We investigated the effectiveness of the TriaC™-Brace regarding the primary curve correction in Idiopathic Scoliosis (IS).
At the beginning of the therapy with the new orthesis the Risser sign was 2,68 at an average. The daily wearing time was instructed with 22–23 hours. Lumbar curves showed an average cobb angle of 26,1 degrees (standard deviation=8,6) and thoracic curves of 24,4 degrees (standard deviation=6,5). The radiological assessment of primary curve correction (cobb-angle) was performed 6,2 weeks after the beginning of the therapy (anterior posterior radiograph of the spine in standing position with orthesis). Further radiological controls were performed every six months. We evaluated the wearing time, comfort and leisure activity with a valid scoring system (Quality of Life Profile for Spine Deformities). The overall mean wearing time of the Triac™-Brace was 14,7 months.
A insufficient primary curve correction (defined as <
30% of the initial cobb-angle) was observed in 16 thoracic curves (89%) and in 4 lumbar curves (30%). An increasing correction during the therapy as reported by Veldhuizen (2002) could not be observed. There was a curve progression of at least 5 degrees of the cobb-angle in 4 cases. The evaluation by the scoring system (response in 85%) resulted in a high score for cosmetics (4,2/5) and mobility of the back (4,6/5). The wearing time was reported by 90% of the patients with 22–23h.
Larger studies are necessary to investigate the effectiveness of the orthesis in lumbar curves. The improved wearing comfort and cosmetics are a potential advantages of this new orthesis.
Results: The concentrations of cobalt and chromium ions in the serum amounted on average to 4.75μg/l (standard deviation 2,71) for cobalt and 1.10μg/l (standard deviation 1,24) for chromium. Compared to the control group, both the chromium and cobalt levels in the serum showed significant increases (Mann-Whitney Rank Sum Test, p=0.0120). At follow-up the Oswestry Disability Score was on average significantly decreased by 24.4 points (L5/S1) (t-test, p <
0.05) and by 26.8 points (L4-S1)(t-test, p <
0.05). The improved clinical situation is also represented by a significant decrease of the Visual Analog Pain Scale of 42,2points after the follow-up (t-test, p<
0,05).