European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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Randomized Controlled Trial
A randomized double-blinded clinical trial to evaluate the safety and efficacy of a novel superelastic nickel-titanium spinal rod in adolescent idiopathic scoliosis: 5-year follow-up.
To evaluate the safety and efficacy of a superelastic shape-memory alloy (SNT) rod used in the treatment of adolescent idiopathic scoliosis (AIS). ⋯ This is the first randomized clinical trial of a novel SNT rod for treating patients with AIS, noting it to be safe and has potential to gradually correct scoliosis over time. This study serves as a pilot and platform to properly power future large-scale studies to demonstrate efficacy and superiority.