R-FIX (Rib-FIXation System) for Severe Progressive Spinal Deformity

R-FIX（肋骨固定系统）用于治疗严重进行性脊柱畸形

• 批准号: 10482559
• 负责人: Richard H. Gross
• 金额: $ 29.99万
• 依托单位: APEX ORTHOPAEDIC TECHNOLOGIES LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10482559
• 关键词: 10 year old; 3-Dimensional; Anatomy; Animal Model; Anterior; Applications Grants; Basic Science; Biomechanics; Biomedical Engineering; Case Study; Chest; Child; Childhood; Clinical; Clinical Data; Clinical Trials; Complex; Complication; Data; Deformity; Development; Devices; Distal; Early treatment; Epiphysial cartilage; Equipment; Etiology; Failure; Family suidae; Fracture; Geometry; Grant; Growth; Histologic; Human; Hybrids; Hyperkyphosis; Implant; Institution; Kyphosis deformity of spine; Label; Lateral; Legal patent; Lung; Mechanics; Methods; Nervous System Trauma; Operative Surgical Procedures; Orthopedics; Osteoporosis; Osteoporotic; Patients; Performance; Phase; Prosthesis; Protocols documentation; Publishing; Research; Rib Fractures; Risk; Rod; Safety; Secondary to; Series; Site; Small Business Innovation Research Grant; Spinal; Spinal Curvatures; Spinal Fusion; Structure; Study models; Surgeon; System; Techniques; Technology; Testing; Titanium; Torque; Torsion; United States National Institutes of Health; Universities; Vertebral column; biomechanical test; cortical bone; design; early childhood; early onset; efficacy evaluation; high risk; implant design; implantation; innovation; instrument; instrumentation; novel; off-label use; rib bone structure; risk minimization; safety assessment; sample fixation; scoliosis; spine bone structure; standard of care; user-friendly

Project Summary Early-onset spinal deformity (EOSD) is deformity that begins before 10 years of age. Curvature can be in the lateral direction (scoliosis), anterior direction (hyperkyphosis) or both (kyphoscoliosis). The most common surgical treatment for EOSD is expandable growing rods fixed to the spine with pedicle screws. There are many challenging problems with this technique. Auto-fusion of the vertebrae is common, resulting in stunted spinal growth and sub-optimal pulmonary development. Complication rates are high including proximal fixation failure (pedicle screw pull-out), rod fracture, proximal junctional kyphosis (PJK), and neurological injury. Proximal fixation failure is especially problematic in osteoporotic patients with hyperkyphotic or kyphoscoliotic deformity, and can sometimes make successful treatment of these patients impossible. The VEPTR (Vertical Expandable Prosthetic Titanium Rib) is an alternative device, but it cannot be contoured in the sagittal plane and is contraindicated for hyperkyphosis and kyphoscoliosis. This application proposes a new technique called the rib construct for correcting EOSD. Instead of anchoring rods to the spine with pedicle screws, the rib construct moves proximal fixation to the ribs using a series of hooks. This approach is a conceptual shift in approaching spinal deformity, in that the thorax is manipulated to secondarily reposition the spine. The rib construct allows the surgeon to manipulate the thorax in any combination of both sagittal, coronal, and axial planes, allowing for safer, more effective, and versatile deformity correction. Rib fixation with the rib construct can be achieved with either: 1) off-label laminar hooks, which are already commercially available for spinal fixation to the lamina but can also be used on the ribs, or 2) rib hooks as part of our novel patented R-FIX (Rib-FIXation System). While laminar hooks have performed favorably compared to pedicle screws in our preliminary clinical use, these have been used entirely off-label and there is no commercially available surgical system designed for this technique. There have been issues with loss of fixation under torsional forces, implant prominence, and occasional cases of rib fracture with laminar hooks. The R-FIX System, which originated from a bioengineering lab (one of the applicants' lab) at Clemson University and has been further developed by Apex Orthopaedic Technologies, is designed to resolve these issues. The objective of this proposal is twofold: 1) to prove the overall concept of rib fixation with the rib construct by obtaining basic science data to support the clinical data we have already obtained and 2) to demonstrate the superior performance of R-FIX rib hooks compared to laminar hooks. This research will be conducted over 12 months and the data obtained from this grant proposal will be used in a 510(k) application for FDA clearance and the NIH SBIR Phase II application. Major milestones to be achieved with this grant include 1) ex vivo biomechanical evaluation of R-FIX rib hooks compared to pedicle screws and laminar hooks, and 2) assessment of the safety and efficacy of R-FIX rib hooks compared to pedicle screws and laminar hooks in a pediatric hyperkyphosis porcine animal model.

项目摘要 早发脊柱畸形（EOSD）是在10岁之前开始的畸形。曲率可以在 横向方向（脊柱侧弯），前方向（高温）或两者（脑霍斯镜）。最常见的 EOSD的手术治疗是用椎弓根螺钉固定在脊柱上的可扩展生长棒。有许多 这种技术具有挑战性的问题。椎骨的自动融合很常见，导致脊柱发育不良 生长和亚最佳肺发育。并发症率很高，包括近端固定失败 （椎弓根螺钉拉出），杆骨折，近端连接症（PJK）和神经损伤。近端 固定衰竭在骨质疏松性患者中尤其有问题 有时可能使这些患者成功治疗。 VEPTR（垂直扩展 假体钛肋骨）是一种替代设备，但不能在矢状平面上轮廓 禁忌出于高温和脑膜炎。该应用程序提出了一种称为肋骨的新技术 构建用于校正EOSD。肋骨构建 使用一系列钩子将近端固定移至肋骨。这种方法是接近的概念转变 脊柱畸形，因为胸部被操纵以重新放置脊柱。肋骨结构允许 外科医生以矢状，冠状和轴向平面的任何组合来操纵胸部，以允许 更安全，更有效，多功能畸形校正。可以用肋骨结构固定肋骨结构 两者：1）标签外层钩子，已经在商业上可以固定到椎板上，但是 也可以在肋骨上使用，或2）肋钩作为我们新型专利的R框（肋骨固定系统）的一部分。尽管 与我们的初步临床用途中的椎弓根螺钉相比，层状钩的表现优异 被完全使用，并且没有为此技术设计的市售手术系统。 在扭转力，植入物的突出和偶尔情况下失去固定的问题 带有层状钩的肋骨骨折。 R-fix系统起源于生物工程实验室（其中之一 克莱姆森大学的申请人实验室），由Apex骨科技术进一步开发 旨在解决这些问题。该提议的目的是双重的：1）证明肋骨的整体概念 通过获得基础科学数据来支持我们已经拥有的临床数据，将肋骨结构固定 与层状钩相比，获得的和2）证明了R框肋钩的出色性能。这 研究将在12个月内进行，并从该赠款提案中获得的数据将用于 510（k）FDA清除率和NIH SBIR II期应用。要实现的主要里程碑 与该赠款一起包括1）与椎弓根螺钉和 与椎弓根螺钉和 小儿高温猪动物模型中的层状钩子。