Safety and Efficacy of Spinecall Spinal Fixation System for Adolescent Idiopathic Scoliosis

M. Goethel, P. Fonseca, Felipe Augusto Rozales Lopes, Ricardo André Acácio dos Santos, Rodrigo Fetter Lauffer, Carlos Henrique Maçaneiro, Roberto Garcia Gonçalves, Victor de Oliveira Matos, C. Chaves, Saulo Terror Giesbrecht, J. Vilas-Boas
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Abstract

Study design: Retrospective case series including patient outcome assessment. Objective: To study the safety and the efficacy of the Spine call spinal fixation system in comparison with similar series. Background: The purpose was to determine the safety and the efficacy of a system which has been widely used in Brazil for over 15 years. Methods: A total of 76 consecutive patients were treated by posterior instrumentation and arthrodesis from 2011 through 2017. Safety was evaluated by complications, reoperation type and occurrence. Efficacy was studied by the incidence of deformity corrections. Results: There were no deaths, spinal cord or nerve root problems, or acute posterior wound infections. Proven pseudo-arthrosis occurred in one patient (1.3%) and in two cases was necessary debridement to remove infected tissue (2.6%). The implant-related reoperation rate was 1.3%, where an increased curvature was observed. The break of one screw (0.07% per screw) was reported, which did not lead to the need for reoperation. The largest Cobb angle averaged 57° pre-operative and 20.7° at latest follow-up, which means a 63.3% correction (p<0.001). Conclusions: Spinecall spinal fixation system seems to be at least as safe and effective as other instrumentations as used for the surgical treatment of adolescent idiopathic scoliosis.
脊柱固定系统治疗青少年特发性脊柱侧凸的安全性和有效性
研究设计:回顾性病例系列,包括患者预后评估。目的:比较脊柱固定系统与同类产品的安全性和有效性。背景:目的是确定在巴西广泛使用超过15年的系统的安全性和有效性。方法:从2011年到2017年,共有76例连续患者接受后路内固定和关节融合术治疗。根据并发症、再手术类型及发生情况评价安全性。通过畸形矫正的发生率来研究疗效。结果:无死亡、脊髓或神经根问题、急性后伤口感染。1例(1.3%)发生假性关节,2例(2.6%)需要清创去除感染组织。植入物相关的再手术率为1.3%,其中观察到曲率增加。报告1颗螺钉断裂(每颗螺钉0.07%),无需再次手术。最大Cobb角术前平均为57°,最新随访时平均为20.7°,矫正率为63.3% (p<0.001)。结论:脊柱固定系统在青少年特发性脊柱侧凸的手术治疗中至少与其他器械一样安全有效。
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