Teli Marco, Lovi Alessio, Brayda-Bruno Marco
Department of Spinal Surgery, Galeazzi Orthopaedic Institute, Milano (Milan), Italy.
Indian J Orthop. 2010 Jan;44(1):23-7. doi: 10.4103/0019-5413.58602.
Growing rod systems have been used in the last 30 years for the treatment of early onset scoliosis (EOS) with variable success rates. We report the results of treatment of EOS with a newly developed hybrid rod distraction system applied to the rib cage and spine with a nonfusion technique in a prospective multicenter clinical trial.
A total of 22 patients affected by progressive EOS resistant to cast and/or brace treatment were enrolled from 2004 to 2005 after informed consent into a trial of surgical treatment with a single spine-to-rib growing rod instrumentation growing spine profiler (GSP). Curves >60 degrees Cobb in the frontal plane or bending < 50% were addressed with staged anterior annulotomy and fusion and posterior implantation of a GSP rod. Less severe and rigid curves were treated with posterior implantation of GSP only. The elongation of GSP was planned according to spinal growth. Patients were kept in a brace between elongations.
A total of 20 patients were available to follow-up with complete data. The mean follow up is 4.1 years. Mean age at time of initial surgery was 5 years (3-8). Nine patients had staged antero-posterior surgeries, 11 posterior only surgeries. Mean spinal growth was 1.9 cm (1.5-2.3) or 0.5 cm per year. Mean coronal Cobb's angle correction was from 56 degrees to 45 degrees . Major complications affected 40% of patients and included rod failure in 6/20 and crankshaft in 5/20 (all in the anteroposterior surgery group).
Treatment of EOS with spine-to-rib growing rod in the present form provides similar correction and complication rates to those published in the series considering traditional single or dual growing rod systems. Based on this, the authors recommend revision of the GSP design and a new clinical trial to test safety and efficacy.
在过去30年中，生长棒系统已被用于治疗早发性脊柱侧弯（EOS），成功率各不相同。我们报告了一项前瞻性多中心临床试验的结果，该试验使用一种新开发的混合棒撑开系统，通过非融合技术应用于胸廓和脊柱来治疗EOS。
2004年至2005年，在获得知情同意后，共有22例对石膏和/或支具治疗无效的进行性EOS患者入组一项采用单根脊柱至肋骨生长棒器械（生长脊柱轮廓仪，GSP）的手术治疗试验。对于额状面Cobb角>60度或弯曲度<50%的曲线，采用分期前路椎间盘切开融合术和后路植入GSP棒进行处理。对于不太严重和僵硬的曲线，仅采用后路植入GSP进行治疗。GSP的延长根据脊柱生长情况进行规划。患者在两次延长之间佩戴支具。
共有20例患者可进行完整数据的随访。平均随访时间为4.1年。初次手术时的平均年龄为5岁（3 - 8岁）。9例患者进行了分期前后路手术，11例仅进行了后路手术。平均脊柱生长为1.9厘米（1.5 - 2.3厘米），即每年0.5厘米。平均冠状面Cobb角矫正从56度降至45度。主要并发症影响了40%的患者，包括20例中的6例棒断裂和20例中的5例曲轴现象（均发生在前后路手术组）。
以目前形式的脊柱至肋骨生长棒治疗EOS，其矫正率和并发症发生率与考虑传统单根或双根生长棒系统的系列研究中所发表的相似。基于此，作者建议修订GSP设计并开展一项新的临床试验以测试其安全性和有效性。
