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The
Bone
Journal
of
and Joint
American
VOLUME
77-A,
NO.
JUNE
t 995 try. 1/it? Jiiur,rvil
Effectiveness
Have
ALF
I..
In vestiguhion
ABSTRACT:
In
o)I:
STUDY
MD..
THE
perforicied
a prospective
CONTROLLED
BRACE
NACIIEMSON.
MEMBERS
iiiri/ finn!
,S?iiri,?eri.
OF
PH.D.t.
BRACE
GROUP
by
STUDY
BASED
SOLIOSIS
PETERSON.
OF
THE
the
idioof 25
PH,[)4.
GOTEITORG.
U,iivc?r,sit
an underarm
surface
G#{246}teborg
plastic
electrical
Thirty-nine
AND
Sf)(?IE?I?Y*
G#{228}tehorg
nighttime
patients).
SWEI)EN.
RESEARCH
acid .Statisz?ic?.s;
and
FROM
SoclEi?Y*
SCOLIOSIS
(129 patients),
Scoliosis
in
Scoliosis
DATA
ON
RESEAR?H
of Orthopaedics
Research
Society,
286 girls who had adolescent
pathic scoliosis,
a thoracic
or thoracolumbar
curve
a Brace
Idiopathic
LARS-ERIK
STEJI)Y
at the !)epart?nents
study
THE
1995
Imiiorj;iirartd
with
Adolescent
PRosPEmvE.
THE
iif Biiiii?
of Treatment
Who
A
BY
Volume
6
(?ispvrigtst
Girls
Surgery
patients
brace (111 patients),
stimulation
(forty-six
were
lost
to
follow-up,
to 35 degrees,
and a mean age of twelve
years and seven
months
(range,
ten to fifteen
years)
were followed
to de-
leaving
termine
failure of the assigned
treatment.
The end point of failure of treatment
was defined as an increase
in the curve
of at least 6 degrees,
from the time of the first roentgenogram,
on two consecutive
roentgenograms.
the
effect
*No benefits
from
a commercial
of this
the
article.
in any form
party
have
related
with
been
observation
received
directly
or will
or indirectly
only
be received
to the
subject
Funds were received
in total or partial support
of
or clinical study presented
in this article. The funding
research
sources
of treatment
were
the
Scoliosis
Research
and
Society
Neuherghs
Foundation.
tI)epartnient
of Orthopaedics.
Sahlgren
University.
S-413
45 Gotehorg.
Sweden.
Please
reprints
to Dr. Nachemson.
the
Bertha
and
Felix
lDepartment
of Statistics.
Hospital.
address
Gotehorg
requests
for
13. Gotehorg
Viktoriagatan
University.
5-41 1 25 Gotehorg.
Sweden.
)avid
S. Bradford.
M.D..
Department
of Orthopaedic
Surgery.
University
of (?alifornia.
San Francisco.
California:
R. Geoffrey
Burwell.
M.D.,
Scoliosis
Clinic.
Harlow
Wood
Orthopaedic
Hospital.
Nottingham.
Justine.
National
Kingdom:
tJnited
Kingdom:
Morris
Montr#{233}al. Qu#{233}bec. Canada:
Orthopaedic
Michael
Hospital
M.
Eppig.
M.D.. H#{244}pital
Sainte-
Duhaime.
Michael
Trust.
M.D.. Spine
A.
Stanmore.
Center.
Edgar.
M.D..
Middlesex.
Saint
Royal
United
Lukes
Hospi-
tal. Cleveland.
Ohio:
Alan
D. H. Gardner.
M.D..
Basildon
Hospital.
Essex.
United
Kingdom:
Douglas
K. Kehl.
M.D..
Childrens
Hospital of Atlanta.
Scottish
Rite Childrens
Hospital.
Atlanta.
Georgia;
Jan Lidstr#{246}m. M.D..
Department
of Orthopaedics.
Sahlgren
Hospital.
G#{246}tehorg University.
Gotehorg.
Sweden:
John E. Lonstein.
M.D.. Mmnesota
Spine
(?enter.
Minneapolis.
Minnesota:
Peter
L. Meehan,
M.D..
Emory
Clinic.
Atlanta.
Georgia:
Raymond
T. Morrissy.
M.D..
Children?s
Hospital
of Atlanta.
Scottish
Rite Children?s
Hospital.
Atlanta.
Georgia;
Clyde
L. Nash.
M.D..
Spine
Center.
Saint
Luke?s
Hospital. Cleveland.
Ohio:
Anders
Nordwall.
M.D..
Department
of Orthopaedics.
Sahlgren
Hospital.
Gotehorg
University.
Gotehorg.
Sweden:
James Ogilvie. M.D.. Twin Cities Scoliosis
Center. University
of Mmnesota. Minneapolis.
Minnesota:
Benoit
Poitras.
M.D.. H#{244}pital SainteJustine.
Montreal.
Quhec.
Canada:
John
K. Webb.
M.D..
Clinic.
Harlow
Wood
Orthopaedic
Hospital.
Nottingham.
Kingdom:
Stig V. Willner.
M.D..
Department
of Orthopaedic
Malmo
General
M. I).. Minnesota
Hospital.
Malmo.
Sweden:
and Robert
Spine (?enter. Minneapolis.
Minnesota.
Scoliosis
United
Surgery.
B. Winter.
rity
with
247 (86 per cent)
or
who
were
who
dropped
were
from
the
As determined
with use of this
a brace
failed
in seventeen
observation
only,
electrical
in fifty-eight
stimulation,
patients.
According
with a brace
was
followed
study
because
of
end point, treatment
of the 111 patients;
129 patients;
of the
in twenty-two
to survivorship
associated
with
until matu-
and
of the forty-six
analysis,
a success
treatment
rate of 74
per cent (95 per cent confidence
interval,
52 to 84) at
four years; observation
only, with a success
rate of 34
per cent (95 per cent confidence
interval,
16 to 49); and
electrical
stimulation,
with a success
rate of 33 per cent
(95 per cent confidence
interval,
12 to 60). The thirtynine
patients
in the
they
who
were
survivorship
were
in the
Treatment
in preventing
lost
to follow-up
were
for the
time-period
analysis
included
that
study.
with a brace was successful
(p < 0.0001)
6 degrees
of increase
or more until the
patients
were
sixteen
analysis,
in which
the
years
old.
twenty-three
Even
a worst-case
patients
who
were
dropped
from the study after management
with a brace
were considered
to have had failed treatment,
showed
that
fect
ence
the
was
brace
prevented
significant
(p
in the degree
progression
=
0.0005).
of increase
patients
who were managed
those
who were managed
and
There
in the curve
that
this
ef-
no differbetween
the
was
with observation
only
with electrical
stimulation.
and
15
816
A.
A
number
of
retrospective
reviews
of
the
L.
NACHEMSON
well
designed
study
must
include
a large
cohort
of similar patients
who have similar patterns
of deformity and similar
degrees
of curvature.
All patients
should
be followed
from the time of inclusion
in the
study
at least until skeletal
maturity.
Such a cohort
of patients
should
then be randomized
to different
methods
of treatment,
and the results should be evaluated in relation
to a predefined
end point.
For the current
study, we designed
a multicenter
prospective
trial. After discussion
with the board of directors
of the Scoliosis
Research
Society
in 1984 and
1985, and with the support
of the membership,
a controlled
clinical
trial was established
to determine
the
effectiveness
of treatment
with a brace in a well defined group of patients
who had adolescent
idiopathic
scoliosis.
Materials
Design
ofthe
AL.
TABLE
results
of the use of the Milwaukee
brace or an underarm
brace
for the treatment
of idiopathic
scoliosis
have
been reported3u2452.
However,
none
of these
studies met the stringent
criteria for scientific
evidence
that must be used to prove the effectiveness
of treatment2u2b$$37. Studies from European
centers have shown
that there is insufficient
evidence
to support
claims of
the effectiveness
of treatment
with a brace?4?27. In 1993,
the United
States Preventive
Services
Task Force recommended,
on the basis of poor scientific
evidence
of
the effectiveness
of treatment
with a brace, the discontinuation
of school-screening
for adolescent
idiopathic
scoliosis5t-. This view was supported
by the work of the
Canadian2
and British task forces7.
A
ET
and Methods
Study
Ideally. the effectiveness
of a brace in the treatment
of adolescent
idiopathic
scoliosis
should be studied with
a prospective,
randomized
triaP#{176}-#{176}.
However,
because
of
the ethical difficulties
involved
in the implementation
of
such a study in a large scoliosis
clinic that serves young,
sensitive
adolescents
and their concerned
parents, many
physicians
are reluctant
to participate.
Furthermore,
in
such a trial, patients
would
be followed
by different
physicians
at the same center and would be managed
in different
ways for exactly the same degree of deformity. The patients
could meet and discuss the different
treatment
protocols,
and randomization
might be compromised.
Physicians
in turn would find it difficult
to
recommend
a form of treatment
that they did not believe in.
In view of these concerns,
we conducted
a multicenter, multinational
prospective
trial in which each participating center adhered
to its own preferred
method
of
treatment.
This method
was first proposed
by Van der
Linden58?9 and was recently
recommended
as a better
alternative
to randomization3?.
The population
of patients to be included
was to be similar
at all of the
centers. Management
of patients
in a manner consistent
ESTIMATION
DETECt?
OF
THE
DIFFERENCES
TREATMENT
NIJMHER
PRoGEssIoN
Rate of Progress
No
THE
OF
20
THE
TO
MEFHODS
RATES
OF
OF
CURvE
No. of Patients
Required
to Detect
a Given
Difference
the 5 Per Cent Significance
Treatment
30
REQUIRED
DIFFERENT
DIFFERENT
ion (Per cent)
Treatment
PAFIENFs
Two
BETWEEN
AND
I
OF
Power
=
0.90
Power
at
Level
=
20
391
294
10
82
62
5
47
36
10
266
199
5
101
73
0.80
with their physicians?
beliefs should serve to avoid ethical difficulties.
It should also help to ensure equivalence
between
the treatment
groups, thus mitigating
the effect
of patient
selection,
at least with regard to known
covariants.
With regard to unknown
covariants.
security
could be addressed,
as in randomized
trials, by the enrollment
of a sufficient
number of patients
who met well
defined
criteria for inclusion.
Inclusion
in the study was
based on each participating
physician?s
strict adherence
to the criteria. This process
does not affect patient
care
or violate
the physician-patient
relationship.
and it can
be performed
independently
any number
of times.
Members
of the Scoliosis
Research
Society.
from
centers
that were known to manage
many patients
who
have adolescent
idiopathic
scoliosis,
were asked to participate
in the study. We included
only physicians
who
firmly believed
in the effectiveness
of treatment
with
a brace for adolescent
girls who have idiopathic
scoliosis and those who firmly believed
that bracing
was
ineffective
and thus managed
their patients
with careful observation
until a predetermined
increase
in the
curve was observed.
In 1985. physicians
at two of the
largest treatment
centers
in one city advocated
the use
of lateral electrical
surface
stimulation,
and they were
allowed
to enter their patients
in the study. Preliminary
studies
on the use of electrical
stimulation
demonstrated some early beneficial
effects?5?2.
However,
toward the end of the 1980?s.
this method
was dismissed
as being ineffectiveh33s.
All of the physicians
agreed, in writing, to include all
consecutive
patients
who met the criteria for selection
and to adhere
to all of the protocols
that were established by representatives
from the different
centers. The
protocols
contained
information
on the initial Cobb angles7 and the clinical and roentgenographic
parameters
used to predict the risk of progression5.
The biostatistician (L.-E. P.) helped to design and evaluate
the results
of the study and was an active participant
in all of the
meetings.
We estimated
that 3(X) patients
would
be sufficient
for the detection
of a difference
of only 10 per cent
between
treatment
methods,
given a significance
level of
5 per cent and a power of either 0.80 or 0.90 (Table
I).
THE
JOURNAL
OF
BONE
AND
JOINT
SURGERY
FFFE(FIVFNESS
OF
TREATMENT
WITH
A
BRACE
IN
GIRLS
TABLE
EsIIStAIIo
NtSII3ER
AND
Art?AI.
OF
PATIENTS
NtSIIOERS
TO
THAT
BE
WERE
WHO
HAVE
ADOLESCENT
IDIOPATHIC
817
SCOLIOSIS
II
INCLUDED
IN(?LUJDEI)
IN
AND
THE
THAT
STUDY
IN
WERE
LOST
THE
FIRST
TO
YEAR.
FoLLow.vP
No. of
Center
Estimated
No.
of Patients
per Yr.
Treatment
Total
No.
of Patients
after
Patients
Lost to
Followup*
4 Yrs.
Stanmore
Brace
65
17
23
Nottingham
Observation
only
40
7
12
Essex
Observation
only
35
3
7
Atlanta
Brace
110
42
51
26 (4)
Minneapolis
Electrical
stimulation
I 20
31
49
10(3)
(two
centers)
Cleveland
Observation
only
70
7
14
3
Montreal
Observation
only
55
16
32
2 (1)
35
31
41
0
60
51
65
205
294
Malni#{246}
Brace
Goteborg
Observation
only
Total
590
The
numbers
in parentheses
indicate
therefore
categorized
as non-eligible.
were
Initially,
on
the
patients
who
enrolling
patients
basis
patients
of estimates
who
of
the
were
found.
numbers
during
of
be seen each year in each of the
participating
centers,
a two-year
period
of enrollment
was deemed
sufficient
to meet the requirements
of the
study. At the third meeting.
after the centers
had been
found
was
decided
years
would
for one
to have
year.
been
to continue
the influx
lower
enrolling
than
of new
(),f the
Execittion
patients
and
for a total
we
of four
Nineteen
Studs?
physicians
from
ten different
centers
ticipated
in this study
(Table
II). The study
April
1. 1985. and ended
on March
31. 1989.
group
met nine
times.
between
1984 and
at least one representative
from each center
at least
L.-E.
patients
expected
in order
to he able to detect
a significant
differin accordance
with the statistical
power analysis.
ence
eight
of the
meetings.
Two
long
one
made
with
cassette
member
the study
ability
the
patient
(thirty
by ninety
at each
center.
(1985
to 1986).
by having
on each
evaluations
ference
in the
measurements
degrees
for scoliosis
able
�
end
genograms
vertebrae
that
reported
recently545.
The error
77.A.
were
of a given
to those
NO.
were
tr. JUNE
used
patient.
obtained
estimates
L. N. and
roentgenowith
use
of a
were sent
first year
three
the
degrees
to
of
vanseparate
observers
(�
for kyphosis).
an intenobserver
degrees
and an intraobserver
after two additional
rounds
same
with
attending
interobserver
perform
among
and
to achieve
1992.
set of roentgenograms.
The first
revealed
a considerable
dif-
measurements
of these
three
were
and
centimeters),
During
the
we assessed
all participants
lateral
standing
par-
began
on
The study
of us (A.
P.) attended
all of the meetings.
Ten sets of anteroposterior
and
grams.
VOl..
Actual
No.
of Patients
after 2 Yrs.
variability
of 2.2
of evaluation
of 1.2
degrees
in which
for all consecutive
These
results
are
course
of the
study.
ilan measurements
not
to meet
the
for the different
criteria
centers:
for inclusion
and
we found
no
reason to believe
that there was a systematic
difference
between
the different
centers.
It can be predicted,
with
a 95 per cent level of confidence,
that the difference
between
successive
measurements
will not exceed
5 degrees
more
than approximately
5 per cent
of the time
because
of an observer
error.
Our
definition
of failure
of treatment
was based on error estimates
that
been determined
before
the start of the study. It
decided
that an increase
of 6 degrees
or more. noted
two consecutive
roentgenograms,
constituted
failure
treatment.
The purpose
of the current study was to
termine
if treatment
with
a brace.
in a defined
had
was
on
of
de-
popula-
tion of patients
who had adolescent
idiopathic
scoliosis,
could prevent
an increase
in the curve. The late treatment and results of patients
for whom the prescribed
treatment
failed were not included
in this study. The
treatment
of any given patient was not changed
during
the trial. The patients
were expected
to wear the brace
for at least sixteen
hours in a twenty-four-hour
period.
Compliance
with electrical
stimulation
was measured
and monitored
with use of an electrical
device.
The data were collected
on printed forms and were
sent
to one
of us (A.
L. N.),
who
served
as a coordinator.
Twice a year, all of the information
was entered
into a
database.
As far as possible,
missing data were obtained
from the participating
physicians
at our yearly meetings
and through
repeated
requests.
Approximately
3000
mailings
and
calls were
several
made
from
hundred
international
our office
during
telephone
the period
of the
study.
the
roentsimilar
similar
methods
and
that we performed
showed
sim-
IPJ5
with
We
variability
the
3
47 (8)
Criteria
for
Selection
Only girls who had adolescent
idiopathic
scoliosis,
a skeletal
age of between
ten and fifteen years?.
and a
single curve with the apex between
the eighth thoracic
and first lumbar vertebrae
were included
in the study.
818
A.
TABLE
CLINICAL
AND
ent
(No.
of
DATA
Stimulation
(N111)
not return
(N=46)
age
effort
posed
37
yrs.
81
82
>13 yrs.
48
29
-
9
age2
44
64
22
>13
yrs.
59
42
21
26
5
3
75
41
was
missing
at least
once
to skeletal
every
four
six months.
for a scheduled
her
Anteroposterior
and
patient
were
visit,
and
lateral
If, by chance,
premen-
a concerted
to continue
the
pro-
roentgenograms,
made
the six hours
all patients
with
months
and postIf a patient
did
follow-up
to locate
standing,
a year;
maturity,
with
for all patients
follow-up
visit. The brace was supposed
at least six hours before the roentgenograms
yrs.
Data
measured
was made
treatment.
the
13
Apical
was
to be followed
archal
patients
being seen
menarchal
patients,
every
Patients)
Brace
AL.
age
were
Electrical
Only
(N=129)
Skeletal
ET
etal
FOLLOW-UP
Observation
13
NACHEMSON
III
ROENTGENOGRAPHIC
Treatm
Chronological
L.
at each
to be removed
were made.
had not elapsed,
the patient
vertebra
T8-T11
104
T12-L1
degrees
25-29
degrees
Development
iliac
sign
sign 2-5
Data
and
hour
70
82
33
By the end of March 1989. after four years of enrollment, 294 patients
had been entered
into the study, and
54
28
13
by September
1, 1993,
sixteen
or
0 or 1
5
1
had awakened
years
because
56
65
Yes
73
46
tients
Yes
59
25
11
tients
No
66
86
34
were
missing
in height
39
71
<30 mm
79
36
11
4
Data missing
1
Rib hump?#{176}
not
were
met
patients.
analysis.
were
managed
three
seven
of the
of the
with
82
85
35
29
24
8
stimulation
were
skeletal
maturity,
18
2
3
them;
these
angle?7)
51
50
17
21
58
59
27
2
degrees
Data missing
20
2
18
33
14
105
77
28
analysis
in the
nine
the
left
survivor-
of the
129 who
only,
twenty-
with a brace,
and
nighttime
electrical
before
they reached
attempts
to locate
patients
for
patients
II). This
observation
lost to follow-up
despite
numerous
thirty-nine
survivorship
pa-
six pa-
eight
included
were managed
who received
course
and
(Table
patients,
regular
111 who
forty-six
degrees
were
286
the
of these
These
of
study
two
for inclusion
time.
age
the
During
that
as non-eligible
Of these
degrees
<2ldegrees
one
the
from
curve.
criteria
all of whom
7
missing
in the
only
reached
dropped
we found
the
seen
had
been
however,
8
Kyphosis
all either
had
categorized
ship
3Omm
trial,
had
286
1
4
in the morning.
of an increase
of the
Imbalance
(Cobb
up
one
tient
No
Data
to jump
for at least
19
Menarche
Increase
brace.
27
missing
Data
to wait
39
crest
Risser
the
and
72
of
Risser
remove
times,
54
75
angle?7)
30-35
to
several
before
the roentgenograms
were
made.
For patients
who were
managed
with electrical
stimulation,
roentgenograms
were
made
at least four hours
after the pa-
Scoliosis
(Cobb
instructed
down
S
36
25
were
time
included
that
study. Excluding
these
thirty-nine
(86 per cent) were followed
until
ure of the treatment.
they
in the
were
patients.
maturity
in the
247 patients
or until fail-
Rotation47S
or 4+
2+,
3+.
Oor
1+
Data
The clinical
and
at the follow-up
ical
4
6
missing
made
and
arche,
The
curve
measured
vertebrae,
had
to comprise
between
and the
the
Cobb
at least
five
vertebrae
cephalad
and caudad
angle?7 had to average
as
neutral
between
25 and 35 degrees.
A
single
compensatory
ity and
the
curve
curve
rotation
was
considered
was
at least
5 degrees
apical
vertebra,
of the
the criteria
of Nash and
exceed
that of the curve
was
hand
Other
determined
with
and wrist
signs of
physiological
age
present
of the
the
in sever-
according
to
Moe47 or of Perdrioll&#{176}, did not
to be treated.
Skeletal
maturity
use of a roentgenogram
and the
maturity
when
less
of the
atlas of Greulich
and
were the chronological
child
and
the
Risser
sign.
skeletal
age,
imbalance
as
Skel-
the
presence
or absence
measured
with
the
of menplumb-line
method,
any increase
in height during the
observation
as measured
in millimeters,
and extent
of a rib hump
as determined
method
described
by Bunnell?,
the level
vertebra,
and the Risser
sign. Kyphosis
first year of
the presence
with the
of the apical
and scoliosis
were
and
measured
with
the
Cobb
method?7,
rotation
was assessed
with the method
of Perdriolle5
or of Nash
and Moe47 (Table III). All of these factors
were used
to predict progression
of the curve in a separate
study?.
Results
left
Pyl&?.
and
roentgenographic
observations
evaluations
included
chronolog-
The
the
lowed
best
method
survivorship
for different
THE
for evaluation
analysis?433.
as
durations
JOURNAL
the
before
OF
BONE
of the
results
patients
were
fol-
reaching
ma-
either
AND
JOINT
SURGERY
was
Survival EFFE(?TIVENESS
OF
TREATMENT
WITH
Survival
proportion
A
BRACE
IN
WHO
HAVE
6#{176}.2
1.0
confidence
interval,
0.6
cent
vorship
0.4
819
SCOLIOSIS
52 to 84);
--
Obs
-
El stim
0.2
curves
with
0.0
Patients
0.0
still at risk
0.5
1.0
1.5
Survival
function
estimates33
who were
managed
electrical
stimulation.
tion
only.
There
was
between
the patients
two groups;
significant.
Brace
15
14
Obs
37
5
Elstim
6
A
2.5
3.0
2.0
FI;.
patients
observation
only,
with
a
3.5
4.0
comparing
the
results
the forty-six
managed
between
treatment
confidence
one
By 1988,
stimulation
Years
for
the
who
I 11
received
with a brace
and the other
only, with a success
rate of
with a success
rate of 33 per
intervals
are shown
for the
three
and
year
did
who
or having
a documented
increase
in the
a brace.
seventeen
had a failed
result
were lost to follow-up.
Of the forty-six
with
electrical
stimulation,
curve
managed
result and
managed
of
with
nine
with
and twenty-three
patients
managed
twenty-two
had
a failed
re-
sult and seven
were
lost to follow-up.
The thirty-nine
patients
who were lost to follow-up
were included
in the
survivorship
analysis
for
the
time
that
increase
this increased
the accuracy
As expected
in a clinical
study
distribution
of some variables
between
were
managed
with observation
only
received
one
skewed
(Table
of
the
other
III).
This
two
types
deviation
separate
papers?
on the statistical
study;
it did not interfere
with
from the survivorship
analysis.
the
0.6
aspects
of the
the conclusions
in a
current
drawn
associated
progression
of the curve,
(p < 0.0001).
According
at three years, treatment
with
an 80 per
cent
with
confidence
a 46 per
interval,
cent success
VOl..
77-A.
o.
NO.
JUNE
1995
cent
success
and
the
or
this
ef-
to the surwith
a brace
rate
(95
per
66 to 88); observation
only,
rate (95 per cent confidence
analysis
was
performed
with
a brace,
number
more
(p
=
of
in
until
0.0005)
failures,
(Fig.
I).
category
the pa-
for
with
the
the
treatment
preventing
pa-
brac-
and
this
estimates,
a
of
benefit
2). Information
of patients
for
is not relevant
Survival
with
progression
maturity,
(Fig.
management
protocol
failed
6
was
on the
sub-
whom
the estabto the current
worst
case
6#{176}
#{149}
2
Termination:
=
0.0005
Brace
0.4
--
Obs
-
El stim
0.2
0.0
Survivorship
curves
were constructed
for the three
treatment
groups
(Fig. 1). Differences
between
groups
were
tested
with the log-rank
test52. Treatment
with a
brace
prevented
fect was significant
vivorship
analysis,
the
only,
trial
to this
managed
successful
was
analyzed
for
that electrical
centers
in Mm-
patients
p
who
who
was
of the
indicated
the two
new
managed
that
1.0
the patients
and those
of treatment
to
observation
initiation
any
Survival
proportion
analysis.
magnitude,
of the
of this
add
were
was
sequent
lished
0.8
were
not
in
brace
in the
they
the
binomial
who were
similar
with
had already
not effective3239;
to a conser-
quadratic
ing in the twenty-three
patients
who had been dropped
from the study considered
as having failed. Despite
this
degrees
at least 6 degrees.
Of the 129 patients
observation
only. fifty-eight
had a failed
were lost to follow-up.
Of the 1 1 1 patients
was
managed
after
worst-case
tients
significant
turity
according
but elected
to follow, according
to the protocol,
tients already enrolled
in the study.
A
the latter
two groups
was not
with a brace
was associated
with
were
studies
was
neapolis
with a brace,
who were
95 per cent
intervals.
constructed
stimulation
who
within
3
A
1
a success rate of 74 per cent; observation
34 per cent; and electrical
stimulation,
cent. The
four-year
rate
were
electrical
patients
and the 129 who were managed
with observaa highly
significant
(p < 0.0001)
difference
the difference
At four years.
success
vative modification
of the Wilson
procedure.
The success rate for the patients
Brace
was
IDIOPATHIC
(95 per cent confidence
interval, 16 to 49); and electrical
stimulation,
with a 33 per
cent success
rate (95 per cent confidence
interval,
12 to
60). The 95 per cent confidence
intervals
for the survi34 per
0.8
study:
ADOLESCENT
interval,
25 to 56); and electrical
stimulation,
with a 39
per cent success
rate (95 per cent confidence
interval,
19 to 59). At four years, treatment
with a brace was
associated
with a 74 per cent success
rate (95 per cent
estimates
Termination:
GIRLS
0.0
0.5
1.0
1.5
2.0
Fiu.
Worst-case
mined
after
the number
group
analysis.
the
of patients
who did not comply
managed
with
treatment
number
The survival
2.5
3.0
3.5
4.0
Years
2
function
who
were
estimates33
lost
with the prescribed
were
to follow-up
treatment.
with a brace,
were added
to the seventeen
a brace
failed.
The survival
rate in this
deterand
in the
for whom
entire
group
was compared
with that of the other two groups. and the superiority
of treatment
with a brace was significant
(p = 0.OOIJS).
820
A.
study;
the
participating
record
the
later
physicians
course
and
were
treatment
not
L.
NACHEMSON
asked
of the
to
disease.
use of a brace
for the treatment
of adolescent
idscoliosis
has never gained
universal
acceptance
among
orthopaedic
surgeons?524.
convinced
of
its
history
long-term
of
Even
efficacy
those
have
Some
untreated
prognosis,
scoliosis
mainly
who
admitted
studies
of the
have
due to
have
only
severe
associated
thoracic
with
Some
late
authors
vantages
associated
Several
with
minished
found
brace
disad-
self-image?6,
compliance
and easier
self-image.
that
by
making
the
device
the effectiveness
of the brace
lescent
scoliosis
idiopathic
mixed populations
tion and evaluation
overview
less
concerns
precise
have
the
The
to
visible
about
data on
in the treatment
because
of
it di-
and this may
to wear, thereby
diminishing
It has been difficult
to obtain
of ado-
studies
have
had
of patients
and the criteria for selechave not been clearly
defined.
A
of some
of the published
reports
following
a Risser
age
substan-
sign
of the
Risser
authors
were
had
treatment
a curve
been
those
of
2 or
not
a single
The rate
or more
patient
more.
given.
thoracic
of failure
(an
or operative
of an initial
thoracic
for those
for those
at the
Patients
time
who
who
of more
documented.
of the study
25 degrees
than
be managed
rather
than
who
had
of presentation:
sign; and,
in girls.
the menarchal
recommended
that immature
of 0 should
initial
visit
a brace?62324.
of the treatment
suggested
study
curve of 30 to 39 degrees
was 47 per cent
had a Risser
sign of 0 or 1 and 22 per cent
have
with
the
patients)
curve pattern.
curve
of 5 degrees
intervention)
the
to be
compliance
with the prescribed
regimen.
of underarm
braces-?42
was intended
increase
brief
been
(389
had
psychological
studies
a Milwaukee
the patient?s
decreased
introduction
has
from
cent
double-curve
pattern
had a poorer
prognosis.
Over-all,
Lonstein
and Winter
found
progression
of the curve
to
be related
to the pattern
and magnitude
of the curve;
revealed
a poor
cardiopulmonary
treatment
follow-up
per
natural
disturbances4.
reported
with
long-term
scoliosis
scoliosis
psychological
have
dropped
failures
complications?4.
Other studies
have suggested
a better
prognosis
for patients
who have a moderate
curve49?2,
and
were
or thoracolumbar
increase
in the
The
iopathic
and complicationsc25373es).
who
AL.
Thirty-eight
Discussion
been
ET
the
status.
adolescents
and
a
These
who
a Risser
sign
with
after
a brace at the time of the
progression
has already
The results
on predictive
of the present
study and
factors
for progression5?
support
this recommendation.
Bassett
et al.3 evaluated
the results
in immature
boys
and girls who had been managed
with the Wilmington
underarm
brace
for a curve
of 20 to 39 degrees.
However, they included
only patients
who had complied
with
the recommended
treatment.
and many of their patients
were
not mature
at the time
of the latest
follow-up
evaluation.
Emans
1600 patients
who
brace between
varying
types
1971 and 1981. They analyzed
that
had averaged
between
found
an increase
in the rate
had been more than 40 degrees
ment.
and they noted
poorer
of failure
for curves
that
at the initiation
of treatresults
in non-compliant
the
patients.
Montgomery
had had a curve
followed
or more,
and
125 patients
brace.
who
Keiser
and
Morris2?
had
followed
been
only
managed
Shufflebarger35
with
followed
fifty-two
a Milwaukee
123
who had been managed
with a Milwaukee
Only 103 of the 123 had adolescent
idiopathic
sis, and poor results
were noted
in those who
patients
complied
with the treatment
al.#{176}
reported
the late (five-year)
with
a Milwaukee
who were
regimen.
results
of
of 300
brace.
scoliohad not
Mellencamp
et
after treatment
brace in forty-seven
(of ninety-four)
available
for follow-up.
These authors
patients
included
various
types
of curves,
degrees
(range,
17 to
75
which
degrees)
at
tients
with
who
a Milwaukee
discontinued
brace.
the
The
treatment
sixteen
years.
The patients
were
after discontinuation
The
treatment
and
was
considered
curve
increased
to more
patients
who had a thoracic
been
managed
with either
Boston
brace.
44
a rate
of failure
the
initiation
of
the Boston
brace. However,
leading
in that the analysis
numbers
themselves
of paand
a Risser
that, in
sufficient
ulation
osis
had been
less
These
authors
244 girls who
a skeletal
age of
sign of less than
to have
that
was
failed
than 45 degrees.
or thoracolumbar
the Milwaukee
The Milwaukee
had completed
The results
who
old.
followed
for an additional
of the management
with
averaged
Lonstein
and Winter3? reported
on 1020 patients
had adolescent
idiopathic
scoliosis
and had been
managed
and Willner3
of 25 degrees
had
treatment.
Carr et al.?5 reported
the long-term
results
of treatment
with a Milwaukee
brace
in 133 patients.
eight to sixteen
years old, in whom
the curves
had ranged
from
12 to 74 degrees.
Non-compliant
patients
were
excluded
and several
patterns
of curves
were included.
who
less than
included
patients
than fifteen
years
of
59
degrees,
than ten
literature.
they
more
curves
20 and
tiates this conclusion.
Kehi and Morrissy?.
in their
critical review,
pointed
out that the benefit
of treatment
of
adolescent
idiopathic
scoliosis
with a brace
remains
unsubstantiated
by prospective,
controlled
studies.
Focarile et al.4 expressed
a similar
opinion
after a review
of
Edmonson
and
and
et al. evaluated
the results
in 295 of
had been managed
with the Boston
five
was associated
times
higher
this conclusion
included
only
of patients
who
had
than
idiopathic
based
defined
adolescent
sixteen
THE
JOURNAL
Our
OF
BONE
study.
AND
which
JOINT
on a
popscoli-
at
old.
of
treatment
program.
made it obvious
to us
patients
years
with
that
have to be drawn
from several
centers.
would also have to be followed
until they
least
the
may be mispatients
who
order
to obtain
firm conclusions
number
of similar
patients.
a well
would
when
Sixty-seven
curve had
brace
or the
brace
the recommended
of these studies
4.
two years
the brace.
The
were
included
SURGERY
EFFE(?IIVENESS
patients
OF
from
teen
plete.
ten
TREATMENT
different
WITH
centers
and
participating
physicians.
took
Two
hundred
and forty-seven
cent)
were
figure
available
Admittedly,
trial.
for
and
the
the
the
present
patients
were
current
that
use
between
effective
surface
of
IN
involved
GIRLS
was
was
high
the
results
of
the
was 20 per cent. It may
were
lost to follow-up
would
probably
as those
prospectively
thoracic
therefore,
had
were
cent
electrical
with
more
of
stimulation.
ment
with
eight
patients
was
is probably
observation
crude
rate
19 per cent
[1 1 1 patients
same
observation
than
The
a brace
the
the sixteen
who
rates
are similar
earlier
In another
clinical
were dropped
from
to those
reported
delineated
progression.
have
been
collected
informanot be interpreted
as a
resembling
those in the
information
pathic
scoliosis.
than
who
and
or
of treat-
and
have
the
for the
treatment
study
of adolescent
for whom
who
can
of
We
the highest
risk for
physician
with addiwill include
until they were
us to determine
of patients
is indicated
the importance
of progression.
A subsequent
were followed
this may help
percentage
of eighty-
we discussed
for the prediction
the patients
who
thereby
providing
tional
twenty-three
reports?522224#{176}5364??
reports.
parameters
rate
alone
of failure
of
only;
more
(seventeen
minus
the corresponding
present
study should
be managed
with a brace. Our study
was not intended
to address
the end result after maturity.
all patients
who
with a brace
a brace
effective
while
based
on incomplete,
retrospectively
tion. However,
our results
should
recommendation
that all patients
analyses
at the
with
the studyj),
821
SCOLIOSIS
for the patients
who had the other forms
was 50 per cent (eighty
of 159 patients
minus
these
conclusions
curve
worst-case
progression
managed
treatment
20 per
and
be inferred
that
after
management
have
who
best
from
IDIOPATHIC
The current study has also revealed
the risk. if the
curve is untreated,
of progression
of 6 degrees
or more
until the patient
reaches
maturity.
We believe
that the
of
an attempt
many diffi-
25 and 35 degrees
in girls was 40 per cent more
than treatment
with observation
alone or with
electrical
stimulation
(Fig. 1). The difference
be-
tween
dropped
175 patients
the study]);
analysis,
that proIt became
appar-
a right
ADOLESCENT
a randomized
performed
for
HAVE
rate of failure
of treatment
to com(86 per
independent
because
trial poses
a worst-case
data possible.
a brace
not
observed
WHO
were
nine-
years
patients
a relatively
-
study
not
study
in a manner,
including
vided the most accurate
ent
BRACE
study.
their treating
physician.
However,
to perform
a perfect
randomized
culties,
nine
follow-up
for a multicenter
A
eighteen
years old,
the approximate
treatment
thereby
idiopatients
avoid
with
the
a brace
need
for
an
operation.
who
References
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surface stimulation
for the treatment
of progressive
242-260.
1983.
2. Axelgaard,
J.; Nordwall,
A.; and Brown,
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1. Axelgaard,
463-481.
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muscle
scoliosis.
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Spine,
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atscl Joint
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electrical
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Edmonson,
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