Treatment of early adolescent idiopathic scoliosis using the SpineCor System

Abstract

The purpose of this prospective observational study was to evaluate the effectiveness of the Dynamic SpineCor System for adolescent idiopathic scoliosis in accordance with the standardized outcome criteria proposed by the Scoliosis Research Society Committee on Bracing and Nonoperative Management. The SpineCor System is the first and only truly dynamic brace, which provides a progressive correction of Idiopathic Scoliosis from 15 degrees Cobb angle and above. The new therapeutic approach is based on a new concept upon the etiology and pathogenesis of idiopathic scoliosis; a pathology of the neuro-musculoskeletal system in growth and maturation. This prospective observational study was carried out on a group of 639 patients (92.3% females) having idiopathic scoliosis treated with the SpineCor brace. Five hundred and eighty three patients met the criteria for inclusion, and 234 patients were still actively being treated. Overall, 349 patients have a definitive outcome. All girls were premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness included (1) percentage of patients who have 5 degrees or less curve progression, and percentage of patients who have 6 degrees or more progression; (2) percentage of patients who have been recommended/undergone surgery before skeletal maturity; (3) percentage of patients with curves exceeding 45 degrees at maturity (end of treatment); and (4) Two-year follow-up beyond maturity to determine the percentage of patients who subsequently underwent surgery. Successful treatment (correction, > 5 degrees, or stabilization, +/- 5 degrees) was achieved in 259 (74.2%) of the 349 patients from the time of the fitting of the SpineCor brace to the point in which it was discontinued (or at the time of the surgery). Fifty one immature patients (14.6%) required surgical fusion while receiving treatment. Eight mature patients out of 298 (2.7%) required surgery within 2 years of follow-up beyond skeletal maturity. The conclusion drawn from these findings is that the SpineCor brace is effective for the treatment of adolescent idiopathic scoliosis. Moreover, positive outcomes are maintained after 2 years because 151 (93.2%) of 162 patients stabilized or corrected their end of bracing Cobb angle up to 2 years after bracing.