Christine Coillard, Alin Circo, Rivard Charles H
Ste-Justine Hospital, Montreal, Canada.
Stud Health Technol Inform. 2008;135:341-55.
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.
这项前瞻性观察性研究的目的是，根据脊柱侧弯研究学会支具与非手术治疗委员会提出的标准化结果标准，评估动态SpineCor系统治疗青少年特发性脊柱侧弯的有效性。SpineCor系统是首个也是唯一真正的动态支具，可对15度及以上Cobb角的特发性脊柱侧弯进行渐进性矫正。这种新的治疗方法基于关于特发性脊柱侧弯病因和发病机制的新概念；一种生长和成熟过程中的神经肌肉骨骼系统病变。这项前瞻性观察性研究针对一组639例接受SpineCor支具治疗的特发性脊柱侧弯患者开展（92.3%为女性）。583例患者符合纳入标准，234例患者仍在接受积极治疗。总体而言，349例患者有明确的结果。所有女孩均处于月经初潮前或月经初潮后不到1年。支具有效性评估包括：（1）侧弯进展5度或更小的患者百分比，以及进展6度或更大的患者百分比；（2）骨骼成熟前被推荐/接受手术的患者百分比；（3）治疗结束（成熟时）侧弯超过45度的患者百分比；（4）成熟后两年的随访，以确定随后接受手术的患者百分比。从佩戴SpineCor支具到停用（或手术时），349例患者中有259例（74.2%）成功治疗（矫正>5度，或稳定，±5度）。51例未成熟患者（14.6%）在接受治疗时需要手术融合。298例成熟患者中有8例（2.7%）在骨骼成熟后的2年随访期内需要手术。从这些发现得出的结论是，SpineCor支具治疗青少年特发性脊柱侧弯有效。此外，积极结果在2年后仍得以维持，因为162例患者中有151例（93.2%）在支具治疗后长达2年的时间里稳定或矫正了支具治疗结束时的Cobb角。
