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.

Abstract

To evaluate the safety and efficacy of a superelastic shape-memory alloy (SNT) rod used in the treatment of adolescent idiopathic scoliosis (AIS). AIS Patients with Lenke 1 curves undergoing fusion surgery were randomized (1:1) at the time of surgery to receive either the SNT or a conventional titanium alloy (CTA) rod. Radiographs were obtained preoperatively and postoperatively up to 5 years of follow-up. Parameters assessed included coronal and sagittal Cobb angles, and overall truncal and shoulder balance. Sagittal profiles were subcategorized into Types A (<20°), B (20-40°), and C (>40°). Twenty-four patients with mean age of 15 years were recruited. A total of 87.0% of subjects were followed up till postoperative 5 years, but all patients had minimum 2 years of follow-up. The fulcrum-bending correction index for the SNT group was 113% at postoperative day 4 and 127% at half-year, while the CTA group was 112% at postoperative day 4 and only 106% at half-year. In terms of sagittal profile, the SNT group moved toward type B profile at half-year follow-up with a mean correction of 7.6°, while no significant change was observed in the CTA group (-0.7°). Nickel levels remained normal, and there were no complications. 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.