Oh Taemin, Patel Manan, Nice Emily, Pahys Joshua M, Hwang Steven W, Samdani Amer F
Shriners Children's Philadelphia, Philadelphia, Pennsylvania.
Department of Orthopaedic Surgery, Cooper Medical School of Rowan University, Camden, New Jersey.
JB JS Open Access. 2025 Sep 11;10(3). doi: 10.2106/JBJS.OA.25.00171. eCollection 2025 Jul-Sep.
Vertebral body tethering (VBT) offers an alternative treatment for patients with idiopathic scoliosis. We present our finalized Food and Drug Administration Investigational Device Exemption (IDE) study results on VBT.
We retrospectively reviewed patients with Lenke Type IA/B curves who underwent VBT between 2011 and 2015. Clinical, radiographic, perioperative, and complications data were prospectively collected.
Fifty-seven patients (mean age 12.4 ± 1.3 years) were enrolled and followed for 6.6 ± 1.6 years (range: 3.0-10.2 years). Thoracic Cobb angle measured 40.4 ± 6.8° preoperatively with correction to 14.5 ± 9.0° at 2 years and slight regression to 22.1 ± 12.4° at last follow-up. Median Sanders and Risser were 3 and 0, respectively. At last follow-up, 71% of patients (39/56) had curves ≤30° and 98% (55/56) had achieved skeletal maturity. There were no major neurologic or pulmonary complications. However, 10 patients required 13 revisions; 2 required conversion to fusion. Percent predicted forced expiratory volume and forced vital capacity dropped from 85% and 87%, respectively, to 80% and 82% at the final follow-up.
These finalized IDE results highlight VBT as a safe, effective treatment for skeletally immature patients with idiopathic scoliosis. However, complication and revision rates remain concerning, and patients should be counseled appropriately.
Level III. See Instructions for Authors for a complete description of levels of evidence.
椎体牵张成骨术（VBT）为特发性脊柱侧凸患者提供了一种替代治疗方法。我们展示了我们关于VBT的最终美国食品药品监督管理局（FDA）研究器械豁免（IDE）研究结果。
我们回顾性分析了2011年至2015年间接受VBT治疗的Lenke IA/B型曲线患者。前瞻性收集临床、影像学、围手术期及并发症数据。
纳入57例患者（平均年龄12.4±1.3岁），随访6.6±1.6年（范围：3.0 - 10.2年）。术前胸椎Cobb角为40.4±6.8°，2年时矫正至14.5±9.0°，末次随访时轻度回退至22.1±12.4°。Sanders和Risser中位数分别为3和0。末次随访时，71%的患者（39/56）曲线≤30°，98%（55/56）达到骨骼成熟。无重大神经或肺部并发症。然而，10例患者需要13次翻修；2例需要转为融合手术。预计用力呼气量和用力肺活量百分比在末次随访时分别从85%和87%降至80%和82%。
这些最终的IDE结果表明VBT是治疗骨骼未成熟的特发性脊柱侧凸患者的一种安全、有效的方法。然而，并发症和翻修率仍然令人担忧，应给予患者适当的咨询。
III级。有关证据级别的完整描述，请参阅作者指南。
