• Eur Spine J · Feb 2018

    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.

    • Cheung Jason Pui Yin JPY 0000-0002-7052-0875 Department of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China., Dino Samartzis, Kelvin Yeung, Michael To, Luk Keith Dip Kei KDK Department of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China., and Kenneth Man-Chee Cheung.
    • Department of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China.
    • Eur Spine J. 2018 Feb 1; 27 (2): 327-339.

    PurposeTo evaluate the safety and efficacy of a superelastic shape-memory alloy (SNT) rod used in the treatment of adolescent idiopathic scoliosis (AIS).MethodsAIS 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°).ResultsTwenty-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.ConclusionsThis 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.

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