European Vertebral  Deviations Center - Clinique du Parc - Lyon (France)  - The Lyon Method  Results Frontal

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Scoliosis > 40°


Results in the Frontal plane

SOSORT 2019 San francisco

FINAL Results 2 years after Weaning for the first 111 patients with SRS-SOSORT criteria

The dropout rate calculated for the first 125 patients is 14%.
 

Description of the population
111 (92 women and 19 men) AIS (Adolescent Idiopathic Scoliosis) meeting the inclusion criteria were treated from 29/04/2013 to 02/09/2015. There were 49 primary thoracic curves, 25 double major curves and 37 thoraco-lumbar curves. This is a consecutive series extracted from a prospective database started in 1998. The average age at the start of treatment is 13 years and 5 months (± 1 year). At the time of the study 1125 patients had been treated with the ARTbrace. As the lumbar curves continue to be treated by a short brace, it is mainly thoracic, thoraco-lumbar and double major curves.
Statistical analysis
The patients were divided into 2 groups according to the anatomo-radiological location of the curvature: group A = 74 thoracic curvatures and group B 62 lumbar and thoraco-lumbar curvatures. The clinical and radiological parameters were studied throughout the treatment: 1. Initial; 2. in-brace; 3. Six months after placement of the brace (Rx without brace) 4. Removal of the brace; 5. 6 months after weaning; 6. 2 years after weaning.
Standard statistical methods were used for descriptive statistics. Normally distributed continuous variables were analysed using a t-test based on an independent sample. Angular changes in Cobb’s angle were evaluated using unidirectional analysis of variance for repeated measurements.
Demography
111 patients with 136 curvatures divided into 74 thoracic curvatures and 62 primary thoraco-lumbar and lumbar curvatures. 25 patients had double major curves. The mean age at the start of treatment was 13.5 (± 1.35).
The initial mean angulation was: 29.9 ° (± = 8.05) (20 ° to 48 °)
The average in-brace angulation was: 8.83 ° (± = 9.24)
Mean angulation at 6 months without brace was: 17.3 ° (± = 10.7)
Mean angulation at weaning was: 18,5 ° (± 11,8)
Mean angulation 6 months after weaning was: 19.5 ° (± = 11.5)

Mean angulation two years after weaning was: 19.1 ° (± = 11.5)
The average percentage of in-brace correction was 73%, the final average correction two years after weaning was 36% .

95% of the curves are improved by more than 5 °, 5% are stable, no curve is worsened Cobb Init In-brace Weaning
29,9° ± 8.0 8,83° ± 9,24 (73% ± 24.6) 18.5° ± 11,8 (33.0% ± 23.6)


For Group A (n = 74), the mean initial angulation was 29.88 ° (± 9.12). The in-brace angulation was 11.05 ° (± 9.07) (63% correction). Angulation at 6 months without brace was 19.74 (± 10.49). The angulation at weaning was 20.81 (± 11.58). Angulation 6 months after weaning was: 21.76 (± 11.93). Angulation 2 years after weaning was 22.03 ± 11.45, (final correction 34%).
For Group B (n = 62), the mean initial angulation was 27.26 ° (± 6.92). The in-brace angulation was 6.03 ° (± 8.42) (78% correction). Angulation at 6 months without brace was 14.13 (± 9.70). The angulation at weaning was 15.73 (± 10.05). Angulation 6 months after weaning was: 16.56 (± 9.86). Angulation 2 years after weaning was 15.85 ° (± 9.75), (final correction 42%)


A Pearson correlation coefficient was calculated to evaluate the relationship between Cobb angulation at 6 months and Cobb angulation 2 years after weaning. There was an excellent positive correlation between the two variables: r = 0.907, n = 74 p <0.001, for the thoracic curves and r = 0.900, n = 62 p <0.001 for the lumbar curves.
A Pearson correlation coefficient was calculated to evaluate the relationship between in-brace correction and Cobb angulation 2 years after weaning. There was a good positive correlation between the two variables, r = 0.866, n = 74, p <0.001 for thoracic curves and r = 0.742, n = 62 p <0.001 for lumbar curves.
Cohort Results
Comparison <30 °and ≥30 ° for all curves
34 patients had a curve greater than or equal to 30 ° or 25 thoracic curvatures and 20 lumbar curves. For the group of 71 patients with angulation between 20 and 30 ° we note 43 thoracic curves and 40 lumbar curves. 6 patients with a curve greater than 40 ° were not included. The results are shown in Table 1.

<30°

Mean

SD

≥30° Mean

SD

T init

24,05

2,87

34,88

5,83

T in brace

6,28

5,26

15,2

7,97

T 6 months

14,19

6,32

23,84

7,45

T Weaning

14,19

6,89

26,60

8,17

T W + 6m

14,81

6,38

27,56

8,12

T W + 2y

15,49

6,65

27,72

8,11

L init

23,15

2,89

33,85

5,04

L in brace

3,15

6,98

10,15

7,84

L 6 months

10,40

7,61

19,45

8,72

L Weaning

12,28

7,53

20,15

9,82

L W + 6m

13,03

6,91

21,10

9,86

L W + 2y

12,25

7,50

20,75

2,00

Table 1: Evolution of the results according to the initial angulation for a cut off of 30 °


DISCUSSION
The ARTbrace is currently the most effective brace (70% average in-brace correction) in respect of the frontal plane. This work confirms that there is a strong correlation between the in-brace reduction and the final result of nearly 90% for thoracic and lumbar curvatures. The remaining 10% are probably related to compliance. The average in-brace correction could be compared [10]: Rigo System Chêneau 48% [11]; Scoliologic Lightweight 51% [12]; old Lyon brace 38.7% [8]; TriaC 22% [13]; Osaka Medical College (OMC) 46.8% [14]; and the Boston 50% [15]


The improvement of almost 40% of the in-brace correction compared to the most recent braces is explained by the new biomechanical concepts of the ARTbrace: 1. It is no longer a flat geometry, but of a geometry of solids. The brace performs a kind of Bobsleigh track in the opposite direction of the scoliosis torso column. There is no more press hold, but a soft contact that will vary with the different positions during the day. This is a dynamic brace; 2. Specific digital correction with superposition of 3 blocks. The asymmetry is not the consequence of a complex classification, but the result of 3 successive scanners, the first in translation along the vertical axis, the second in lumbar shift and physiological lordosis, the third in bending and thoracic kyphosis. The very precise protocol ensures the reproducibility of the measurements; 3. Untwisting is achieved by coupled motions in the frontal plane and in the sagittal plane. Detorsion is geometric and mechanical; 4. The correcting moment combines an action in the transversal plane by tightening at the level of the chondro-costal awnings using a rack closure and a translation along the vertical axis that can be compared to that of the a lever corkscrew with lowering of initially raised shoulders as the detorsion of the spine is progressing; 5. The very high rigidity of the polycarbonate, however, requires a high 1mm precision of CAD / CAM digitizer technology and professional software. [16].
The importance of immediate in-brace reduction also explains the prognosis of the final result only 6 months after fitting the brace, which may encourage the child’s compliance. The other parameters with improved curves in the sagittal plane and in the horizontal plane have already been presented [5,9].
The goals of non-surgical orthopaedic treatment can be expanded. It is no longer only a question of avoiding surgery with a lower than 50 ° angulation, nor even of stabilizing the scoliosis during the period of growth, but of getting a final gain of approximately 30% at the end of treatment.
This treatment has the advantage of promoting teamwork with the doctor who performs the digital cast and the orthopaedic technician who will make the final brace.

Correlations
There is a negative correlation between initial angulation and end treatment percent correction, r=-0.414, n=43, p=0.001 for thoracic curves and less r=-0.292, n=53, p=0.034 for lumbar curves.
There is a strong positive correlation between in-brace correction rate and end treatment correction rate, r=0.684, n=43, p=0.000 for thoracic curves and r=0.596, n=53, p=0.000 for lumbar curves.
In our experience, the weaning results are very close to those 2 years after weaning and can be considered as significant. Patients are a little older (14.4 vs 13.4) and with lower initial angulation than in the general statistics (26.84 vs 29.61). The in-brace reduction is greater (79.4% vs 69.4%) which explains the outstanding weaning correction rate (50% vs 25% for the old Lyon brace)

CONCLUSION
For the same indications and with the same management principles, we can confirm that:
1. The early treatment with low angle,
2. The quality of immediate in-brace correction
is fundamental to a successful outcome.