Shriners Hospitals for Children-Philadelphia, Philadelphia, Pennsylvania.
Lewis Katz School of Medicine at Temple University, Philadelphia Pennsylvania.
J Bone Joint Surg Am. 2021 Sep 1;103(17):1611-1619. doi: 10.2106/JBJS.20.01503.
Anterior vertebral body tethering (aVBT) has emerged as a novel treatment option for patients with idiopathic scoliosis. We present the results from the first U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study on aVBT.
In this prospective review of a retrospective data set, eligible patients underwent aVBT at a single center from August 2011 to July 2015. Inclusion criteria included skeletally immature patients with Lenke type-1A or 1B curves between 30° and 65°. Clinical and radiographic parameters were collected, with the latter measured by an independent reviewer.
Fifty-seven patients (49 girls and 8 boys), with a mean age (and standard deviation) of 12.4 ± 1.3 years (range, 10.1 to 15.0 years), were enrolled in the study. The patients had a mean of 7.5 ± 0.6 levels tethered, the mean operative time was 223 ± 79 minutes, and the mean estimated blood loss was 106 ± 86 mL. The patients were followed for an average of 55.2 ± 12.5 months and had a mean Risser grade of 4.2 ± 0.9 at the time of the latest follow-up. The main thoracic Cobb angle was a mean of 40.4° ± 6.8° preoperatively and was corrected to 18.7° ± 13.4° at the most recent follow-up. In the sagittal plane, T5-T12 kyphosis measured 15.5° ± 10.0° preoperatively, 17.0° ± 10.1° postoperatively, and 19.6° ± 12.7° at the most recent follow-up. Eighty percent of patients had curves of <30° at the most recent follow-up. The most recent Scoliosis Research Society (SRS) scores averaged 4.5 ± 0.4, and scores on the self-image questionnaire averaged 4.4 ± 0.7. No major neurologic or pulmonary complications occurred. Seven (12.3%) of 57 patients had a revision: 5 were done for overcorrection and 2, for adding-on.
Anterior VBT is a promising technique that has emerged as a treatment option for patients with immature idiopathic scoliosis. We present the results from the first FDA-approved IDE study on aVBT, which formed the basis for the eventual Humanitarian Device Exemption approval. The findings affirm the safety and efficacy of this technique and suggest opportunities for improvement, particularly with respect to reoperation rates.
Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
前路椎体拴系术（aVBT）已成为治疗特发性脊柱侧凸患者的一种新的治疗选择。我们报告了首例美国食品和药物管理局（FDA）研究性器械豁免（IDE）研究中 aVBT 的结果。
在这项对回顾性数据集的前瞻性回顾中，符合条件的患者于 2011 年 8 月至 2015 年 7 月在一个中心接受 aVBT。纳入标准包括骨骼未成熟的 Lenke 1A 或 1B 型曲线在 30°至 65°之间的患者。收集了临床和影像学参数，后者由独立审查员进行测量。
57 名患者（49 名女孩和 8 名男孩），平均年龄（标准差）为 12.4±1.3 岁（范围 10.1 至 15.0 岁），入组研究。患者平均有 7.5±0.6 个节段被拴系，平均手术时间为 223±79 分钟，平均估计失血量为 106±86 毫升。患者平均随访 55.2±12.5 个月，末次随访时平均 Risser 分级为 4.2±0.9。主胸 Cobb 角术前平均为 40.4°±6.8°，末次随访时矫正为 18.7°±13.4°。在矢状面，T5-T12 后凸角术前为 15.5°±10.0°，术后为 17.0°±10.1°，末次随访时为 19.6°±12.7°。80%的患者在末次随访时曲线<30°。最近的脊柱侧凸研究协会（SRS）评分平均为 4.5±0.4，自我形象问卷评分平均为 4.4±0.7。没有发生重大神经或肺部并发症。57 名患者中有 7 名（12.3%）进行了翻修：5 例因过度矫正，2 例因追加矫形。
前路 VBT 是一种有前途的技术，已成为治疗骨骼未成熟特发性脊柱侧凸患者的一种治疗选择。我们报告了首例经美国 FDA 批准的 aVBT IDE 研究结果，这为最终获得人道主义设备豁免批准奠定了基础。研究结果证实了该技术的安全性和有效性，并提示存在改进的机会，特别是在再次手术率方面。
治疗性 IV 级。请参阅作者指南，以获取完整的证据水平描述。
