http://www.scoliosissystems.com/images/spinecor_brace.jpg Many conservative treatments are available for adolescents with idiopathic scoliosis (AIS). Although there are numerous studies in literature that have tried to summarize the results of treatment,1Y7 the evidence for their accepted use is still unclear...

Effectiveness of the SpineCor Brace Based on the New Standardized Criteria Proposed by the Scoliosis Research Society for Adolescent Idiopathic Scoliosis. (article form http://www.scoliosissystems.com/SpineCor/JPOSpineCorPaper.pdf_)
Christine Coillard, MD,* Valerie Vachon, MSc,Þ Alin B. Circo, MSc,* Marie Beause´jour, MScA,*and Charles H. Rivard, MD, FRCS(c), FAAOS, FACS*

Abstract: The purpose of this prospective observational study was

to evaluate the effectiveness of the Dynamic SpineCor brace for

adolescent idiopathic scoliosis in accordance with the standardized

criteria proposed by the Scoliosis Research Society Committee on

Bracing and Nonoperative Management. They proposed these

guidelines to make the comparison among studies more valid and

reliable. From 1993 to 2006, 493 patients were treated using the

SpineCor brace. Two hundred forty-nine patients met the criteria

for inclusion, and 79 patients were still actively being treated.

Overall, 170 patients have a definitive outcome. All girls were

premenarchal or less than 1 year postmenarchal. Assessment of

brace effectiveness included (1) percentage of patients who have

5 degrees or less curve progression, and percentage of patients who

have 6 degrees or more progression; (2) percentage of patients who

have been recommended/undergone surgery before skeletal maturity;

(3) percentage of patients with curves exceeding 45 degrees

at maturity (end of treatment); and (4) Two-year follow-up

beyond maturity to determine the percentage of patients who

subsequently underwent surgery. Successful treatment (correction,

95 degrees, or stabilization, T5 degrees) was achieved in 101

(59.4%) of the 170 patients from the time of the fitting of the

SpineCor brace to the point in which it was discontinued. Thirty-nine

immature patients (22.9%) required surgical fusion while receiving

treatment. Two (1.2%) of 170 patients had curves exceeding

45 degrees at maturity. One mature patient (2.1%) required surgery

within 2 years of follow-up beyond skeletal maturity. The conclusion

drawn from these findings is that the SpineCor brace is effective for

the treatment of adolescent idiopathic scoliosis. Moreover, positive

outcomes are maintained after 2 years because 45 (95.7%) of 47

patients stabilized or corrected their end of bracing Cobb angle up to

2 years after bracing. Therapeutic studyVinvestigating the results of

treatment: level II.

Key Words: adolescent idiopathic scoliosis, conservative treatment

effectiveness, SpineCor brace, standardized criteria

Many conservative treatments are available for adolescents with idiopathic scoliosis (AIS). Although here are numerous studies in literature that have tried to summarize the results of treatment,1Y7 the evidence for their accepted use is still unclear.8 In addition, the lack of consistency of both the inclusion criteria and the definitions (the people who will take care of this can finish formatting fonts)…of brace effectiveness9 makes many clinicians skeptical

about the efficacy of conservative treatments.10,11

The Scoliosis Research Society (SRS) thought it was

necessary to establish parameters for all future AIS bracing

studies9 to be able to make comparison among studies more

valid and reliable. Such guidelines will allow the promotion

of the effectiveness of different braces using different

approaches, for instance the 3-point pressure principle used

by rigid braces and the Corrective Movement used by the

Dynamic SpineCor brace (Fig. 1).

The effectiveness of the SpineCor brace has been

shown for milder and moderate curves.1 The purpose of the

present review is to evaluate the effectiveness of the SpineCor

brace for AIS in accordance with the new standardized

criteria proposed by the SRS Committee on Bracing and

Nonoperative Management.9

METHODS

The Studied Population

This prospective observational study was conducted on

a group of 493 patients (92.7% girls) having idiopathic

scoliosis treated with the SpineCor brace.

Radiographic Analysis

The initial pretherapeutic radiograph used a digital

technique where the irradiation is half as much as that of a

standard radiograph.12 The initial evaluation included a

posteroanterior and a lateral radiograph without brace within

a maximum of 1 month before brace fitting. Control

radiographs (erect posteroanterior position) with the Spine-

Cor brace (and shoe lift when prescribed) were obtained on

the day of the fitting, at 4 to 6 weeks, and then every 5 months

until weaning. Lateral radiographs were obtained once a year.

At the end of the treatment, the use of controls was continued

at 6 months, 1 year, and once every year. These evaluations

were performed without brace.

The inclusion criteria were as follows:

& idiopathic scoliosis diagnosis and radiological confirmation

of absence of significant pathological malformation

of the spine;

ORIGINAL ARTICLE

J Pediatr Orthop & Volume 27, Number 4, June 2007 375

From the *Research Center, Sainte-Justine Hospital, Montreal, Quebec,

Canada, and †SpineCorporation Limited.

Study conducted at the Research Center, Sainte-Justine Hospital and

University of Montreal, Canada.

Study was funded by the Research Center, Sainte-Justine Hospital and the

Spine Corporation.

Reprints: Charles H. Rivard, MD, FRCS(c), FAAOS, FACS, Research

Center, Sainte-Justine Hospital, 3175 Coˆte Ste-Catherine, Montreal,

Quebec, Canada H3T 1C5. E-mail: chrivard@gmail.com.

Copyright * 2007 by Lippincott Williams & Wilkins

Copyright @ Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

& age older than 10 years and younger than 15 years when

brace is prescribed;

& Risser 0, 1, or 2;

& if female, either premenarchal or less than 1 year

postmenarchal;

& initial Cobb angle of 25 degrees or greater;

& initial Cobb angle of 40 degrees or lesser; and

& no previous treatment for scoliosis.

The exclusion criteria were as follows:

& presence of a congenital malformation of the spine, spina

bifida aperta, or spondylolisthesis;

& neuromuscular scoliosis; and

& postural scoliosis.

Skeletal maturity is considered achieved when Risser 4

or more is reached and, in girls, when the patient is 2 years

postmenarchal. The US grading system13 for Risser sign was

used in this study. Taking into account the criteria mentioned,

we needed to exclude some patients from the actual study. Of

493 patients who accepted the treatment using the SpineCor

brace between 1993 and 2006, 59 patients were younger than

10 years at the initial visit, 61 patients had a Risser 3 to 5 or

were more than 1 year postmenarchal, 112 had an initial Cobb

angle less than 25 degrees, and 12 patients had a curvature

greater than 40 degrees. From the remaining 249 patients who

respected those inclusion criteria, 79 patients were still

actively being treated at the time of the analysis, for a total of

170 patients with an outcome. From this cohort of patients, 47

patients had 2 years of follow-up after weaning of the brace.

Description of the Bracing System

and Treatment Protocol

The Dynamic SpineCor brace, developed in 1992Y1993,

uses a specific Corrective Movement dependent on the type of

the curve. Curve classification was based on the classification

presented by Ponseti and Friedman.14 The curve-specific

Corrective Movement is performed, and the brace is applied

according to definitions contained in the SpineCor Assistant

software. To be effective and to obtain a neuromuscular

integration, the brace must maintain and amplify the

corrective movement over time. The brace must be worn 20

hours a day for a minimum of 18 months to create a

neuromuscular integration of the Corrective Movement

through active biofeedback. Generally, the brace is stopped

at skeletal maturity (at least Risser 4) (Fig. 2).

Improvement of more than 5 degrees or stabilization of

T5 degrees of the scoliosis curvature was defined as a positive

outcome. An aggravation of the spinal curvature of more than

5 degrees, progression exceeding 45 degrees, withdrawal, and

surgery were defined as negative outcomes. The data

collected were analyzed in 4 outcomes, as suggested by the

SRS Committee on Bracing and Nonoperative Management.9

To strengthen the ability to compare and combine results

FIGURE 1. Corrective Movement for the right thoracic type 1

curve: counterclockwise rotation of the thorax and clockwise

rotation of the shoulders in the horizontal plane.

FIGURE 2. Front and back views of the SpineCor

brace fitted for the right thoracic type 1 curve:

the brace keeps and stimulates the specific

corrective movement for the right thoracic curve.

Coillard et al J Pediatr Orthop & Volume 27, Number 4, June 2007

376 * 2007 Lippincott Williams & Wilkins

Copyright @ Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

across studies, we stratified our results according to curve

type, curve magnitude grouping, and skeletal maturity.

Descriptive statistics were used to analyze the population.

RESULTS

One hundred seventy patients (158 girls and 12 boys)

treated using the SpineCor brace respected the inclusion

criteria and were not actively being treated. All girls were

premenarchal or less than 1 year postmenarchal. Thirty-nine

immature patients required surgery during brace treatment,

12 patients withdrew from the SpineCor treatment and

refused any other conservative treatment, and 14 patients

were weaned before reaching skeletal maturity because they

had an authorized end of treatment and a Cobb angle inferior

representing a stable corrective result. Forty-seven patients

had 2 years of postbracing follow-up.

Assessment of brace effectiveness includes all of the

following:

1) Percentage of patients who have 5 degrees or less

curve progression and the percentage of patients who

have 6 degrees or more progression.

One hundred one (59.4%; 87 + 14) of 170 patients

corrected or stabilized their initial Cobb angle, and 18

patients (10.6%) had 6 degrees or more progression of their

initial Cobb angle (without surgery) (Table 1).

Forty-seven patients with a successful outcome at the

weaning point reached the 2 years of follow-up.

With postbrace treatment follow-up observation

(Table 2), the treatment success rate at 2 years was 95.7%

(n = 47), comparing the end of bracing Cobb angle with the

one at 2 years after bracing. Forty of 47 patients stabilized

their Cobb angle, and 5 patients still improved from the time

the brace was discontinued up to 2 years of follow-up.

2) Percentage of patient who have had surgery

recommendation/undergone before skeletal maturity.

Thirty-nine immature patients (22.9%) from a total of

170 required surgical fusion while receiving treatment

(Table 1). The average curve magnitude at bracing in this

particular group was 34 T 5.1 degrees (range, 25Y40

degrees). The general indication for fusion in all patients

was progression of primary curve at more than 60 degrees

TABLE 1. Outcome for the 170 Patients Treated Using the SpineCor Brace, Comparing the Initial Cobb Angle With the One

at the Weaning Point

SpineCor Dynamic Corrective Bracing (n = 170)

e5 Degrees 95 Degrees (945 Degrees)

Patient Weaned Before

Skeletal Maturity* Withdraw Surgery† Total

No. patients 87 18 (2) 14 12 39 170

Type of curve

Thoracic 37 10 (2) 5 3 19 74

Thoracolumbar 29 1 (0) 5 5 9 49

Double 13 6 (0) 2 3 11 35

Lumbar 8 1 (0) 2 1 0 12

Initial Cobb angle

[25Y29 degrees] 37 10 (0) 10 4 6 67

[30Y40 degrees] 50 8 (2) 4 8 33 103

Initial Risser sign

0 39 17 (2) 13 7 36 112

1 23 0 (0) 1 1 2 27

2 25 1 (0) 0 4 1 31

*The 14 patients received an authorized end of treatment because of a stable corrective result.

†Of the 39 patients requiring corrective surgery, 36 had a Risser sign 0 at the beginning of treatment and 33 were in the group with Cobb angle of 30 to 40 degrees.

TABLE 2. Outcome for the 47 Patients Treated Using the

SpineCor Brace, Comparing the Cobb Angle at the Weaning

Point With the One at 2 Years of Follow-up After Bracing

SpineCor Dynamic Corrective Bracing (n = 47)

e5 Degrees 95 Degrees 945 Degrees* Surgery†

No. patients 45 2 4 1

Type of curve

Thoracic 18 2 3 1

Thoracolumbar 12 0 0 0

Double 12 0 1 0

Lumbar 3 0 0 0

Initial Cobb angle

[25Y29 degrees] 21 0 0 0

[30Y40 degrees] 24 2 4 1

Initial Risser sign

0 25 2 4 1

1 9 0 0 0

2 11 0 0 0

*Four patients had a scoliosis beyond 45 degrees angle at maturity 2 years after

bracing. Only 2 of them had a progression of their Cobb angle after the weaning point;

the 2 other patients had a stabilization of their scoliosis. Their initial Cobb angles were

40 degrees, 36 degrees, 40 degrees, and 39 degrees, and their Cobb angle at the end of

bracing were 44 degrees, 42 degrees, 51 degrees, and 51 degrees, respectively. Their

Cobb angles at 2 years of follow-up after bracing visit were 47 degrees, 48 degrees, 55

degrees, and 61 degrees.

†Regarding this particular subgroup of patients, surgery was required for the patient

who had a Cobb angle of 39 degrees at the initial visit, 51 degrees at the end of bracing,

and 61 degrees at the last visit after bracing. Surgical treatment was not an option for the

3 other patients with a Cobb angle beyond 45 degrees.

J Pediatr Orthop & Volume 27, Number 4, June 2007 Effectiveness of the SpineCor Brace

* 2007 Lippincott Williams & Wilkins 377

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in thoracic region and 45 degrees in thoracolumbar and

lumbar regions.

3) Percentage of patients with curves exceeding 45

degrees at maturity.

In addition to patients referred for surgery before

maturity, 2 of 170 patients progressed beyond 45-degree

curve at maturity (end of bracing Cobb angle) (Table 1).

4) Two-year follow-up beyond maturity to determine

the percentage of patients who subsequently

undergo surgery.

Four (8.5%) of 47 patients had curves exceeding 45

degrees at 2 years of follow-up (Table 2). However, only 2 of

them had a progression of their Cobb angle after the weaning

point; the 2 other patients had a stabilization of their scoliosis.

The Cobb angles of the progressive ones at the end of bracing

were 42 and 51 degrees, respectively. Their Cobb angles at 2

years of follow-up after bracing visit were 48 and 61 degrees.

Regarding this particular subgroup of patients, surgery

was required for only 1 patient, the one who had a Cobb

magnitude of 51 degrees at the end of bracing and 61 degrees

at the last visit after bracing. Surgical treatment was not an

option for the other 3 patients.

5) Results stratified according to curve type, curve

magnitude grouping, and skeletal maturity.

The results were analyzed separately according to curve

type (thoracic, thoracolumbar, lumbar, and double curves),

curve magnitude, and skeletal maturity (Tables 1 and 2).

Bracing success depending on curve type (Table 1)

was achieved at a rate of 56.8% for thoracic (37 + 5 =

42/74), 69.4% for thoracolumbar (29 + 5 = 34/49), 42.9%

for double curves (13 + 2 = 15/35), and 83.3% for lumbar

curve (8 + 2 = 10/12), comparing the initial Cobb angle

with the one at maturity. To study the effect of curve

magnitude on outcome, the patients were divided into

2 groups. Group 1 consisted of 67 patients whose curves

magnitude at bracing was 25 to 29 degrees, and group

2 consisted of 103 patients with curve magnitude of 30 to

40 degrees. Group 1 had 70.1% of success compared with

52.4% of success for group 2. Comparison of brace success

among initial Risser signs (Table 1) 0, 1, and 2 and at

skeletal maturity is 46.4%, 88.9%, and 80.6%, respectively.

DISCUSSION

The purpose of this prospective observational study was

to evaluate the effectiveness of the Dynamic SpineCor brace

for adolescent idiopathic scoliosis after the standardized

criteria proposed by the SRS Committee on Bracing and

Nonoperative Management. In addition, we wanted to

compare the effectiveness of the SpineCor brace with rigid

braces, particularly the Boston brace,2,3 the Wilmington

brace,4 the Milwaukee brace,5 the Charleston brace,6,15 and

the Rosenberger brace.7 We used these reference articles as

an alternative of other because they used very similar

inclusion and exclusion criteria as in our study.

A previous study has been published in 2003 in

European Spine Journal1 on the first 195 patients from the

same prospective cohort. This preliminary study in 2003

revealed that on the 29 patients who had a minimum

posttreatment follow-up of 2 years, 55% obtained a

correction of their initial Cobb angle, 38% stabilized their

Cobb angle, and only 7% worsened by more than 5-degree

angle. The recent results follow a similar trend. Comparing

the end of bracing Cobb angle to the one at 2 years after

bracing, our study reveals that the follow-up of orthopaedic

treatment was a success in 95.7% of the patients, with a

mean correction angle of 8.6 T 1.7 degrees. As reported by

Montgomery et al,16 a follow-up of 2 years is sufficient to

foresee progression after weaning from the brace. It seems

possible with the SpineCor brace to have sustainable

correction or stabilization of scoliotic curves up to 2

years after discontinuation of brace treatment.

Our results also demonstrated variable positive outcome

for patients having a lumbar (83.3%), thoracolumbar

(69.4%), thoracic (56.8%), and double curves (42.8%).

Double curves were a little bit less successful compared

with the other type of curves. This may be explained by the

fact that we detected them later compared with the other types

of curves because the posture is more often quite normal and

they are more rigid. Positive outcome was also achieved for

group 1 with 70.1% rate of success (initial curvature, between

25 and 29 degrees) compared with 50.2% for group 2 (initial

curvature, between 30 and 40 degrees), comparing the

beginning of bracing to the weaning point. Those results

demonstrate the fact that it is possible to achieve higher rate

of correction or stabilization when the conservative treatment

is started in the early stage. Despite this fact, it was surprising

to find out that success was attained in 46.4% of patients

having an initial Risser sign of 0 compared with 88.9% and

80.6% for patients having a Risser sign of 1 and 2,

respectively.

Although early reports indicated that the Milwaukee

brace17 could afford some lasting reduction in the degree of

spinal curvature, subsequent studies with longer follow-up

demonstrated that after the cessation of brace treatment,

curves that had demonstrated some correction at the end of

bracing with traditional rigid braces tended then to continually

increase toward the pretreatment angle.2,4,5,18 In the

study of Noonan et al,5 63% of the 88 patients wearing the

Milwaukee brace were classified as a failure. Noonan et al

showed that 27 patients (31%) had an arthrodesis; of these, 18

patients (67%) had curve progression while they wore the

brace, and 9 (33%) had progression of the curve after a trial of

intentional weaning. Similar loss of correction over time was

also observed with other braces such as Wilmington and

Boston braces. In the study of Gabos et al,4 22% of 55 patients

demonstrated an increase in the curvature of 5 degrees or

greater between the end of bracing using the Wilmington

brace and the time of final follow-up (mean, 14.6 years after

the completion of treatment). In addition, 13% demonstrated

an increase in the curvature of 5 degrees or greater between

the end of bracing and the time of final follow-up that resulted

in a curve that was 5 degrees or greater than the angle of

deformity measured at the time of the initial treatment.

Olafsson et al3 studied a population of patients with AIS

wearing the Boston brace but with smaller curves (magnitude,

22 to 44 degrees). For this cohort of patients, the mean Cobb

angle at treatment start was 32 T 6 degrees, 12.1 T 7.6 degrees

Coillard et al J Pediatr Orthop & Volume 27, Number 4, June 2007

378 * 2007 Lippincott Williams & Wilkins

Copyright @ Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

after bracing, 25.4 T 11.3 degrees after weaning, and 29 T 12

degrees at follow-up. However, our results show that it is

possible to obtain a correction or a stabilization of the

pretreatment Cobb angle (59.4%), and it seems possible to

maintain the brace success for 2 years after the end of the

treatment using SpineCor brace because only 2 of 47 patients

who have completed the 2 years of follow-up had a curve

worsening during this follow-up period.

In summary, the SpineCor Brace is effective for the

treatment of AIS. Moreover, the positive outcomes are

maintained up to 2 years of follow-up beyond skeletal

maturity. This particular feature of the SpineCor brace makes

it very different to the already published literature on brace, in

which apparent correction obtained during treatment can be

expected to be lost over time.4,18 However, future studies that

will support and reinforce this finding are necessary. Forthcoming

studies using the same standardized criteria for

AIS brace studies as used in this study will allow valid and

reliable comparison between the SpineCor brace and any

other rigid braces.

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* 2007 Lippincott Williams & Wilkins 379