European Vertebral Deviation Center - Clinique du Parc - Lyon (France)
The new Lyon ARTbrace versus the historical Lyon Stagnara brace: a matched cohort study of in-brace correction and 6 months results of 264 adolescent scoliosis of more than 40°
Background: The first studies of the new Lyon brace: ARTbrace reports an excellent in-brace correction of the Cobb angle of 70% in adolescent scoliosis of more than 20° treated since May 2013, a value of correction 40% higher than the former Lyon Stagnara brace.
The aim of this study is to compare this first results for pediatric scoliosis of more than 40°.
Material and Methods: The group A is constituted by the 132 patients with scoliosis of more than 40° Cobb angle to which it was proposed an ARTbrace from May 2013 to May 2016 and selected from our prospective database initiated in 1998. The group B is constituted by a similar matched cohort of 132 consecutive scoliosis of more than 40° treated before May 2013.with the historical Lyon method (initial plaster cast followed by the Stagnara Brace).
Patients were evaluated radiographically both immediately in plaster cast and after 6 months of treatment without brace.
Data were studied with the statistical package SPSS v20
Results: In group A and in group B. no difference were noted for gender (20 males for each group) and age (14 years ± 2.12). There was not a significant difference Cobb angle before brace (CAST 45.841 ± 6.16 vs ART 46.568 ± 7.80, t(262)= 0.84, p= 0.2020).
An independent-samples t-test was conducted to compare Cobb angles, in-brace and at 6 months without brace.
In-brace correction results were slightly better for ART, but there was not a significant difference: ART : 24.186 ± 8.22 vs CAST 24.288± 9.17, t(262)=0.05, p=.346
CAST Rate = 46,70 % | ART Rate = 48,04 %.
At 6 months the angulation without brace had statistically significant lower angulation for the ART (31.48° ± 7.39°) compared to the Stagnara brace (36.22° ± 9.67°), t(138) = 3.238, p = 0.002.
Conclusion: The new Lyon ARTbrace makes it possible to avoid the realization of the plaster cast for scoliosis of more than 40° with the same result. The results at 6 months are better in ARTbrace confirming that the ARTbrace is more effective than the Stagnara brace.
Scoliosis of more than 40° is often treated surgically, because the percentage of in-brace correction of most actual braces do not sufficiently correct the curvature to reverse the pressures at the level of the apical vertebra. . The Lyon management with plaster cast proved its effectiveness, but the difficulties of the cast limited its use to some specialized centers.  The symmetric Sforzesco brace has proved that cast can be avoided for this type of scoliosis by using the very high rigidity of the polycarbonate.  The new Lyon ARTbrace has proved its efficiency compared to the old Lyon Stagnara brace for the curves of more than 20°. [4,5]
The objective is to verify the radiological effectiveness of the asymmetric polycarbonate ARTbrace during the in-brace correction and after 6 months without brace for scoliosis of more than 40°.
Since 1998 all scoliotic patients are included in a monocentric prospective database for analytic observational study. The group A is a cohort of 132 patients with scoliosis of more than 40° Cobb angle to which it was proposed an ARTbrace from May 2013 to May 2016. The group B is a matched cohort of 132 consecutive patients treated before May 2013. Written consent was obtained from the relative for publication of this study.
All patients monitored in brace were included in group A. Since 2010 most X-rays have been performed with the EOS system for a better quality of measure.
The eligibility criteria for group B were: initial angulation, gender and age at the start of treatment. The management is identical in both groups.
The initial X-ray is performed less than 3 months before the plaster cast or the ARTbrace. The in-brace X-ray immediately after the plaster cast and not more than 3 days after the ARTbrace fitting. The 6 months X-ray is performed after 1 hour without brace. 73 patients in group A and 67 patients in group B were eligible.
All X-rays are measured according to Cobb method on A3 film or photographic paper, by the same senior expert. In both groups, we noted patients with previous treatment failure. In both groups, the lumbar curves are excluded, because treated by the short polyethylene brace GTB.
For each patient, the primary curve was chosen and for the double major curves, the angulation of the thoracic curve.
An independent-samples t-test was conducted to compare Cobb angles before brace, in-brace and at 6 months without brace. (SPSS v20 package with 95% confidence interval)
Government body regulating human research: CNIL 1831534/20150202
132 patients were included in the ART brace group, and 132 in the historical Lyon Brace method group. No differences were noted for gender (20 males for each group), age (14 years ± 2.12).
There was not a significant difference Cobb angle before brace (group A: 46.568 ± 7.80 vs group B: 45.841 ± 6.16, t(262)= 0.84, p= 0.2020).
In-brace correction results were slightly better for ART, but there was not a significant difference: group A: 24.186 ± 8.22 vs group B: 24.288± 9.17, t(262)=0.05, p=0.346
Group A Rate = 48.04 % | group B Rate = 46.70 %.
On the other side, for ART-brace there was a significant difference for curves 40°-49° and > 50° (Curves 40°-49°: 21.594± 6.00, Curves >50°: 24.486± 8.67, t(130)=-2,167, p=0.032
The correction rate decreases as the angulation increase (Curves 40°-49° Rate: 49.98 %, Curves >50° Rate: 44.08 %.)
At 6 months this study found that the angulation without brace had statistically significant lower angulation for the group A (31.48° ± 7.39°) compared to the group B (36.22° ± 9.67°), t(138) = 3.238, p = 0.002.
The result is also statistically significant if we compare the difference between Cobb in-brace angulation and Cobb without brace after 6 months: group A (9.90° ± 5.66°) compared to group B (14.33° ± 7.27°), t(138) = 4.001, p = 0.000.
The improvement in results at 6 months could be explained by the lower effectiveness of the old Stagnara Lyon brace compared to plaster cast.
Like the Sforzesco brace, the asymmetric polycarbonate ARTbrace avoids the plaster cast in better technical conditions for the child: lightness, hygiene ...  The 3-block digital cast is easier to implement and more reliable for the physician than the plaster cast. 
The percentage of drop-out and surgery remains high at 6 months: Group A 44.69%, Group B 56.81%. We had shown that it was mostly boys and previous bracing.
The old Lyon Stagnara brace was less effective than plaster cast, which can explain the significant difference in favor of ARTbrace, 6 months after the beginning of treatment. 
Beyond 40°, the dropout rate is much more important than between 20-40°, either because the constraints of the treatment with 4 months of “full time” make the surgery more attractive, or because some dysplasic curves react badly to the conservative treatment. 
The correction decreases as the initial angulation increases. Another negative factor is the existence of prior brace treatment. In addition to the stiffness generated by the brace, the failure of previous treatment is a negative psychological factor.
These results must be confirmed by the outcome 2 years after the end of treatment, but the results at 6 months are predictive of the outcome. 
For scoliosis of more than 40°, this study confirms a maximal in-brace correction effect of new Lyon ARTbrace like the old plaster Cast. This effect is confirmed, further improved and becomes statistically significant at 6 months, on an X-ray without brace. So, ARTbrace allows to avoid the use of the initial plaster cast for these severe scoliotic curves >40°, without having to make a new brace after the cast. ARTbrace may be an alternative to surgery for this type of scoliosis
1. Clin J, Aubin C, Sangole A, Labelle H, Parent S. Correlation between immediate in-brace correction and biomechanical effectiveness of brace treatment in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2010 Aug 15;35(18):1706-13.
3. Negrini S, Negrini F, Fusco C, Zaina F. Idiopathic scoliosis patients with curves more than 45 Cobb degrees refusing surgery can be effectively treated through bracing with curve improvements. Spine J. 2011 May;11(5):369-80.
4. de Mauroy JC, Lecante C, Barral F, Pourret S. Prospective study and new concepts based on scoliosis detorsion of the first 225 early in-brace radiological results with the new Lyon brace: ARTbrace. Scoliosis. 2014 Nov 19;9:19.
5. de Mauroy JC, Journe A, Gagaliano F, Lecante C, Barral F, Pourret S. The new Lyon ARTbrace versus the historical Lyon brace: a prospective case series of 148 consecutive scoliosis with short time results after 1 year compared with a historical retrospective case series of 100 consecutive scoliosis; SOSORT award 2015 winner. Scoliosis. 2015 Aug 19;10:26. äde. 2000 Jun;29(6):500-6.
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