A prospective randomized controlled trial of the natural history of idiopathic scoliosis versus treatment with the SpineCor brace. Sosort Award 2011 winner.

AIM

The purpose of this randomized controlled trial was to evaluate the efficacy of the Dynamic SpineCor brace for early idiopathic scoliosis (15°-30°) compared to the natural evolution of the disease. 68 patients participated in this study (32 treated and 36 controls) with at least 5 years follow-up.

METHODS

The inclusion criteria were: 1) high risk of evolution: family history and/or proven progressive; 2) no significant pathological malformation of the spine; 3) initial Cobb angle between 15° and 30°; 4) risser 0, 1 or 2. Assessment of brace efficacy included the percentage of patients who have 5º or less curve progression and the percentage of patients who have 6º or more progression at skeletal maturity.

RESULTS

At five-year follow-up a correction was achieved in 50% of treated patient and only in 9.5% of controls, stabilization in 42.3% treated and 47.7% in controls and progression in 26.9% for the treated group and 42.8% for controls. For the control patients we considered as a failure if the Cobb angle worsened by more then 5° from the original angle and the patient then received treatment.

CONCLUSION

The results 5 years after the treatment suggested that the SpineCor brace reduced the probability of the progression of early idiopathic scoliosis comparing with its natural history. Moreover, the positive outcome appears to be maintained in the long term.