PDF(Pubmed)
Abstract：
Adolescent idiopathic scoliosis (AIS) is a three-dimensional growth disorder. Corrective surgical procedures are the recommended treatment option for a thoracic angle exceeding 50° and a lumbar major curve of 40°. Over the past few years, dynamic growth modulation implants have been developed as alternatives to permanent fusion. The ApiFix system was designed as a 2D \"posterior dynamic device\" for curve correction. After implantation in a minimally invasive procedure, it uses polyaxial joints and a self-adjusting rod to preserve the degree of motion and to accommodate the patient\'s growth. It provides an effective method of controlling deformity and fills the gap between the conservative treatment of major curves that are >35° and the fusion procedure. The objective of the two-center cohort study was the analysis of the correction results of patients, who underwent surgical intervention with the ApiFix system. The inclusion criteria were AIS, Lenke type 1 or type 5, a major curve on bending films of ≤30°, and an angle of the major curve of between 35° and 60°. Postoperative radiograph data were obtained longitudinally for up to 24 months of follow-up and compared to preoperative (preop) values. For comparisons of the different time points, non-parametric tests (Wilcoxon) or paired t-tests for normally distributed values were used to analyze repeated measures. Overall, 36 patients (25 female and 11 male) were treated with the ApiFix system from April 2018 to October 2020. Lenke type 1 was identified in 21 (58%) cases and Lenke type 5 was identified in 15 (42%) cases. The average angle of the thoracic major curve for Lenke 1 was 43°. The preoperative lumbar major curve (Lenke 5) was determined to be 43°. Over a follow-up of 24 months, a correction of the major curve to an average of 20° was observed for Lenke 1 and that to an average of 15° was observed for Lenke 5. Lenke type 1 and type 5 showed significant changes in the major curve over the individual test intervals in the paired comparisons compared to the starting angle (Lenke 1: preop-24 months, 0.002; Lenke 5: preop-24 months, 0.043). Overall, 11 events were recorded in the follow-up period, that required revision surgery. We distinguished between repeated interventions required after reaching the maximum distraction length of the implant due to the continued growth of the patient (n = 4) and complications, such as infections or problems associated with the anchorage of the implant (n = 7). The results from the present cohort revealed a statistically significant improvement in the postoperatively measured angles of the major and minor curves in the follow-up after 24 months. Consequently, the results were comparable to those of the already established vertebral body tethering method. Alignment in AIS via dynamic correction systems in combination with a possible growth modulation has been a treatment alternative to surgical fusing procedures for more than a decade. However, the long-term corrective effect has to be validated in further studies.
摘要：
青少年特发性脊柱侧凸（AIS）是一种三维生长障碍。对于超过50°的胸角和40°的腰椎大弯，矫正外科手术是推荐的治疗选择。在过去的几年里，动态生长调节植入物已被开发为永久性融合的替代品。ApiFix系统被设计为用于曲线校正的2D“后部动态设备”。在微创手术中植入后，它使用多轴关节和自调节杆，以保持运动的程度，以适应病人的成长。它提供了一种控制畸形的有效方法，并填补了>35°的主要曲线的保守治疗与融合程序之间的空白。双中心队列研究的目的是分析患者的矫正结果,他们接受了ApiFix系统的手术干预。纳入标准是AIS，Lenke1型或5型，弯曲薄膜上的主曲线≤30°，并且主曲线的角度在35°和60°之间。在长达24个月的随访中纵向获得术后X光片数据，并与术前（术前）值进行比较。为了比较不同的时间点，非参数检验(Wilcoxon)或正态分布值的配对t检验用于分析重复测量.总的来说,2018年4月至2020年10月，36名患者（25名女性和11名男性）接受了ApiFix系统治疗。在21例（58％）中发现了Lenke1型，在15例（42％）中发现了Lenke5型。Lenke1的胸大曲的平均角度为43°。术前腰椎大弯（Lenke5）确定为43°。在24个月的随访中，对于Lenke1观察到主曲线的平均校正为20°，对于Lenke5观察到平均校正为15°。与起始角度相比，Lenke1型和5型在配对比较中的各个测试间隔中显示出主要曲线的显着变化（Lenke1：pre-24个月，0.002；伦克5：24个月前，0.043).总的来说,在随访期间记录了11个事件，需要翻修手术。我们区分了由于患者的持续生长（n=4）和并发症而达到植入物的最大牵引长度后所需的重复干预措施。例如与植入物的锚固相关的感染或问题(n=7)。本队列的结果显示，在24个月后的随访中，术后测量的主要和次要曲线的角度有统计学上的显着改善。因此,结果与已经建立的椎体束缚方法相当。十多年来，通过动态校正系统与可能的生长调节相结合的AIS对准一直是手术融合程序的替代治疗方法。然而,长期的纠正效果需要在进一步的研究中得到验证。
