Worldwide Results

The SpineCor System is currently used in 17 countries and over 100 treatment centres around the world. It has been offered as a bracing option in the KK Women's and Children's Hospital (Singapore) since Jan 2009.

Nearly 725 patients were in-treatment world wide at the time of the last result update in April 2002. The latest available visit for these patients, including all sizes and levels of curves, is presented in Figure 1, which demonstrates an improvement or stabilisation for 89% of the patients in treatment.

(Note: A change in the Cobb angle at the end of treatment and/or the last available visit in reference to the initial visit was utilized to identify a correction (decrease of more than 5° in Cobb angle), a stabilization (change of ±5°), or aggravation (increase of more than 5°).

 

Figure 1 : The last available visit in brace for the patients treated world wide with the SpineCor system.

 

Figure 2 below shows the results for patients treated in 2 different SpineCor centres (Gerona, Spain and Budapest, Hungary) including all sizes and levels of curves. An improvement or stabilisation for 87% of patients is achieved at both centres.

 

Figure 2 : The last available visit for the patients treated at the SpineCor centre based in Gerona, Spain and Budapest, Hungary (February 2005). Results for the 2 centres are similar.

Comparison Results

Background

In 2006 the Scoliosis Research Society (SRS) published guidelines for all future studies of Idiopathic Scoliosis treatments. The strict inclusion and exclusion criteria allowed study of only the highest progression risk group of patients. Together with standardised outcome measures, the SRS guidelines make possible for the first time ever comparison of treatment methods. Since only the highest progression risk patients are studied, outcomes for all brace treatments are not as favourable as generally believed. However, the first study in 2007 published in the Journal of Pediatric Orthopedics shows a very clear difference in outcome for three different treatment methods.

 

Treatment Studied

SpineCor - a flexible dynamic brace developed in 1992

TLSO - (generic term for Boston type) rigid plastic spinal braces extensively used around the world for over 30 years.

Providence - a relatively new night-time-only rigid plastic brace used by a small number of clinics in the United States.

* Patients included in theses studies range from 20° to 50° and Risser 0-3, or pre-menarche. Therapeutic success is defined according to the SRS definitions as either improvement (Cobb reduction of 6° or greater) and stabilisation (Cobb increase of up to 5°).

 

Results

The results table above shows a dramatic difference in treatment outcomes:

- 15% success (by SRS definitions) with the most commonly used TLSO versus 59% with the SpineCor dynamic corrective brace. This made SpineCor 4 times more effective than TLSO in stopping progression of the curve.

- SpineCor is 76.5% effective in avoiding surgery, Providence is 40% effective and TLSO is 21% effective.

- Compared to TLSO group of 56%, only 1% of the SpineCor group progress more than 45°.

 

References

1. Janicki J A, Poe-Kochert C, Armstrong DG, Thompson GH. A comparison of the Thoracolumnosacral Orthosis and Providence Orthosis in the Treatment of Adolescent Idiopathic Scoliosis: Results using the New SRS Inclusion and Assessment Criteria for Bracing Studies. J Pediatr Orthop, 2007 Jun; 27(4):369-374

2. Coillard C, Vachon V, Circo AB, Beausejour M, Rivard CH. Effectiveness of the SpineCor Brace Based on the New Standardised Criteria Proposed by the Scoliosis Research Society for Adolescent Idiopathic Scoliosis. J Pediatr Orthop. 2007 Jun; 27(4):375-379