A prospective interventional cohort study of 175 patients treated by the SpineCor orthosis, following the Scoliosis Research Society Criteria

Abstract

Background: The mainstay of the conservative treatment still remains the orthosis, which was demonstrated to provide a reduction of curve progression, possibly a decrease in the need for surgery, and sometimes a correction of the existing deformity. The effectiveness of the SpineCor orthosis compared with the natural history of the disease has already been shown for milder and moderate curves[1]. Aim: To provide confirmation on the demonstrated effectiveness of the Dynamic SpineCor orthosis for adolescent idiopathic scoliosis, following the standardized criteria proposed by the SRS Committee on Bracing and Nonoperative Management[2], and to confirm the stability of the results two years after the end of the treatment. Method: From 1993 to 2011, 390 patients treated using the SpineCor orthosis respected the criteria for inclusion recommended by the SRS committee. 198 have a definitive outcome, and 175 have at least 2 years of follow-up. Assessment of brace effectiveness included; 1) percentage of patients who have 5 degree or less curve progression, and the percentage of patients who have 6 degree or more progression at skeletal maturity, 2) percentage of patients who have had surgery recommended/undergone before skeletal maturity, 3) percentage of patients with curves exceeding 45 degree at maturity (end of treatment) and 4) 2-years follow-up beyond maturity to determine the percentage of patients who subsequently underwent surgery. Results: At two years post skeletal maturity, successful treatment (correction >5 degree or stabilization +/-5 degree) was achieved in 100 patients of the 175 patients (57.2%) from the time of the fitting of the SpineCor orthosis to the 2 years follow-up point. 41 immature patients (23.4 %) required surgical fusion.(34 while receiving treatment and 5 in the follow-up period). Conclusions: The SpineCor orthosis is effective for the treatment of adolescent idiopathic scoliosis. Positive outcomes are maintained after the weaning of the orthosis, since 86.1% of the patients stabilized or corrected their Cobb angle. Moreover, out of the 86.1%, 11.7 % of the patients still had correction of their Cobb angle 2 years after the end of the treatment.