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The effectiveness of the SpineCor brace for the conservative treatment of adolescent idiopathic scoliosis. Comparison with the Boston brace
Accepted Manuscript Title: The effectiveness of the SpineCor brace for the conservative treatment of adolescent idiopathic scoliosis. comparison with the boston brace. Author: Gabriel Gutman, Mathieu Benoit, Julie Joncas, Marie Beausejour, Soraya Barchi, Hubert Labelle, Stefan Parent, Jean-Marc Mac-Thiong PII: DOI: Reference:
S1529-9430(16)00129-7 http://dx.doi.org/doi: 10.1016/j.spinee.2016.01.020 SPINEE 56828
To appear in:
The Spine Journal
Received date: Revised date: Accepted date:
24-7-2015 27-11-2015 11-1-2016
Please cite this article as: Gabriel Gutman, Mathieu Benoit, Julie Joncas, Marie Beausejour, Soraya Barchi, Hubert Labelle, Stefan Parent, Jean-Marc Mac-Thiong, The effectiveness of the SpineCor brace for the conservative treatment of adolescent idiopathic scoliosis. comparison with the boston brace., The Spine Journal (2016), http://dx.doi.org/doi: 10.1016/j.spinee.2016.01.020. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
1
Title. The effectiveness of the SpineCor brace for the conservative treatment of adolescent
2
idiopathic scoliosis. Comparison with the Boston brace.
3 4
Authors names.
5
Gabriel Gutman1,2, Mathieu Benoit1,2, Julie Joncas2, Marie Beausejour2, Soraya Barchi2,
6
Hubert Labelle1,2, Stefan Parent1,2,3 and Jean-Marc Mac-Thiong1,2,3
7 8 9
Affiliation. -
10 11
14
Department of Surgery, Faculty of Medicine, University of Montreal, C.P. 6128,
succursale Centre-ville, Montréal (Québec) Canada H3C 3J7 -
12 13
1
2
Department of Surgery, CHU Sainte-Justine, 3175 Ch de la Côte-Sainte-Catherine,
Montreal (Québec) Canada H3T 1C4 -
3
Department of Surgery, Hôpital du Sacré-Coeur de Montréal, 5400 Boul Gouin O,
Montréal (Québec) Canada H4J 1C5
15
Corresponding author:
16
Jean-Marc Mac-Thiong
17
3175 chemin côte Sainte-Catherine, Montréal, QC H3T 1C5
18
Tel. 1-514-345-4876
19
Email : [email protected]
20
Research funding :
21
Subvention de formation des IRSC en évaluation et traitement des troubles de la mobilité et de la
22
posture (Programme MENTOR, TGF-53914). SC: SpineCor Bb: Boston brace
1 Page 1 of 17
1
Abstract
2
Background Context: The Boston brace (Bb) is the most widely used brace design to treat
3
adolescent idiopathic scoliosis (AIS). The dynamic SpineCor (SC) brace is prescribed in several
4
scoliosis clinics worldwide but its effectiveness remains controversial.
5
Purpose: To compare the treatment effectiveness of the SC in patients with AIS treated by the
6
developers of the brace with that of the Bb at a single institution.
7
Study Design/Setting. Retrospective comparison between a cohort of patients treated for AIS
8
using the SC brace and a cohort treated with the Bb.
9
Patient Sample. We assessed 243 patients treated with either a Bb or a SC brace to prevent the
10
progression AIS.
11
Outcome Measures. The primary outcome was the progression in main Cobb angle when
12
reaching one of the following end point criteria: (1) progression of Cobb angle ≥6°, (2) main
13
Cobb angle ≥45°, (3) surgery undertaken, or (4) reaching skeletal maturity (Risser sign of 5 or
14
growth <1cm in previous 6 months).
15
Methods. Patients were identified at a single institution between 2000 and 2012 following the
16
SRS criteria for brace treatment: (1) diagnosis of AIS (2) Risser sign ≤2, (3) curve magnitude
17
between 25º to 40º, and (4) age ≥10 years. A total of 97 patients treated with the SC by the
18
developers of the brace and 146 patients treated with the Bb were identified. Data collection and
19
radiograph measurements were performed by a single experienced nurse not involved in the
20
decision-making for brace treatment nor in the data analysis. Age and Risser sign at onset of
21
treatment, initial main Cobb angle, curve type and duration of the follow-up were similar in both
SC: SpineCor Bb: Boston brace
2 Page 2 of 17
1
cohorts. Statistical analysis was done using chi-square and logistic regression models with a level
2
of significance of 0.05.
3
Results. The average progression was 14.7º±11.9º in the SC cohort compared with 9.6º±13.7º in
4
the Bb cohort (p=0.003). The average Cobb angle at the endpoint of the study reached 47º±13º in
5
the SC cohort and 41.7º±14.2º in the Bb cohort (p=0.005), while it was 32.2º±4.9º and 32.2º±4.4º
6
respectively for the SC and Bb cohorts at the onset of bracing. The percentage of patients with a
7
progression ≥6º was 76% in the SC cohort and 55% in the Bb cohort (p=0.001). The proportion
8
of patients reaching 45º in the SC and Bb cohorts was respectively 51 % and 37 % (p=0.03),
9
while the proportion of patients referred to surgery was 39 % and 30% respectively for the SC
10
and Bb cohorts (p=0.2). The odds of progressing ≥6° and of reaching ≥45° were 2.67 and 2.07
11
times greater respectively when using the SC brace.
12
Conclusion. The SC brace did not prevent curve progression as effectively as the Bb. Although
13
it has the potential benefit of increasing mobility during brace wear, the SC brace was associated
14
with increased curve progression in comparison to the Bb. There is also a trend for increased risk
15
of requiring surgery when a SC brace is worn.
16
Keywords: Scoliosis, brace, Child, Orthopedics/methods, Treatment outcome, Spine, Spinal
17
deformity
18
Classification: Level of evidence III
19
SC: SpineCor Bb: Boston brace
3 Page 3 of 17
1
Introduction
2
Brace treatment is widely used for the nonoperative treatment of adolescent idiopathic scoliosis
3
(AIS) and has been proven to be effective (1). Rigid bracing with a thoracolumbosacral orthosis
4
(TLSO) is most commonly used. It stabilizes the spine by exerting pressure/force in strategic
5
areas to control the progression of the deformity (2). On the other hand, it has the potential
6
disadvantages of compliance, mobility and cosmesis. The Boston brace (© 2009-2015 Boston
7
Brace. All Rights Reserved) (Bb) is the most widely used type of TLSO. A non-rigid, more
8
esthetic and effective brace could however be a valuable alternative. With this concept in mind,
9
the Dynamic SpineCor (© Copyright The SpineCorporation Limited) (SC) brace has been
10
developed using thoracic corrective elastic bands anchored to a pelvic base, and uses a specific
11
corrective movement depending on the type of the curve. Appropriate tensioning of the bands
12
induces a dynamic corrective strategy to prevent curve progression, also with the aim of
13
achieving neuromuscular integration of the corrective movement through active biofeedback (3).
14
This corrective movement has the potential benefit of allowing some degree of controlled
15
mobility, therefore providing the opportunity to re-educate and maintain the neuromuscular
16
control of such spinal corrective movement.
17
Weinstein et al (1) recently reported a 75% success rate in preventing progression of the main
18
curve up to 50 degrees or more of Cobb angle in patients wearing a rigid TLSO compared to
19
42% in patients under observation without bracing. The randomized trial was stopped
20
prematurely owing to the clear efficacy of bracing. Indications for bracing were the following: an
21
age of 10 to 15 years, Risser sign of 0 to 2 and a primary Cobb angle of 20 to 40 degrees.
22
Some studies suggest that the SC brace is very effective (3-5). Unfortunately, these suggestions
23
are mainly from clinicians involved in the development of the brace and an observer bias may SC: SpineCor Bb: Boston brace
4 Page 4 of 17
1
not be excluded. In a descriptive study with 170 AIS patients without a control group, Coillard et
2
al (5) reported in 2007 a failure rate of 33% (18 patients had more than 5 degrees main curve
3
progression and 39 had surgery; 12 patients were withdrawn) with regard to curve progression of
4
more than 5 degrees using the SC brace. More recently, Coillard et al (4) reported in a RCT of 68
5
patients with mild idiopathic scoliosis (15 to 30 degrees of main Cobb angle), a progression of
6
more than 5 degrees in 27% of the treated patients with the SC in comparison to 43% in patients
7
treated by observation. However, their study did not include patients according to the SRS
8
indication criteria for bracing treatment and did not involve a comparison with patients treated
9
with a rigid TLSO, which is usually considered as the gold standard for brace treatment.
10
Only a few studies compared the effectiveness of the SC and TLSO, and their conclusions are
11
debated because of limited sample sizes and/or non-standardized patient selection criteria. One
12
study (6) reported no difference in the outcome between patients wearing the rigid TLSO or the
13
SC. However, their sample size (35 TLSO vs. 32 SC) may not be sufficient to obtain adequate
14
power, considering that the proportion of patients showing a progression 6 or a final Cobb
15
angle 45 was increased in the SC cohort. On the contrary, Weiss et al (17) showed increased
16
progression for patients using the SC as compared to a matched cohort of patients using a TLSO,
17
but their study only included 12 and 15 patients in the SC and TLSO cohorts, respectively. Wong
18
et al (7) reported in their prospective randomized study a 32% failure rate in a cohort of 22
19
patients with moderate AIS (main Cobb angle between 20-30 degrees) wearing the SC brace
20
compared to a 4.7% failure rate in a cohort of 21 patients wearing a TLSO after 45 months
21
follow up. In order to comply with the standardized criteria proposed by the SRS (Scoliosis
22
Research Society) for the selection of patients for bracing, Guo J et al (8) conducted a
23
randomized controlled trial in which they found that 35% of the 20 AIS patients treated by SC
SC: SpineCor Bb: Boston brace
5 Page 5 of 17
1
progressed more than 5 degrees compared to 5.6% of the 18 patients treated by a TLSO.
2
However, despite formal training in using the SC, there was still criticism with regard to the
3
capacity of the authors to properly fit the SC (9), thereby adding to the controversy. Indeed,
4
developers of the SC often suggest that poor results with the SC is typically related to the lack of
5
knowledge for using this specific brace, which requires extensive and supervised training.
6
Unfortunately, no clear conclusion can be made currently with regard to the comparison between
7
the SC and Bb since there is no study comparing both braces with large cohorts selected
8
according to the SRS criteria, and also involving “expert” users/orthotists for both braces. To
9
overcome these limitations and verify whether the SC could represent an adequate alternative to
10
the Bb, we performed a study that compares the effectiveness of the SC and Bb in a large sample
11
of AIS patients, in which all braces were fitted by experienced and competent users/orthotists.
12
SC: SpineCor Bb: Boston brace
6 Page 6 of 17
1
Materials and methods
2
The local institutional ethics committee approved this retrospective cohort study. We reviewed
3
the prospective database including all patients seen at the spine clinic of our institution since
4
April 2000. All patients with AIS treated by bracing between 2000 and 2012 were identified. All
5
patients were treated by one of five spine surgeons. Patients were included into the study if they
6
were treated with either SC or Bb, and if they fulfilled the following SRS indication criteria for
7
bracing (10): (1) diagnosis of AIS, (2) Risser sign ≤2, (3) main curve magnitude between 25º to
8
40º, (4) age ≥10 years. A total of 243 eligible patients were assessed until the following end point
9
criteria: (1) ≥6° progression in Cobb angle of their main curve, (2) Cobb angle of main curve
10
exceeding 45°, (3) surgery undertaken, or (4) skeletal maturity achieved with <1 cm change in
11
standing height between consecutive visits at least 6 months apart. If standing height
12
measurements have not been obtained, a Risser sign of 5 and a minimum of two years
13
postmenarchal for girls were considered as reaching skeletal maturity.
14
The SC cohort consisted in 97 patients while the Bb cohort consisted in 146 patients. Sex, age
15
and Risser sign at onset of bracing, initial main Cobb angle, curve type and duration of the
16
follow-up in both cohorts are detailed in Table 1. A double curve type was defined as a scoliosis
17
comprising two main curves, while the smaller curve is between 15 and 25 degrees in Cobb
18
angle.
19
Patients in both cohorts were instructed to wear their brace full-time with a minimum of 20 hours
20
a day. Selection of the type of brace was based on the physician’s preference for each patient.
21
The SC brace was prescribed by only one surgeon whom is one of the developers of the brace,
22
while the Bb was prescribed by the four other surgeons. The SC braces were adjusted by the
SC: SpineCor Bb: Boston brace
7 Page 7 of 17
1
developers of the brace, while all Bb were molded and adjusted by the same group of accredited
2
orthotists affiliated with the hospital.
3
Patients were followed with standing full spine radiographs using the same EOS system (EOS
4
Imaging, France) every 6 months during brace wear. Postero-anterior and lateral radiographs
5
were taken without the brace, as patients were instructed to remove the brace the night before
6
each visit. The measurement of all radiographic parameters (Risser sign, curve magnitude, curve
7
levels and curve type) and the collection of clinical data from the medical chart were performed
8
by a single experienced nurse not involved in the data analysis. The physicians providing the
9
care for the patients were not involved in the data collection nor in performing the statistical
10
analysis.
11
The primary outcome was the proportion of patients with a progression of the main Cobb angle
12
≥6°, which was considered as a failure of bracing to prevent significant progression. Secondarily,
13
the degree of progression in main Cobb angle when reaching the endpoint of the study, the
14
proportion of patients reaching a main Cobb angle of ≥45º or ≥50º, and the rate of surgery were
15
also considered.
16
Data analysis was done using SPSS 20.0 software (SPSS Inc, Chicago, IL). It was performed and
17
validated by two of the authors who were not involved in the measurement of the radiographic
18
parameters. Comparisons were made using chi-squared tests for categorical data and proportions.
19
For continuous data, student t-tests or Mann-Whitney U tests for variables showing kurtotic and
20
skewed distribution were used. Odds ratios were calculated to assess the relationships between
21
the treatment groups and each of the outcomes, in bivariate and multiple logistic regression
22
models (to assess possible confounders). Logistic regression models were also used to explore
23
stratified analysis based on different parameters assessed at the onset of bracing (gender, curve
SC: SpineCor Bb: Boston brace
8 Page 8 of 17
1
type, skeletal maturity [Risser sign of 0, 1 or 2] and main Cobb angle [small <30º - large ≥30º]).
2
All analyses were performed with a significance level of p<0.05.
3
SC: SpineCor Bb: Boston brace
9 Page 9 of 17
1
Results
2
Sex, age, curve type, initial main Cobb angle, initial Risser and length of follow-up were similar
3
between both cohorts (Table 1).
4
The proportion of patients with a progression of the main Cobb angle ≥ 6º was increased in the
5
SC cohort (76%) compared to the Bb cohort (55%) (p=0.001), with an odds ratio of 2.67 [1.49-
6
4.76].
7
Although the initial main Cobb angle was similar for the SC cohort (32.2º±4.9º) and the Bb
8
cohort (32.2º±4.4º), the final main Cobb angle was increased in the SC cohort, as the SC cohort
9
reached 46.9º±13.1º while the Bb cohort reached 41.7º±14.6º (p=0.003). Average curve
10
progression was also increased in the SC cohort at 14.7º±11.9º in comparison to 9.6º±13.7º in the
11
Bb cohort (p=0.001) (table 2).
12
Similarly, a progression up to a Cobb angle ≥45º was more likely in the SC cohort (51% vs.
13
37%) with an odds ratio of 2.07 [1.16-3.70]. There was a trend for progressing to a Cobb angle
14
≥50º (36% vs. 31%) and requiring surgery (39% vs. 30%) in the SC cohort, but the differences
15
were not significant (table 3). As independent predictors of the ≥ 6º progression and Cobb angle
16
≥ 45º outcomes, initial Cobb angle and Risser sign produced a small confounding effects when
17
assessing the associations between group treatments and the outcomes.
18 19
The stratified analysis results allow us to formulate a posteriori hypothesis that TL and small
20
curves are more likely to progress with the SC rather than with the Bb as compared to other types
21
of curve. Number of males was insufficient to investigate the possible modifying effect of gender
22
and no heterogeneity in odds ratios was found for Risser sign.
23
SC: SpineCor Bb: Boston brace
10 Page 10 of 17
1
Discussion
2
This is the largest study directly comparing the effectiveness of the SC and the Bb braces
3
prescribed and fitted by “expert” users for the treatment of AIS. This study design overcomes the
4
main limitations associated with previous assessments of the SC brace, that either involved
5
physicians not optimally trained to fitting the brace (7, 8, 11) or a failure to use a control group
6
with an effective brace design such as the Bb (3-5, 11-16). In addition, all measurements and
7
statistical analyses were performed by independent observers not involved in the management of
8
patients in either SC or Bb cohorts. Other strengths of the current study are the inclusion of a
9
large number of patients and the use of the SRS criteria for their inclusion (10).
10
The results show that in patient groups with similar baseline characteristics, the Bb was more
11
effective in preventing progression of the main curve. For patients wearing the SC brace, curve
12
progression during follow-up was higher by 5 on average, as the mean final Cobb angle of the
13
main curve exceeded 45 in the SC cohort. Moreover, an increased proportion of patients
14
wearing the SC brace progressed ≥ 6º and reached a final main Cobb angle ≥45º.
15
In our study, the failure rate of 31% with regard to patients reaching a Cobb angle ≥50º in the Bb
16
cohort was similar to the failure rate of 28% observed by Weinstein et al (1) for patients wearing
17
a rigid TLSO, supporting the validity of our results with the Bb. Although a greater proportion of
18
patients with the SC progressed over 50º and required surgery, the difference was not significant.
19
These patients could represent a subset of patients for whom progression to a point where
20
surgery is required is ineluctable despite any type of bracing, as suggested by some authors (17-
21
19).
22
Previous studies comparing the SC to a rigid TLSO failed to consider in their statistical analysis
23
baseline characteristics of patients that may influence the progression with the brace. Although
SC: SpineCor Bb: Boston brace
11 Page 11 of 17
1
this study questions the general effectiveness of the SC for patients with AIS with high risk of
2
progression, the SC brace could be effective for small subsets of patients with specific baseline
3
characteristics such as patients with main curve magnitude of less than 30 degrees of main Cobb
4
angle or juvenile idiopathic scoliosis (4, 20).
5
Available baseline characteristics of the patients in the two treatment groups were not
6
statistically different. Distribution of curve types differed slightly among the groups, with a
7
small excess of lumbar curves and lower proportion of thoracic curves in the SC cohort. The
8
curve type variable was not identified as a confounding variable in the studied associations but
9
was explored as a possible effect modifier.
The subgroup analysis of the most sensitive
10
progression (≥6º) criteria with regard to the curve type and magnitude raises the a posteriori
11
hypothesis that higher proportion of failure is expected in TL and small curves with the SC rather
12
than with the Bb. Although no definite conclusions can be made, future studies should be done in
13
order to validate these hypotheses.
14
The main limitation of the present study is related to its retrospective nature. A randomized
15
prospective trial comparing the SC and Bb in a large number of patients could be performed.
16
However, the current study is highly relevant because its design is associated with a “best case
17
scenario” with using both braces, as “expert’ users were involved independently for each cohort.
18
Another limitation relates to the lack of evaluation of the compliance, as poor compliance would
19
be detrimental with either brace. Self-reported compliance was however inquired at each visit
20
and it is of routine practice for all our surgeons to discontinue the brace when the self-reported
21
compliance is too low to expect optimal bracing results (typically less than 15 hours a day).
22
SC: SpineCor Bb: Boston brace
12 Page 12 of 17
1
Conclusion
2
The SpineCor brace did not prevent curve progression as effectively as the Boston brace did in
3
the current study. Although it has the potential benefit of increased mobility during brace wear,
4
patients and their parents should be advised that increased curve progression and reaching a
5
curve magnitude greater than 45 degrees at the end of treatment is more likely to occur with a
6
SpineCor brace in comparison to a Boston brace in patients with AIS. There is also a trend for
7
increased risk of surgery when a SpineCor brace is worn.
8
SC: SpineCor Bb: Boston brace
13 Page 13 of 17
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45
References 1. Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. The New England journal of medicine. 2013;369(16):1512-21. 2. Labelle H, Dansereau J, Bellefleur C, Poitras B. Three-dimensional effect of the Boston brace on the thoracic spine and rib cage. Spine. 1996;21(1):59-64. 3. Coillard C, Leroux MA, Zabjek KF, Rivard CH. SpineCor--a non-rigid brace for the treatment of idiopathic scoliosis: post-treatment results. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2003;12(2):141-8. 4. Coillard C, Circo AB, Rivard CH. A prospective randomized controlled trial of the natural history of idiopathic scoliosis versus treatment with the SpineCor brace. Sosort Award 2011 winner. European journal of physical and rehabilitation medicine. 2014;50(5):479-87. 5. Coillard C, Vachon V, Circo AB, Beausejour M, Rivard CH. Effectiveness of the SpineCor brace based on the new standardized criteria proposed by the scoliosis research society for adolescent idiopathic scoliosis. Journal of pediatric orthopedics. 2007;27(4):375-9. 6. Gammon SR, Mehlman CT, Chan W, Heifetz J, Durrett G, Wall EJ. A comparison of thoracolumbosacral orthoses and SpineCor treatment of adolescent idiopathic scoliosis patients using the Scoliosis Research Society standardized criteria. Journal of pediatric orthopedics. 2010;30(6):531-8. 7. Wong MS, Cheng JC, Lam TP, Ng BK, Sin SW, Lee-Shum SL, et al. The effect of rigid versus flexible spinal orthosis on the clinical efficacy and acceptance of the patients with adolescent idiopathic scoliosis. Spine. 2008;33(12):1360-5. 8. Guo J, Lam TP, Wong MS, Ng BK, Lee KM, Liu KL, et al. A prospective randomized controlled study on the treatment outcome of SpineCor brace versus rigid brace for adolescent idiopathic scoliosis with follow-up according to the SRS standardized criteria. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2014;23(12):2650-7. 9. Cook T. Comment on Guo et al. entitled "a prospective randomized controlled study on the treatment outcome of SpineCor brace versus rigid brace for adolescent idiopathic scoliosis with follow-up according to the SRS standardized criteria". European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2014;23(7):1579. 10. Richards BS, Bernstein RM, D'Amato CR, Thompson GH. Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine. 2005;30(18):2068-75; discussion 76-7. 11. Szwed A, Kolban M. Results of SpineCor dynamic bracing for idiopathic scoliosis. Studies in health technology and informatics. 2012;176:379-82. 12. Christine C, Alin C, Rivard CH. Treatment of early adolescent idiopathic scoliosis using the SpineCor System. Studies in health technology and informatics. 2008;135:341-55. 13. Plewka B, Sibinski M, Synder M, Witonski D, Kolodziejczyk-Klimek K, Plewka M. Radiological evaluation of treatment with SpineCor brace in children with idiopathic spinal scoliosis. Ortopedia, traumatologia, rehabilitacja. 2013;15(3):227-34. 14. Plewka B, Sibinski M, Synder M, Witonski D, Kolodziejczyk-Klimek K, Plewka M. Clinical assessment of the efficacy of SpineCor brace in the correction of postural deformities in the course of idiopathic scoliosis. Polish orthopedics and traumatology. 2013;78:85-9. SC: SpineCor Bb: Boston brace
14 Page 14 of 17
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
15. Zaina F, Donzelli S, Negrini A, Romano M, Negrini S. SpineCor, exercise and SPoRT rigid brace: what is the best for Adolescent Idiopathic Scoliosis? Short term results from 2 retrospective studies. Studies in health technology and informatics. 2012;176:361-4. 16. Weiss HR, Weiss GM. Brace treatment during pubertal growth spurt in girls with idiopathic scoliosis (IS): a prospective trial comparing two different concepts. Pediatr Rehabil. 2005;8(3):199-206. 17. Dolan LA, Weinstein SL. Surgical rates after observation and bracing for adolescent idiopathic scoliosis: an evidence-based review. Spine. 2007;32(19 Suppl):S91-S100. 18. O'Neill PJ, Karol LA, Shindle MK, Elerson EE, BrintzenhofeSzoc KM, Katz DE, et al. Decreased orthotic effectiveness in overweight patients with adolescent idiopathic scoliosis. The Journal of bone and joint surgery American volume. 2005;87(5):1069-74. 19. Karol LA. Effectiveness of bracing in male patients with idiopathic scoliosis. Spine. 2001;26(18):2001-5. 20. Coillard C, Circo AB, Rivard CH. SpineCor treatment for Juvenile Idiopathic Scoliosis: SOSORT award 2010 winner. Scoliosis. 2010;5:25.
16 17
SC: SpineCor Bb: Boston brace
15 Page 15 of 17
1
Table 1. Baseline characteristics for both cohorts.
2
Gender males females Age (years)
Boston
11
21
86
125
13.1
±
1.2
13.0
Curve type* T
37
71
D
34
53
TL
13
14
L
13
8
Average initial main Cobb angle (°)
32.2
±
4.9
32.2
Initial Risser sign 0
57
93
1
25
29
2
15
24
Average follow-up (years) 3
SpineCor
3.4
±
1.6
3.5
p 0.49
±
1.3
0.75 0.09
±
4.4
0.96
0.55
±
1.9
0.58
*T= Thoracic. D= Double. TL= Thoraco-Lumbar. L= Lumbar.
4 5
Table 2. Results of the average initial final main Cobb angle and the average progression angle.
6 SpineCor
Boston
p
Average initial main Cobb angle ( °)
32.2 ± 4.9
32.2 ± 4.4
0.96
Average final main Cobb angle (°)
46.9 ± 13.1
41.7 ± 14.6
0.003
Average progression (°)
14.7 ± 11.9
9.6 ± 13.7
0.001
7
SC: SpineCor Bb: Boston brace
16 Page 16 of 17
1 2
Table 3. Associations between treatment groups and outcomes: progression ≥6º, final Cobb 45º,
3
final Cobb 50º and surgery rate.
SpineCor no./total no. % ≥6° progression
reaching >45° reaching ≥50°
Surgery rate
74 /
49 /
35 /
37 /
97
97
97
97
76
51
36
39
Boston no./total no. 81 /
54 /
45 /
44 /
146
146
146
146
p
Crude OR, [95%CI]
Adjusted OR, [95%CI]
2.58*,
2.67*,
[1.46-5.57]
[1.49-4.76]
1.74*,
2.07*,
[1.03-2.93]
[1.16-3.70]
1.27,
1.43,
[0.74-2.18]
[0.79-2.60]
1.43,
1.63,
[0.83-2.46]
[0.90-2.94]
% 55
37
31
30
0.001
0.04
0.39
0.2
4
OR: Odds ratio
5
95%CI: 95% confidence interval
6
§ Odds ratios adjusted for: age, initial Cobb angle and initial Risser sign.
7
* Statistically significant at p<0.05
8 9
SC: SpineCor Bb: Boston brace
17 Page 17 of 17
S1529-9430(16)00129-7 http://dx.doi.org/doi: 10.1016/j.spinee.2016.01.020 SPINEE 56828
To appear in:
The Spine Journal
Received date: Revised date: Accepted date:
24-7-2015 27-11-2015 11-1-2016
Please cite this article as: Gabriel Gutman, Mathieu Benoit, Julie Joncas, Marie Beausejour, Soraya Barchi, Hubert Labelle, Stefan Parent, Jean-Marc Mac-Thiong, The effectiveness of the SpineCor brace for the conservative treatment of adolescent idiopathic scoliosis. comparison with the boston brace., The Spine Journal (2016), http://dx.doi.org/doi: 10.1016/j.spinee.2016.01.020. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
1
Title. The effectiveness of the SpineCor brace for the conservative treatment of adolescent
2
idiopathic scoliosis. Comparison with the Boston brace.
3 4
Authors names.
5
Gabriel Gutman1,2, Mathieu Benoit1,2, Julie Joncas2, Marie Beausejour2, Soraya Barchi2,
6
Hubert Labelle1,2, Stefan Parent1,2,3 and Jean-Marc Mac-Thiong1,2,3
7 8 9
Affiliation. -
10 11
14
Department of Surgery, Faculty of Medicine, University of Montreal, C.P. 6128,
succursale Centre-ville, Montréal (Québec) Canada H3C 3J7 -
12 13
1
2
Department of Surgery, CHU Sainte-Justine, 3175 Ch de la Côte-Sainte-Catherine,
Montreal (Québec) Canada H3T 1C4 -
3
Department of Surgery, Hôpital du Sacré-Coeur de Montréal, 5400 Boul Gouin O,
Montréal (Québec) Canada H4J 1C5
15
Corresponding author:
16
Jean-Marc Mac-Thiong
17
3175 chemin côte Sainte-Catherine, Montréal, QC H3T 1C5
18
Tel. 1-514-345-4876
19
Email : [email protected]
20
Research funding :
21
Subvention de formation des IRSC en évaluation et traitement des troubles de la mobilité et de la
22
posture (Programme MENTOR, TGF-53914). SC: SpineCor Bb: Boston brace
1 Page 1 of 17
1
Abstract
2
Background Context: The Boston brace (Bb) is the most widely used brace design to treat
3
adolescent idiopathic scoliosis (AIS). The dynamic SpineCor (SC) brace is prescribed in several
4
scoliosis clinics worldwide but its effectiveness remains controversial.
5
Purpose: To compare the treatment effectiveness of the SC in patients with AIS treated by the
6
developers of the brace with that of the Bb at a single institution.
7
Study Design/Setting. Retrospective comparison between a cohort of patients treated for AIS
8
using the SC brace and a cohort treated with the Bb.
9
Patient Sample. We assessed 243 patients treated with either a Bb or a SC brace to prevent the
10
progression AIS.
11
Outcome Measures. The primary outcome was the progression in main Cobb angle when
12
reaching one of the following end point criteria: (1) progression of Cobb angle ≥6°, (2) main
13
Cobb angle ≥45°, (3) surgery undertaken, or (4) reaching skeletal maturity (Risser sign of 5 or
14
growth <1cm in previous 6 months).
15
Methods. Patients were identified at a single institution between 2000 and 2012 following the
16
SRS criteria for brace treatment: (1) diagnosis of AIS (2) Risser sign ≤2, (3) curve magnitude
17
between 25º to 40º, and (4) age ≥10 years. A total of 97 patients treated with the SC by the
18
developers of the brace and 146 patients treated with the Bb were identified. Data collection and
19
radiograph measurements were performed by a single experienced nurse not involved in the
20
decision-making for brace treatment nor in the data analysis. Age and Risser sign at onset of
21
treatment, initial main Cobb angle, curve type and duration of the follow-up were similar in both
SC: SpineCor Bb: Boston brace
2 Page 2 of 17
1
cohorts. Statistical analysis was done using chi-square and logistic regression models with a level
2
of significance of 0.05.
3
Results. The average progression was 14.7º±11.9º in the SC cohort compared with 9.6º±13.7º in
4
the Bb cohort (p=0.003). The average Cobb angle at the endpoint of the study reached 47º±13º in
5
the SC cohort and 41.7º±14.2º in the Bb cohort (p=0.005), while it was 32.2º±4.9º and 32.2º±4.4º
6
respectively for the SC and Bb cohorts at the onset of bracing. The percentage of patients with a
7
progression ≥6º was 76% in the SC cohort and 55% in the Bb cohort (p=0.001). The proportion
8
of patients reaching 45º in the SC and Bb cohorts was respectively 51 % and 37 % (p=0.03),
9
while the proportion of patients referred to surgery was 39 % and 30% respectively for the SC
10
and Bb cohorts (p=0.2). The odds of progressing ≥6° and of reaching ≥45° were 2.67 and 2.07
11
times greater respectively when using the SC brace.
12
Conclusion. The SC brace did not prevent curve progression as effectively as the Bb. Although
13
it has the potential benefit of increasing mobility during brace wear, the SC brace was associated
14
with increased curve progression in comparison to the Bb. There is also a trend for increased risk
15
of requiring surgery when a SC brace is worn.
16
Keywords: Scoliosis, brace, Child, Orthopedics/methods, Treatment outcome, Spine, Spinal
17
deformity
18
Classification: Level of evidence III
19
SC: SpineCor Bb: Boston brace
3 Page 3 of 17
1
Introduction
2
Brace treatment is widely used for the nonoperative treatment of adolescent idiopathic scoliosis
3
(AIS) and has been proven to be effective (1). Rigid bracing with a thoracolumbosacral orthosis
4
(TLSO) is most commonly used. It stabilizes the spine by exerting pressure/force in strategic
5
areas to control the progression of the deformity (2). On the other hand, it has the potential
6
disadvantages of compliance, mobility and cosmesis. The Boston brace (© 2009-2015 Boston
7
Brace. All Rights Reserved) (Bb) is the most widely used type of TLSO. A non-rigid, more
8
esthetic and effective brace could however be a valuable alternative. With this concept in mind,
9
the Dynamic SpineCor (© Copyright The SpineCorporation Limited) (SC) brace has been
10
developed using thoracic corrective elastic bands anchored to a pelvic base, and uses a specific
11
corrective movement depending on the type of the curve. Appropriate tensioning of the bands
12
induces a dynamic corrective strategy to prevent curve progression, also with the aim of
13
achieving neuromuscular integration of the corrective movement through active biofeedback (3).
14
This corrective movement has the potential benefit of allowing some degree of controlled
15
mobility, therefore providing the opportunity to re-educate and maintain the neuromuscular
16
control of such spinal corrective movement.
17
Weinstein et al (1) recently reported a 75% success rate in preventing progression of the main
18
curve up to 50 degrees or more of Cobb angle in patients wearing a rigid TLSO compared to
19
42% in patients under observation without bracing. The randomized trial was stopped
20
prematurely owing to the clear efficacy of bracing. Indications for bracing were the following: an
21
age of 10 to 15 years, Risser sign of 0 to 2 and a primary Cobb angle of 20 to 40 degrees.
22
Some studies suggest that the SC brace is very effective (3-5). Unfortunately, these suggestions
23
are mainly from clinicians involved in the development of the brace and an observer bias may SC: SpineCor Bb: Boston brace
4 Page 4 of 17
1
not be excluded. In a descriptive study with 170 AIS patients without a control group, Coillard et
2
al (5) reported in 2007 a failure rate of 33% (18 patients had more than 5 degrees main curve
3
progression and 39 had surgery; 12 patients were withdrawn) with regard to curve progression of
4
more than 5 degrees using the SC brace. More recently, Coillard et al (4) reported in a RCT of 68
5
patients with mild idiopathic scoliosis (15 to 30 degrees of main Cobb angle), a progression of
6
more than 5 degrees in 27% of the treated patients with the SC in comparison to 43% in patients
7
treated by observation. However, their study did not include patients according to the SRS
8
indication criteria for bracing treatment and did not involve a comparison with patients treated
9
with a rigid TLSO, which is usually considered as the gold standard for brace treatment.
10
Only a few studies compared the effectiveness of the SC and TLSO, and their conclusions are
11
debated because of limited sample sizes and/or non-standardized patient selection criteria. One
12
study (6) reported no difference in the outcome between patients wearing the rigid TLSO or the
13
SC. However, their sample size (35 TLSO vs. 32 SC) may not be sufficient to obtain adequate
14
power, considering that the proportion of patients showing a progression 6 or a final Cobb
15
angle 45 was increased in the SC cohort. On the contrary, Weiss et al (17) showed increased
16
progression for patients using the SC as compared to a matched cohort of patients using a TLSO,
17
but their study only included 12 and 15 patients in the SC and TLSO cohorts, respectively. Wong
18
et al (7) reported in their prospective randomized study a 32% failure rate in a cohort of 22
19
patients with moderate AIS (main Cobb angle between 20-30 degrees) wearing the SC brace
20
compared to a 4.7% failure rate in a cohort of 21 patients wearing a TLSO after 45 months
21
follow up. In order to comply with the standardized criteria proposed by the SRS (Scoliosis
22
Research Society) for the selection of patients for bracing, Guo J et al (8) conducted a
23
randomized controlled trial in which they found that 35% of the 20 AIS patients treated by SC
SC: SpineCor Bb: Boston brace
5 Page 5 of 17
1
progressed more than 5 degrees compared to 5.6% of the 18 patients treated by a TLSO.
2
However, despite formal training in using the SC, there was still criticism with regard to the
3
capacity of the authors to properly fit the SC (9), thereby adding to the controversy. Indeed,
4
developers of the SC often suggest that poor results with the SC is typically related to the lack of
5
knowledge for using this specific brace, which requires extensive and supervised training.
6
Unfortunately, no clear conclusion can be made currently with regard to the comparison between
7
the SC and Bb since there is no study comparing both braces with large cohorts selected
8
according to the SRS criteria, and also involving “expert” users/orthotists for both braces. To
9
overcome these limitations and verify whether the SC could represent an adequate alternative to
10
the Bb, we performed a study that compares the effectiveness of the SC and Bb in a large sample
11
of AIS patients, in which all braces were fitted by experienced and competent users/orthotists.
12
SC: SpineCor Bb: Boston brace
6 Page 6 of 17
1
Materials and methods
2
The local institutional ethics committee approved this retrospective cohort study. We reviewed
3
the prospective database including all patients seen at the spine clinic of our institution since
4
April 2000. All patients with AIS treated by bracing between 2000 and 2012 were identified. All
5
patients were treated by one of five spine surgeons. Patients were included into the study if they
6
were treated with either SC or Bb, and if they fulfilled the following SRS indication criteria for
7
bracing (10): (1) diagnosis of AIS, (2) Risser sign ≤2, (3) main curve magnitude between 25º to
8
40º, (4) age ≥10 years. A total of 243 eligible patients were assessed until the following end point
9
criteria: (1) ≥6° progression in Cobb angle of their main curve, (2) Cobb angle of main curve
10
exceeding 45°, (3) surgery undertaken, or (4) skeletal maturity achieved with <1 cm change in
11
standing height between consecutive visits at least 6 months apart. If standing height
12
measurements have not been obtained, a Risser sign of 5 and a minimum of two years
13
postmenarchal for girls were considered as reaching skeletal maturity.
14
The SC cohort consisted in 97 patients while the Bb cohort consisted in 146 patients. Sex, age
15
and Risser sign at onset of bracing, initial main Cobb angle, curve type and duration of the
16
follow-up in both cohorts are detailed in Table 1. A double curve type was defined as a scoliosis
17
comprising two main curves, while the smaller curve is between 15 and 25 degrees in Cobb
18
angle.
19
Patients in both cohorts were instructed to wear their brace full-time with a minimum of 20 hours
20
a day. Selection of the type of brace was based on the physician’s preference for each patient.
21
The SC brace was prescribed by only one surgeon whom is one of the developers of the brace,
22
while the Bb was prescribed by the four other surgeons. The SC braces were adjusted by the
SC: SpineCor Bb: Boston brace
7 Page 7 of 17
1
developers of the brace, while all Bb were molded and adjusted by the same group of accredited
2
orthotists affiliated with the hospital.
3
Patients were followed with standing full spine radiographs using the same EOS system (EOS
4
Imaging, France) every 6 months during brace wear. Postero-anterior and lateral radiographs
5
were taken without the brace, as patients were instructed to remove the brace the night before
6
each visit. The measurement of all radiographic parameters (Risser sign, curve magnitude, curve
7
levels and curve type) and the collection of clinical data from the medical chart were performed
8
by a single experienced nurse not involved in the data analysis. The physicians providing the
9
care for the patients were not involved in the data collection nor in performing the statistical
10
analysis.
11
The primary outcome was the proportion of patients with a progression of the main Cobb angle
12
≥6°, which was considered as a failure of bracing to prevent significant progression. Secondarily,
13
the degree of progression in main Cobb angle when reaching the endpoint of the study, the
14
proportion of patients reaching a main Cobb angle of ≥45º or ≥50º, and the rate of surgery were
15
also considered.
16
Data analysis was done using SPSS 20.0 software (SPSS Inc, Chicago, IL). It was performed and
17
validated by two of the authors who were not involved in the measurement of the radiographic
18
parameters. Comparisons were made using chi-squared tests for categorical data and proportions.
19
For continuous data, student t-tests or Mann-Whitney U tests for variables showing kurtotic and
20
skewed distribution were used. Odds ratios were calculated to assess the relationships between
21
the treatment groups and each of the outcomes, in bivariate and multiple logistic regression
22
models (to assess possible confounders). Logistic regression models were also used to explore
23
stratified analysis based on different parameters assessed at the onset of bracing (gender, curve
SC: SpineCor Bb: Boston brace
8 Page 8 of 17
1
type, skeletal maturity [Risser sign of 0, 1 or 2] and main Cobb angle [small <30º - large ≥30º]).
2
All analyses were performed with a significance level of p<0.05.
3
SC: SpineCor Bb: Boston brace
9 Page 9 of 17
1
Results
2
Sex, age, curve type, initial main Cobb angle, initial Risser and length of follow-up were similar
3
between both cohorts (Table 1).
4
The proportion of patients with a progression of the main Cobb angle ≥ 6º was increased in the
5
SC cohort (76%) compared to the Bb cohort (55%) (p=0.001), with an odds ratio of 2.67 [1.49-
6
4.76].
7
Although the initial main Cobb angle was similar for the SC cohort (32.2º±4.9º) and the Bb
8
cohort (32.2º±4.4º), the final main Cobb angle was increased in the SC cohort, as the SC cohort
9
reached 46.9º±13.1º while the Bb cohort reached 41.7º±14.6º (p=0.003). Average curve
10
progression was also increased in the SC cohort at 14.7º±11.9º in comparison to 9.6º±13.7º in the
11
Bb cohort (p=0.001) (table 2).
12
Similarly, a progression up to a Cobb angle ≥45º was more likely in the SC cohort (51% vs.
13
37%) with an odds ratio of 2.07 [1.16-3.70]. There was a trend for progressing to a Cobb angle
14
≥50º (36% vs. 31%) and requiring surgery (39% vs. 30%) in the SC cohort, but the differences
15
were not significant (table 3). As independent predictors of the ≥ 6º progression and Cobb angle
16
≥ 45º outcomes, initial Cobb angle and Risser sign produced a small confounding effects when
17
assessing the associations between group treatments and the outcomes.
18 19
The stratified analysis results allow us to formulate a posteriori hypothesis that TL and small
20
curves are more likely to progress with the SC rather than with the Bb as compared to other types
21
of curve. Number of males was insufficient to investigate the possible modifying effect of gender
22
and no heterogeneity in odds ratios was found for Risser sign.
23
SC: SpineCor Bb: Boston brace
10 Page 10 of 17
1
Discussion
2
This is the largest study directly comparing the effectiveness of the SC and the Bb braces
3
prescribed and fitted by “expert” users for the treatment of AIS. This study design overcomes the
4
main limitations associated with previous assessments of the SC brace, that either involved
5
physicians not optimally trained to fitting the brace (7, 8, 11) or a failure to use a control group
6
with an effective brace design such as the Bb (3-5, 11-16). In addition, all measurements and
7
statistical analyses were performed by independent observers not involved in the management of
8
patients in either SC or Bb cohorts. Other strengths of the current study are the inclusion of a
9
large number of patients and the use of the SRS criteria for their inclusion (10).
10
The results show that in patient groups with similar baseline characteristics, the Bb was more
11
effective in preventing progression of the main curve. For patients wearing the SC brace, curve
12
progression during follow-up was higher by 5 on average, as the mean final Cobb angle of the
13
main curve exceeded 45 in the SC cohort. Moreover, an increased proportion of patients
14
wearing the SC brace progressed ≥ 6º and reached a final main Cobb angle ≥45º.
15
In our study, the failure rate of 31% with regard to patients reaching a Cobb angle ≥50º in the Bb
16
cohort was similar to the failure rate of 28% observed by Weinstein et al (1) for patients wearing
17
a rigid TLSO, supporting the validity of our results with the Bb. Although a greater proportion of
18
patients with the SC progressed over 50º and required surgery, the difference was not significant.
19
These patients could represent a subset of patients for whom progression to a point where
20
surgery is required is ineluctable despite any type of bracing, as suggested by some authors (17-
21
19).
22
Previous studies comparing the SC to a rigid TLSO failed to consider in their statistical analysis
23
baseline characteristics of patients that may influence the progression with the brace. Although
SC: SpineCor Bb: Boston brace
11 Page 11 of 17
1
this study questions the general effectiveness of the SC for patients with AIS with high risk of
2
progression, the SC brace could be effective for small subsets of patients with specific baseline
3
characteristics such as patients with main curve magnitude of less than 30 degrees of main Cobb
4
angle or juvenile idiopathic scoliosis (4, 20).
5
Available baseline characteristics of the patients in the two treatment groups were not
6
statistically different. Distribution of curve types differed slightly among the groups, with a
7
small excess of lumbar curves and lower proportion of thoracic curves in the SC cohort. The
8
curve type variable was not identified as a confounding variable in the studied associations but
9
was explored as a possible effect modifier.
The subgroup analysis of the most sensitive
10
progression (≥6º) criteria with regard to the curve type and magnitude raises the a posteriori
11
hypothesis that higher proportion of failure is expected in TL and small curves with the SC rather
12
than with the Bb. Although no definite conclusions can be made, future studies should be done in
13
order to validate these hypotheses.
14
The main limitation of the present study is related to its retrospective nature. A randomized
15
prospective trial comparing the SC and Bb in a large number of patients could be performed.
16
However, the current study is highly relevant because its design is associated with a “best case
17
scenario” with using both braces, as “expert’ users were involved independently for each cohort.
18
Another limitation relates to the lack of evaluation of the compliance, as poor compliance would
19
be detrimental with either brace. Self-reported compliance was however inquired at each visit
20
and it is of routine practice for all our surgeons to discontinue the brace when the self-reported
21
compliance is too low to expect optimal bracing results (typically less than 15 hours a day).
22
SC: SpineCor Bb: Boston brace
12 Page 12 of 17
1
Conclusion
2
The SpineCor brace did not prevent curve progression as effectively as the Boston brace did in
3
the current study. Although it has the potential benefit of increased mobility during brace wear,
4
patients and their parents should be advised that increased curve progression and reaching a
5
curve magnitude greater than 45 degrees at the end of treatment is more likely to occur with a
6
SpineCor brace in comparison to a Boston brace in patients with AIS. There is also a trend for
7
increased risk of surgery when a SpineCor brace is worn.
8
SC: SpineCor Bb: Boston brace
13 Page 13 of 17
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45
References 1. Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. The New England journal of medicine. 2013;369(16):1512-21. 2. Labelle H, Dansereau J, Bellefleur C, Poitras B. Three-dimensional effect of the Boston brace on the thoracic spine and rib cage. Spine. 1996;21(1):59-64. 3. Coillard C, Leroux MA, Zabjek KF, Rivard CH. SpineCor--a non-rigid brace for the treatment of idiopathic scoliosis: post-treatment results. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2003;12(2):141-8. 4. Coillard C, Circo AB, Rivard CH. A prospective randomized controlled trial of the natural history of idiopathic scoliosis versus treatment with the SpineCor brace. Sosort Award 2011 winner. European journal of physical and rehabilitation medicine. 2014;50(5):479-87. 5. Coillard C, Vachon V, Circo AB, Beausejour M, Rivard CH. Effectiveness of the SpineCor brace based on the new standardized criteria proposed by the scoliosis research society for adolescent idiopathic scoliosis. Journal of pediatric orthopedics. 2007;27(4):375-9. 6. Gammon SR, Mehlman CT, Chan W, Heifetz J, Durrett G, Wall EJ. A comparison of thoracolumbosacral orthoses and SpineCor treatment of adolescent idiopathic scoliosis patients using the Scoliosis Research Society standardized criteria. Journal of pediatric orthopedics. 2010;30(6):531-8. 7. Wong MS, Cheng JC, Lam TP, Ng BK, Sin SW, Lee-Shum SL, et al. The effect of rigid versus flexible spinal orthosis on the clinical efficacy and acceptance of the patients with adolescent idiopathic scoliosis. Spine. 2008;33(12):1360-5. 8. Guo J, Lam TP, Wong MS, Ng BK, Lee KM, Liu KL, et al. A prospective randomized controlled study on the treatment outcome of SpineCor brace versus rigid brace for adolescent idiopathic scoliosis with follow-up according to the SRS standardized criteria. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2014;23(12):2650-7. 9. Cook T. Comment on Guo et al. entitled "a prospective randomized controlled study on the treatment outcome of SpineCor brace versus rigid brace for adolescent idiopathic scoliosis with follow-up according to the SRS standardized criteria". European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2014;23(7):1579. 10. Richards BS, Bernstein RM, D'Amato CR, Thompson GH. Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine. 2005;30(18):2068-75; discussion 76-7. 11. Szwed A, Kolban M. Results of SpineCor dynamic bracing for idiopathic scoliosis. Studies in health technology and informatics. 2012;176:379-82. 12. Christine C, Alin C, Rivard CH. Treatment of early adolescent idiopathic scoliosis using the SpineCor System. Studies in health technology and informatics. 2008;135:341-55. 13. Plewka B, Sibinski M, Synder M, Witonski D, Kolodziejczyk-Klimek K, Plewka M. Radiological evaluation of treatment with SpineCor brace in children with idiopathic spinal scoliosis. Ortopedia, traumatologia, rehabilitacja. 2013;15(3):227-34. 14. Plewka B, Sibinski M, Synder M, Witonski D, Kolodziejczyk-Klimek K, Plewka M. Clinical assessment of the efficacy of SpineCor brace in the correction of postural deformities in the course of idiopathic scoliosis. Polish orthopedics and traumatology. 2013;78:85-9. SC: SpineCor Bb: Boston brace
14 Page 14 of 17
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
15. Zaina F, Donzelli S, Negrini A, Romano M, Negrini S. SpineCor, exercise and SPoRT rigid brace: what is the best for Adolescent Idiopathic Scoliosis? Short term results from 2 retrospective studies. Studies in health technology and informatics. 2012;176:361-4. 16. Weiss HR, Weiss GM. Brace treatment during pubertal growth spurt in girls with idiopathic scoliosis (IS): a prospective trial comparing two different concepts. Pediatr Rehabil. 2005;8(3):199-206. 17. Dolan LA, Weinstein SL. Surgical rates after observation and bracing for adolescent idiopathic scoliosis: an evidence-based review. Spine. 2007;32(19 Suppl):S91-S100. 18. O'Neill PJ, Karol LA, Shindle MK, Elerson EE, BrintzenhofeSzoc KM, Katz DE, et al. Decreased orthotic effectiveness in overweight patients with adolescent idiopathic scoliosis. The Journal of bone and joint surgery American volume. 2005;87(5):1069-74. 19. Karol LA. Effectiveness of bracing in male patients with idiopathic scoliosis. Spine. 2001;26(18):2001-5. 20. Coillard C, Circo AB, Rivard CH. SpineCor treatment for Juvenile Idiopathic Scoliosis: SOSORT award 2010 winner. Scoliosis. 2010;5:25.
16 17
SC: SpineCor Bb: Boston brace
15 Page 15 of 17
1
Table 1. Baseline characteristics for both cohorts.
2
Gender males females Age (years)
Boston
11
21
86
125
13.1
±
1.2
13.0
Curve type* T
37
71
D
34
53
TL
13
14
L
13
8
Average initial main Cobb angle (°)
32.2
±
4.9
32.2
Initial Risser sign 0
57
93
1
25
29
2
15
24
Average follow-up (years) 3
SpineCor
3.4
±
1.6
3.5
p 0.49
±
1.3
0.75 0.09
±
4.4
0.96
0.55
±
1.9
0.58
*T= Thoracic. D= Double. TL= Thoraco-Lumbar. L= Lumbar.
4 5
Table 2. Results of the average initial final main Cobb angle and the average progression angle.
6 SpineCor
Boston
p
Average initial main Cobb angle ( °)
32.2 ± 4.9
32.2 ± 4.4
0.96
Average final main Cobb angle (°)
46.9 ± 13.1
41.7 ± 14.6
0.003
Average progression (°)
14.7 ± 11.9
9.6 ± 13.7
0.001
7
SC: SpineCor Bb: Boston brace
16 Page 16 of 17
1 2
Table 3. Associations between treatment groups and outcomes: progression ≥6º, final Cobb 45º,
3
final Cobb 50º and surgery rate.
SpineCor no./total no. % ≥6° progression
reaching >45° reaching ≥50°
Surgery rate
74 /
49 /
35 /
37 /
97
97
97
97
76
51
36
39
Boston no./total no. 81 /
54 /
45 /
44 /
146
146
146
146
p
Crude OR, [95%CI]
Adjusted OR, [95%CI]
2.58*,
2.67*,
[1.46-5.57]
[1.49-4.76]
1.74*,
2.07*,
[1.03-2.93]
[1.16-3.70]
1.27,
1.43,
[0.74-2.18]
[0.79-2.60]
1.43,
1.63,
[0.83-2.46]
[0.90-2.94]
% 55
37
31
30
0.001
0.04
0.39
0.2
4
OR: Odds ratio
5
95%CI: 95% confidence interval
6
§ Odds ratios adjusted for: age, initial Cobb angle and initial Risser sign.
7
* Statistically significant at p<0.05
8 9
SC: SpineCor Bb: Boston brace
17 Page 17 of 17