Department of Orthopaedic Surgery, University Medical Center Utrecht, Heidelberglaan 100, NL-3584CX Utrecht, The Netherlands.
Department of Biomechanical Engineering, University of Twente, Drienerlolaan 5, 7522 NB Enschede, The Netherlands.
Spine J. 2021 Aug;21(8):1376-1386. doi: 10.1016/j.spinee.2021.03.015. Epub 2021 Mar 20.
Scoliosis is a 3D deformity of the spine in which vertebral rotation plays an important role. However, no treatment strategy currently exists that primarily applies a continuous rotational moment over a long period of time to the spine, while preserving its mobility. We developed a dynamic, torsional device that can be inserted with standard posterior instrumentation. The feasibility of this implant to rotate the spine and preserve motion was tested in growing mini-pigs.
To test the quality and feasibility of the torsional device to induce the typical axial rotation of scoliosis while maintaining growth and mobility of the spine.
Preclinical animal study with 14 male, 7 month old Gottingen mini-pigs. Comparison of two scoliosis induction methods, with and without the torsional device, with respect to 3D deformity and maintenance of the scoliosis after removal of the implants.
Fourteen mini-pigs received either a unilateral tether-only (n=6) or a tether combined with a contralateral torsional device (n=8). X-rays and CT-scans were made post-operative, at 8 weeks and at 12 weeks. Flexibility of the spine was assessed at 12 weeks. In 3 mini-pigs per condition, the implants were removed and the animals were followed until no further correction was expected.
At 12 weeks the tether-only group yielded a coronal Cobb angle of 16.8±3.3°For the tether combined with the torsional device this was 22.0±4.0°. The most prominent difference at 12 weeks was the axial rotation with 3.6±2.8° for the tether-only group compared to 18.1±4.6° for the tether-torsion group. Spinal growth and flexibility remained normal and comparable for both groups. After removal of the devices, the induced scoliosis reduced by 41% in both groups. There were no adverse tissue reactions, implant complications or infections.
The present study indicates the ability of the torsional device combined with a tether to induce a flexible idiopathic-like scoliosis in mini-pigs. The torsional device was necessary to induce the typical axial rotation found in human scoliosis.
The investigated torsional device could induce apical rotation in a flexible and growing spine. Whether this may be used to reduce a scoliotic deformity remains to be investigated.
脊柱侧凸是脊柱的三维畸形,其中椎体旋转起着重要作用。然而,目前还没有一种治疗策略主要应用连续的旋转力矩作用于脊柱很长一段时间,同时保持其活动性。我们开发了一种可与标准后路器械一起插入的动态扭转装置。该植入物旋转脊柱并保持运动的可行性在生长中的小型猪中进行了测试。
测试扭转装置在诱导脊柱典型轴向旋转的同时保持脊柱生长和活动性的质量和可行性。
14 只 7 月龄雄性哥廷根小型猪的临床前动物研究。比较两种脊柱侧凸诱导方法,一种是有扭转装置,另一种是没有扭转装置,比较两种方法在去除植入物后对三维畸形和脊柱侧凸的维持情况。
14 只小型猪分别接受单侧牵引(n=6)或单侧牵引联合对侧扭转装置(n=8)。术后、8 周和 12 周进行 X 线和 CT 扫描。12 周时评估脊柱的柔韧性。在每个条件下的 3 只小型猪中,去除植入物并在没有进一步矫正的情况下进行随访。
12 周时,仅使用牵引的组获得冠状 Cobb 角 16.8±3.3°,而使用牵引结合扭转装置的组为 22.0±4.0°。在 12 周时,最显著的差异是轴向旋转,仅使用牵引的组为 3.6±2.8°,而使用牵引结合扭转装置的组为 18.1±4.6°。两组的脊柱生长和柔韧性均保持正常且相似。去除器械后,两组诱导的脊柱侧凸均减少了 41%。没有不良的组织反应、器械并发症或感染。
本研究表明,扭转装置结合牵引可在小型猪中诱导出灵活的特发性脊柱侧凸。扭转装置是诱导人脊柱侧凸中典型轴向旋转所必需的。
所研究的扭转装置可在灵活生长的脊柱中诱导顶点旋转。是否可以用它来减少脊柱侧凸畸形仍有待研究。