A novel spinal orthosis with embedded shape memory alloy for adolescent idiopathic scoliosis.

Bracing is the most effective measure for the treatment of mild-to-moderate adolescent idiopathic scoliosis (AIS). However, the balance between three-dimensional correction of scoliosis and wear comfort is still not ideal. To design a novel bracing with embedded shape memory alloy for the treatment of AIS that can improve patients' comfort and provide sustained and effective three-dimensional correction force, as well as to preliminarily verify its clinical efficacy. A Ni‒Ti shape memory alloy material was constructed with 20 ℃ martensite and 0 ℃ austenite. On the basis of the traditional rigid thoracolumbosacral scoliosis braces, when considering the three-dimensional correction of scoliosis and the wear comfort of the patient, a novel spinal orthosis with embedded shape memory alloy was designed and manufactured, and the performance of the novel brace was tested. Ten patients with mild-to-moderate scoliosis were included to evaluate clinical efficacy. The bending test and minimum surface temperature of the embedded shape memory alloys met the deformation requirements for the novel brace. The thoracic kyphosis and lumbar lordosis angle were larger and the interface pressure was lower in the novel brace group than in the traditional brace group (P < 0.05). The SRS-22 assessment with the novel brace was better than with the traditional brace (P < 0.05). The novel brace provided a better three-dimensional correction effect to adolescent idiopathic scoliosis patients and also increased wearing comfort than traditional orthoses, which can improve compliance of patients.