
beneficial
in
filling
bone
voids,
such
as
those
that
remain
after
reduction
of
impacted
articular
fractures.
9,14,15
Fast-setting
calcium
phosphate
cements
have
several
advantages
over
other
bone
fillers,
which
have
been
shown
clinically
in
multiple
studies.
9,16
They
decrease
pain
at
the
fracture
site,
which
may
allow
earlier
mobilization
15,17
and
several
studies
have
demonstrated
improved
functional
outcomes
with
use
of
calcium
phosphate
cement.
15,17
Other
authors
have
demonstrated
that
calcium
phosphate
cements
are
superior
to
traditional
bone
graft
or
no
bone
graft
with
respect
to
preventing
fracture
subsidence.
9,15,17
Additionally,
the
need
for
allograft
or
autograft
is
eliminated,
such
that
there
is
no
risk
of
potential
shortage
of
cadaveric
bone
material,
patient
objections,
allograft
disease
transmission,
or
donor
site
morbidity.
18,19
Attempts
have
been
made
to
modify
traditional
instruments
in
order
to
obtain
articular
reductions
in
a
minimally
invasive
fashion.
20
The
lead
author
(henceforth
referred
to
as
the
author)
has
previously
reported
a
potentially
minimally
invasive
technique
for
addressing
wound
concerns,
as
well
as
providing
several
other
advantages
(e.g.
void
creation
for
calcium
phosphate),
for
the
reduction
of
the
articular
surface
itself
using
the
Kyphoplasty
IBT
in
a
non-traditional
way.
21
Since
then,
this
tool
has
been
developed
by
Medtronic
Spine
LLC
to
fit
specific
needs
of
extremity
articular
fracture
reduction
(personal
communication;
InflateFX
TM
).
The
purpose
of
this
study
is
to
determine
whether
the
novel
technique,
balloon
reduction
and
minimally
invasive
fixation
(BRAMIF),
developed
by
the
author,
using
a
Kyphon
inflatable
bone
tamp,
results
in
radiographically
satisfactory
outcomes
in
the
reduction
of
calcaneus,
tibial
pilon,
tibial
plateau
and
distal
radius
fractures.
Using
a
novel
scoring
system
described
herein
for
quantifying
radiographic
outcomes
of
fracture
treatments,
includ-
ing
the
rate
of
successfully
and
satisfactorily
reduced
fractures,
the
quality
of
the
reduction
and
its
maintenance
at
the
12
week
follow-
up
appointment
is
evaluated.
Materials
and
methods
Study
design
This
retrospective
review
of
patient
charts
and
radiographs
was
approved
by
the
ProMedica
Health
System
Institutional
Review
Board
prior
to
the
collection
of
data.
All
skeletally
mature
patients,
between
the
ages
of
18
and
95
years
of
age,
who
were
treated
for
the
reduction
of
calcaneus,
tibial
plateau,
tibial
pilon,
or
distal
radius
fractures
from
August
2008
through
August
2010
using
the
BRAMIF
technique
(Fig.
2A–H)
as
previously
described
21
at
ProMedica
Health
System
were
included
in
the
study.
Patients
who
were
not
being
treated
in
follow-up
by
the
lead
author,
were
missing
radiographic
evaluations
either
post-operatively
or
at
12
weeks
post-operatively,
had
radiographs
which
were
felt
to
be
inadequate
for
review
were
excluded
from
the
study.
In
total,
51
patients
underwent
the
procedure,
of
which
41
were
eligible
to
be
included
in
the
review.
Study
product/therapy/technique
The
study
reviewed
the
quality
of
fracture
reduction
achieved
by
first
using
the
KYPHON
1
XPANDER
Inflatable
Bone
Tamp
and
the
KYPHON
1
Osteo
Introducer
1
System,
with
bone
filler.
The
Fig.
1.
KYPHON
1
XPANDER
Inflatable
Bone
Tamp
is
comprised
of
three
biocompatible
parts:
a
proximal
luer
fitting,
a
central
catheter,
and
a
distal
inflatable
tip
with
radiopaque
markers.
Fig.
2.
(A)
Pre-operative
radiographic
AP
of
a
tibial
plateau
fracture
with
a
large
soft
tissue
envelope.
(B)
Fluoroscopic
lateral
with
insertion
of
the
trochar.
(C)
Fluoroscopic
AP
demonstrating
the
insertion
of
the
hand
drill
bit
underneath
the
fracture.
(D)
Fluoroscopic
lateral
with
IBT
placed
underneath
the
fracture
depression.
(E)
Fluoroscopic
AP
noting
reduced
articular
surface
with
IBT
inflation,
there
is
also
a
percutaneously
placed
peri-articular
clamp
to
prevent
the
split
from
widening
during
inflation
and
a
guide
wire
for
a
cannulated
screw
can
be
noted.
(F)
Fluoroscopic
lateral
noting
reduced
articular
surface
with
IBT
inflation,
there
is
also
a
percutaneously
placed
peri-articular
clamp
to
prevent
the
split
from
widening
during
inflation.
(G)
Fluoroscopic
AP
with
final
reduction,
hardware
and
calcium
phosphate
having
filled
the
void.
(H)
Fluoroscopic
lateral
with
final
reduction,
hardware
and
calcium
phosphate
having
filled
the
void.
J.P.
Heiney
et
al.
/
Injury,
Int.
J.
Care
Injured
44
(2013)
1127–1134
1128
Page 2
KYPHON
1
XPANDER
Inflatable
Bone
Tamp
tools
in
their
current
form
were
specifically
designed
for
reduction
of
spinal
fractures
by
creating
a
void
and
compacting
cancellous
bone
in
the
vertebral
body.
This
corrects
the
vertebral
body
deformity
and
allows
for
delivery
of
bone
cement
(i.e.
PMMA,
polymethylmethacrylate).
The
inflatable
bone
tamp
also
allows
for
accurate
placement
of
bone
cement;
importantly,
visualization
of
the
balloon
during
placement
is
made
possible
by
radiopaque
markers.
Inflation
with
contrast
medium
(Omnipaque
TM
)
allows
one
to
visualize
the
entire
process,
while
volume
measurements
ensure
that
the
correct
amount
of
bone
cement
will
be
prepared
and
injected
into
the
void.
Though
these
instruments
were
developed
to
correct
spinal
deformity,
the
inflatable
bone
tamp
has
received
510(k)
marketing
clearance
from
the
U.S.
Food
and
Drug
Administration
for
use
‘‘as
conventional
bone
tamps
for
the
reduction
of
fractures
and/or
creation
of
a
void
in
cancellous
bone
in
the
spine,
hand,
tibia,
radius
and
calcaneus’’.
22
The
author
has
applied
the
science
of
balloon
Kyphoplasty
in
an
FDA
approved
manner
to
extremity
fractures
in
a
technique
that
he
has
developed
and
has
successfully
demonstrated
that
the
principles
can
be
applied
to
non-vertebral
fractures
with
the
application
of
fast-
setting
calcium
phosphate
in
place
of
PMMA.
21
The
author
did
not
deviate
from
his
standard
treatment
of
non-
weight
bearing
for
approximately
10
weeks
(i.e.
begin
axial
loading
on
the
joint)
prior
to
starting
partial
weight
bearing
increasing
to
full
by
16
weeks
at
all
anatomic
locations.
The
authors
believe
that
in
the
future
weight
bearing
will
be
able
to
proceed
earlier,
as
suggested
by
the
results
of
more
recent
investigations.
23
However,
mobilization
was
begun
at
tibial
pilon,
calcaneus
and
distal
radius
at
7–10
days
post-operatively
while
the
tibial
plateaus
were
allowed
to
move
immediately
post-operatively.
Study
procedures
Three
independent
orthopaedic
surgeons,
all
familiar
with
the
procedure,
volunteered
to
independently
review
blinded
radio-
graphs.
The
reviewers
indicated
the
quality
of
each
radiograph,
their
choice
of
three
gestalt
terms
for
the
overall
quality
of
reduction
(i.e.
good,
adequate,
or
poor),
and
then
provided
specific
measurements
relevant
to
each
anatomic
site.
The
reviewers
were
unaware
that
the
authors
had
pre-determined
discrete
values
of
2,
1,
and
0
to
coincide
with
the
reviewers’
measurements
per
the
literature.
Fracture
union,
post-traumatic
arthritis
and
structural
void
filler
support
were
all
given
three
choices
as
shown
in
Table
1,
and
reviewers
were
also
blinded
to
the
discrete
values
associated
with
their
selected
choice
ratings
of
these
categories.
The
scale
was
based
upon
numerical
measurements
commonly
referenced
within
the
literature
for
each
respective
anatomic
location
(Table
1).
This
scale
takes
into
account
the
most
often
measured
and
accepted
angles
and
distances
for
each
location,
while
also
building
in
aspects
of
fracture
reduction
that
are
not
typically
reported
in
a
quantitative
fashion,
such
as
the
extent
of
support
provided
by
the
void
filler
9,15,16
and
the
extent
of
post-
traumatic
arthritis.
Using
accepted
angles
and
distances,
9,16,17,24–38
the
reviewers’
measurements
were
translated
into
an
overall
score
by
assigning
discrete
values
to
each
measurement,
such
that
the
closer
the
reviewer’s
measurement
was
to
an
anatomical
reduction,
the
higher
the
discrete
value
assigned.
These
measurements
were
then
totaled
to
give
a
sum
scale,
providing
a
numerical
scale
to
correlate
with
radiographic
measurements
that
were
then
given
a
subjective
term.
This
scale
was
determined
to
be
11–14
=
good
results,
7–10
=
adequate
(or
fair)
results,
and
0–6
=
poor
results.
Immediate
post-operative
films
were
not
scored
on
post-traumatic
arthritis
nor
degree
of
healing
as
neither
is
expected
in
the
immediate
post
operative
period.
Therefore,
the
scoring
scale
for
immediate
post-operative
was
8–10
=
good
results,
6–7
=
adequate
(fair)
results
and
0–
5
=
poor
results
hence
giving
the
‘‘H-R
post-operative’’
scale
score.
A
‘‘partial’’
H-R
score
was
used
for
the
12
week
period
in
which
both
post-traumatic
arthritis
and
union
was
removed
to
compare
directly
H-R
post-operative
scores
to
the
H-R
12
week
scores.
Importantly,
the
orthopaedic
surgeons
were
blinded
to
the
scale
they
were
scoring
the
reductions
against
in
order
to
internally
validate
the
scale.
Also,
while
they
were
recording
the
measurements
for
each
radiograph,
but
they
also
scored
each
reduction
on
a
good/adequate
(‘‘fair’’)/poor
score
scale
(on
data
collection
forms).
This
allowed
the
authors
to
correlate
the
reviewer’s
overall
opinion
with
the
overall
scaled
score
to
determine
the
congruency
for
the
H-R
scale
with
the
qualitative
assessments
assigned.
Additionally,
two
experienced
outside
fellowship
trained
orthopaedic
trauma
surgeons
unrelated
to
the
study
were
asked
to
review
the
(Heiney–Redfern)
scale
and
assess
their
level
of
agreement
with
the
defined
variables
as
laid
out
within
it,
such
that
in
total
three
separate
orthopaedic
surgeons
who
frequently
perform
open
reduction
and
internal
fixation
procedures
of
the
distal
radius,
calcaneus,
and
proximal
and
distal
tibia
had
approved
the
use
of
this
scale.
Table
1
The
Heiney–Redfern
scale
(H–R
scale).
H-R
score
0
1
2
Distal
radius
fracture
measurements
Volar
tilt
24
<08
or
>208
08–58
or
158–208
68–148
Radial
inclination
24
<178
or
>338
178–208
or
308–338
218–298
Radial
shortening
26
>3
mm
>2–3
mm
2
mm
Tibial
plateau
fracture
measurements
MPTA
a
29
<808
or
>948
808–848
or
918–948
858–908
PPTA
b
29
<38
or
>158
38–58
or
138–158
68–128
Tibial
Plateau
Widening
31
>5
mm
>2–5
mm
0–2
mm
Calcaneus
fracture
measurements
Bo
¨
hler
angle
33
<108
or
>558
108–248
or
418–558
258–408
Calcaneocuboid
joint
Varus
35,36
>388
or
<138
338–388
or
138–178
188–328
Shortening
35,36
>5
mm
>2–5
mm
2
mm
Tibial
pilon
fracture
measurements
LDTA
c
38
<828
or
>968
828–858
or
938–968
868–928
ADTA
d
30,34,38
<768
or
>838
768–778
or
828–838
788–818
Gapping
of
Articular
Surface
32
>5
mm
>2–5
mm
2
mm
Measurements
collected
for
all
fractures
Fracture
union
25
No
evidence
Partial
Complete
Post-traumatic
arthritis
28
Severe
Moderate
None
Articular
step-off
or
gap
e
25
>5
mm
>2-5
mm
2
mm
Structural
void
Filler
support
37
Incorrect
position
and
insufficient
concentration
Partial
void
filling
and
concentration
Correct
position
and
sufficient
concentration
a
MPTA
=
medial
proximal
tibial
angle
=
coronal
plane
alignment
=
frontal
plane
alignment.
b
PPTA
=
posterior
proximal
tibial
angle
=
sagittal
plane
alignment.
c
LDTA
=
lateral
distal
tibial
angle
=
coronal
plane
alignment
=
frontal
plane
alignment.
d
ADTA
=
anterior
distal
tibial
angle
=
sagittal
plane
alignment.
e
Except
tibial
pilon
which
measures
only
articular
step-off
as
gap
is
already
accounted
for.
J.P.
Heiney
et
al.
/
Injury,
Int.
J.
Care
Injured
44
(2013)
1127–1134
1129
Page 3
Statistical
analysis
The
R
Project
for
Statistical
Computing
(version
2.12.2)
was
used
in
data
analysis.
Kruskal
Wallis
tests
were
used
to
test
for
differences
in
the
distribution
of
the
H-R
scores
given
by
the
three
reviewers.
Spearman
rank
correlation
was
used
to
test
the
strength
of
the
relationships
between
ordinal
variables.
Contingency
tables
were
constructed
and
Fisher’s
exact
test
was
used
to
test
for
the
statistical
independence
of
the
cross-tabulated
variables.
Kruskal
Wallis
tests
results
with
p-value
greater
than
0.05
would
be
supportive
of
the
hypothesis
that
there
is
no
location
shift
in
the
distribution
of
scores.
Sprearman
rank
correlation
was
set
such
that
from
range
1
to
1,
the
increasing
the
score
past
zero
would
indicate
a
monotonically
increasing
relationship.
The
Fisher
Exact
test
p-values
less
than
0.05
would
be
supportive
of
the
hypothesis
that
there
is
a
correlation
between
the
two
rating
systems
(H-R
score
and
overall
subjective
evaluation).
Results
Success
rate
of
the
BRAMIF
procedure
All
patients
went
on
clinically
to
heal
and
only
one
calcaneus
case
had
any
complications.
This
case
represented
a
case
that
was
severe
in
nature
and
had
a
traditional
‘‘L’’
extensile
incision
and
the
inflatable
bone
tamp
was
used
to
replace
a
traditional
bone
tamp
to
raise
the
articular
surface
‘‘en
masse’’
and
to
pack
bone
graft.
This
patient
eventually
went
on
to
union,
but
the
plate
was
removed
prior
to
full
soft-tissue
healing.
Tables
2
and
3
summarize
the
data
in
the
subjective
and
objective
forms.
Interobserver
reliability
Three
H-R
scores
were
computed
for
each
patient:
H-R
score
post-operatively,
partial
H-R
score
12
weeks,
H-R
score
at
12
weeks.
The
H-R
score
post-operatively
represented
the
total
score
computed
based
on
the
radiographic
images
taken
just
after
the
procedure
was
completed.
The
partial
H-R
score
12
weeks
was
the
score
computed
based
on
the
radiographic
image
taken
12
weeks
after
the
procedure,
but
was
computed
exactly
the
same
as
the
post-operative
score
and
hence
it
did
not
include
the
union
and
arthritis
evaluation.
The
H-R
score
at
12
weeks
was
the
score
computed
based
on
the
radiographic
images
taken
at
12
weeks
and
included
the
scores
for
union
and
arthritis.
Because
the
H-R
scores
computed
by
the
different
reviewers
were
not
exact
matches,
the
Kruskal
Wallis
Test
was
then
used
to
statistically
analyze
the
apparent
lack
of
congruence
(Table
4).
Assessment
of
maintenance
of
reduction
The
post-operative
H-R
scores
were
compared
with
the
partial
H-R
scores
at
12
weeks
in
order
to
assess
whether
the
reduction
obtained
post-operatively
maintained
at
12
weeks.
All
the
data
from
each
surgery
was
graphed
for
each
reviewer.
Kruskal
Wallis
Table
2
The
number
and
percentage
of
patients
whose
outcome
were
rated
‘‘good’’
or
‘‘adequate’’
both
subjectively
and
objectively.
Sample
Size
Patients
with
‘‘Good’’
or
‘‘Adequate’’
results
Post
operation
At
12
weeks
Counts
Percentage
Counts
Percentage
S
HR
S
HR
S
HR
S
HR
Distal
radius
Reviewer1
17
15
16
88
94
14
16
82
94
Reviewer2
17
17
17
100
100
17
17
100
100
Reviewer3
17
17
17
100
100
15
16
88
94
Calcaneus
Reviewer1
8
8
8
100
100
7
7
87
87
Reviewer2
8
8
8
100
100
8
8
100
100
Reviewer3
8
8
8
100
100
8
8
100
100
Tibial
pilon
Reviewer1
7
7
7
100
100
7
7
100
100
Reviewer2
7
7
7
100
100
7
7
100
100
Reviewer3
7
7
7
100
100
7
7
100
100
Tibial
plateau
Reviewer1
9
9
9
100
100
9
9
100
100
Reviewer2
9
9
9
100
100
9
9
100
100
Reviewer3
9
9
9
100
100
8
8
89
89
S:
rating
based
on
the
reviewer’s
subjective
overall
assessment.
HR:
rating
based
on
the
H-R
score
computed
by
the
reviewer.
Table
3
Distribution
of
reviewers’
subjective
and
objective
ratings
in
all
3
subjective
categories
of
patient
outcomes
post-operatively
and
12
week
post-operatively.
Post
operation
12
Weeks
Poor
Adequate
Good
Poor
Adequate
Good
S
HR
S
HR
S
HR
S
HR
S
HR
S
HR
Distal
radius
Reviewer1
2
1
2
9
13
7
3
1
2
5
12
11
Reviewer2
0
0
3
5
14
12
0
0
3
4
14
13
Reviewer3
0
0
5
5
12
12
2
1
0
2
15
14
Calcaneus
Reviewer1
0
0
2
0
6
8
1
1
2
1
5
6
Reviewer2
0
0
2
2
6
6
0
0
3
3
5
5
Reviewer3
0
0
1
0
7
8
0
0
1
1
7
7
Tibial
pilon
Reviewer1
0
0
3
0
4
7
0
0
2
1
5
6
Reviewer2
0
0
0
0
7
7
0
0
0
0
7
7
Reviewer3
0
0
0
0
7
7
0
0
0
0
7
7
Tibial
plateau
Reviewer1
0
0
1
0
8
9
0
0
2
1
7
8
Reviewer2
0
0
1
1
8
8
0
0
2
1
7
8
Reviewer3
0
0
1
0
8
9
1
1
0
0
8
8
S:
rating
based
on
the
reviewer’s
subjective
overall
assessment.
HR:
rating
based
on
the
H-R
score
computed
by
the
reviewer.
J.P.
Heiney
et
al.
/
Injury,
Int.
J.
Care
Injured
44
(2013)
1127–1134
1130
Page 4
p-values
were
calculated
to
determine
whether
the
distribution
of
scores
had
changed
between
post-operative
and
the
12
week
period.
Next,
Spearman
rank
correlation
was
used
to
test
for
ordinality
of
the
data.
Kruskal
Wallis
tests
confirmed
that
the
distribution
of
postoperative
scores
was
very
similar
to
the
distribution
of
scores
obtained
at
12
weeks
postoperatively,
as
evidenced
by
high
p-values
(Table
4).
A
majority
of
the
graphs
also
had
positive
Spearman
rank
correlation
values
which
indicates
that
the
H-R
scores
have
similar
order
(i.e.
high
scores
immediately
post-operatively
also
had
high
scores
at
12
weeks,
Table
4).
Congruence
of
objective
and
subjective
ratings
The
objective
ratings
of
the
reviewers
were
interpreted
by
the
H-R
scale
score
then
compared
to
the
overall
subjective
rating
that
the
reviewers
gave
at
those
same
evaluations.
Two
separate
sets
of
data
were
analyzed
with
the
Spearman
rank
correlation
coefficient
to
see
how
closely
they
were
correlated.
This
was
done
to
compare
congruence
of
reviewer’s
scores
post-operatively
and
the
scores
they
assigned
at
postoperative
week
12.
While
subjective
and
objective
scores
for
the
postoperative
radiographs
were
weakly
correlated
with
one
another
(0.267–0.425),
H-R
scores
and
objective
overall
ratings
correlated
well
with
one
another
(0.534–0.893)
and
Fisher
exact
tests
revealed
that
these
associa-
tions
were,
in
fact,
significant
(p-value
<
0.05;
Table
4).
The
present
study
demonstrated
overall
that
the
reductions
were
judged,
both
subjectively
(by
the
evaluators)
and
objectively
(via
the
H-R
score),
to
be
good/adequate
outcomes
in
nearly
all
cases
post-operatively
and
at
12
weeks
(Tables
2
and
3).
Only
distal
radius
data
at
12
weeks
indicated
that
a
poor
reduction
was
achieved,
as
rated
by
two
reviewers
(Tables
2
and
3).
Based
on
this
data,
IBT
with
fast-setting
calcium
phosphate
can
be
a
useful
tool
that
is
capable
of
obtaining
and
maintaining
a
good/adequate
reduction
for
articular
fractures
in
these
locations.
This
study
also
confirmed
that
reductions
were
maintained
from
the
post-operative
radiographs
to
the
12
week
radiographs.
The
Kruskal
Wallis
score
indicated
that
the
distribution
of
H-R
scores
at
12
weeks
was
statistically
similar
to
that
of
the
post-
operative
H-R
scores
(Table
4).
A
positive
Spearman
rank
correlation
indicated
that
the
order
of
the
H-R
scores
had
a
monotonically
increasing
relationship
for
the
post-operative
and
12
week
evaluations
(i.e.
if
a
high
score
was
achieved
post-
operatively
then
it
was
also
achieved
at
12
weeks).
This
combination
of
large
p-values
and
positive
Spearman
rank
correlations
support
the
view
that
the
reduction
was
well
maintained
from
post-operative
radiographs
to
the
12
week
mark.
In
addition,
the
subjective
and
objective
evaluations
have
a
good
correlation
(e.g.
if
a
reviewer
gave
numerical
values
that
correlated
with
a
score
of
good
reduction
then
that
reviewer
gave
a
gestalt
subjective
score
of
good
as
well).
This
was
calculated
by
Spearman
rank
correlation
(Table
4).
Therefore,
we
can
deduce
that
the
H-R
score
is
a
good
method
for
determining
and
translating
objective
numbers
into
subjective
data.
In
total,
this
data
supports
the
hypothesis
that
from
both
a
subjective
and
an
objective
point
of
view,
the
IBT
was
able
to
obtain
and
maintain
reductions
to
the
12
week
mark
radiographically.
Discussion
The
author
has
explored
and
developed
a
novel
technique
for
reduction
of
articular
extremity
fractures
using
an
IBT
and
a
fast-
setting
calcium
phosphate
cement.
21
In
practice,
the
reduction
of
impacted
articular
fractures
as
well
as
bone-grafting
of
residual
metaphyseal
defects
can
be
difficult,
especially
when
using
minimally
invasive
methods.
The
author
has
found
that
the
technique
of
inflatable
bone
tamp
reduction
of
impacted
extremity
articular
fractures
to
be
a
reproducibly
successful
approach
that
is
adaptable
to
many
fractures.
This
minimally
invasive
technique
includes
the
reduction
of
articular
surfaces
using
a
percutaneous
balloon
with
fluoroscopic
evaluation,
followed
by
insertion
of
an
appropriate
amount
of
fast-setting
calcium
phosphate
cement
into
a
well
developed
and
positioned
void,
and
finally
placement
of
fracture
fixation
hardware
as
needed.
This
study
demonstrates
acceptable
clinical
results
per
peer
reviewed
radiographs,
and
introduces
a
reproducible,
novel
evaluation
system
to
judge
reductions
in
these
anatomic
areas
of
interest.
Prior
to
discussing
the
outcomes
of
the
procedure,
it
is
important
to
note
that
the
author
believes,
which
has
been
confirmed
by
other
orthopaedic
surgeons
(personal
communica-
tions),
that
there
is
a
sufficient
learning
curve
on
using
this
tool
and
technique,
especially
for
those
who
do
not
have
prior
Kyphoplasty
experience.
These
scores
reported
in
this
study
included
every
patient
from
the
surgeon’s
initial
cases,
which
likely
accounts
for
the
few
poor
radiographic
outcomes,
as
the
poor
outcomes
were
early
cases
in
the
surgeon’s
practice.
With
experience,
the
learning
curve
will
lead
to
improved
results
as
it
is
especially
difficult
to
master
the
reduction
of
the
distal
radius
and
calcaneus
fractures
initially.
However,
through
proper
training,
the
inflatable
bone
tamp
can
be
an
irreplaceable
tool
that
allows
a
surgeon
to
perform
the
procedure
in
a
manner
that
either
was
not
able
to
be
done
previously
or
can
now
be
done
in
a
manner
that
gives
improved
reduction,
explanation
forthcoming.
23
A
laboratory
study
has
been
conducted,
which
has
yet
to
be
published,
using
the
inflatable
bone
tamp
in
place
of
a
traditional
bone
tamp
in
reducing
tibial
plateau
fractures
percutaneously
without
direct
visualization
of
the
joint.
It
was
discovered
that
the
Table
4
H-R
ratings
versus
the
overall
subjective
ratings
immediately
post-operatively
and
at
the
12
week
mark
and
the
H-R
ratings
post-operatively
compared
to
the
H-R
ratings
at
the
12
week
mark.
H-R
rating
vs.
overall
rating
Sample
size
Reviewer
Fisher
exact
test
p-value
Spearman
rank
correlation
All
data
post
operation
41
Reviewer1
0.007
0.319
41
Reviewer2
0.028
0.425
41
Reviewer3
0.027
0.267
All
data
12
weeks
41
Reviewer1
0.003
0.534
41
Reviewer2
<0.001
0.893
41
Reviewer3
<0.001
0.795
H-R
score
post
operation
vs.
partial
H-R
score
at
12
weeks
Sample
Size
Reviewer
Kruskal
Wallis
test:
p-value
Spearman
rank
correlation
Combined
data
for
all
procedures
41
Reviewer1
0.729
0.802
41
Reviewer2
0.255
0.814
41
Reviewer3
0.463
0.882
J.P.
Heiney
et
al.
/
Injury,
Int.
J.
Care
Injured
44
(2013)
1127–1134
1131
Page 5
articular
surface
was
reduced
more
anatomically,
appeared
better
reduced
by
surgeons
on
fluoroscopy,
CT
and
direct
visualization
with
the
IBT
than
the
traditional
metal
bone
tamp.
Also,
the
construct
performed
superior
biomechanically
to
loading
and
displacement
after
reduction
by
IBT
over
traditional
metal
tamp.
23
Heiney
and
Redfern
developed
their
novel
scale
based
on
the
best
literature
data
available
for
several
reasons.
First,
it
was
developed
to
give
the
study
two
overviews
of
rating
the
reductions
using
the
novel
technique.
Second,
the
score
attempts
to
put
discrete
numbers
on
what
has
traditionally
been
reported
as
a
gestalt
overview
without
any
specific
direction.
Third,
to
deter-
mine
objectively
if
reductions
were
maintained
per
scoring
from
the
post-operative
day
zero
to
12
weeks,
the
latter
a
time
period
when
most
fractures
are
traditionally
deemed
healed.
Fourth,
the
score
was
developed
to
determine
whether
evaluators
were
consistent
between
their
number
scores
and
their
subjective
scoring
to
further
strengthen
the
outcome
data.
There
are
numerous
potential
advantages
that
this
tool
and
technique
offer.
First,
it
acts
as
a
reduction
tool
in
a
minimally
invasive
way.
The
balloon
only
needs
a
small
cannula
(8
gauge,
4.0
mm)
to
be
inserted
in
the
cortical
bone,
and
the
defect
or
fracture
can
be
easily
reduced.
This
allows
a
much
larger
volume
of
bone
to
be
lifted
up
‘‘en
masse’’
than
the
traditional
bone
tamp.
Second,
there
is
no
need
to
account
for
the
often
difficult
angles
needed
to
insert
a
larger
bone
tamp,
as
even
the
largest
IBT
is
inserted
through
the
same
size
cannula.
Also,
the
surgeon
can
modify
the
position
of
the
balloon
as
needed
for
optimal
fracture
reduction.
Third,
instead
of
just
having
visual
feedback,
there
is
an
additional
feedback
of
a
pressure
gauge.
If
the
balloon
is
placed
correctly
within
a
fractured
area,
the
balloon
pressure
increases
but
stays
relatively
low
with
an
initial
drop
from
maximal
pressure
that
levels
out,
allowing
the
surgeon
to
know
that
the
IBT
is
in
the
correct
position.
All
these
pressure
readings
give
feedback
that
the
surgeon
cannot
appreciate
when
manually
raising
the
bone
with
conventional
bone
tamps.
With
enough
experience,
this
feedback
eliminates
some
of
the
need
to
use
fluoroscopy
to
monitor
the
fracture
reduction,
potentially
decreasing
radiation
amounts.
Also,
the
visual
feedback
is
improved
fluoroscopically
as
the
shape
of
the
balloon
gives
the
user
additional
information
about
position
and
reduction.
Fourth,
it
is
a
powerful
tool
that
performs
reduction
in
a
much
more
controlled
fashion.
Traditionally,
swinging
a
mallet
can
be
difficult
to
control
often
causing
penetration
of
the
tamp
into
the
joint.
With
the
IBT
a
simple
twist
of
the
wrist
allows
for
inflation
and
movement
of
reduction
fragments
in
small
increments.
Finally,
it
provides
a
superior
void
for
fast
setting
calcium
phosphate.
The
advantages
of
the
current
tool
and
technique
include
improved
void
for
the
delivery
of
fast-setting
calcium
phosphate.
This
technique
also
allows
placement
of
fast-setting
calcium
phosphate
cement
in
a
reproducible
manner,
directly
beneath
the
impacted
bone,
with
less
likelihood
of
intra-articular
spillage
or
leaking
out
of
the
wound
because
of
the
well
defined
void.
Often,
due
to
the
high
injection
pressures
inside
the
bone,
calcium
phosphate
finds
cracks
and
comes
out
of
the
cortical
shell.
Worse
yet,
calcium
phosphate
will
also
follow
cracks
through
the
articular
cartilage
and
diffuse
into
the
joint.
The
current
IBT
allows
for
a
well
sealed
void
that
compresses
up
to
400
psi
the
surrounding
cancellous
bone
in
order
to
seal
off
escape
of
the
calcium
phosphate.
This
principle
has
been
shown
in
balloon
Kyphoplasty
in
the
spine
in
compacting
cancellous
bone,
as
the
balloon
reduces
the
likelihood
of
PMMA
from
escaping
outside
the
vertebral
body.
10,12
This
potentially
percutaneous
delivery
of
ideal
bone
filler
can
be
performed
more
effectively
than
is
done
with
traditional
open
delivery
because
the
instruments
used
are
superior
to
the
traditional
syringe
and
needle,
as
the
pusher
is
a
constant
diameter,
hence
not
creating
a
pressure
gradient.
Also,
the
balloon
indicates
exactly
how
much
calcium
phosphate
will
be
needed
by
simply
reading
the
inflation
gauge
prior
to
deflation
of
the
balloon.
Common
pitfalls
to
avoid
are
as
follows.
It
is
important
to
make
sure
that
the
fragments
do
not
become
entrapped
(i.e.
the
trap
door
effect,
which
has
been
noted
in
the
literature).
39
Not
mentioned
previously
in
the
literature
is
the
fact
that
this
applies
not
only
to
tibial
plateaus
but
at
all
anatomic
locations.
If
the
articular
surface
is
squeezed
or
shortened
as
is
common
in
calcaneus
fractures
then
it
will
not
be
possible
to
anatomically
reduce
the
articular
surface.
Also,
it
is
critically
important
to
‘‘dock’’
the
working
cannula
in
a
few
millimetres;
otherwise
it
will
move
slightly
and
cause
difficulty
in
delivery
of
the
calcium
phosphate
to
the
correct
position.
The
third
pitfall
is
the
delivery
of
the
calcium
phosphate
itself.
It
needs
to
be
backfilled
from
the
most
distal
aspect
from
the
working
cannula
in
the
void
and
slowly
backfill
until
the
proximal
aspect
of
the
void
is
reached,
as
calcium
phosphate
lays
down
like
mortar
(unlike
PMMA
which
‘‘mushrooms’’
out
and
will
fill
a
void
wherever
you
fill
from).
A
fourth
pitfall
also
includes
the
delivery
of
the
calcium
phosphate.
It
should
be
filled
by
pushing
it
in
using
‘‘one
finger’’
and
as
soon
as
resistance
is
felt
back
up
a
millimetre
or
two
and
continue
to
push
with
‘‘one
finger’’.
It
is
found
that
in
delivery
of
the
calcium
phosphate
if
resistance
is
felt
and
the
surgeon
pushes
harder,
it
will
clog
the
delivery
device
and
render
it
unable
to
fill
the
void.
Each
anatomic
location
has
details
related
to
the
procedure,
and
while
the
authors
here
suggest
that
the
inflatable
bone
tamp
is
a
tool
which
can
be
used
in
numerous
ways
depending
on
needs
of
the
surgeon
and
fracture,
there
are
some
generalizations
that
can
be
made
from
the
first
author’s
experience.
Generally,
the
volume
of
calcium
phosphate
(equal
to
the
volume
of
inflation)
per
anatomic
location
ranged
as
follows:
distal
radius
1–2
cc,
tibial
plateau
2–3
cc,
tibial
pilon
3–4
cc,
and
calcaneus
4–5
cc.
In
particular,
the
authors
believe
that
the
distal
radius
should
be
kept
to
a
very
small
volume
and
rarely
should
more
than
2
cc
be
used.
The
radiation
exposure
is
minimal,
requiring
only
a
few
seconds
to
find
placement
with
the
most
being
used
going
‘‘live’’
during
fill
of
the
void
using
the
backfill
technique.
The
15
mm
and
4
cc
volume
bone
tamps
were
used
and
typically
only
one
was
needed,
except
in
the
calcaneus
where
using
two
was
the
standard
inflating
both
approximately
2–3
cc.
The
entry
point
is
suggested
to
be
positioned
in
such
a
way
that
the
working
cannula
is
in
several
millimetres
of
bone
to
stabilize
it,
maximizing
the
lifting
power
of
the
IBT
(i.e.
the
largest
surface).
Therefore,
the
authors
have
found
the
best
technique
for
them
per
anatomic
area
is
generally,
tibial
plateau
medial
to
lateral
2–5
mm
under
the
deepest
part
of
the
articular
surface,
calcaneus
posterior
to
anterior
centered
under
the
fracture
from
lateral
to
medial
5–10
mm
under
the
deepest
part
of
the
articular
depression,
tibial
pilon
lateral
to
medial
2–5
mm
under
the
deepest
part
of
the
depression
and
finally
the
distal
radius
from
mid-axial
radial
towards
the
ulna
to
reduce
any
die
punch
and
restore
any
dorsal
comminution.
There
is
a
paucity
of
literature
regarding
inflatable
bone
tamps
outside
the
spine
and
this
has
left
a
deficit
of
experience
for
a
potentially
revolutionary
technique
for
fracture
treatmen t.
21,40
The
author s
believe
that
the
principles
of
minimally
invasive
or
percutaneous
surgery
should
be
applied
whenever
possible
in
order
to
minimize
wound
complications,
and
have
found
the
BRAMIF
technique
to
be
safe,
reproducible,
and
valuable.
These
benefits
may,
in
turn,
provide
a
means
to
perform
reductions
and
internal
fixations
in
patients
on
whom
we
may
have
been
rightfully
hesitant
to
operate
in
the
past.
Other
surgical
approaches
to
these
fractures
may
require
a
delay
while
the
soft
tissues
settle
down,
often
with
temporary
use
of
an
external
fixator
requiring
an
additional
surgery.
Future
research
must
be
done
to
evaluate
whether
using
an
IBT
with
bone
void
filler
allows
earlier
definitive
surgery
and
leads
to
better
outcomes,
including
J.P.
Heiney
et
al.
/
Injury,
Int.
J.
Care
Injured
44
(2013)
1127–1134
1132
Page 6
earlier
mobilization,
earlier
discharge
from
the
hospital,
fewer
surgeries,
less
infections
and
even
more
overall
cost
savings.
Limitations
of
the
study
include
the
retrospective
nature
of
data
collection.
This
was
a
radiographic
study
intended
to
evaluate
whether
this
technique
was
capable
of
obtaining
and
maintaining
reductions
radiographically.
While
we
only
noted
one
complica-
tion
and
that
all
patients
went
on
to
union,
there
was
no
validated
scoring
system
used.
In
general
the
technique
can
be
used
anywhere
there
is
a
depression
of
the
articular
surface
because
of
the
previously
described
benefits
(e.g.
en
masse
lifting,
more
anatomic
reduction,
better
biomechanical
construct,
easy
delivery
of
calcium
phosphate).
However,
the
surgeon
should
be
cautioned
to
do
simple
fractures
early
in
the
learning
curve
then
later
as
the
surgeon
becomes
more
facile
at
the
technique
to
modify
it
in
such
a
way
that
the
surgeon
can
use
other
techniques
to
turn
difficult
fractures
into
simple
fractures
and
to
then
use
the
tool.
The
advantages
of
the
study
included
that
the
radiographs
were
evaluated
by
two
different
systems,
one
being
subjective
and
one
objective,
by
three
independent
reviewers.
Also,
this
scoring
system
was
found
to
be
reproducible
and
was
vetted
by
three
additional
experienced
orthopaedic
trauma
surgeons
prior
to
testing.
In
summary,
this
study
confirmed
that
the
inflatable
bone
tamp
with
a
fast-setting
calcium
phosphate
is
capable
of
obtaining
and
maintaining
a
reduction
radiographically
in
clinical
practice.
It
is
clear
that
there
are
several
potential
advantages
associated
with
the
use
of
this
tool
as
part
of
a
larger
technique.
These
economic
and
clinical
potential
advantages
need
to
be
studied
further.
Also,
it
is
clear
to
the
authors
that
a
learning
curve
is
present
even
for
users
with
inflatable
bone
tamp
experience
(e.g.
Kyphoplasty).
There-
fore,
the
authors
recommend
prior
training
to
using
this
tool
in
practice.
As
it
may
at
first
appear
to
be
intuitive,
however
there
are
pitfalls
that
training
will
help
avoid.
This
study
also
demonstrates
a
reproducible,
novel,
objective,
radiographic
evaluation
scale
score.
Conclusion
In
conclusion,
the
authors
herein
report
the
extensive
use
of
the
FDA-approved
application
of
an
inflatable
bone
tamp
with
insertion
of
a
fast-setting
calcium
phosphate
in
articular
fractures
of
the
calcaneus,
distal
radius,
proximal
and
distal
tibia
with
metal
hardware
as
needed.
A
thorough
radiographic
analysis
by
independent
reviewers
indicates
that
the
tool
is
capable
of
obtaining
and
maintaining
those
reductions
in
a
good
or
adequate
manner
at
12
weeks
post-operatively.
Introduced
is
a
potential
novel
evaluation
scale
scoring
system
for
these
articular
fractures
that
appears
to
evaluate
the
important
anatomic
considerations
reproducibly
in
fracture
reductions.
There
are
many
potential
benefits
that
remain
speculative
to
this
type
of
tool
within
a
procedure,
and
therefore
this
tool
and
technique
warrants
further
research.
Conflicts
of
Interest
Funding
was
provided
in
a
form
of
a
grant
from
Medtronic
Spine
LLC
to
support
the
study
itself
(retrospective
review
of
data).
No
money
was
given
for
equipment,
principal
investigator
surgeon
support
or
surgeries
themselves.
Money
was
funded
for
radiographic
chart
reviews
by
outside
surgeons.
Jake
P.
Heiney,
MD,
MS
is
a
paid
speaker,
trainer
and
consultant
for
Medtronic
Spine
LLC,
Sunnyvale,
CA.
The
other
authors
have
nothing
to
declare.
Acknowledgements
The
authors
would
like
to
thank
Emily
Benson,
MD,
Van
Boggus,
MD,
and
Serge
Kaska,
MD
for
their
assistance
with
the
project.
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